Jubilant Pharmova's Roorkee Facility Completes USFDA Pre-Approval Inspection with 4 Observations
Jubilant Pharmova announced the completion of a USFDA pre-approval inspection at its Roorkee solid dosage formulations facility, operated by subsidiary Jubilant Generics Limited. The inspection, concluded on August 1, 2025, resulted in four observations. The company plans to submit an action plan to address these. Notably, the Roorkee site's US market revenue represents less than 1% of Jubilant Pharmova's total revenues for the July 2024 to June 2025 period.

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Jubilant Pharmova announced the completion of a pre-approval inspection (PAI) by the United States Food and Drug Administration (USFDA) at its solid dosage formulations facility in Roorkee, India. The inspection, which concluded on August 1, 2025, was conducted at the facility operated by Jubilant Generics Limited, a subsidiary of Jubilant Pharma Limited.
Inspection Outcome
The USFDA issued four observations following the audit. Jubilant Pharmova has stated that it will submit an action plan to address these observations. The company did not disclose the nature of the observations in its announcement.
Facility's Contribution to Revenue
In a notable disclosure, Jubilant Pharmova revealed that the Roorkee site's revenue from the US market represents less than one percent of the company's total revenues for the trailing twelve-month period from July 2024 to June 2025. This information suggests that while the facility is important for the company's US operations, its current financial impact is relatively small in the context of Jubilant Pharmova's overall business.
Company Background
Jubilant Pharmova Limited, formerly known as Jubilant Life Sciences Limited, is a global pharmaceutical and life sciences company. Its subsidiary, Jubilant Pharma Limited, is an integrated global pharmaceutical company engaged in various segments including:
- Radiopharmaceuticals
- Allergy Immunotherapy
- Contract Manufacturing of Sterile Injectables and Non-sterile products
- Solid Dosage Formulations
The company operates multiple manufacturing facilities catering to regulated markets, including the USA and Europe. With a team of around 5,500 multicultural employees across the globe, Jubilant Pharmova has established itself as a 'Partner of Choice' for leading pharmaceutical companies worldwide.
Implications and Next Steps
While the issuance of observations is a common occurrence in FDA inspections, it is crucial for pharmaceutical companies to address them promptly and thoroughly. Jubilant Pharmova's commitment to submitting an action plan demonstrates its proactive approach to regulatory compliance.
The company will likely focus on implementing corrective and preventive actions in response to the FDA's observations. The resolution of these observations will be important for maintaining the facility's good standing with the USFDA and ensuring continued smooth operations for US market supply.
Investors and stakeholders will be watching closely to see how quickly and effectively Jubilant Pharmova addresses these observations, as regulatory compliance is a critical factor in the pharmaceutical industry's operations and market access.
Historical Stock Returns for Jubilant Pharmova
1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
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-1.87% | -2.38% | -6.23% | +6.66% | +33.30% | +35.19% |