The United States Food and Drug Administration (USFDA) has conducted an inspection at the Unichem Laboratories’ Kolhapur API facility from January 27, 2026 to February 02, 2026.
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity. The Company will provide the necessary response to USFDA within stipulated 15 days.
Unichem Laboratories is engaged in manufacturing formulations, pharmaceuticals and active pharmaceutical ingredients (APIs).
