USFDA issues EIR with Voluntary Action Indicated status for Alivus Life Sciences’ API unit

04 Apr 2025 Evaluate

The United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status for Alivus Life Sciences’ API manufacturing facility at Plot No. 3102 to 3109, 3103, GIDC Industrial Estate, Gujarat.

Earlier, the USFDA had conducted an inspection of company’s API manufacturing facility at same facility from January 27, 2025 to January 31, 2025.

Alivus Life Sciences (Formally known as Glenmark Life Sciences) is a leading developer and manufacturer of select high value, non-commoditized active pharmaceutical ingredients (APIs) in chronic therapeutic areas, including cardiovascular disease (CVS), central nervous system disease (CNS), pain management and diabetes. 


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