The Mumbai-based drug major has received tentative approval from the US Food and Drug Administration (USFDA) to market the product in the strength of 100 and 150 mg, Glenmark Pharmaceuticals said in a statement.
The company’s product is the generic version of Boehringer Ingelheim Pharmaceuticals Inc’s Ofev capsules.
According to IQVIA sales data for the 12 month period ending April 2021, the Ofev capsules (100 mg and 150 mg) had achieved annual sales of around USD 1.6 billion.
Glenmark said its current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications (ANDA’s) pending approval with the USFDA.
In addition to these internal filings, the drug maker continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, it added.
Glenmark has presence across generics, specialty and OTC business with operations in over 50 countries.