Emcure Pharmaceuticals, a leading global pharmaceutical company, recently underwent a current Good Manufacturing Practices (cGMP) inspection by the United States Food and Drug Administration (US FDA) at its Active Pharmaceutical Ingredient (API) manufacturing facility in Kurkumbh, Pune. The inspection was conducted from February 19, 2025, to February 25, 2025.
At the conclusion of the inspection, the company received two observations in Form 483. These observations indicate areas where the FDA believes improvements are necessary to meet regulatory compliance standards.
In the exchange filing, the company shared, “The United States Food and Drug Administration (“US FDA”) had conducted a current Good Manufacturing Practices (‘cGMP’) inspection of Company’s API manufacturing facility located at M.I.D.C., Kurkumbh, Taluka – Daund, Pune – 413802, Maharashtra, from February 19, 2025 to February 25, 2025. On conclusion of the inspection, the Company received two observations in Form 483.”
Emcure Pharmaceuticals is fully committed to maintaining the highest quality and regulatory standards. The company is actively addressing the observations and will provide a comprehensive response to the US FDA within the stipulated timeframe.
