Jubilant Pharmova Limited announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at the company’s solid dosage formulations facility located in Roorkee, India. The facility is operated by Jubilant Generics Limited, a subsidiary of Jubilant Pharma Limited, which in turn is a wholly owned subsidiary of Jubilant Pharmova.
The inspection was conducted on August 1, 2025, and concluded with the USFDA issuing four observations. While the company did not disclose specific details of the observations, it confirmed that it will be submitting a comprehensive action plan to address the regulatory agency’s concerns.
Jubilant Pharmova clarified that the Roorkee facility’s revenue contribution from the U.S. market during the trailing twelve months (July 2024 to June 2025) was less than 1% of the company’s total revenue in the same period, minimizing any potential financial impact.
The company stated its commitment to working closely with the USFDA to resolve the issues raised and ensure full compliance with regulatory standards.