Speciality and Complex Generics 2026
Speciality generics are generic versions of high-cost, high-touch medicines used to treat chronic and complex conditions such as cancer, autoimmune disorders, and rare diseases. Complex generics, meanwhile, are defined by their scientific difficulty — products with complex active ingredients, formulations, dosage forms, or routes of delivery that make establishing bioequivalence to the reference product genuinely challenging. Together, these categories represent some of the most technically demanding and commercially rewarding opportunities in the global generics landscape.
India's pharmaceutical industry has built formidable manufacturing scale in conventional generics, but competing in speciality and complex generics for the US, EU, and other regulated markets demands a different capability set: deeper formulation and analytical science, rigorous characterisation and bioequivalence methodologies, sharper regulatory and IP strategy, and closer alignment between CDSCO and international expectations. It also requires sustained investment in specialised talent, advanced testing infrastructure, and cross-functional collaboration between R&D, regulatory affairs, and manufacturing.
This conference brings together scientists, regulatory strategists, and industry leaders to address these gaps directly, with a focus on oral, ophthalmic, transdermal, and nasal complex products. It offers a focused platform for India's industry to strengthen the scientific and strategic foundations needed to lead in this space.
About the Organisers
This conference is brought to you by the Glostem team behind InjectablesX in Ahmedabad. With 14 years of experience working closely with the formulation industry, the team has pioneered several landmark conferences, including QbD in Pharma Development, NanoPharmaceuticals, Data Integrity in Clinical Trials, Nitrosamine Impurities in Pharmaceutical Products, and many more, held in Hyderabad and other pharma hubs across India.
Conference Dates
19-11-2026 to 20-11-2026
Past Conference Speakers (Injectables X (IJX26))
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
- Regulatory Strategy & Market Access
- Complex Oral Products — Formulation & Design
- Complex Ophthalmic Products — Formulation & Design
- Transdermal Products — Formulation & Design
- Nasal Products — Formulation & Design
- Analytical & Characterization Science
- Bioequivalence Methodology for Complex Generic Formulations
- Emerging Science & Talent
Agenda Topics for Complex Generics 2026
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Regulatory Strategy & Market Access
- Comparative regulatory pathways: US (ANDA 505(j) vs 505(b)(2)), EU (hybrid Art 10(3), biosimilar Art 10(4)), and India's CDSCO framework — alignment and divergence across the three
- India's complex generics landscape: policy support (PLI schemes, manufacturing investment) and case studies of successful complex generic launches in the US/EU
- Patent and IP strategy: Paragraph IV litigation, method-of-use and device patents, and designing non-infringing formulation/device architecture
- Regulatory intelligence and harmonization: FDA Product-Specific Guidances and patent expiry tracking as early opportunity signals; EMA-FDA parallel scientific advice pilot; EU member-state divergence in hybrid application review
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Complex Oral Products — Formulation & Design
- QbD applied to oral complex generic development
- Complex oral suspensions and liquids: particle engineering and polymorph control
- Abuse-deterrent oral formulation technologies
- Complex oral solid formulation design: oral NBCDs (sevelamer, iron-carbohydrate complexes), modified/extended-release systems, ODTs, multiparticulates, and complex fixed-dose combinations
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Complex Ophthalmic Products — Formulation & Design
- Device/dropper design: tip geometry, drop size/volume consistency
- Sterility assurance and preservative efficacy considerations
- Preservative-free and multi-dose ophthalmic formulation design
- Formulation design for ophthalmic suspensions, emulsions, and gels: including particle size and polymorphic form control — impact on ocular residence time and irritation
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Transdermal Products — Formulation & Design
- Used-patch residual drug and abuse-deterrence considerations for controlled substances
- Navigating device/patch design patents: non-infringing architecture
- Permeation enhancer selection: efficacy vs irritation/sensitization trade-offs
- Transdermal delivery system architecture: drug-in-adhesive vs reservoir vs matrix systems, including adhesive selection and patch construction
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Nasal Products — Formulation & Design
- Nasal spray formulation design: suspension vs solution systems
- Nasal-to-systemic vs locally-acting nasal products — divergent design goals
- Deposition and mucociliary clearance considerations in formulation design
- Actuator/device selection and design for nasal sprays
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Analytical & Characterization Science
- Advanced analytical tools and cross-regional method validation
- Dissolution and drug release method development for complex oral and semisolid products
- Dosage-form-specific performance testing
- Q1/Q2/Q3 sameness and physicochemical characterization
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Bioequivalence Methodology for Complex Generic Formulations
- Device-in-use testing and human factors studies as part of the BE package
- In vivo and modeling-based BE approaches• In vivo and modeling-based BE approaches
- In vitro BE methodologies
- BE philosophy and statistical framework for complex generics
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Emerging Science & Talent
- Building analytical and regulatory talent pipelines in India
- Green/sustainable manufacturing for complex generic processes
