Complex Injectables for Highly Regulated Markets
Overview
Navigating the highly regulated markets of the US and Europe with complex generic injectables is a monumental challenge that requires a deep understanding of evolving regulatory frameworks and technical excellence. Unlike simple generics, these products, which include nanosuspensions, liposomes, and complex drug-device combinations, often lack a clear regulatory pathway. This necessitates a proactive approach where developers engage with agencies like the FDA and EMA early on to align on development strategies and data requirements. Demonstrating "sameness" or bioequivalence is not straightforward and often requires a combination of advanced physicochemical characterization, in vitro release testing, and sometimes, even comparative clinical studies. The goal is to provide a comprehensive, model-integrated evidence package that not only meets but anticipates regulatory expectations, ensuring a faster and more predictable route to market approval. This strategic navigation is key to unlocking the immense value of these products and increasing patient access to affordable, high-quality treatments.
InjectablesX (Complex Injectables for Highly Regulated Markets) is meticulously crafted for R&D scientists, formulators, analytical experts, regulatory professionals, process development as well as manufacturing personnel who are at the forefront of developing next-generation parenteral products. Our agenda is a comprehensive exploration of the entire product and production lifecycle, from initial portfolio selection and rational formulation design to advanced characterization and rigorous bioequivalence studies. We will tackle the complexities of portfolio management for injectable generics and demystify the challenges in lifecycle management. Discover the secrets of reverse engineering innovator products and master "fit for purpose" characterization techniques for complex APIs and excipients. The conference will feature dedicated sessions on the rational design of intricate delivery systems, including long-acting injectables, nanomaterials like liposomes and self-assembling nanotubes, and cutting-edge drug-device combination products. You'll gain practical insights into the latest in vitro dissolution and release testing methods, including establishing crucial in vitro-in vivo correlations (IVIVC).
Beyond formulation, InjectablesX will address the critical aspects of manufacturing and quality control. Learn about robust process control strategies for ensuring sterility, explore the role of specialized equipment in aseptic environments, and understand how to mitigate human error through effective training. We will also explore the transformative potential of AI/ML and digitalization in modern injectable R&D. Join us at InjectablesX to stay ahead of the curve, build invaluable connections, and shape the future
Embark on a journey into the future of pharmaceutical innovation with InjectablesX, a premier technical conference dedicated to advancing the science of injectable complex generics. Join us in Ahmedabad on January 29-30, 2026, for two days of intensive knowledge exchange, collaboration, and extensive research into the technical intricacies that define this high-growth sector.
Please note that photography/videography of the scientific contents presented at the conference is strictly prohibited. We will share the presentations with the delegates only if provided and allowed by the respective speakers.
Conference Dates
29-01-2026 to 30-01-2026
Arvind Bansal's Biography
Dr. Arvind Kumar Bansal is a Professor in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab, India. With a career spanning over three decades, he is a globally recognized leader in pharmaceutical research and development, renowned for bridging academic innovation with industrial application.
Dr. Bansal earned his M.Pharm. in Pharmaceutics (1988) and Ph.D. (1993) from the University of Delhi, India. Before joining NIPER in 2000, he honed his expertise as a Senior Scientist and Group Leader at JK Pharmaceuticals and Ranbaxy Research Laboratories for eight years. There, he spearheaded the conceptualization, formulation strategy, and technology transfer of novel chemical entities (NCEs) and generic drug products, laying the groundwork for his impactful academic career.
At NIPER, Dr. Bansal has pioneered advancements in pre-formulation and formulation development, with expertise in amorphous form stabilization, polymorphism, pseudo-polymorphism, particle engineering, salt form screening, oral bioavailability enhancement, compaction physics, and lyophilization. Guided by his mission to develop \"science-based, industrially viable pharmaceutical technologies,\" his research group collaborates closely with the pharmaceutical industry to translate innovations into commercially viable products.
Dr. Bansal’s contributions have earned him prestigious accolades, including being named the first India-based Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2016. His awards include the AAPS Distinguished Educator and Researcher Award, the Innocentive Award, the Organization of Pharmaceutical Producers of India (OPPI) Award, and the Indian Pharmaceutical Association (IPA)-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form.
His prolific research output includes over 650 industry-sponsored projects in pharmaceutical material characterization, de-formulation studies, and formulation development. Dr. Bansal holds 11 granted patents, has filed 27 additional patents, and has authored 200 research articles and 27 review articles, with a Google Scholar h-index of 60. He serves on the editorial boards of RSC Pharmaceutics, Journal of Excipients and Food Chemicals, Drug Development Research, and Pharmaceutics, and advises the editorial boards of Journal of Pharmaceutical Sciences and Molecular Pharmaceutics.
Dr. Bansal’s leadership extends beyond research, fostering strong academia-industry partnerships and mentoring the next generation of pharmaceutical scientists. His visionary work continues to shape the future of drug development, making significant contributions to global healthcare.
Matthias G. Wacker's Biography
Matthias G. Wacker is Professor of Biopharmaceutics in the Drug Delivery and Disposition Lab at KU Leuven. He received his Ph.D. in Pharmaceutical Technology from Goethe University Frankfurt and completed his habilitation under Prof. Jennifer Dressman and Prof. Jörg Kreuter.
Prior to joining KU Leuven, he led translational formulation research at the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) and served as Associate Professor at the National University of Singapore, where he established an internationally recognized program in biopharmaceutics and complex drug delivery systems.
His research focuses on biopredictive in vitro testing, IVIVC, and the mechanistic transformation of complex dispersed dosage forms, including liposomes, lipid nanoparticles, and long-acting injectables, under physiologically relevant conditions. Prof. Wacker actively contributes to international standardization through USP and ISO committees and serves on several editorial boards. His work has been recognized with multiple awards, and he has been listed among the World’s Top 2% of Scientists since 2022.
Vikram Shukla's Biography
Vikram Shukla is a seasoned pharmaceutical professional with over 30 years of distinguished experience in world-class formulation development and manufacturing. Known for his unwavering integrity, strategic foresight, and transformative leadership, Vikram has consistently driven operational excellence across global pharmaceutical landscapes.
He has played pivotal roles in leading manufacturing and quality units, with a strong track record in navigating complex regulatory audits and successfully resolving warning letter challenges. His expertise spans compliance with international regulatory standards, including USFDA, EMA, MHRA, and WHO.
Vikram has held leadership positions at several leading multinational organizations, including Pfizer Inc., Dr. Reddy’s Laboratories, Fresenius Kabi, Lupin, and Zydus Lifesciences, where he currently serves as President of the Injectable vertical. In this role, he oversees end-to-end operations and quality functions, championing innovation and excellence across the business unit.
His technical portfolio encompasses a wide range of dosage forms, including injectables (SVP, LVP, lyophilized, dry powder), sterile APIs, and solid orals. He is also deeply committed to fostering quality-centric cultures, optimizing manufacturing processes, and delivering impactful training in GMP compliance, microbiology, cleanroom practices, and validation methodologies.
An alumnus of INSEAD France, Vikram holds a postgraduate degree in Microbiology from Bombay University (1995) and is a Gold Medallist graduate from Nagpur University (1993).
Govind S. Pandey's Biography
Dr. Govind S. Pandey is Director of Gamp Technologies Private Limited. He has over three decades of experience in the pharmaceutical industry. He is a professional experienced in sterile operations, solid oral dosage forms, semi solid dosage forms and API. He possesses a deep understanding of business strategy relating to Operations, Quality Assurance, Quality
control, CMC submissions, Facility design, Tech transfer& Regulatory guidelines. In addition, he is black belt certified person on “Six Sigma- Process optimization and Problem solving”. He has provided expert scientific support for the timely resolution of issues raised by USFDA & other Regulatory agencies.
He has held several positions including Chief Operating Officer and Board of Director - Sentiss Pharma Pvt. Ltd., Sr. Vice President - Operations head, responsible for all formulation sites of Wockhardt, Sr. Vice President -Responsible for Intas Pharma sites operations including API, Director - Ranbaxy Labs ltd Mohali, Vice president - Operations head, responsible for Mylan Nashik Site, Vice president - Operations head, responsible for Alkem Baddi site.
He is Six sigma black belt certified on ‘Process Optimisation and Problem Solving’ and an Expert on Computer system Validation and GAMP 5 guideline as well as data integrity assessments in Quality Control laboratories. He has sound knowledge of HVAC and Water system and is good in Engineering, Facility design and Validations.
