USFDA2 Aug 2025, 05:30 am
Jubilant Pharmova Completes USFDA Pre-approval Inspection of Solid Dosage Manufacturing Facility
AI Summary
Jubilant Pharmova Limited announced that the United States Food and Drug Administration (USFDA) has concluded pre-approval inspection (PAI) of the solid dosage formulations facility at Roorkee site, India of Jubilant Generics Limited. The USFDA has issued 4 observations pursuant to the completion of the audit. The site’s revenue from the US market in the trailing twelve month period is less than one percent of Jubilant Pharmova revenues in the same period.
Key Highlights
- Jubilant Pharmova Limited announced the completion of pre-approval inspection (PAI) by USFDA of its solid dosage manufacturing facility at Roorkee, India
- The USFDA has issued 4 observations which the company will address with an action plan
- The site’s revenue from the US market in the trailing twelve month period is less than one percent of Jubilant Pharmova revenues in the same period
- Jubilant Pharma Limited is an integrated global pharmaceutical company involved in manufacturing and supply of Radiopharmaceuticals, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations