Shilpa Pharma Lifesciences Clears USFDA Inspection at Raichur Unit-2

16 Mar 2025 , 11:29 PM

Shilpa Medicare Ltd filed that its 100% owned subsidiary – Shilpa Pharma Lifesciences Ltd has successfully passed the inspection by the US Food and Drug Administration (USFDA) at its Unit-2 facility located in Raichur.

The inspection was conducted from March 10 to March 14, 2025, and concluded without any Form 483 observations. It’s the second consecutive no-finding inspection at Unit-2, further reinforcing the company’s commitment to regulatory compliance.

No regulatory issues were raised by the USFDA at Unit-2 during the inspection, the company said in a regulatory filing. It also reiterated its adherence to high-quality standards in pharmaceutical manufacturing.

A week earlier, an inspection was concluded by the USFDA at Unit-1 of Shilpa Pharma Lifesciences Ltd at Raichur. For Unit-1, the inspection occurred from March 3 to March 7, 2025, with a single observational item issued under Form 483.

The company explained that the finding was procedural and did not signal any urgent compliance issues. Shilpa Medicare said it is closely working with the USFDA to resolve the observation in a timely, comprehensive manner.

The firm reiterated its compliance with regulations and said that it would take all necessary steps to address the observation as directed within the timeline provided. These successful back-to-back inspections highlight the company’s commitment to regulatory compliance and manufacturing excellence. This step further aids Shilpa Medicare’s efforts to tap into the global market through adherence to stringent global pharmaceutical standards.