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Glenmark Pharmaceuticals receives ANDA approval for Potassium Chloride Extended-Release Capsules USP, 10 mEq

Mumbai, India, January 21, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Potassium Chloride Extended-Release Capsules USP, 10 mEq, the therapeutic equivalent to the reference listed drug product, Potassium Chloride Extended-Release Capsules USP, 10 mEq, of Actavis Laboratories FL, Inc.

According to IMS Health sales data for the 12 month period ending November 2015, the Potassium Chloride Extended-Release Capsules, 10 mEq Market¹ achieved annual sales of approximately $74.1 million*.

Glenmark’s current portfolio consists of 105 products authorized for distribution in the U.S. marketplace and 63 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, November 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 five countries and has six R&D centers.

For further information, please contact:
Rajdeep Barooah/Shibani Shah
Tel: [+91 22] 40189984/1348
Email: corpcomm@glenmarkpharma.com  

Glenmark Pharmaceuticals receives ANDA approval for Potassium Chloride Extended-Release Capsules USP, 10 mEq

Mumbai, India, January 21, 2016: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Potassium Chloride Extended-Release Capsules USP, 10 mEq, the therapeutic equivalent to the reference listed drug product, Potassium Chloride Extended-Release Capsules USP, 10 mEq, of Actavis Laboratories FL, Inc.

According to IMS Health sales data for the 12 month period ending November 2015, the Potassium Chloride Extended-Release Capsules, 10 mEq Market¹ achieved annual sales of approximately $74.1 million*.

Glenmark’s current portfolio consists of 105 products authorized for distribution in the U.S. marketplace and 63 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, November 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 five countries and has six R&D centers.

For further information, please contact:
Rajdeep Barooah/Shibani Shah
Tel: [+91 22] 40189984/1348
Email: corpcomm@glenmarkpharma.com