Jubilant Pharmova announced that its joint venture, Jubilant HollisterStier General Partnership (JHSGP), received communication from the USFDA regarding the Contract Manufacturing Organization (CMO) facility in Montreal, Canada. The regulatory agency has classified the inspection outcome as “Official Action Indicated” (OAI), following the audit conducted in October & November 2025. JHSGP is actively implementing remediation measures, and production operations have resumed in Q4 of FY26.
USFDA Inspection Classification Update
Jubilant Pharmova Limited today disclosed a significant regulatory update concerning its Contract Manufacturing Organization (CMO) facility located in Montreal, Canada. The facility is operated by the Jubilant HollisterStier General Partnership (“JHSGP”).
The United States Food and Drug Administration (USFDA) has issued a communication classifying the recent inspection, conducted in October & November 2025, as “Official Action Indicated” (OAI). This matter was originally reported by the Company on November 4, 2025.
Remediation and Operations Status
JHSGP affirmed its commitment to diligently addressing all observations raised during the audit. Following the implementation of robust remediation measures across the facility, production operations have officially resumed. This resumption took place during the Q4 of the current Financial Year (FY26).
JHSGP is a strategic alliance jointly owned by subsidiaries of Jubilant Pharmova Limited and plays a vital role in the company’s global Contract Development and Manufacturing Organization (CDMO) capabilities, specializing in sterile products.
Jubilant Pharmova Business Overview
Jubilant Pharmova Limited operates globally across several key segments, including Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, CRDMO, and Generics/Proprietary Novel Drugs. The Company is recognized globally as a ‘Partner of Choice’ by leading pharmaceutical organizations.
Its wholly-owned subsidiary, Jubilant Pharma Limited (JPL), is an integrated global player offering services ranging from Radiopharmaceuticals to Contract Manufacturing of sterile and non-sterile products, serving regulated markets including the USA and Europe.
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