Mukesh Kumar's Biography
Mukesh is one of the founder directors of Ortiv-Q3 (A Sotax joint venture), a pioneering pharmaceutical research and testing organization well acknowledged globally for its specialized skill set in IVRT, Q2/Q3 characterization and complex parenterals formulation development. He is a pharmaceutical veteran with over 30 years of industrial experience. He earned his M Pharm (Pharmaceutics) from Jamia Hamdard, New Delhi in (1992) and Ph.D. (2021) from BAMU, Aurangabad. His expertise includes Niche steriles, Value added generics, Topicals and NCEs. He holds 18+ US/EU Patents/Application to his credit and is specially versed in nanotechnology-based platforms including Nanoemulsions, Nanosuspensions, Liposomes, Microspheres, Insitu forming depots and associated Q2/Q3 characterization. He has profound knowledge in formulation development, Quality & compliance, preclinical evaluation, process development, optimisation, and scale-up of formulations for regulated markets. In his past assignments he was associated with many reputed companies like Ranbaxy, Dabur Pharma, Fresenius Kabi, Emcure, Wockhardt and Claris in Sr positions like, Asst. Director, AVP & Technical head (R&D). He is co-inventor of the innovative microdialysis based IVRT technology developed by Ortiv-Q3 which has been successfully commercialized globally (Indian patent granted, US patent applied). He is also the co-inventor of indigenously developed patented nanoparticle technology for Polymeric micellar delivery of Paclitaxel (NanoxelTM - Fresenius Kabi) that reached from bench scale to the market. He contributed in many products approvals for various markets including US, EU in his past career. He has also been ranked as the top 2% most-cited scientists in a list published by Stanford University (2021).
Avijit Kelkar's Biography
Dr. Avijit Kelkar is the Co-founder of Aharav Consultants and creator of the flagship product "HORIZONS" established in May 2018. As a renowned Product, Portfolio, and IP strategist, he brings executive-level experience from top generic pharmaceutical companies, including Dr. Reddy's and Sun Pharma, where he previously headed Portfolio Strategy and IP. Dr. Kelkar provides a broad range of technical expertise essential for strategic risk mitigation and product success, specializing in:
Product Selection and Strategic Risk Assessment
Bioequivalence in Drug Development
Patent Strategy and Litigation Support (including drafting, invalidation, and Trademark actions)
He holds a Post-Doctorate in Organic Chemistry, is a certified European Patent Practitioner, and possesses specialized expertise as a GDPR Consultant within the pharmaceutical sector
Jatin Gajjar's Biography
Jatin Gajjar is the President of QuoSolve – Pharmaceutical Consultants, advising global pharmaceutical companies on R&D strategy, formulation and analytical troubleshooting, regulatory readiness, and quality-focused development. With 34+ years of experience across leading generic organizations—including Aurobindo, Par/Endo, Amneal, Sun Pharma, and Sanofi—he has contributed to 250+ ANDA/eCTD submissions and supported numerous PAIs, scale-ups, and technology transfers. A Gujarat University topper and gold-medallist, Jatin specializes in complex drug-delivery systems spanning oral solids, transdermal, inhalation products, injectables, and LAIs. He also mentors scientists and serves on the Academic and Research Advisory Councils of L.M. College of Pharmacy. Jatin is empanelled as an expert consultant with BCG and is recognized for helping organizations elevate scientific rigor, reduce development risk, and deliver high-quality generic medicines.
Sanju Dhawan's Biography
Dr. Sanju Dhawan serves as the Director of Research & Development at Baxter Pharmaceuticals India, where she leads end-to-end pharmaceutical R&D with a focus on formulation science, analytical development, technology transfer, and regulatory-driven innovation. With more than 26 years of extensive industry experience, she has held senior scientific and leadership roles at several prominent organizations, including Pfizer, Cadila Healthcare, Dr. Reddy’s Laboratories, and Panacea Biotec.
Her work spans a wide spectrum of complex product development—ranging from injectables and sterile formulations to advanced drug delivery systems. Dr. Dhawan has contributed to numerous successful product launches and global submissions, supported by her strong expertise in quality systems, problem-solving approaches, and multidisciplinary team leadership.
A prolific contributor to pharmaceutical science, she holds multiple patents, has authored several research publications, and is widely recognized for her commitment to scientific rigor and innovation. At Baxter, she continues to lead strategic R&D initiatives that strengthen the company’s innovation pipeline and support the development of high-quality, patient-centric healthcare solutions.
Satish Naik's Biography
Dr. Satish Naik is a Principal Scientist at Delpharm Development, Leiden, Netherlands, with over two decades of experience spanning analytical development, CMC strategy, and regulatory science for complex pharmaceutical products. He has extensive expertise in the characterization and development of complex injectables, including liposomes, nanosuspensions, polymer-based depots, peptides, and biologics, supporting products across development and commercialization stages.
Dr. Naik has held senior scientific and analytical leadership roles at Delpharm, Dr. Reddy’s Laboratories (Netherlands and India), Cipla R&D, and served as a CMC Fellow at the U.S. Food and Drug Administration (FDA), where he contributed to advanced characterization strategies for liposomal drug products. His work aligns closely with global regulatory expectations from FDA, EMA, ICH, and other agencies.
He holds a Ph.D. in Chemistry from Goa University and an M.Sc. from Karnatak University, and has authored multiple high-impact scientific publications. His professional focus includes QbD-driven analytics, advanced physicochemical characterization, and regulatory-ready CMC documentation for complex injectable products.
Deepak Murpani's Biography
Deepak Murpani
Chief Scientific Officer (CSO) & Chief Operational Officer (COO)
Andersen Pharma Global
Dr. Deepak Murpani is a senior pharmaceutical R&D leader with over 30 years of experience in the generic pharma industry and 15 years at VP and C-level roles in EU and US based companies. He is currently one of the key stake holders in Andersen Pharma Global LLC, an Australia based company. He has led global R&D organizations of more than 500 scientists, delivered over 350+ products to US and EU markets, and driven innovation across complex drug delivery technologies. His expertise spans R&D strategy, portfolio optimization, and value-based leadership in regulated markets.
Jayant Karajgi's Biography
A seasoned pharmaceutical leader with over 34 years of industry experience, including significant exposure to the US generics market, he has progressed from formulation development scientist to senior executive roles including R&D Head, Chief Scientific Officer, and Chief Operating Officer. He has led end-to-end research, manufacturing, quality, regulatory, and business operations, contributing to the development and launch of 300+ products across global markets, including first-to-file generics and exclusivity products. His career spans leading organizations such as Ranbaxy, Sun Pharma, Jubilant, Mylan, Aurobindo, Wockhardt, and he is currently associated with Shilpa Medicare as COO.
Hari Raghuram Desu's Biography
Hari Raghuram Desu
Director and Head, Complex Products
Aizant Drug Research Solutions Private Limited
Hari Raghuram Desu, Ph.D. holds a Master’s degree (1999) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research (NIPER, Chandigarh) and Doctorate degree (2009) in Pharmaceutics from the University of Tennessee, Memphis, USA. Dr. Hari has held various positions in pharmaceutical companies – Aizant Drug Research Solutions (India), Dr. Reddy’s Research Laboratories (India), InnoPharma (acquired by Pfizer, USA), and Schering-Plough Center for Sterile Products (affiliated with University of Tennessee Health Science Center, Memphis, USA). Currently, Dr. Hari is Director and Head of Research, Complex Products at Aizant Drug Research Solutons. His specific interests include drug delivery, optimization of product compositions with focus on peptides, proteins and nucleic acids, characterization of chemical moieties in solid and liquid states, drug-device combinations, simulation and modelling approaches for optimization of pharmaceutical dosage forms. He has contributed to international peer-reviewed journals, book chapters and is a co-assigneee of patents and patent applications. He has been presenting at international research conferenes such as American Association of Pharmaceutical Sciences (AAPS) and Controlled Release Society (CRS) for several years.
Arani Chatterjee's Biography
Dr. Arani Chatterjee is currently President (CRO) at Cadila Pharmaceuticals, which is one of the oldest and the largest privately held pharmaceutical company of India. In this role, Dr. Chatterjee is responsible for Pre-Clinical and Clinical Research including BA/BE studies, bioanalytical assays and clinical trials. He also oversees Pharmacovigilance at Cadila Pharmaceuticals.
Prior to joining Cadila pharmaceuticals, he served at Aurobindo Pharma, Biological E, Panacea Biotec and Dr. Reddy’s Research Foundation since 1998. During his tenure he made significant contributions to the clinical development of New Chemical Entities, vaccines, novel drug delivery products, complex generics and biologics.
Dr. Arani Chatterjee earned his medical degree from Christian Medical College, Vellore and postgraduate degree from National Institute of Mental Health and Neuro Sciences, Bangalore, India. He is also an alumnus of Indian Institute of Management, Indore, India.
