The United States Food and Drug Administration (US FDA) has granted final approval to Glenmark Pharmaceuticals Limited for Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, the generic version of Chiesi USA, Inc.’s Cardene Capsules, 20 mg.
Glenmark Pharmaceuticals Inc., USA will distribute Nicardipine Hydrochloride Capsules, 20 mg, and 30 mg, in the United States, according to an official statement from the firm.
As per Live Mint, according to IQVIA sales statistics for the 12-month period ending in October 2022, the Cardene Capsules, 20 mg, and 30 mg market generated roughly $10.9 million in annual sales.
Currently, Glenmark has 178 pharmaceuticals approved for distribution in the United States and 46 ANDAs pending clearance with the US Food and Drug Administration.
In addition to these internal filings, Glenmark continues to find and investigate external development collaborations to augment and expedite the expansion of its existing pipeline and portfolio, according to the statement.
In a warning letter addressed to Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals, the USFDA noted a number of breaches at the Goa-based facility in Bardez that produces medicinal formulations.
According to the US Health Authority, the warning notice details major violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
The US FDA inspected the manufacturing facility from May 12 to May 20. According to the government, the company’s drug goods are contaminated because it’s manufacturing, processing, packaging, or holding techniques, facilities, or controls do not adhere to CGMP standards.
