Shilpa Medicare Limited has appointed Dr. Uday N. Harle as the Chief Executive Officer (CEO) of Shilpa Biologicals Private Limited, its wholly owned subsidiary. The appointment is effective August 3, 2026, and forms part of the company’s senior managerial leadership.
Dr. Harle brings nearly 24 years of experience in the global biopharmaceutical industry, including more than 18 years in biologics and biosimilars and over 14 years in leadership roles spanning research and development, clinical development, regulatory affairs, manufacturing, commercialization, and business management.
Before joining Shilpa Biologicals, Dr. Harle served as Chief Business Officer at Artemis Medicare Services Limited and Premedium Pharma (Apollo Group). Earlier in his career, he held leadership positions as Assistant Vice President & Global Head – Clinical Development at Amneal Group/Kashiv Biosciences, Global Head – Clinical Development at Abbott, and Associate Director & R&D Head at Ferring Pharmaceuticals. He has also worked with Bharat Serums & Vaccines, Sun Pharma, and several other leading pharmaceutical organizations.
His expertise covers the complete biologics value chain, including portfolio strategy, research and development, chemistry, manufacturing and controls (CMC), clinical development, regulatory approvals, manufacturing, commercialization, CDMO partnerships, and P&L management. He has extensive experience across biosimilars, novel biologics, peptides, recombinant proteins, cell therapies, including CAR-T, and medical devices.
Dr. Harle has significant global regulatory experience, having worked extensively with regulatory agencies such as the USFDA, EMA, MHRA, Health Canada, and CDSCO. During his career, he has contributed to the development of more than 10 biosimilars and over five novel biologics, including multiple IND and BLA submissions.
Academically, Dr. Harle holds a Ph.D. in Pharmaceutical Sciences from RTM Nagpur University, a Master of Science in Pharmacy, and postgraduate diplomas in Business Management and Marketing Management from IGNOU.
In addition to his industry leadership, he has authored approximately 40 scientific publications, published two books, and holds two patents. He has also received multiple industry awards in recognition of his contributions to biopharmaceutical research and development.
With his extensive expertise in biologics, global clinical development, regulatory strategy, and commercialization, Dr. Harle is expected to play a key role in advancing Shilpa Biologicals’ growth strategy and strengthening its position in the global biopharmaceutical market.
