Alkem Laboratories Ltd announced on March 13, 2025, that the US Food and Drug Administration (US FDA) has successfully completed an inspection at the company’s Bioequivalence Center in Taloja, Maharashtra. The inspection, conducted from March 10 to March 13, concluded without any issuance of a Form 483, indicating no major regulatory observations.
This development comes as a positive sign for the company, ensuring compliance with global regulatory standards. A clean slate from the US FDA inspection reinforces Alkem’s adherence to quality and operational excellence in its pharmaceutical research and development.
Alkem Laboratories, a key player in the pharmaceutical sector, has been expanding its presence in international markets, and regulatory approvals play a crucial role in maintaining its reputation and business operations.
The news of the successful US FDA inspection came after the markets had closed. At the time of closing, Alkem Laboratories’ shares traded at ₹4,681.40, down 1.43% or ₹68 from the previous close of ₹4,749.40.
