Jubilant Pharmova's Montreal Facility Completes USFDA Audit with 9 Observations
Jubilant Pharmova Limited announced the completion of a USFDA audit at its contract manufacturing facility in Montreal, Canada, operated by Jubilant HollisterStier General Partnership. The audit, concluded on November 3, 2025, resulted in 9 observations. The company plans to submit an action plan to address these observations. The facility is jointly owned by subsidiaries of Jubilant Pharma Limited, a wholly-owned subsidiary of Jubilant Pharmova Limited.

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Jubilant Pharmova Limited , a global pharmaceutical company, has announced the completion of a United States Food and Drug Administration (USFDA) audit at its contract manufacturing facility in Montreal, Canada. The audit, which concluded on November 3, 2025, resulted in 9 observations from the regulatory authority.
Audit Details
The USFDA audit was conducted at the facility operated by Jubilant HollisterStier General Partnership (JHSGP), which is jointly owned by subsidiaries of Jubilant Pharma Limited, a wholly-owned subsidiary of Jubilant Pharmova Limited. The company has stated that it will submit an action plan to address the observations made during the audit.
Key Points
| Aspect | Details |
|---|---|
| Audit Location | Montreal, Canada |
| Facility Operator | Jubilant HollisterStier General Partnership (JHSGP) |
| Audit Completion Date | November 3, 2025 |
| Number of Observations | 9 |
| Next Steps | Submission of action plan on the observations |
Company Overview
Jubilant Pharmova Limited, formerly known as Jubilant Life Sciences Limited, is a diverse pharmaceutical company with global operations. The company's portfolio includes:
- Radiopharmaceuticals
- Allergy Immunotherapy
- Contract Development and Manufacturing Organization (CDMO) for Sterile Injectables
- Contract Research and Development Manufacturing Organization (CRDMO)
- Generics
- Proprietary Novel Drugs
The company operates multiple manufacturing facilities catering to regulated markets worldwide, including the USA and Europe. With a workforce of approximately 5,500 employees across the globe, Jubilant Pharmova has established itself as a 'Partner of Choice' for leading pharmaceutical companies.
Implications
While the specific details of the USFDA observations have not been disclosed, such audits are crucial for pharmaceutical companies operating in regulated markets. The outcome of this audit and the company's response to the observations may have implications for Jubilant Pharmova's operations and regulatory compliance status.
Investors and stakeholders will likely be watching closely to see how the company addresses these observations and any potential impact on its contract manufacturing business in North America.
As the pharmaceutical industry continues to face stringent regulatory scrutiny, the ability to successfully navigate such audits and maintain compliance remains a critical factor for companies operating in this sector.
Historical Stock Returns for Jubilant Pharmova
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -2.90% | +2.38% | +2.64% | +27.84% | -10.15% | +63.43% |












































