At the FDD Conclave 2025, Dr. Ajay Jaysingh Khopade, VP FR&D, Sun Pharmaceutical Industries, delivered an insightful presentation that delved into the future roadmap, challenges, and opportunities surrounding formulation strategies for complex injectables.
Dr Khopade highlighted Sun Pharma’s initiatives such as leveraging known FDA PSGs for liposomes and long-acting injectables in the near term, to investing in depot R&D platforms, nanosystems, and smart injector biosimilar combinations in the years ahead. Then, Dr Khopade emphasised how complex generic parenterals are poised for growth as blockbuster injectable products near patent expiry by 2030.
He outlined the need to bridge scientific complexities with robust regulatory planning to optimise this growth potential and spoke on the significance on investing in avanced analytical tools such as Cryo-TEM, PBPK modeling, and stability platforms. Dr Khopade also stressed the growing importance of combination products and backward-compatible device design to drive differentiation and ease of use.
On the regulatory front, Dr Khopade addressed global pathways that could accelerate approvals, such as the EU’s hybrid pathway and the US FDA’s 505(b)(2) route. He emphasised that proactive regulatory engagement strategies like pre-ANDA meetings and controlled correspondences can de-risk complex product filings.
He also shared case studies such as Nanotecton platform technology – a drug self-assembly system that eliminates the need for toxic excipients and offers enhanced safety and usability. Another highlight was Sun Pharma’s innovations in ophthalmics which offer oncedaily dosing, BKC-free formulations, and improved patient compliance.
He concluded with strategic recommendations for companies looking to enter this space such as risk-sharing models, platform-based R&D, impurity control strategies, and robust portfolio planning based on market potential.