USFDA6 Aug 2026, 04:40 pm
Alkem Labs Facility Gets OAI Status from US FDA
AI Summary
Alkem Laboratories Ltd has announced an update regarding its manufacturing facility in Amaliya, Daman. Following a US FDA inspection from April 20 to May 1, 2026, where seven observations were noted on Form FDA 483, the facility's status has now been classified as Official Action Indicated (OAI). Despite this classification, the company continues to manufacture and supply approved products from this facility to the U.S. market. Alkem Laboratories stated its commitment to working with the regulator to achieve full compliance.
Key Highlights
- Alkem's Daman facility classified as Official Action Indicated (OAI) by US FDA.
- Previous inspection in April-May 2026 yielded seven observations.
- Manufacturing and supply to the U.S. market continue from the facility.
- Company aims to achieve full compliance with regulatory requirements.
Price Impact
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