USFDA21 Nov 2025, 04:20 pm
Natco Pharma's Manali API Unit Receives Seven Observations from US FDA
AI Summary
Natco Pharma Limited announced the conclusion of a US FDA inspection at their Manali, Chennai Active Pharmaceutical Ingredients (API) Unit. The inspection, conducted from November 17 to November 21, 2025, resulted in seven observations in the Form-483. The company believes these observations are procedural in nature and is confident in addressing them comprehensively. Natco Pharma is committed to being cGMP compliant and supplying high-quality products to customers and patients globally.
Key Highlights
- US FDA inspection at Natco Pharma's Manali, Chennai API unit
- Seven observations in Form-483 issued by US FDA
- Observations believed to be procedural in nature
- Natco Pharma confident in addressing the observations
- Commitment to being cGMP compliant and supplying high-quality products