Oct 26: Sun Pharmaceuticals and Industries Ltd, the largest domestic generic, formulations and branded drug maker in the country, has announced that one of its wholly owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Coreg CR , (carvedilol phosphate) extended release capsules, 10mg, 20mg, 40mg, 80 mg.
“These generic carvedilol phosphate extended release capsules, 10mg, 20mg, 40mg, 80mg are therapeutic equivalents of GSK’s Coreg CR extended release capsules. As per IMS, Coreg CR had annual sales of approximately US$208 million in the US for the 12 months ended August 2017,” the company said in a statement.
Headquartered in Mumbai, Sun Pharma manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States. The company offers formulations in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology and diabetology. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as well as anticancers, steroids, peptides and controlled substances.