Jubilant Pharmova Limited announced the USFDA has completed an audit of its Jubilant HollisterStier General Partnership (JHSGP)’s contract manufacturing facility in Montreal, Canada on November 3, 2025. The USFDA issued 9 observations, and JHSGP will submit an action plan. JHSGP is jointly owned by subsidiaries of Jubilant Pharma Limited.
Montreal Facility Audit Concluded
Jubilant Pharmova Limited announced on November 4, 2025, the completion of a USFDA audit at the Jubilant HollisterStier General Partnership (JHSGP) contract manufacturing facility located in Montreal, Canada.
Audit Findings
The USFDA issued 9 observations upon completion of the audit on November 3, 2025. JHSGP is preparing to submit an action plan to address these observations. The Montreal facility is a contract manufacturing site.
About JHSGP
JHSGP is jointly owned by subsidiaries of Jubilant Pharma Limited, a wholly owned subsidiary of Jubilant Pharmova Limited.
About Jubilant Pharma Limited
Jubilant Pharma Limited (JPL) is an integrated 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. JPL has a network of 45 radio-pharmacies in the US and operates multiple manufacturing facilities. The company has a team of around 3,200 multicultural people across the globe.
About Jubilant Pharmova Limited
Jubilant Pharmova Limited is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. The Company has a team of around 5,500 multicultural people across the globe.
Source: BSE