He has served as a WHO Adviser for the Global Polio Eradication Initiative and was a member of the drafting group for WHO Guidelines on clinical evaluation of vaccines: regulatory expectations. He was a member of several Brighton Collaboration groups for vaccine safety. He has participated in WHO Strategic Advisory Group of Experts on Immunization and Global Vaccine Safety Initiative meetings, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines meetings at UNICEF. He has also participated in in-person pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia) and NORCB (Egypt) as well as expert group meetings on Indian GCP guidelines and National Technology Advisory Group on Immunisation meetings.
Dr. Chatterjee serves as a reviewer for the journal ‘Vaccine’ and has 24 peer-reviewed international research publications and 4 book chapters to his credit. He was awarded the prestigious 2012 Charles C. Shepard Award from CDC, Atlanta in 2012.
Sujoy Mukherjee's Biography
Dr. Sujoy Mukherjee is an accomplished scientist working at the forefront of complex injectable drug product development, specializing in advanced formulation design, analytical method development and characterization of complex injectables. He is part of a multidisciplinary team of formulation, container closure, and analytical scientists pioneering complex injectable products, including peptide and iron formulations. His team leverages extensive capabilities in both conventional and advanced characterization techniques to support drug development across regulatory markets. Their work focuses on establishing equivalence with reference listed drugs as well as developing differentiated products beyond existing generics through innovative formulation and analytical strategies. In his prior role, he has contributed to the R&D of several approved and commercialized peptide injectables like the glucagon, ganirelix, and liraglutide (Victoza) generic drug products in the US and other countries. Currently, he’s leading the Complex Product Development team at Baxter Pharmaceuticals India Pvt. Ltd.
Dr. Mukherjee brings strong proficiency in advanced chromatographic, spectroscopic, and light-scattering techniques, complemented by biological assays and immunological risk assessment, enabling robust evaluation of complex drug products. Multifaceted innovation has been central to his contributions in developing both generic and differentiated products for diverse regulatory pathways.
In his previous role in academia, he worked in the area of structural and molecular biology and made meaningful contributions to understanding protein dynamics and their implications for human health. His expertise spans upstream, downstream, and analytical characterization, employing advanced NMR, spectroscopic and computational approaches to elucidate biomolecular structures, interactions, and mechanisms relevant to disease understanding and therapeutic development. He has a B.Tech in Biotechnology & Biochemical Engineering from IIT Kharagpur and PhD in Biophysics & Computational Biology from the University of Illinois, Urbana-Champaign.
Mayur Sankalia's Biography
Dr. Mayur Sankalia is currently serving as the Vice President of Research & Development at Invengene Pvt Ltd, bringing over 25 years of expertise in pharmaceutical product development, spanning conventional and specialty dosage forms. Dr. Sankalia obtained his Bachelor's degree in Pharmacy from Sardar Patel University and went on to complete his Master’s and PhD in Pharmaceutical Sciences from The Maharaja Sayajirao University (MSU) of Baroda. His doctoral research commenced while he was a lecturer at MSU, later transitioning into a full-time Senior Research Fellow under the University Grants Commission (UGC) fellowship.
Post-PhD, he joined Sun Pharma Advanced Research Centre, where he played a pivotal role in the development of complex generic products and contributed to an innovative drug- complex conjugate, securing a world patent in his name. In 2009, he moved to the UK as a Postdoctoral Research Fellow at Queen’s University Belfast, focusing on topical hydrogel stability enhancement. He then joined Norbrook Pharmaceuticals, a global leader in veterinary and animal health medicines, contributing to novel formulation development.
Returning to India in 2011, Dr. Sankalia joined Mylan Laboratories Limited, leading the development of NDDS-based complex generic dosage forms, including oncological and non- oncological injectables, lyophilized formulations, dry powders, ophthalmic formulations, and more. In 2015, he transitioned to Dr. Reddy’s Laboratories, filing multiple products and facilitating technology transfer between the Netherlands and India for liposomal injectables. Subsequently, as Head of R&D at Celon Laboratories, he commercialized complex products such as peptide microspheres, albumin-bound nanoparticles, and oncology formulations.
Currently, at Invengene, Dr. Sankalia is spearheading the establishment of the injectable product development, overseeing R&D operations, regulatory affairs, and seamless technology transfer. His strategic leadership has led to multiple global regulatory approvals and successful commercialization of several formulations. Dr. Sankalia has authored 24 publications in peer-reviewed journals and holds three granted patents. Originally from Saurashtra, Gujarat, he is married to Dr. Jolly Sankalia and is a proud father of two daughters. In his leisure time, he enjoys reading, traveling, and photography.
Nitish Sharma's Biography
Nitish Sharma
Assistant Professor
National Institute of Pharmaceutical Education and Research, Ahmedabad
Dr. Nitish Sharma is an accomplished pharmaceutical analyst and academician with nearly 15 years of extensive experience spanning the pharmaceutical industry and academia. He is currently serving as Assistant Professor in the Department of Pharmaceutical Analysis at the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, an Institute of National Importance under the Government of India, where he has been contributing since April 2021
Dr. Sharma holds a Ph.D. in Chemistry from JNT University, Hyderabad, and an M.Sc. in Organic Chemistry from Jiwaji University, Gwalior. Prior to joining NIPER, he held key leadership and research roles at Sun Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Ltd., where he specialized in analytical research and development for APIs, synthetic peptides, complex injectables, and regulated markets (US–EU)
His core expertise includes analytical method development and validation, impurity profiling, nitrosamine and genotoxic impurity assessment, extractables and leachables studies, HRMS-based characterization, particle size and nano-suspension analysis, and reverse engineering of reference listed products. He has also been actively involved in pre-formulation analytics, impurity isolation, and technical transfer of analytical methods to quality control environments
Dr. Sharma is internationally engaged in pharmacopeial and regulatory science. He is a Member of the Nominating Committee for the Council of Experts at the United States Pharmacopeia (USP) and has participated in the USP Convention in the USA. He is also a Member of the Chromatographic Separation Techniques Working Party of the European Pharmacopoeia and serves as a Technical Assessor with NABL (ISO/IEC 17025)
A recognized contributor to pharmaceutical research, Dr. Sharma has published approximately 45 research and review articles in international journals and serves as a reviewer/editor for academic journals. His achievements have been acknowledged through several prestigious honors, including the Professor M. L. Khorana Memorial Award (IPA), the ICMR Young Travel Scientist Award, and the Faculty Excellence Award (APT-2025, IIT Bombay)
Vaibhav Dubey's Biography
Dr. Vaibhav Dubey is currently working as Senior General Manager and leading the Biologic Formulation, Device and Non-Clinical development at Kashiv Biosciences, LLC . In his previous role, Dr. Vaibhav was General Manager at Alembic Pharmaceuticals where he led various cross-functional teams and initiatives in the areas of new drug/ biologic delivery systems and modalities for both sterile and non-sterile applications. He was also involved in development and commercialization of various ophthalmic and dermatological products. In the other roles, Dr. Dubey worked with Sun Pharma Advanced Research Company Ltd and Dr. Reddy’s Ltd, wherein he led the team of scientists working on 505 b(1)/ 505 b (2) formulation development approaches alongwith development of multiple generic pharmaceutical products for regulated markets. Dr. Dubey holds an M.Pharm and PhD degree in drug delivery from Dr. H.S. Gour University. He was also a Commonwealth Scholar at School of Pharmacy, University of London, and recipient of many awards and accolades at prestigious platforms. With numerous well cited publications and technology patents, he is a sought-after Key Opinion Leader in the areas of drug and biologic formulation and device development.
Conference Agenda
- Portfolio development for complex injectables
- Characterization of complex injectable API, excipient and formulations
- Rational design of complex injectable delivery systems
- In vitro dissolution & release testing for complex injectables
- Bioequivalence approaches for complex injectable API and formulations
- Process control strategies for ensuring sterility and product quality throughout manufacturing
Agenda Topics for Injectables X (IJX26)
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Portfolio development for complex injectables
- Challenges in life cycle management
- Portfolio selection strategies
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Characterization of complex injectable API, excipient and formulations
- API sameness, Q1, Q2, Q3 sameness for Biowaiver, Reverse Engineering of Innovator Products
- “Fit for purpose” characterization for complex excipients,design, functionality, and manufacturing process
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Rational design of complex injectable delivery systems
- Complex API products – Conjugated oestrogens, heparin, botanicals, complex oils, synthetic polymers, metal complexes, peptides, oligonucleotides
- Parenteral drug products containing nanomaterials – Nano-suspensions, nano-emulsions, Liposome formulations, Self-assembling nanotubes, iron/lipid complex formulations
- Long-acting injectable drug products - Oil-based lipophilic solutions, Multivesicular liposomes, suspensions, in-situ gels
- Complex Drug-Device Combination Products-PFS, PFA, cartridge, polymer selection, extractables & leachables, functional performance testing, sterilization methods
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In vitro dissolution & release testing for complex injectables
- Biorelevant dissolution methods for long-acting injectables, liposomes, and microspheres
- In vitro release testing (IVRT) for sustained-release formulations
- In vitro-in vivo correlation (IVIVC) for complex injectable
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Bioequivalence approaches for complex injectable API and formulations
- Demonstrating bioequivalence of liposomal, nanoparticle, and polymeric injectables
- Model-integrated Evidence (MIE) for bioequivalence and innovative study designs
- Strategies for bridging studies in 505(b)(2) applications for injectable products
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Process control strategies for ensuring sterility and product quality throughout manufacturing
- Critical process parameters (CPPs) and critical quality attributes (CQAs) in aseptic filling and lyophilization
- Identifying and mitigating sources of human error in sterile manufacturing
- Sterility assurance &contamination control in aseptic manufacturing
- Specialized equipments for process development using Lyophilizer, zeta sizer, high pressure homogeniser and spray dryer etc in aseptic environment
- AI/ML and Digitalization in Injectable R&D
Who should attend
- Formulation Scientists & Researchers
- Analytical Scientists
- CMC & Regulatory Affairs Professionals
- Process Development & Manufacturing Engineers
Who should attend
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Formulation Scientists & Researchers
- Professionals directly involved in the design, development, and optimization of sterile injectable formulations, including liposomes, nanosuspensions, microspheres, and other complex drug delivery systems or those planning to start work on complex injectables.
