Glenmark Receives FDA Approval to Market Generic Contraceptives in US

Mumbai-based Glenmark Pharmaceuticals announced that its US subsidiary, Glenmark Generics, has won the approval from the US Food and Drug Administration to market its generic contraceptive pills in the country. According to the statement released by the company, the FDA has given its final approval for the manufacture of Norgestimate and Ethinyl Estradiol tablets in strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg.

“Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and Monday's approval marks their fifth female hormonal product authorised for distribution by USFDA”, the company said.



Source-Medindia