Shilpa Medicare Latest Corporate Updates

USFDA Inspection at Unit IV: The USFDA completed a ten-day inspection of Shilpa Medicare's Unit IV facility in Jadcherla, Telangana, on November 21, 2025. The inspection concluded with the issuance of a Form 483 with eight inspectional observations. The company has stated that none of the observations were categorized as a repeat observation and it will provide a comprehensive response within the stipulated time. This facility manufactures sterile injectables, oral tablets, and capsules for US, European, and other global markets. Product Launch for Liver Disease: The company announced the launch of NODUCA™ (Nor Ursodeoxycholic Acid Tablets 500 mg) for the first time in India on November 17, 2025. This product is intended to treat metabolic dysfunction-associated fatty liver disease (MAFLD) and the company highlights it as a first-in-class treatment globally for this condition. Business Segment Progress: In the API division, the company has successfully completed two new product filings in the US and Europe in the latest quarter. Development activities for the high-value peptide product Semaglutide are complete, with planned PV (Process Validation) batches initiated for completion in Q4 FY2026. The company is also investing in a large, dedicated peptide facility expected to be commissioned in the next financial year. Biologics and Pipeline Advancement: In the biologics division, the company has eight biosimilar programs under various stages of development. Their most advanced program, Aflibercept, is currently in Phase III studies, with a planned launch in FY2027 following successful clinical results. Another key program, Nivolumab, is scheduled to begin Phase I/III human clinical trials in India in Q4 FY2026.