Glenmark Generics Gets USFDA Nod For Norethindrone Tabs

Glenmark Generics Gets USFDA Nod For Norethindrone TabsGlenmark Generics, USA, a division of Glenmark Generics, has got US FDA nod for Norethindrone tabs, their generic version of Nor- QD.

Norethindrone tablets will be sold under the trade name Heather and distribution is expected to commence shortly.

Presently, Glenmark is the single Indian company to be given an ANDA sanction on an oral contraceptive pill. The US contraceptive business has historically been the biggest of the seven top markets with sales hitting $4.5 billion during the 12 month period ending December 2009.

While talking on this development, Terrance Coughlin stated. "This is a milestone in the evolving history of Glenmark Generics. Heather represents our first launch of an oral contraceptive in the United States and the first FDA approval on a product out of our hormone facility located in Goa, India."

Norethindrone tabs are a progestin-only oral contraceptive, which is prescribed for the prevention of pregnancy. The total sales of this niche generic contraceptive pill stood at $38 million for the year ended December 2009.

At 01:43 p. m., the shares of the company declined 0.5% to trade at Rs 268.50 on the Bombay Stock Exchange (BSE). The share price has seen a 52-week high of Rs 290 and a low of Rs 165.65 on BSE.

Current EPS & P/E ratio stood at 8.33 and 32.23 respectively.