Monday, October 13, 2025

Shilpa Medicare’s subsidiary receives one procedural observation after USFDA inspection

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Pharmaceutical company Shilpa Medicare Ltd on Friday (March 7) announced that the United States Food and Drug Administration (USFDA) has completed an inspection at Unit-1 of its wholly owned subsidiary, Shilpa Pharma Lifesciences Ltd, in Raichur.”This is to inform you that United States Food and Drugs Administration (USFDA) has conducted an inspection at Unit-1 of Shilpa Pharma Lifesciences Limited, located at Raichur from March 3-7, 2025. On conclusion of inspection, we received 1 (one) observation in form 483, which is procedural in nature,” Shilpa Medicare said in a regulatory filing.

Also Read: Shilpa Medicare arm gets European Certificate Of Suitability for diarrhoea molecule
The inspection, conducted from March 3 to March 7, 2025, resulted in one procedural observation under Form 483. The company stated that it will work closely with the USFDA to address the observation within the stipulated timeframe. “The company will closely work with the agency and remain committed to address this observation comprehensively within stipulated time,” it added.Shares of Shilpa Medicare Ltd ended at ₹667.00, up by ₹6.15, or 0.93%, on the BSE.

Also Read: Shilpa Medicare secures CDSCO’s nod for fatty liver drug, shares spike 8%

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