USFDA19 May 2024, 02:19 pm
Lupin Ltd.: US FDA Concludes Pre-Approval Inspection at Somerset Manufacturing Facility, Issues Form-483 with Six Observations
AI Summary
Lupin Ltd. has announced that the US FDA completed a Pre-Approval Inspection at its Somerset, New Jersey manufacturing facility between May 7, 2024, and May 17, 2024. The inspection resulted in six observations being issued, which the company intends to address comprehensively and respond to within the specified timeframe.
Key Highlights
- US FDA completed Pre-Approval Inspection at Lupin's Somerset, NJ manufacturing facility.
- Six observations were issued during the inspection.
- Company will respond to observations within the stipulated timeframe.
- This is a disclosure pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.