USFDA4 Oct 2025, 12:46 pm
Lupin Ltd Receives 'Official Action Indicated' Classification from U.S. FDA for Pithampur Unit-2
AI Summary
Lupin Ltd, a prominent pharmaceutical company, has received an 'Official Action Indicated' (OAI) classification from the U.S. Food and Drug Administration (FDA) for its Pithampur Unit-2 manufacturing facility. This classification comes after an inspection conducted by the U.S. FDA from July 8 to July 17, 2025, which resulted in the issuance of a Form-483 with four observations. The company is currently collaborating with the U.S. FDA to address and resolve these compliance issues, reaffirming its commitment to comply with Current Good Manufacturing Practice (CGMP) standards at all its manufacturing facilities.
Key Highlights
- Lupin Ltd's Pithampur Unit-2 facility receives 'Official Action Indicated' classification from U.S. FDA
- U.S. FDA inspection at Pithampur Unit-2 from July 8 to July 17, 2025, resulted in a Form-483 with four observations
- Company is working with U.S. FDA to resolve compliance issues
- Lupin Ltd committed to CGMP standards compliance at all manufacturing facilities
- Disclosure made pursuant to Regulation 30 of the SEBI Listing Regulations