USFDA issues EIR for Zydus Lifesciences Ambernath facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-05-15 08:15 GMT   |   Update On 2025-05-15 08:15 GMT

Ahmedabad: Zydus Lifesciences has announced that the company has received the Establishment Inspection Report (EIR) report from the United States Food and Drug Administration (USFDA) for the inspection conducted at its API manufacturing facility located at Ambernath, Maharashtra.

This facility underwent an inspection from 10th to 14th February 2025, and had ended with NIL observations.

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Read also: Zydus' Ambernath API Plant Clears USFDA Inspection with Zero Observations

The EIR report has classified it as No Action Indicated (NAI).

Read also: Zydus Lifesciences bags USFDA nod for Glatiramer Acetate Injection for relapsing forms of Multiple Sclerosis

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

Read also: Zydus Lifesciences inks pact with PAI Partners, other shareholders to buy majority stake in Amplitude Surgical SA




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