Shilpa Medicare announces that Shilpa Pharma Lifesciences – a wholly owned subsidiary – has successfully passed a U.S. Food and Drug Administration (FDA) inspection for its Unit-2 facility in Raichur, India, with no 483 observations.
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This marks the second consecutive clean inspection at the facility, with the FDA conducting the audit from March 10-14.
This latest inspection success demonstrates Shilpa Medicare’s ongoing commitment to meeting and exceeding the highest regulatory standards and empowering its customers with both high-quality manufacturing for generics, as well as innovators through its growing CDMO division.
The Company's Unit-2 API site showcases to the FDA its state-of-the-art infrastructure, the team's strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records. Operational since 21st March 2008, the 22-acre facility is the company's second and largest API manufacturing site. It forms part of a broader network of seven facilities that encompass biologic substance manufacturing, fill-finish capabilities, and large-scale solid dose drug substance production. The successful FDA inspection ensures that the site will continue to support the commercial supply of oncological actives for U.S. patients.
Vishnukant C. Bhutada, managing director of Shilpa Medicare, said: "We are delighted that our Unit-2 API facility has passed its second consecutive FDA inspection with no observations. This achievement further reinforces our dedication to providing our customers with high-quality R&D, API, and finished dose manufacturing solutions."
Unit-2 has capacity for 520 KL and supports more than 250 customers across 25 APIs and part of CDMO offerings.