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Analytical Scientists
- Experts responsible for developing and validating advanced analytical methods for the characterization of complex generics and demonstrating bioequivalence. This includes specialists in techniques like DLS, HPLC, and mass spectrometry.
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CMC & Regulatory Affairs Professionals
- Individuals who prepare the Chemistry, Manufacturing, and Controls sections of regulatory filings and interact with agencies like the CDSCO, US FDA, and EMA for the approval and lifecycle management of generic injectables.
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Process Development & Manufacturing Engineers
- Professionals who scale up lab-scale formulations to commercial manufacturing, focusing on sterile and aseptic processing, QbD implementation, and PAT.
InjectablesX
Selected Photographs of InjectablesX Event, January 29-30, Ahmedabad, India
Conference Officials
WhatsApp: 9041725050
Speakers & Panelists
Arvind Bansal's Biography
Dr. Arvind Kumar Bansal is a Professor in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab, India. With a career spanning over three decades, he is a globally recognized leader in pharmaceutical research and development, renowned for bridging academic innovation with industrial application.
Dr. Bansal earned his M.Pharm. in Pharmaceutics (1988) and Ph.D. (1993) from the University of Delhi, India. Before joining NIPER in 2000, he honed his expertise as a Senior Scientist and Group Leader at JK Pharmaceuticals and Ranbaxy Research Laboratories for eight years. There, he spearheaded the conceptualization, formulation strategy, and technology transfer of novel chemical entities (NCEs) and generic drug products, laying the groundwork for his impactful academic career.
At NIPER, Dr. Bansal has pioneered advancements in pre-formulation and formulation development, with expertise in amorphous form stabilization, polymorphism, pseudo-polymorphism, particle engineering, salt form screening, oral bioavailability enhancement, compaction physics, and lyophilization. Guided by his mission to develop \"science-based, industrially viable pharmaceutical technologies,\" his research group collaborates closely with the pharmaceutical industry to translate innovations into commercially viable products.
Dr. Bansal’s contributions have earned him prestigious accolades, including being named the first India-based Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2016. His awards include the AAPS Distinguished Educator and Researcher Award, the Innocentive Award, the Organization of Pharmaceutical Producers of India (OPPI) Award, and the Indian Pharmaceutical Association (IPA)-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form.
His prolific research output includes over 650 industry-sponsored projects in pharmaceutical material characterization, de-formulation studies, and formulation development. Dr. Bansal holds 11 granted patents, has filed 27 additional patents, and has authored 200 research articles and 27 review articles, with a Google Scholar h-index of 60. He serves on the editorial boards of RSC Pharmaceutics, Journal of Excipients and Food Chemicals, Drug Development Research, and Pharmaceutics, and advises the editorial boards of Journal of Pharmaceutical Sciences and Molecular Pharmaceutics.
Dr. Bansal’s leadership extends beyond research, fostering strong academia-industry partnerships and mentoring the next generation of pharmaceutical scientists. His visionary work continues to shape the future of drug development, making significant contributions to global healthcare.
Professor,
Department of Pharmaceutics, NIPER-Mohali,
India
Matthias G. Wacker's Biography
Matthias G. Wacker is Professor of Biopharmaceutics in the Drug Delivery and Disposition Lab at KU Leuven. He received his Ph.D. in Pharmaceutical Technology from Goethe University Frankfurt and completed his habilitation under Prof. Jennifer Dressman and Prof. Jörg Kreuter.
Prior to joining KU Leuven, he led translational formulation research at the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) and served as Associate Professor at the National University of Singapore, where he established an internationally recognized program in biopharmaceutics and complex drug delivery systems.
His research focuses on biopredictive in vitro testing, IVIVC, and the mechanistic transformation of complex dispersed dosage forms, including liposomes, lipid nanoparticles, and long-acting injectables, under physiologically relevant conditions. Prof. Wacker actively contributes to international standardization through USP and ISO committees and serves on several editorial boards. His work has been recognized with multiple awards, and he has been listed among the World’s Top 2% of Scientists since 2022.
Professor of Biopharmaceutics,
KU Leuven,
Belgium
Vikram Shukla's Biography
Vikram Shukla is a seasoned pharmaceutical professional with over 30 years of distinguished experience in world-class formulation development and manufacturing. Known for his unwavering integrity, strategic foresight, and transformative leadership, Vikram has consistently driven operational excellence across global pharmaceutical landscapes.
He has played pivotal roles in leading manufacturing and quality units, with a strong track record in navigating complex regulatory audits and successfully resolving warning letter challenges. His expertise spans compliance with international regulatory standards, including USFDA, EMA, MHRA, and WHO.
Vikram has held leadership positions at several leading multinational organizations, including Pfizer Inc., Dr. Reddy’s Laboratories, Fresenius Kabi, Lupin, and Zydus Lifesciences, where he currently serves as President of the Injectable vertical. In this role, he oversees end-to-end operations and quality functions, championing innovation and excellence across the business unit.
His technical portfolio encompasses a wide range of dosage forms, including injectables (SVP, LVP, lyophilized, dry powder), sterile APIs, and solid orals. He is also deeply committed to fostering quality-centric cultures, optimizing manufacturing processes, and delivering impactful training in GMP compliance, microbiology, cleanroom practices, and validation methodologies.
An alumnus of INSEAD France, Vikram holds a postgraduate degree in Microbiology from Bombay University (1995) and is a Gold Medallist graduate from Nagpur University (1993).
President, Parenteral BU,
Zydus Lifesciences,
India
Govind S. Pandey's Biography
Dr. Govind S. Pandey is Director of Gamp Technologies Private Limited. He has over three decades of experience in the pharmaceutical industry. He is a professional experienced in sterile operations, solid oral dosage forms, semi solid dosage forms and API. He possesses a deep understanding of business strategy relating to Operations, Quality Assurance, Quality
control, CMC submissions, Facility design, Tech transfer& Regulatory guidelines. In addition, he is black belt certified person on “Six Sigma- Process optimization and Problem solving”. He has provided expert scientific support for the timely resolution of issues raised by USFDA & other Regulatory agencies.
He has held several positions including Chief Operating Officer and Board of Director - Sentiss Pharma Pvt. Ltd., Sr. Vice President - Operations head, responsible for all formulation sites of Wockhardt, Sr. Vice President -Responsible for Intas Pharma sites operations including API, Director - Ranbaxy Labs ltd Mohali, Vice president - Operations head, responsible for Mylan Nashik Site, Vice president - Operations head, responsible for Alkem Baddi site.
He is Six sigma black belt certified on ‘Process Optimisation and Problem Solving’ and an Expert on Computer system Validation and GAMP 5 guideline as well as data integrity assessments in Quality Control laboratories. He has sound knowledge of HVAC and Water system and is good in Engineering, Facility design and Validations.
