USFDA13 Feb 2026, 11:02 pm
Jubilant Pharmova's Montreal Facility Receives USFDA's 'Official Action Indicated' Classification
AI Summary
Jubilant Pharmova Limited announced that Jubilant HollisterStier General Partnership (JHSGP) has received an 'Official Action Indicated' (OAI) classification from the United States Food and Drug Administration (USFDA) for its Contract manufacturing facility at Montreal, Canada. This classification is pursuant to the audit conducted in October and November 2025. JHSGP has been working closely with USFDA and has resumed production operations at the facility in Q4’FY26 after implementing robust remediation measures.
Key Highlights
- Jubilant HollisterStier General Partnership (JHSGP) received an 'Official Action Indicated' (OAI) classification from the USFDA for its Montreal facility.
- The OAI classification is pursuant to the audit conducted in October and November 2025.
- JHSGP has been working closely with USFDA and has resumed production operations at the facility in Q4’FY26.
- JHSGP is a Canada based strategic alliance, jointly owned by subsidiaries of Jubilant Pharmova Limited.
- The Montreal facility is a key contributor to the company’s global CDMO capabilities, offering contract manufacturing services for sterile products.