New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for its generic version of anti-inflammatory drug Indomethacin tablets.
The approval granted to Glenmark Pharmaceuticals Inc by the US Food and Drug Administration (USFDA) is for Indomethacin extended-release capsules of 75 mg strength, the company said in a statement.
It is the generic equivalent of Indocin SR Extended- Release capsules, 75 mg of Iroko Pharmaceuticals LLC, the company added.
Citing IMS Health sales data for the 12-month period ending April 2017, the company said Indocin SR Extended- Release capsules, had an annual sales of approximately USD 6.3 million.
Glenmark’s current portfolio consists of 118 products authorised for distribution in the US and 67 ANDA’s pending approval with the USFDA.