SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Glenmark Generics receives USFDA nod for Norgestimate and Ethinyl Estradiol tablets

09 Apr 2012 Evaluate

Glenmark Generics Inc USA, a subsidiary of Glenmark Generics, has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg. This approval marks Glenmark's tenth female hormonal product authorized for distribution by the USFDA.

Glenmark's approved product is their generic version of Ortho Cyclen tablets by Janssen Pharmaceuticals, Inc. indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

According to IMS Health for the 12 month period ending December 2011, Norgestimate and Ethinyl Estradiol Tablets USP 0.25 mg/0.035 mg garnered total market sales of approximately $88 million.

Glenmark has a number of ANDA’s currently pending approval with the USFDA in this therapeutic segment as well as a sizeable concentration of their pipeline in various stages of development. The company's current portfolio consists of 79 generic products authorized for distribution in the US market and 39 ANDA's filed with the USFDA pending approval.

Glenmark Pharma Share Price

2364.35 -6.70 (-0.28%)
08-May-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1847.30
Dr. Reddys Lab 1293.25
Cipla 1347.70
Zydus Lifesciences 938.90
Lupin 2377.90
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through:

×