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Shilpa’s Unit-2 Facility in India Passes Second FDA Inspection

The 22-acre facility is the company's second and largest API manufacturing site.

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By: Charlie Sternberg

Associate Editor

Shilpa Pharma Lifesciences – a wholly owned subsidiary of Shilpa Medicare – has successfully passed a U.S. Food and Drug Administration (FDA) inspection for its Unit-2 facility in Raichur, India, with no 483 observations. This marks the second consecutive clean inspection at the facility, with the FDA conducting the audit from March 10-14. Operational since March 2008, the 22-acre facility is the company’s second and largest API manufacturing site. It forms part of a broader network of ...

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