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USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant

12 Dec 2022 Evaluate

The US Food and Drug Administration (USFDA) has issued warning letter to Glenmark Pharmaceuticals for lapses at Goa plant. USFDA pointed out various lapses at the company's Bardez-based facility in Goa, which produces drug formulations.

As per the US Health regulator, the warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The USFDA inspected the manufacturing facility from May 12, 2022, to May 20, 2022.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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