The US Food and Drug Administration (FDA) has approved Glenmark Pharmaceuticals’ Nicardipine Hydrochloride Capsules, 20 mg and 30 mg, the generic version of Cardene Capsules, of Chiesi USA, Inc. The company’s Nicardipine Hydrochloride Capsules will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA.
According to IQVIA sales data, the Cardene Capsules market has achieved annual sales of around 10.9 million dollars. Currently, Glenmark Pharmaceuticals consists of 178 products authorized for distribution in the US marketplace and 46 ANDA’s pending approval with the US drug agency.
The company continues to identify and explore external development partnerships to accelerate the growth of Glenmark’s existing pipeline and portfolio. The US Food and Drug Administration (FDA) has also identified a number of failures at the company’s Bardez-based facility in Goa, India, in creating drug formulations.
The US FDA has also conducted an inspection of the company’s manufacturing plant from May 12, 2022 to May 20, 2022. According to the US FDA, the manufacturing, packing procedures, processing, facilities, and control do not meet CGMP standards, and the drug products of the company are also adulterated.
The US health authorities have also highlighted the inability of the company to analyse any unexplained difference or failure of any of its components to meet any of Glenmark’s requirements.