Director,
Gamp Technologies Private Limited,
India
Mukesh Kumar's Biography
Mukesh is one of the founder directors of Ortiv-Q3 (A Sotax joint venture), a pioneering pharmaceutical research and testing organization well acknowledged globally for its specialized skill set in IVRT, Q2/Q3 characterization and complex parenterals formulation development. He is a pharmaceutical veteran with over 30 years of industrial experience. He earned his M Pharm (Pharmaceutics) from Jamia Hamdard, New Delhi in (1992) and Ph.D. (2021) from BAMU, Aurangabad. His expertise includes Niche steriles, Value added generics, Topicals and NCEs. He holds 18+ US/EU Patents/Application to his credit and is specially versed in nanotechnology-based platforms including Nanoemulsions, Nanosuspensions, Liposomes, Microspheres, Insitu forming depots and associated Q2/Q3 characterization. He has profound knowledge in formulation development, Quality & compliance, preclinical evaluation, process development, optimisation, and scale-up of formulations for regulated markets. In his past assignments he was associated with many reputed companies like Ranbaxy, Dabur Pharma, Fresenius Kabi, Emcure, Wockhardt and Claris in Sr positions like, Asst. Director, AVP & Technical head (R&D). He is co-inventor of the innovative microdialysis based IVRT technology developed by Ortiv-Q3 which has been successfully commercialized globally (Indian patent granted, US patent applied). He is also the co-inventor of indigenously developed patented nanoparticle technology for Polymeric micellar delivery of Paclitaxel (NanoxelTM - Fresenius Kabi) that reached from bench scale to the market. He contributed in many products approvals for various markets including US, EU in his past career. He has also been ranked as the top 2% most-cited scientists in a list published by Stanford University (2021).
Founder Director,
Ortiv-Q3,
India
Avijit Kelkar's Biography
Dr. Avijit Kelkar is the Co-founder of Aharav Consultants and creator of the flagship product "HORIZONS" established in May 2018. As a renowned Product, Portfolio, and IP strategist, he brings executive-level experience from top generic pharmaceutical companies, including Dr. Reddy's and Sun Pharma, where he previously headed Portfolio Strategy and IP. Dr. Kelkar provides a broad range of technical expertise essential for strategic risk mitigation and product success, specializing in:
Product Selection and Strategic Risk Assessment
Bioequivalence in Drug Development
Patent Strategy and Litigation Support (including drafting, invalidation, and Trademark actions)
He holds a Post-Doctorate in Organic Chemistry, is a certified European Patent Practitioner, and possesses specialized expertise as a GDPR Consultant within the pharmaceutical sector
Co-founder & Principal Strategist,
Aharav Consultants,
United Kingdom
Jatin Gajjar's Biography
Jatin Gajjar is the President of QuoSolve – Pharmaceutical Consultants, advising global pharmaceutical companies on R&D strategy, formulation and analytical troubleshooting, regulatory readiness, and quality-focused development. With 34+ years of experience across leading generic organizations—including Aurobindo, Par/Endo, Amneal, Sun Pharma, and Sanofi—he has contributed to 250+ ANDA/eCTD submissions and supported numerous PAIs, scale-ups, and technology transfers. A Gujarat University topper and gold-medallist, Jatin specializes in complex drug-delivery systems spanning oral solids, transdermal, inhalation products, injectables, and LAIs. He also mentors scientists and serves on the Academic and Research Advisory Councils of L.M. College of Pharmacy. Jatin is empanelled as an expert consultant with BCG and is recognized for helping organizations elevate scientific rigor, reduce development risk, and deliver high-quality generic medicines.
President,
QuoSolve – Pharmaceutical Consultants,
India
Sanju Dhawan's Biography
Dr. Sanju Dhawan serves as the Director of Research & Development at Baxter Pharmaceuticals India, where she leads end-to-end pharmaceutical R&D with a focus on formulation science, analytical development, technology transfer, and regulatory-driven innovation. With more than 26 years of extensive industry experience, she has held senior scientific and leadership roles at several prominent organizations, including Pfizer, Cadila Healthcare, Dr. Reddy’s Laboratories, and Panacea Biotec.
Her work spans a wide spectrum of complex product development—ranging from injectables and sterile formulations to advanced drug delivery systems. Dr. Dhawan has contributed to numerous successful product launches and global submissions, supported by her strong expertise in quality systems, problem-solving approaches, and multidisciplinary team leadership.
A prolific contributor to pharmaceutical science, she holds multiple patents, has authored several research publications, and is widely recognized for her commitment to scientific rigor and innovation. At Baxter, she continues to lead strategic R&D initiatives that strengthen the company’s innovation pipeline and support the development of high-quality, patient-centric healthcare solutions.
Senior Director GPRD and Site Leader,
Baxter Pharmaceuticals Inc.,
India
Satish Naik's Biography
Dr. Satish Naik is a Principal Scientist at Delpharm Development, Leiden, Netherlands, with over two decades of experience spanning analytical development, CMC strategy, and regulatory science for complex pharmaceutical products. He has extensive expertise in the characterization and development of complex injectables, including liposomes, nanosuspensions, polymer-based depots, peptides, and biologics, supporting products across development and commercialization stages.
Dr. Naik has held senior scientific and analytical leadership roles at Delpharm, Dr. Reddy’s Laboratories (Netherlands and India), Cipla R&D, and served as a CMC Fellow at the U.S. Food and Drug Administration (FDA), where he contributed to advanced characterization strategies for liposomal drug products. His work aligns closely with global regulatory expectations from FDA, EMA, ICH, and other agencies.
He holds a Ph.D. in Chemistry from Goa University and an M.Sc. from Karnatak University, and has authored multiple high-impact scientific publications. His professional focus includes QbD-driven analytics, advanced physicochemical characterization, and regulatory-ready CMC documentation for complex injectable products.
Principal Scientist,
Delpharm Development Leiden,
Netherlands
Deepak Murpani's Biography
Deepak Murpani
Chief Scientific Officer (CSO) & Chief Operational Officer (COO)
Andersen Pharma Global
Dr. Deepak Murpani is a senior pharmaceutical R&D leader with over 30 years of experience in the generic pharma industry and 15 years at VP and C-level roles in EU and US based companies. He is currently one of the key stake holders in Andersen Pharma Global LLC, an Australia based company. He has led global R&D organizations of more than 500 scientists, delivered over 350+ products to US and EU markets, and driven innovation across complex drug delivery technologies. His expertise spans R&D strategy, portfolio optimization, and value-based leadership in regulated markets.
Chief Scientific Officer (CSO) & Chief Operational Officer (COO),
Andersen Pharma Global,
Poland
Jayant Karajgi's Biography
A seasoned pharmaceutical leader with over 34 years of industry experience, including significant exposure to the US generics market, he has progressed from formulation development scientist to senior executive roles including R&D Head, Chief Scientific Officer, and Chief Operating Officer. He has led end-to-end research, manufacturing, quality, regulatory, and business operations, contributing to the development and launch of 300+ products across global markets, including first-to-file generics and exclusivity products. His career spans leading organizations such as Ranbaxy, Sun Pharma, Jubilant, Mylan, Aurobindo, Wockhardt, and he is currently associated with Shilpa Medicare as COO.
Chief Operating Officer,
Shilpa Medicare,
India
Hari Raghuram Desu's Biography
Hari Raghuram Desu
Director and Head, Complex Products
Aizant Drug Research Solutions Private Limited
Hari Raghuram Desu, Ph.D. holds a Master’s degree (1999) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research (NIPER, Chandigarh) and Doctorate degree (2009) in Pharmaceutics from the University of Tennessee, Memphis, USA. Dr. Hari has held various positions in pharmaceutical companies – Aizant Drug Research Solutions (India), Dr. Reddy’s Research Laboratories (India), InnoPharma (acquired by Pfizer, USA), and Schering-Plough Center for Sterile Products (affiliated with University of Tennessee Health Science Center, Memphis, USA). Currently, Dr. Hari is Director and Head of Research, Complex Products at Aizant Drug Research Solutons. His specific interests include drug delivery, optimization of product compositions with focus on peptides, proteins and nucleic acids, characterization of chemical moieties in solid and liquid states, drug-device combinations, simulation and modelling approaches for optimization of pharmaceutical dosage forms. He has contributed to international peer-reviewed journals, book chapters and is a co-assigneee of patents and patent applications. He has been presenting at international research conferenes such as American Association of Pharmaceutical Sciences (AAPS) and Controlled Release Society (CRS) for several years.
Director and Head, Complex Products,
Aizant Drug Research Solutions Private Limited,
India
Arani Chatterjee's Biography
Dr. Arani Chatterjee is currently President (CRO) at Cadila Pharmaceuticals, which is one of the oldest and the largest privately held pharmaceutical company of India. In this role, Dr. Chatterjee is responsible for Pre-Clinical and Clinical Research including BA/BE studies, bioanalytical assays and clinical trials. He also oversees Pharmacovigilance at Cadila Pharmaceuticals.
Prior to joining Cadila pharmaceuticals, he served at Aurobindo Pharma, Biological E, Panacea Biotec and Dr. Reddy’s Research Foundation since 1998. During his tenure he made significant contributions to the clinical development of New Chemical Entities, vaccines, novel drug delivery products, complex generics and biologics.
Dr. Arani Chatterjee earned his medical degree from Christian Medical College, Vellore and postgraduate degree from National Institute of Mental Health and Neuro Sciences, Bangalore, India. He is also an alumnus of Indian Institute of Management, Indore, India.
