The company’s US subsidiary “Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food and Drug Administration (US health regulator) for Triamcinolone acetonide cream USP, 0.1 per cent,” Glenmark said in a filing to the BSE.
The product is a generic version of Delcor Asset Corporation’s Kenalog cream in the same strength, it added.
According to IMS Health sales data for the 12-month period ended June 2016, the Kenalog cream 0.1 per cent market (includes brand and all available therapeutic equivalents) achieved annual sales of approximately $43.6 million, Glenmark said.
The company’s current portfolio consists of 108 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDA’s) pending approval with the US regulator, it added.
Shares in Glenmark Pharmaceuticals, on Monday, ended 1.62 per cent higher at Rs 856.50 apiece on the BSE, whose benchmark Sensex index finished up 0.37 per cent.