United States Food and Drug Administration (USFDA) has concluded an inspection at Unichem Laboratories’ Pithampur API facility. The said inspection conducted from February 24, 2025 to February 28, 2025. The inspection closed with four observations which were more of procedural changes with none of these related to data integrity. The Company will provide the necessary response on these observations to USFDA within stipulated 15 days.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company.