Glenmark gets US FDA nod for high BP capsules


Glenmark Pharmaceuticals Limited has received final approval by the United States Food and Drug Administration (US FDA) for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, the generic version of Cardene Capsules, 20 mg and 30 mg, of Chiesi USA, Inc. 

In an official statement, the company said that Glenmark’s Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately $10.9 million, the statement read. 

Currently, Glenmark consists of 178 products authorized for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA. 

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, the statement added. 

Meanwhile, the USFDA identified a number of failures at the Glenmark Pharmaceuticals’ Bardez-based facility in Goa, creating drug formulations, in a warning letter sent to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha.

The warning notice lists serious infractions of Current Good Manufacturing Practice (CGMP) rules for finished pharmaceuticals, according to the US Health Authority.

The US FDA conducted an inspection of the manufacturing plant from May 12 to 20. According to the agency, the company’s manufacturing, processing, packing or holding procedures, facilities or controls do not follow CGMP standards, and as a result, its drug products are adulterated.

The US health authorities also emphasised the company’s inability to thoroughly analyse any unexplained difference or failure of a batch or any of its components to meet any of its requirements. 

Investigations of rejected batches by Glenmark did not cover other batches, dosage levels, or pharmaceuticals for tablet compression machine settings, it said. 

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