Currently, Glenmark includes 178 products authorized for distribution in the US market and 46 pending ANDA approval with the USFDA.
Glenmark Pharmaceuticals Ltd. 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 Chissy USA, Inc.'s Cardene Capsules, 20 mg and 30 mg.
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 has 178 products authorized for distribution in the US market and 46 ANDAs are pending approval with the US FDA.
In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to complement and accelerate the development of its existing pipeline and portfolio, the statement said.
Meanwhile, the USFDA, in a warning letter sent to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, identified several failures at Glenmark Pharmaceuticals' Bardez-based facility in Goa, which manufactured drug formulations.
According to the US Health Authority, the warning notice lists serious violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
The US FDA inspected the manufacturing plant from 12 to 20 May. According to the agency, the company's manufacturing, processing, packing or holding processes, facilities or controls do not comply with CGMP standards and, as a result, its drug products are substandard. Adulterated.
US health officials stressed the company's inability to fully analyze any unexplained differences or failure of a batch or any of its components to meet any requirements.
It said the testing of the rejected batches by Glenmark did not include other batches, dosage levels or pharmaceuticals for tablet compression machine settings.
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