Glenmark Pharma gets USFDA nod for Aspirin, extended-release Dipyridamole capsules

Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Aspirin and extended-release Dipyridamole capsules in the strength of 25 mg/200 mg, the company said in a BSE filing.

New Delhi: Glenmark Pharmaceuticals Monday said it has received final approval from the US health regulator for antiplatelet agents Aspirin and extended-release Dipyridamole capsules.

The approved product is a generic version of Aggrenox capsules of Boehringer Ingelheim Pharmaceuticals Inc.

Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Aspirin and extended-release Dipyridamole capsules in the strength of 25 mg/200 mg, the company said in a BSE filing.

Read Also: Glenmark Pharma gets USFDA nod for generic version of Vesicare tablets

Citing IQVIA sales data, Glenmark said, the Aggrenox capsules, 25 mg/200 mg market achieved annual sales of approximately USD 165.6 million in the 12-month period ended March 2019.

The company said its current portfolio consists of 155 products authorised for distribution in the US and 58 Abbreviated New Drug Application (ANDA's) pending approval with the USFDA.

The company is headquartered in Mumbai and was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons. The company initially sold its products in India, Russia, and Africa.

The company went public in India in 1999 and used some of the proceeds to build its first research facility. Saldanha's son Glenn took over as CEO in 2001, having returned to India after working at PricewaterhouseCoopers. By 2008 Glenmark was the fifth-biggest pharmaceutical company in India.

Read Also; Glenmark Pharma gets USFDA nod for generic version of Nexium to treat acid reflux