The United States Food and Drug Administration (USFDA) has conducted an inspection at Unichem Laboratories’ Roha API facility from June 16, 2025 to June 20, 2025. The inspection closed with three 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 an international, integrated, specialty pharmaceutical company.