Unichem Laboratories Limited announced that the United States Food and Drug Administration (USFDA) recently conducted an inspection at its Active Pharmaceutical Ingredient (API) facility in Pithampur, Madhya Pradesh.
The inspection took place from February 24, 2025, to February 28, 2025, and concluded with four procedural observations, none of which were related to data integrity.
In the exchange filing, the company shared, “The United States Food and Drug Administration (USFDA) conducted an inspection at the Company’s Pithampur API facility from 24th February 2025 to 28th February 2025. The inspection closed with four observations which were more of procedural changes with none of these related to data integrity.”
The company is committed to maintaining the highest quality and compliance standards. It will submit a comprehensive response to the USFDA within the stipulated 15-day timeline, addressing all observations.
In the meantime, Unichem Laboratories’ shares closed on Friday at ₹603.40, dropping from an opening price of ₹618.80. The stock hit a high of ₹655.00 and a low of ₹600.00 during the session. It remains significantly below its 52-week high of ₹937.95 but above its 52-week low of ₹472.75.
