Emcure Pharma Pune facility gets 2 USFDA observations
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-26 09:44 GMT | Update On 2025-02-26 09:44 GMT
Pune: Emcure Pharmaceuticals Limited has announced that the Company has received two observations in Form 483 from the United States Food and Drug Administration (US FDA) for the Company’s API manufacturing facility located at M.I.D.C., Kurkumbh, Taluka - Daund, Pune – 413802, Maharashtra.
A current Good Manufacturing Practices (‘cGMP’) inspection was conducted from February 19, 2025 to February 25, 2025.
"We are addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe," the company stated in a BSE filing.
Established in 1981, Emcure is an Indian pharmaceuticals company headquartered in Pune engaged in developing, manufacturing and globally marketing a broad range of pharmaceutical products.
Read also: Emcure Pharma launches new dermatology-focused arm Emcutix Biopharma
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