The United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at the manufacturing facility of Enzene Biosciences Limited (Enzene), a subsidiary of Alkem Laboratories Limited in India located at Chakan, Pune. 

The inspection of the Alkem Laboratories subsidiary concluded with six procedural observations and zero data integrity issues.

Enzene is in the process of preparing and submitting its response to the USFDA within the stipulated timeline and has initiated appropriate corrective and preventive actions.