Glenmark Pharma announced in a statement that the US Food and Drug Administration (USFDA) approved bicardipine hydrochloride capsules in strengths of 20 mg and 30 mg.

Glenmark Pharmaceuticals Ltd said on Monday that it has gained final approval from the US Food and Drug Administration for its generic nicardipine hydrochloride capsules, which are used to treat high blood pressure and angina.

Glenmark announced in a statement that the US Food and Drug Administration (USFDA) approved bicardipine hydrochloride capsules in strengths of 20 mg and 30 mg.

It went on to say that they are the generic versions of Chiesi USA, Inc’s Cardene capsules 20 mg and 30 mg.

Glenmark Pharmaceuticals Inc, USA will distribute them in the United States, according to the business.

Cardene capsules 20 mg and 30 mg earned yearly sales of roughly USD 10.9 million for the 12-month period that ended October 2022, according to the business, using IQVIATM sales data.

Glenmark continues to find and pursue external development collaborations to augment and accelerate the expansion of its existing pipeline and portfolio, in addition to these internal filings, according to the statement.

Meanwhile, in a warning letter addressed to Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the USFDA highlighted a number of breaches at the company’s Bardez-based facility in Goa, which produces medicinal formulations.

According to the US Health Authority, the warning letter identifies major violations of Current Good Manufacturing Practice (CGMP) requirements for finished medicines.

The manufacturing factory was inspected by the US FDA from May 12 to May 20. According to the government, the company’s manufacturing, processing, packaging, or holding techniques, facilities, or controls do not meet CGMP requirements, resulting in contaminated drug goods.

The company’s unwillingness to adequately investigate any inexplicable difference or failure of a batch or any of its components to fulfil any of its standards was also highlighted by US health officials.

Glenmark’s investigations of rejected batches did not include additional batches, dose levels, or medications for tablet compression machine settings, according to the company.

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