Change in Director / Key Managerial Personnel
- Nature of change: Appointment of Dr. Uday N. Harle as Chief Executive Officer (CEO) of Shilpa Biologicals Private Limited, a wholly owned subsidiary of Shilpa Medicare Limited. This is classified as an appointment of Senior Managerial Personnel.
- Name and details: Dr. Uday N. Harle. No Director Identification Number (DIN) is provided in the disclosure.
- Effective date: The appointment is effective from 03 August 2026. The term of appointment is stated as "Not Applicable."
- Profile and qualifications: Dr. Harle holds a Ph.D. in Pharmaceutical Sciences from Nagpur University (RTM Nagpur University) and a Master of Science in Pharmacy. He also holds Post-Graduate Diplomas in Business Management and Marketing Management from IGNOU.
- Experience: He brings approximately 24 years of experience in the global biopharmaceutical industry, including over 18 years specifically in biologics and biosimilars. He has more than 14 years of experience in leadership roles encompassing research and development, clinical development, regulatory affairs, manufacturing, commercialization, and business management.
- Previous roles: His most recent assignment was as Chief Business Officer at Artemis Medicare Services Limited and Premedium Pharma (Apollo Group). Prior roles include 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 held key positions at Bharat Serums & Vaccines and Sun Pharma.
- Expertise: His expertise spans the entire biologics value chain, including portfolio strategy, CMC, clinical development, regulatory approvals, manufacturing, commercialization, CDMO partnerships, and P&L management. He has experience with biosimilars, novel biologics, peptides, recombinant proteins, cell therapies (including CAR-T), and medical devices.
- Regulatory experience: Dr. Harle possesses significant global regulatory experience, having worked extensively with the USFDA, EMA, MHRA, Health Canada, and CDSCO. He has contributed to the development of more than 10 biosimilars and over 5 novel biologics, including multiple IND and BLA submissions.
- Publications and patents: He has authored approximately 40 scientific publications, published 2 books, and holds 2 patents. He has also received several industry awards for his contributions to biopharmaceutical R&D.
- Eligibility and compliance: The disclosure confirms the appointment is made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and Master Circular No. HO/49/14/14(7)2025- CFDPOD2/I/3762/2026 dated 30th January 2026. A declaration of non-disqualification or specific eligibility under SEBI norms is not explicitly mentioned in the provided text.
- Relationship with other directors/promoters: No relationship with other directors or promoters of Shilpa Medicare Limited is disclosed.
- Previous KMP: The disclosure does not mention who held the position of CEO at Shilpa Biologicals prior to this appointment or the nature of their exit, so it cannot be determined if the succession was planned or interim.
Key Financial or Operational Approvals
This section is not applicable as the disclosure solely concerns a managerial appointment and does not contain information on financial results, fundraising, or other board approvals.
Strategic or Business Context
This section is not applicable as the disclosure does not contain commentary on business outlook, strategy, or expansion plans related to this appointment.
Any Other Material Information
- Regulatory compliance: The disclosure is formally made to BSE Limited and the National Stock Exchange of India Ltd. under Regulation 30 of the SEBI LODR Regulations.
- Annexure: The requisite details are provided in Annexure A to the main letter, which has been summarized in the 'Change in Director / Key Managerial Personnel' section above.
- Company Secretary: The disclosure is signed by Ritu Tiwary, Company Secretary & Compliance Officer of Shilpa Medicare Limited.