He has served as a WHO Adviser for the Global Polio Eradication Initiative and was a member of the drafting group for WHO Guidelines on clinical evaluation of vaccines: regulatory expectations. He was a member of several Brighton Collaboration groups for vaccine safety. He has participated in WHO Strategic Advisory Group of Experts on Immunization and Global Vaccine Safety Initiative meetings, Asia Pacific Dengue Prevention Board Meeting under the Pediatric Dengue Vaccine Initiative of International Vaccine Institute and Pneumococcal Vaccines meetings at UNICEF. He has also participated in in-person pre-IND meetings with USFDA, scientific advice meetings with BfArM (Germany), ANVISA (Brazil), Medsafe (New Zealand), ALIMS (Serbia) and NORCB (Egypt) as well as expert group meetings on Indian GCP guidelines and National Technology Advisory Group on Immunisation meetings.
Dr. Chatterjee serves as a reviewer for the journal ‘Vaccine’ and has 24 peer-reviewed international research publications and 4 book chapters to his credit. He was awarded the prestigious 2012 Charles C. Shepard Award from CDC, Atlanta in 2012.
President, CRO,
Cadila Pharmaceuticals Ltd.,
India
Sujoy Mukherjee's Biography
Dr. Sujoy Mukherjee is an accomplished scientist working at the forefront of complex injectable drug product development, specializing in advanced formulation design, analytical method development and characterization of complex injectables. He is part of a multidisciplinary team of formulation, container closure, and analytical scientists pioneering complex injectable products, including peptide and iron formulations. His team leverages extensive capabilities in both conventional and advanced characterization techniques to support drug development across regulatory markets. Their work focuses on establishing equivalence with reference listed drugs as well as developing differentiated products beyond existing generics through innovative formulation and analytical strategies. In his prior role, he has contributed to the R&D of several approved and commercialized peptide injectables like the glucagon, ganirelix, and liraglutide (Victoza) generic drug products in the US and other countries. Currently, he’s leading the Complex Product Development team at Baxter Pharmaceuticals India Pvt. Ltd.
Dr. Mukherjee brings strong proficiency in advanced chromatographic, spectroscopic, and light-scattering techniques, complemented by biological assays and immunological risk assessment, enabling robust evaluation of complex drug products. Multifaceted innovation has been central to his contributions in developing both generic and differentiated products for diverse regulatory pathways.
In his previous role in academia, he worked in the area of structural and molecular biology and made meaningful contributions to understanding protein dynamics and their implications for human health. His expertise spans upstream, downstream, and analytical characterization, employing advanced NMR, spectroscopic and computational approaches to elucidate biomolecular structures, interactions, and mechanisms relevant to disease understanding and therapeutic development. He has a B.Tech in Biotechnology & Biochemical Engineering from IIT Kharagpur and PhD in Biophysics & Computational Biology from the University of Illinois, Urbana-Champaign.
Head-Complex Product Development,
Baxter Pharmaceuticals India Pvt. Ltd.,
India
Mayur Sankalia's Biography
Dr. Mayur Sankalia is currently serving as the Vice President of Research & Development at Invengene Pvt Ltd, bringing over 25 years of expertise in pharmaceutical product development, spanning conventional and specialty dosage forms. Dr. Sankalia obtained his Bachelor's degree in Pharmacy from Sardar Patel University and went on to complete his Master’s and PhD in Pharmaceutical Sciences from The Maharaja Sayajirao University (MSU) of Baroda. His doctoral research commenced while he was a lecturer at MSU, later transitioning into a full-time Senior Research Fellow under the University Grants Commission (UGC) fellowship.
Post-PhD, he joined Sun Pharma Advanced Research Centre, where he played a pivotal role in the development of complex generic products and contributed to an innovative drug- complex conjugate, securing a world patent in his name. In 2009, he moved to the UK as a Postdoctoral Research Fellow at Queen’s University Belfast, focusing on topical hydrogel stability enhancement. He then joined Norbrook Pharmaceuticals, a global leader in veterinary and animal health medicines, contributing to novel formulation development.
Returning to India in 2011, Dr. Sankalia joined Mylan Laboratories Limited, leading the development of NDDS-based complex generic dosage forms, including oncological and non- oncological injectables, lyophilized formulations, dry powders, ophthalmic formulations, and more. In 2015, he transitioned to Dr. Reddy’s Laboratories, filing multiple products and facilitating technology transfer between the Netherlands and India for liposomal injectables. Subsequently, as Head of R&D at Celon Laboratories, he commercialized complex products such as peptide microspheres, albumin-bound nanoparticles, and oncology formulations.
Currently, at Invengene, Dr. Sankalia is spearheading the establishment of the injectable product development, overseeing R&D operations, regulatory affairs, and seamless technology transfer. His strategic leadership has led to multiple global regulatory approvals and successful commercialization of several formulations. Dr. Sankalia has authored 24 publications in peer-reviewed journals and holds three granted patents. Originally from Saurashtra, Gujarat, he is married to Dr. Jolly Sankalia and is a proud father of two daughters. In his leisure time, he enjoys reading, traveling, and photography.
Senior Vice President - Formulation and Analytical R & D,
Invengene Pvt Ltd,
India
Nitish Sharma's Biography
Nitish Sharma
Assistant Professor
National Institute of Pharmaceutical Education and Research, Ahmedabad
Dr. Nitish Sharma is an accomplished pharmaceutical analyst and academician with nearly 15 years of extensive experience spanning the pharmaceutical industry and academia. He is currently serving as Assistant Professor in the Department of Pharmaceutical Analysis at the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, an Institute of National Importance under the Government of India, where he has been contributing since April 2021
Dr. Sharma holds a Ph.D. in Chemistry from JNT University, Hyderabad, and an M.Sc. in Organic Chemistry from Jiwaji University, Gwalior. Prior to joining NIPER, he held key leadership and research roles at Sun Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Ltd., where he specialized in analytical research and development for APIs, synthetic peptides, complex injectables, and regulated markets (US–EU)
His core expertise includes analytical method development and validation, impurity profiling, nitrosamine and genotoxic impurity assessment, extractables and leachables studies, HRMS-based characterization, particle size and nano-suspension analysis, and reverse engineering of reference listed products. He has also been actively involved in pre-formulation analytics, impurity isolation, and technical transfer of analytical methods to quality control environments
Dr. Sharma is internationally engaged in pharmacopeial and regulatory science. He is a Member of the Nominating Committee for the Council of Experts at the United States Pharmacopeia (USP) and has participated in the USP Convention in the USA. He is also a Member of the Chromatographic Separation Techniques Working Party of the European Pharmacopoeia and serves as a Technical Assessor with NABL (ISO/IEC 17025)
A recognized contributor to pharmaceutical research, Dr. Sharma has published approximately 45 research and review articles in international journals and serves as a reviewer/editor for academic journals. His achievements have been acknowledged through several prestigious honors, including the Professor M. L. Khorana Memorial Award (IPA), the ICMR Young Travel Scientist Award, and the Faculty Excellence Award (APT-2025, IIT Bombay)
Assistant Professor,
National Institute of Pharmaceutical Education and Research, Ahmedabad,
India
Vaibhav Dubey's Biography
Dr. Vaibhav Dubey is currently working as Senior General Manager and leading the Biologic Formulation, Device and Non-Clinical development at Kashiv Biosciences, LLC . In his previous role, Dr. Vaibhav was General Manager at Alembic Pharmaceuticals where he led various cross-functional teams and initiatives in the areas of new drug/ biologic delivery systems and modalities for both sterile and non-sterile applications. He was also involved in development and commercialization of various ophthalmic and dermatological products. In the other roles, Dr. Dubey worked with Sun Pharma Advanced Research Company Ltd and Dr. Reddy’s Ltd, wherein he led the team of scientists working on 505 b(1)/ 505 b (2) formulation development approaches alongwith development of multiple generic pharmaceutical products for regulated markets. Dr. Dubey holds an M.Pharm and PhD degree in drug delivery from Dr. H.S. Gour University. He was also a Commonwealth Scholar at School of Pharmacy, University of London, and recipient of many awards and accolades at prestigious platforms. With numerous well cited publications and technology patents, he is a sought-after Key Opinion Leader in the areas of drug and biologic formulation and device development.
Senior General Manager,
Kashiv Biosciences, LLC,
India
Application and Product Specialist (USP 4),
Labindia Analytical Instruments Pvt. Ltd,
India
Venue
Hall: The Crystal Ballroom, Novotel Hotel, Ahmedabad
Address: Iscon Cross Roads, Sarkhej - Gandhinagar Hwy, next to Wide Angle Cinema, Ahmedabad, Gujarat 380015
Novotel Ahmedabad offers a perfect blend of comfort, elegance, and convenience. Ideally located on S.G. Highway, it provides easy access to the city’s business hubs, shopping destinations, and cultural landmarks. The hotel features modern, spacious rooms, exceptional dining options, and thoughtful amenities, ensuring a relaxing and memorable stay. With its welcoming ambiance and warm hospitality, Novotel Ahmedabad is an ideal choice for both business and leisure travelers.
