Jubilant Pharmova receives 4 observations from USFDA after Pre-Approval Inspection at Roorkee facility
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.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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