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Glenmark Pharmaceuticals receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%

Mumbai, India, May 09 2022: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%, the generic version of Enstilar^®1 Foam, 0.005%|0.064%, of Leo Pharma AS.

According to IQVIA^TM sales data for the 12 month period ending March 2022, the Enstilar^® Foam, 0.005%|0.064% market² achieved annual sales of approximately $115.2 million*.

Glenmark’s current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 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.

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About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (Glenmark) is a global innovation-driven pharmaceutical company with presence across Specialty, Generics and OTC businesses. Globally, Glenmark focuses on the following key therapy areas: respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. It was ranked among the world’s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa’s Generics Bulletin). The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth consecutive year in a row, most recently in 2021. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. www.glenmarkpharma.com

For more information, please contact:
Udaykumar Murthy
Deputy General Manager, Corporate Communications
+91 9960377617 | corpcomm@glenmarkpharma.com

References:
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, March 2022

Glenmark Pharmaceuticals receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%

Mumbai, India, May 09 2022: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%, the generic version of Enstilar^®1 Foam, 0.005%|0.064%, of Leo Pharma AS.

According to IQVIA^TM sales data for the 12 month period ending March 2022, the Enstilar^® Foam, 0.005%|0.064% market² achieved annual sales of approximately $115.2 million*.

Glenmark’s current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 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.

-------End-------

About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (Glenmark) is a global innovation-driven pharmaceutical company with presence across Specialty, Generics and OTC businesses. Globally, Glenmark focuses on the following key therapy areas: respiratory, dermatology and oncology. The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. It was ranked among the world’s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa’s Generics Bulletin). The company has been listed on the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the fourth consecutive year in a row, most recently in 2021. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. www.glenmarkpharma.com

For more information, please contact:
Udaykumar Murthy
Deputy General Manager, Corporate Communications
+91 9960377617 | corpcomm@glenmarkpharma.com

References:
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, March 2022