Explore some of India's most celebrated attractions including ISKCON temples, the Gandhi Ashram and Swaminarayan Akshardham complex. Punctuate an unforgettable day with a refreshing dip in our sparkling outdoor pool, or indulge in a massage or treatment at our hotel.
| Hotels | Phone No | Distance from Novotel | Price SO | Price DO | Website |
| Hotel Shrimad Residency | 9714112888 (Pawandeep) | 700 m | 2800 + GST | 3300 + GST | Website |
| Hotel Lux Inn | 8238232025 (Rajendra Singh) | 1.2 km | 1500 + GST | 1800+ GST | Website |
| Crowne-Plaza Ahmedabad City Centre | 7967779000 (Surya) | 1.2 km | 10000 + GST | 11000+ GST | Website |
| Hotel Paradiot | 8487082187 (P S Chauhan) | 1.3 km | 2000 | 2200 | |
| Hotel Repose | 9824854440 (Ishwar) | 1.7 km | 2500 | 3000 | |
| Ramada by Wyndham | 7940250000 | 2 km | Website | ||
| Platinum Residency | 9327867882 (Chirag) | 2 km | 3500 + GST | 4200 + GST | Website |
Conference Sponsors
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Injectables X (IJX26)
Download Programme PDFThursday, 29th January 2026
| 09:00 |
Inauguration
|
| 09:05 |
Introduction to Glostem |
| 09:10 |
Introduction to Exhibitors |
| 09:15 |
|
| 09:30 |
Injectable Horizons: Synchronizing Portfolio Strategy with High-Efficiency Growth
|
| 09:35 |
The Complex Injectable Horizon: Strategic Selection and the Pursuit of Low, Moderate or Highly Complex Pipeline with Low Competition in the Global Market View Abstract Avijit Kelkar, Co-founder & Principal Strategist, Aharav Consultants, United Kingdom The seminar shows a unique way to select products and portfolio strategy, that helps you for a faster easier and very efficient way of identifying opportunities, using some of the examples obtained from our flagship Portfolio ideation platform - HORIZONS |
| 10:05 |
Efficiency in Action: How Startups and Small Pharma Fuel Global Pharma Growth — A Stakeholder Perspective View Abstract Deepak Murpani, Chief Scientific Officer (CSO) & Chief Operational Officer (COO), Andersen Pharma Global, Poland This presentation highlights how generic pharma startups complement established players, drive efficiency, and create long-term value for healthcare systems, regulators, and investors, positioning them as critical enablers of growth and innovation in the global generic pharmaceutical ecosystem. |
| 10:35 |
Tea/Coffee Break
|
| 11:05 |
Multi-Dimensional Characterization: Bridging the Gap Between API, Excipient, and Complex Formulations
|
| 11:10 |
Characterization of Complex Products with Specific Reference to API, Excipients & Formulations View Abstract Hari Raghuram Desu, Director and Head, Complex Products, Aizant Drug Research Solutions Private Limited, India The purpose of this session is to discuss the scientific principles and practical considerations that inform current FDA thinking about the characterization of complex products to support product development and assessments. Approximately 110 NDAs are approved each year, and 25% of these approvals meet complex product criteria. And 20% of the total generic approvals represent complex products. |
| 11:40 |
Advanced Characterization of Peptide Injectables: Recent Learnings from Regulatory Guidances, Publications & Funded Programs View Abstract Sujoy Mukherjee, Head-Complex Product Development, Baxter Pharmaceuticals India Pvt. Ltd., India Characterization of peptide injectables is an essential step to proving sameness of generic drugs with their branded counterparts. Typically, this includes assessing primary, secondary, tertiary and higher order structures of the peptide API using orthogonal methods. Depending on the nature of complexity of the peptide, additional studies on oligomerization and aggregation are also usually requirements to demonstrate the sameness of the generic product. In addition to these "one-time" studies, proving functional efficacy of the peptide molecule in a given formulation to elicit appropriate biological response by suitable in-vitro biological assays is another fundamental requirement for approvability of peptide products. Finally, this talk will also dwell on FDA guidelines on immunological risk assessment for peptide formulations of synthetic origins as well as using requirements to qualify impurities that are above acceptable threshold. |
| 12:10 |
Exploring Structural Complexity in Glycopeptide Therapeutics: A Case Study View Abstract Nitish Sharma, Assistant Professor, National Institute of Pharmaceutical Education and Research, Ahmedabad, India In this study, the second-generation lipoglycopeptide Dalbavancin (DAL) was comprehensively evaluated under heat, light, freezethaw and mechanical agitation to assess stress-induced structural alterations. DAL exhibited sensitivity under all tested conditions, leading to the formation of diverse structural alterations and degradation products identified by high-performance liquid chromatography indicating modifications in its primary structure. |
| 12:40 |
Interactive Session
|
| 13:20 |
Group Photograph
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| 13:30 |
Lunch
|
| 14:30 |
ANALYTICAL CONTROL: ENSURING SAMENESS IN COMPLEX INJECTABLES
|
| 14:30 |
Analytics of Complex Injectables: Characterization to control View Abstract Satish Naik, Principal Scientist, Delpharm Development Leiden, Netherlands This presentation will be delivered as a science-focused, case-driven discussion linking analytical method design to formulation behavior, process understanding, and regulatory expectations. Key topics include multi-technique particle size and morphology characterization, rheological assessment of injectability and syringeability, solid-state and molecular-weight analytics for polymer-based depots, and evolving in vitro release testing methodologies for long-acting injectables. Analytical artifacts associated with sample preparation and scale will be critically discussed. The talk will emphasize CQA-driven, phase-appropriate analytics within a QbD and risk-based framework, and conclude with emerging trends in digital and platform-based analytical strategies for complex injectables. |
| 15:15 |
Tea/Coffee Break
|
| 15:45 |
BRIDGING THE IN VITRO/IN VIVO INTERFACE: FROM REGULATORY IVRT TO ADVANCED SIMULATIONS
|
| 15:50 |
IVRT for Complex Parenterals: Regulatory Expectations and Practical Challenges View Abstract Mukesh Kumar, Founder Director, Ortiv-Q3, India This presentation outlines key scientific and regulatory considerations in designing IVRT methods for complex injectables. It will cover the strengths and limitations of compendial and non-compendial systems, delivery-system-specific challenges, and practical pathways for establishing fit-for-purpose release methods.A special focus will be on Ortiv-Q3 Research’s Microdialysis-based IVRT platform (Indian Patent Granted, US patent pending), developed to address current gaps in release testing of complex parenterals. The technology, recognized as a finalist in “Innovation of the year” category at the CPHI India Pharma Awards 2023, offers a novel, faster, more discriminatory and biorelevant approach to measuring drug release from advanced injectable systems. |
| 16:20 |
IVIVC development for complex injectables View Abstract Matthias G. Wacker, Professor of Biopharmaceutics, KU Leuven, Belgium This workshop will provide a practical, principle-based overview of IVIVC development for complex injectables, focusing on bioprediction fundamentals and fit-for-purpose model development strategies. Key topics will include selection of predictive in vitro tests, approaches for IVIVC model development and verification, and common validation expectations. The session will also highlight how IVIVC models can serve as a starting point for design space development, supporting formulation optimization and informed decision-making across development and lifecycle management. |
| 16:50 |
Technology Spotlight Presentation
|
| 16:50 |
Advanced Dissolution Testing of Complex Injectables Using USP Apparatus 4 View Abstract Satyawan Doke, Application and Product Specialist (USP 4), Labindia Analytical Instruments Pvt. Ltd, India This presentation discusses the limitations of USP Apparatus 1 and 2 for injectable products and highlights the technical and regulatory advantages of USP Apparatus 4 (Flow-Through Cell) in dissolution testing of complex injectables. Practical aspects of flow-through cell technology, open and closed loop configurations, and real case studies are presented to demonstrate how USP Apparatus 4 enables physiologically relevant dissolution testing and supports in-vitro–in-vivo correlation.
