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Glenmark Pharmaceuticals receives ANDA approval for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet

Mumbai, India; July 17, 2018: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, the generic version of Welchol^®1 for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, of Daiichi Sankyo Inc.

According to IQVIA^TM sales data for the 12 month period ending May 2018, Welchol^® for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet achieved annual sales of approximately $73.0 million*.

Glenmark’s current portfolio consists of 138 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.

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

*IQVIA^TM National Sales Perspectives: Retail & Non-Retail, May 2018

About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017). 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 oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark along with its subsidiary has 17 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:
Isha Trivedi / Ramkumar Uppara Glenmark, Mumbai, India
Tel: [+91 22] 4018 9801
Email: corpcomm@glenmarkpharma.com

Glenmark Pharmaceuticals receives ANDA approval for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet

Mumbai, India; July 17, 2018: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Colesevelam Hydrochloride for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, the generic version of Welchol^®1 for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet, of Daiichi Sankyo Inc.

According to IQVIA^TM sales data for the 12 month period ending May 2018, Welchol^® for Oral Suspension, 1.875 grams/Packet and 3.75 grams/Packet achieved annual sales of approximately $73.0 million*.

Glenmark’s current portfolio consists of 138 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.

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

*IQVIA^TM National Sales Perspectives: Retail & Non-Retail, May 2018

About Glenmark Pharmaceuticals Ltd.:
Glenmark Pharmaceuticals Ltd. (GPL) is a research‐driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2017). 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 oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark along with its subsidiary has 17 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:
Isha Trivedi / Ramkumar Uppara Glenmark, Mumbai, India
Tel: [+91 22] 4018 9801
Email: corpcomm@glenmarkpharma.com