USFDA issues EIR with NAI classification for Alivus Life Sciences’ API unit

28 Jul 2025 Evaluate

The United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) classification for Alivus Life Sciences’ API Manufacturing facility at Dahej, Gujarat. The USFDA had conducted an inspection from May 26, 2025 to May 30, 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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