Jubilant Pharmova's Canada Plant Gets USFDA OAI Status, Remediation Underway
New Delhi: Jubilant Pharmova Limited has announced that the United States Food and Drug Administration (USFDA) has classified its contract manufacturing facility in Montreal, Canada, as "Official Action Indicated" (OAI) following an inspection conducted in October and November 2025.
In a regulatory filing, the company informed that United States Food and Drug Administration communicated the inspection classification to Jubilant HollisterStier General Partnership (JHSGP). The communication was received on February 12, 2026, at 10:08 AM (PST), corresponding to 11:38 PM (IST).
The OAI classification pertains to the audit of the Contract Manufacturing Organization (CMO) facility in Montreal carried out during October and November 2025. The audit had earlier been reported by the company on November 4, 2025. Since then, JHSGP has been working closely with the USFDA and has committed to addressing the audit observations.
The company stated that following the implementation of robust remediation measures, production operations at the Montreal facility were resumed in the fourth quarter of FY26.
Jubilant HollisterStier General Partnership, based in Canada, is a strategic alliance jointly owned by subsidiaries of Jubilant Pharmova Limited, Jubilant HollisterStier Inc., Draxis Pharma LLC, and 1359773 B.C. Unlimited Liability Company. The partnership is a key contributor to the group’s global Contract Development and Manufacturing Organization (CDMO) capabilities, offering contract manufacturing services for sterile products, including liquid and lyophilized injectables, ophthalmic solutions, and sterile ointments.
Jubilant Pharma Limited, a Singapore-incorporated wholly owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in the manufacturing and supply of radiopharmaceuticals through a network of 45 radio-pharmacies in the United States. It also operates in allergy immunotherapy, contract manufacturing of sterile injectables and non-sterile products, and solid dosage formulations across regulated markets including the US and Europe. The company employs around 3,200 multicultural professionals across more than 75 countries.
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) has a global presence across radiopharma, allergy immunotherapy, CDMO sterile injectables, Contract Research Development and Manufacturing Organisation (CRDMO), generics, and proprietary novel drugs. Its CRDMO business includes drug discovery services through research centers in Bengaluru, Noida, and France, as well as a CDMO-API business manufacturing active pharmaceutical ingredients. Jubilant Therapeutics, its proprietary novel drugs arm, focuses on developing therapies in oncology and autoimmune disorders. The company operates multiple manufacturing facilities catering to regulated markets worldwide and has a workforce of around 5,500 employees globally.
