Lupin’s Pune Biotech Facility Receives Five USFDA Observations Following Inspection
Lupin Ltd. announced that its biotech facility in Pune underwent a pre-approval inspection by the U.S. Food and Drug Administration (USFDA) from September 25 to October 4, 2024. Following the inspection, the USFDA issued five observations to the facility. Although the specific details of the observations were not disclosed, Lupin confirmed that it is addressing them thoroughly and will submit a response within the stipulated timeframe.
The Pune facility is integral to Lupin’s global operations, particularly for the development and manufacturing of biosimilars. It is part of a larger biotech complex that includes the Lupin Biotech for manufacturing, Lupin Research Park for biosimilar research, and Lupin Bioresearch Center, which handles Phase 1 clinical trials and other testing. The biotech facility is designed to meet global regulatory standards, following guidelines from the USFDA, EMA, WHO, and other regulatory bodies.
USFDA inspections are routine and aimed at ensuring compliance with regulations. Observations made during these inspections highlight areas needing improvement, and firms are required to submit a corrective action plan within 15 days. Lupin is currently working to resolve the observations and ensure its facility continues to meet global pharmaceutical standards.
This follows a recent inspection of Lupin’s Pithampur facility, where six observations were made, three of which related to active pharmaceutical ingredients and finished products.