New Delhi, Feb 26: Emcure Pharmaceuticals has announced that the US Food and Drug Administration (USFDA) has issued two observations following an inspection of its active pharmaceutical ingredients (API) manufacturing facility in Pune.
The regulatory filing by the company stated that the USFDA conducted a current Good Manufacturing Practices (cGMP) inspection at the plant from February 19 to 25. At the conclusion of the inspection, the company received two observations in Form 483.
Emcure Pharmaceuticals assured that it is taking corrective measures and will submit a comprehensive response to the USFDA within the stipulated timeframe.
As per USFDA guidelines, Form 483 is issued to a company’s management when investigators identify conditions that may indicate non-compliance with the Food, Drug, and Cosmetic (FD&C) Act.
The company has not disclosed specific details regarding the nature of the observations. However, compliance with USFDA norms is crucial for ensuring continued operations in the US market.