Glenmark Pharma gets tentative USFDA approval for Azelaic Acid Gel

Glenmark currently has 106 products authorised for distribution in the US marketplace and 62 ANDA’s pending approval with the USFDA The Dollar Business Bureau

: On Tuesday, the Ministry of Finance approved Glenmark’s FDI proposal for allotment of 103,000 equity shares to the foreign nationals’ employee worth $3.34 crore

Mumbai-based Glenmark Pharma Ltd. on Wednesday announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for its Azelaic Acid Gel used for the treatment of skin inflammation. “Glenmark will market this product upon receiving final approval of its Azelaic Acid Gel, 15% ANDA. The patent listed in the Orange Book for Finacea Topical Gel, 15% is scheduled to expire on November 18, 2018,” Glenmark Pharma said in a statement. According to IMS Health sales data, the Finacea market achieved annual sales of about $128.0 million during the period January - December 2015. Glenmark currently has 106 products authorised for distribution in the US marketplace and 62 ANDA’s pending approval with the USFDA. 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 in the global market. Glenmark has a significant presence in branded generics markets across emerging economies including India. The drug major along with its subsidiary has 16 manufacturing facilities in four countries and has six R&D centers. Glenmark’s generic business serves the US and Western Europe. On Tuesday, the Ministry of Finance also approved Glenmark’s FDI proposal for allotment of 103,000 equity shares to the foreign nationals’ employee worth $3.34 crore. Glenmark Pharma Ltd., a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) primarily focused in the areas of inflammation and pain, is ranked among the top 80 pharma & biotech companies of the world in terms of revenues.

February 17, 2016 | 05:15pm IST

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The Dollar Business Bureau - Feb 17, 2016 11:37 IST

Glenmark Pharma gets tentative USFDA approval for Azelaic Acid Gel

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