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Glenmark Pharmaceuticals receives ANDA approval for Pimecrolimus Cream, 1%

Mumbai, India; August 30, 2019: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Pimecrolimus Cream, 1%, a generic version of Elidel®¹ Cream, 1%, of Bausch Health US, LLC.

According to IQVIA^TM sales data for the 12 month period ending July 2019, the Elidel® Cream, 1% market² achieved annual sales of approximately $198.8 million*.

Glenmark’s current portfolio consists of 160 products authorized for distribution in the U.S. marketplace and 55 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.

¹All brand names and trademarks are the property of their respective owners.

²Market includes brand and all available therapeutic equivalents

*IQVIA^TM National Sales Perspectives: Retail & Non-Retail, July 2019

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About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). 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 focused in the areas of oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European 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:

Harsh Sheth

Glenmark, Mumbai, India

Tel: +91 22 4018 9999

Email: corpcomm@glenmarkpharma.com

Glenmark Pharmaceuticals receives ANDA approval for Pimecrolimus Cream, 1%

Mumbai, India; August 30, 2019: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Pimecrolimus Cream, 1%, a generic version of Elidel®¹ Cream, 1%, of Bausch Health US, LLC.

According to IQVIA^TM sales data for the 12 month period ending July 2019, the Elidel® Cream, 1% market² achieved annual sales of approximately $198.8 million*.

Glenmark’s current portfolio consists of 160 products authorized for distribution in the U.S. marketplace and 55 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.

¹All brand names and trademarks are the property of their respective owners.

²Market includes brand and all available therapeutic equivalents

*IQVIA^TM National Sales Perspectives: Retail & Non-Retail, July 2019

--End--

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). 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 focused in the areas of oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European 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:

Harsh Sheth

Glenmark, Mumbai, India

Tel: +91 22 4018 9999

Email: corpcomm@glenmarkpharma.com