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Glenmark Pharmaceuticals receives tentative ANDA approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg

Mumbai, India; April 19, 2017: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg, the generic version of Pradaxa^® Capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IMS Health sales data for the 12 month period ending February 2017, the Pradaxa^® Capsules, 75 mg, 110 mg and 150 mg market¹ achieved annual sales of approximately $913 million*.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the U.S. marketplace and 65 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, February 2017

About Glenmark Pharmaceuticals  

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark’s current respiratory pipeline is aimed at addressing the global public health burden of allergic rhinitis, asthma, and COPD, and includes four investigational treatments across the disease spectrum and devices. Headquartered in Mumbai, India, with U.S. headquarters in Mahwah, NJ, Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com.

For further information, please contact: Ramkumar Uppara/ Shibani Shah
Glenmark, Mumbai, India
Tel: [+91 22] 40189984/348
Email: corpcomm@glenmarkpharma.com

Glenmark Pharmaceuticals receives tentative ANDA approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg

Mumbai, India; April 19, 2017: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg, the generic version of Pradaxa^® Capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc.

According to IMS Health sales data for the 12 month period ending February 2017, the Pradaxa^® Capsules, 75 mg, 110 mg and 150 mg market¹ achieved annual sales of approximately $913 million*.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the U.S. marketplace and 65 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, February 2017

About Glenmark Pharmaceuticals  

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark’s current respiratory pipeline is aimed at addressing the global public health burden of allergic rhinitis, asthma, and COPD, and includes four investigational treatments across the disease spectrum and devices. Headquartered in Mumbai, India, with U.S. headquarters in Mahwah, NJ, Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com.

For further information, please contact: Ramkumar Uppara/ Shibani Shah
Glenmark, Mumbai, India
Tel: [+91 22] 40189984/348
Email: corpcomm@glenmarkpharma.com