8 months ago
Pharma Companies Navigate FDA Inspections
Two Indian pharmaceutical companies, Piramal Pharma and SMS Pharmaceuticals, recently had inspections by the US FDA.
Piramal Pharma received four observations at its factory in Kentucky, but these are not very serious.
SMS Pharmaceuticals had only one minor observation at its factory in Andhra Pradesh.
Both companies will fix these issues and send reports to the FDA.
Piramal's stock price went up a little after the news.
Both companies are committed to making sure their medicines are of high quality.
Piramal Pharma received four observations from the US FDA after a GMP inspection at its Lexington facility.
SMS Pharmaceuticals received one minor observation from the US FDA at its Visakhapatnam API plant.
Both inspections took place in December 2025, with some overlap in dates.
The observations are expected to be classified as VAI, which do not require mandatory regulatory action.
Both companies are preparing detailed responses to submit to the US FDA within the stipulated timeframe.
- Who
- Piramal Pharma Ltd and SMS Pharmaceuticals Ltd
- What
- Received observations from the US FDA after GMP inspections
- Where
- Piramal: Lexington, Kentucky; SMS: Visakhapatnam, Andhra Pradesh
- When
- Piramal: December 3-10, 2025; SMS: December 8-12, 2025
- Why
- To ensure compliance with Good Manufacturing Practices (GMP)
Key facts
- Company 1
- Piramal Pharma Ltd
- Company 2
- SMS Pharmaceuticals Ltd
- Regulator
- US Food and Drug Administration (US FDA)
- Form Issued
- Form 483
- Piramal Observations
- 4
- SMS Observation
- 1
- Piramal Inspection Location
- Lexington, Kentucky
- SMS Inspection Location
- Visakhapatnam, Andhra Pradesh
- Piramal Inspection Dates
- December 3-10, 2025
- SMS Inspection Dates
- December 8-12, 2025
- Observation Classification
- Voluntary Action Indicated (VAI)
- Stock Price Change
- ₹172.10 (up 0.65%)
- SMS Facility Capacity
- 3,000 KL multipurpose API facility
Quotes
P. Vamsi Krishna
Executive Director of SMS Pharmaceuticals Ltd
“This marks the fourth inspection for this facility and the twelfth across our manufacturing sites, including two audits of our Central Laboratory Analytical Services (CLAS). This milestone further strengthens our position as a reliable partner to global pharmaceutical companies and supports the continued supply of high-quality APIs to key international markets.”
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