|
| 17:10 |
Exhibition and Networking
|
| 17:10 |
Live Demonstration of Advance Dissolution Testing Apparatus |
| 17:30 |
Explore & Network |
| 19:00 |
The Gala Dinner
|
| 21:00 |
End of Day 1 |
Friday, 30th January 2026
| 09:30 |
INNOVATIONS IN COMPLEX INJECTABLE FORMULATIONS: FROM SELF-ASSEMBLING SYSTEMS TO LONG-ACTING CHALLENGES
|
| 09:35 |
Parenteral Drug Products Containing Nanomaterials: Nano-Suspensions, Nano-Emulsions, Liposome Formulations, Self-Assembling Nanotubes, Iron Complex Formulations View Abstract Mayur Sankalia, Senior Vice President - Formulation and Analytical R & D, Invengene Pvt Ltd, India This presentation provides an integrated, end-to-end perspective on nanomaterial-based parenteral drug products, covering nano-suspensions, nano-emulsions, liposomal formulations, self-assembling nanostructures, and iron complex formulations. |
| 10:05 |
Complex Injectables: Tackling a Long-Acting Challenge View Abstract Matthias G. Wacker, Professor of Biopharmaceutics, KU Leuven, Belgium In this talk, I will share how our work on LAIs evolved from early exploratory studies that exposed fundamental blind spots in conventional in vitro testing, to the intentional construction of more physiologically and mechanically relevant test environments. I will show how systematic, data-driven interrogation of the literature using machine-learning tools helps to clarify which formulation strategies matter, which experimental variables dominate performance, and where common assumptions fail.A central part of the presentation focuses on the development and validation of BioJect, a new device platform designed specifically to interrogate long-acting injectable behavior under controlled yet dynamic conditions.This talk will offer a clear, experience-driven perspective on how to think about complex injectables: what to test, how to test it, and how emerging computational tools can be meaningfully integrated into LAI development workflows to move beyond trial-and-error toward truly informed design. |
| 10:35 |
A Lyophilization-Enabled Approach to Parenteral Nanocrystal Systems View Abstract Arvind Bansal, Professor, Department of Pharmaceutics, NIPER-Mohali, India I will present a case study using aspirin, highlighting how process variables—particularly freezing rate and the choice and concentration of bulking agents—critically define particle size and phase behavior. These insights offer a foundation for the systematic development of next-generation lyophilized parenterals featuring in-situ nanocrystallization, enabling broader access to challenging molecules and improving therapeutic outcomes. |
| 11:05 |
Tea/Coffee Break
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| 11:35 |
SYNERGY IN FORMULATION AND HARDWARE: NAVIGATING COMPLEX DRUG-DEVICE COMBINATIONS
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| 11:40 |
Innovations in Formulation and Drug–Device Integration for Biosimilar Therapeutics View Abstract Vaibhav Dubey, Senior General Manager, Kashiv Biosciences, LLC, India This presentation highlights advanced formulation and drug–device combination strategies that reconcile regulatory compliance with innovation, ultimately enhancing therapeutic performance, patient experience, and the commercial sustainability of biosimilar products. |
| 12:10 |
Complex Drug-Device Combination Products – Prefilled Syringe. View Abstract Sanju Dhawan, Senior Director GPRD and Site Leader, Baxter Pharmaceuticals Inc., India Global prefilled syringe market comprises delivery for small drug molecule, peptides, biologics, oligonucleotide, gene therapy market; it is projected to expand from USD 74.38 billion in 2025 to approximately USD 133.24 billion by 2035, reflecting a CAGR of 6.% over the forecast period. The session would provide insights into various aspects of business, development, scale up and regulatory of new products . |
| 12:40 |
BIOEQUIVALENCE CONTROL: ENSURING SAMENESS IN COMPLEX INJECTABLES
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| 12:40 |
Bioequivalence Approaches for Complex Injectable API and Formulations View Abstract Arani Chatterjee, President, CRO, Cadila Pharmaceuticals Ltd., India The diverse nature of complex injectables poses challenges for the development of regulatory guidelines for generic versions. While complexity is not new in medicines, the technical capacity to measure and analyze data has increased. This requires a determination of which measurements and studies are relevant to demonstrate bioequivalence. This presentation provides pragmatic solutions for approving complex injectables by making best use of existing U.S. Food and Drug Administration’s abbreviated approval pathways. Decisions on submitting an application can build on the FDA’s complex drug product classification as well as the FDA’s much applauded product specific guidance documents. |
| 13:20 |
Lunch
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| 14:15 |
THE FUTURE LANDSCAPE OF INJECTABLES: STERILITY, QUALITY, AND OPERATIONAL CHALLENGES
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| 14:20 |
Complex Injectables: Opportunities, Challenges, and the Road Ahead View Abstract Govind S. Pandey, Director, Gamp Technologies Private Limited, India This presentation will analyze the critical scientific and technical hurdles faced by industry scientists across the product lifecycle. We will address the ambiguity of the Regulatory Landscape, including the lack of clear Bioequivalence criteria and the complexity of CMC data packages for generics in USFDA and EMA markets.Finally, the talk will map the road ahead, highlighting opportunities driven by technological advances (AI in formulation modeling, microfluidics) and favorable regulatory support (FDA's Complex Generics Guidance) to ensure commercial success and patient access. |
| 14:50 |
Sterility Assurance: Current Challenges and Future Changes View Abstract Vikram Shukla, President, Parenteral BU, Zydus Lifesciences, India In this presentation, key challenges in sterility assurance for injectable manufacturing will be discussed in light of evolving global regulatory expectations such as US FDA and EU GMP Annex 1. The session will highlight how advanced technologies—including isolators, automation, Rapid Microbiological Methods, and real-time monitoring—are enabling proactive, design-based contamination control through robust Contamination Control Strategies, ensuring stronger compliance and patient safety. |
| 15:20 |
Tea/Coffee Break
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| 15:50 |
REGULATORY RIGOR AND INSPECTION READINESS: A FRAMEWORK FOR COMPLEX INJECTABLES
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| 15:55 |
Regulatory and Compliance Challenges in Design, Development and Manufacturing of Complex Injectables View Abstract Jayant Karajgi, Chief Operating Officer, Shilpa Medicare, India This Talk will cover the practical aspects, based on actual case studies, for complex injectables. The specific focus shall be on lipid and nano particle based novel injectables, suspension injectables and drug-device combinations.The listeners shall get an overview of regulatory and quality challenges and problems encountered commonly during the scaleup and manufacture of some of complex injectables; including their risk mitigation and trouble shooting |
| 16:25 |
Regulatory Inspections - From Fear to Framework View Abstract Deepak Murpani, Chief Scientific Officer (CSO) & Chief Operational Officer (COO), Andersen Pharma Global, Poland This talk will include the latest trends in regulatory inspections and the most frequent observations currently facing the industry, ranging from gaps in contamination control strategies to the heightened scrutiny of process variability in advanced formulations. The presentation highlights the critical pivot "From Fear to Framework," advocating for a move away from reactive audit preparation. |
| 16:55 |
PANEL DISCUSSION: High-Risk, High-Reward: Strategic Portfolio Selection for Highly Regulated Markets
MODERATOR |
| 17:30 |
VALEDICTORY SESSION
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Details
Who should attend
- Formulation Scientists & Researchers
- Professionals directly involved in the design, development, and optimization of sterile injectable formulations, including liposomes, nanosuspensions, microspheres, and other complex drug delivery systems or those planning to start work on complex injectables.
- Analytical Scientists
- Experts responsible for developing and validating advanced analytical methods for the characterization of complex generics and demonstrating bioequivalence. This includes specialists in techniques like DLS, HPLC, and mass spectrometry.
- CMC & Regulatory Affairs Professionals
- Individuals who prepare the Chemistry, Manufacturing, and Controls sections of regulatory filings and interact with agencies like the CDSCO, US FDA, and EMA for the approval and lifecycle management of generic injectables.
- Process Development & Manufacturing Engineers
- Professionals who scale up lab-scale formulations to commercial manufacturing, focusing on sterile and aseptic processing, QbD implementation, and PAT.
Registration
Registration closed (Closed: 13 Feb 2026)| Category | Currency | Base Fee | GST / Tax % | Total (incl.) |
|---|---|---|---|---|
|
Industry Delegate till October 31
|
INR | ₹18,000.00 | 18% | ₹21,240.00 |
|
Industry Delegate till December 31
|
INR | ₹20,000.00 | 18% | ₹23,600.00 |
|
Delegate from Industry
|
INR | ₹22,000.00 | 18% | ₹25,960.00 |
|
Business Delegate
|
INR | ₹27,500.00 | 18% | ₹32,450.00 |
|
Overseas Delegate from Europe
|
EUR | €275.00 | 18% | €324.50 |
|
Overseas Delegate from US
|
USD | $300.00 | 18% | $354.00 |
- Manual: Cheque / NEFT / RTGS (confirmation number required)
- Razorpay: UPI, NetBanking, Credit/Debit Cards (INR)
- ICICI Payment Gateway (as enabled)
- Access to all conference sessions
- Conference kit & materials
- Tea/Coffee & Lunch (as per program)
- Certificate of participation