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Glenmark Pharmaceuticals receives ANDA approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg-0.025 mg, 0.215 mg-0.025 mg, and 0.25 mg-0.025 mg

Mumbai, India; February 24, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, the generic version of Ortho Tri-Cyclen^® Lo Tablets of Janssen Pharmaceuticals, Inc.


According to IMS Health sales data for the 12 month period ending December 2015, the Ortho Tri- Cyclen^® Lo Tablets market¹ achieved annual sales of approximately $503.9 million*.

Glenmark’s current portfolio consists of 107 products authorized for distribution in the U.S. marketplace and 62 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

All brand names and trademarks are the property of their respective owners.
¹Market includes brand and all available therapeutic equivalents
*IMS Health National Sales Perspectives: Retail & Non-Retail, December 2015


About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues. (SCRIP 100 Rankings published in the year 2016). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain].

The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 16 manufacturing facilities in four countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western Europe markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

For further information, please
contact: Rajdeep Barooah/Shibani
Shah Glenmark, Mumbai, India
Tel: [+91 22] 4018 9984/9348
Email: corpcomm@glenmarkpharma.com

Glenmark Pharmaceuticals receives ANDA approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg-0.025 mg, 0.215 mg-0.025 mg, and 0.25 mg-0.025 mg

Mumbai, India; February 24, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, the generic version of Ortho Tri-Cyclen^® Lo Tablets of Janssen Pharmaceuticals, Inc.


According to IMS Health sales data for the 12 month period ending December 2015, the Ortho Tri- Cyclen^® Lo Tablets market¹ achieved annual sales of approximately $503.9 million*.

Glenmark’s current portfolio consists of 107 products authorized for distribution in the U.S. marketplace and 62 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

All brand names and trademarks are the property of their respective owners.
¹Market includes brand and all available therapeutic equivalents
*IMS Health National Sales Perspectives: Retail & Non-Retail, December 2015


About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenues. (SCRIP 100 Rankings published in the year 2016). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain].

The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has 16 manufacturing facilities in four countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western Europe markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

For further information, please
contact: Rajdeep Barooah/Shibani
Shah Glenmark, Mumbai, India
Tel: [+91 22] 4018 9984/9348
Email: corpcomm@glenmarkpharma.com