
Jubilant Pharmova Completes USFDA Audit of Contract Manufacturing Facility in Montreal, Canada with 9 Observations
Jubilant Pharmova Limited announced on November 4, 2025, that the United States Food and Drug Administration (USFDA) has concluded an audit of Jubilant HollisterStier General Partnership’s contract manufacturing facility located in Montreal, Canada on November 3rd, 2025. The USFDA has issued 9 observations pursuant to the completion of the audit. Jubilant HollisterStier General Partnership will submit an action plan to address these observations. Jubilant Pharmova Limited is a global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through multiple manufacturing facilities that cater to all the regulated markets including USA, Europe and other geographies.
Key Highlights
- USFDA concluded audit of Jubilant HollisterStier General Partnership’s contract manufacturing facility in Montreal, Canada
- 9 observations were issued by the USFDA
- Jubilant HollisterStier General Partnership will submit an action plan to address these observations
- Jubilant Pharmova Limited is a global pharmaceutical company
- Company engaged in manufacturing and supply of various pharmaceutical products