Compliance review: Sun Pharma’s Halol plant gets 8 USFDA observations; company vows remedial steps after inspection – Times of India

Compliance review: Sun Pharma’s Halol plant gets 8 USFDA observations; company vows remedial steps after inspection – Times of India

Sun Pharmaceutical Industries Ltd on Saturday said the US Food and Drug Administration (USFDA) has issued a Form 483 with eight observations following an inspection of its Halol manufacturing facility in Gujarat.The inspection, which focused on Good Manufacturing Practices (GMP), was conducted between June 2 and June 13, 2025, the company said in a regulatory…

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Zydus Lifesciences receives 6 observations from USFDA for Gujarat API unit – Times of India

Zydus Lifesciences receives 6 observations from USFDA for Gujarat API unit – Times of India

Zydus Lifesciences on Saturday said it received six observations from the US Food and Drug Administration (USFDA) following a surveillance inspection of its active pharmaceutical ingredient (API) manufacturing facility in Dabhasa, Gujarat.In a regulatory filing, the company stated that the inspection was conducted between April 21 and April 25, 2025.“We wish to inform that the…

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