The US health regulator has given final approval to Glenmark Pharmaceuticals for a generic version of Minastrin 24 tablets, which is used to prevent pregnancy.
In a BSE filing the company stated, “Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol tablets USP and Ferrous Fumarate tablets, 1 mg/20 mcg, the generic version of Minastrin 24 Fe tablets.”
Furthermore, the company’s current portfolio includes 130 products authorized for distribution in the US market and has 58 Abbreviated New Drug Applications (ANDA) pending for approval with the USFDA.