- Technology transfer and scale-up from lab to commercial manufacturing
- AI/ML applications in formulation development and BE prediction
Who should attend
- R&D and Formulation Leaders
- Analytical & Bioequivalence Professionals
- Regulatory Affairs & IP Strategy Teams
- Quality & Manufacturing Teams
- Business Strategy & Senior Leadership
- Service & Solution Providers
Who should attend
-
R&D and Formulation Leaders
Scientists and heads working on complex oral, ophthalmic, transdermal, or nasal dosage forms; formulation development and product design teams
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Analytical & Bioequivalence Professionals
Analytical R&D and characterization scientists (Q1/Q2/Q3 sameness, particle/rheological characterization); bioequivalence and clinical pharmacology professionals working on IVRT, IVPT, IVIVC, PBPK modeling, and PD/clinical endpoint studies
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Regulatory Affairs & IP Strategy Teams
Professionals managing US, EU, and CDSCO submissions for complex generics; IP and patent strategy teams handling Paragraph IV litigation and formulation/device patents
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Quality & Manufacturing Teams
Quality assurance and quality control professionals overseeing complex product testing and release; manufacturing and technology transfer teams responsible for scale-up
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Business Strategy & Senior Leadership
Business development and portfolio strategy leaders evaluating speciality/complex generic opportunities; senior leadership and R&D heads shaping organizational investment and capability-building
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Service & Solution Providers
CDMOs and CROs offering formulation, analytical, or clinical testing services to generic manufacturers
Conference Officials
WhatsApp: 9041725050
Venue
The Park Hyderabad Hotel
Address: 22, Raj Bhavan Road, Somajiguda, Hyderabad 500082, India.
The Park Hyderabad Hotel offers top-notch services and amenities, ensuring guests experience utmost comfort. Share your photos and respond to emails at your convenience, thanks to the free Wi-Fi internet access offered by hotel. The Park Hyderabad Hotel provides a superb assortment of leisure amenities for guests to enjoy. Unwind after a long day by stopping by massage, hot tub, salon, steam room, spa and sauna to rejuvenate your senses. Each day at hotel, immerse yourself in the invigorating waters of the pool, perfect for a rejuvenating plunge or a series of revitalizing laps.Bypass the formal attire and choose a laid-back mixed drink or brew at hotel's waterside lounge. For individuals who don't want to skip their exercise routine, visiting the hotel fitness center ensures you maintain your vitality and wellness.
Speciality & Complex Generics for Highly Regulated Markets brings together formulation scientists, regulatory strategists, analytical experts, and senior industry leaders from across India's pharmaceutical sector — a rare, focused gathering of decision-makers driving the next phase of India's complex generics growth.
For sponsors and exhibitors, this is a unique opportunity to connect directly with R&D heads, regulatory affairs professionals, quality and manufacturing leaders, and business strategy decision-makers actively investing in complex oral, ophthalmic, transdermal, and nasal product capabilities.
Who Should Sponsor or Exhibit
- Analytical instrument and characterisation technology providers
- CDMOs and contract manufacturing organizations
- CROs offering bioequivalence, IVRT/IVPT, and clinical testing services
- Excipient, API, and raw material suppliers
- Formulation and drug delivery technology companies
- Device and packaging component manufacturers (droppers, actuators, patch systems)
- Regulatory and IP consulting firms
- Laboratory equipment and software solution providers
Sponsorship & Exhibition Opportunities
- Gold/Silver/Bronze Sponsorships
- Exhibition booths in the networking/exhibit area
- Branding across conference materials, signage, and digital promotion
- Speaking opportunities and technical presentation (TechSpots) slots
- Delegate bag inserts and welcome kit branding
- Networking lunch/dinner sponsorships
Why Partner With Us
- Direct access to a curated, senior-level industry audience
- Positioning as a knowledge partner in a high-growth, high-value segment of the generics industry
- Association with an organising team with 14 years of credibility in the formulation industry, behind conferences such as InjectablesX, QbD in Pharma Development, NanoPharmaceuticals, and more
- Two full days of concentrated engagement with formulation, analytical, regulatory, and business decision-makers
Get Involved
We offer flexible sponsorship packages tailored to your marketing and business development goals. For sponsorship tiers, exhibition floor plans, and customised partnership options, please contact the organising team at [Ms Swati Kanwar, 8289015050 or Ms Farheen Zainab, 7696425050].
Registration
Register Now| Category | Currency | Base Fee | GST / Tax % | Total (incl.) |
|---|---|---|---|---|
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Business Delegate
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INR | ₹27,500.00 | 18% | ₹32,450.00 |
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Industry Delegate till Sept 15
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INR | ₹18,000.00 | 18% | ₹21,240.00 |
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Overseas Delegate from Europe
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EUR | €275.00 | 18% | €324.50 |
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Industry Delegate
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INR | ₹22,000.00 | 18% | ₹25,960.00 |
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Overseas Delegate from US
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USD | $300.00 | 18% | $354.00 |