Glenmark Pharmaceuticals USA has been granted final approval by the US Food & Drug Administration (USFDA) for generic oral contraceptive norgestimate ethinyl estradiol tablets.
The approval has been granted for generic version of Ortho Tri-cyclen Lo tablets of Janssen Pharmaceuticals, Inc.
Glenmark said that Ortho Tri-cyclen Lo tablets achieved annual sales of around USD 503.9 million.
Glenmark current portfolio consists of 107 products authorized for distribution in the U.S. marketplace and 62 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.
Today, Glenmark Pharmaceuticals shares were trading at Rs 738.40 apiece on BSE, down 1.32 percent.