Search Result for : Glenmark Pharma

Aurobindo Pharma receives USFDA nod for anti-infective injection

The Dollar Business Bureau Aurobindo Pharma on Monday announced that it has received the go-ahead from the US-based health regulator USFDA to manufacture and market its anti-infective Linezolid injection in the American market.  "The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Linezolid injection, 600 mg/300 mL (2 mg/mL)," Aurobindo Pharma said in a statement. The company plans to launch the product during the second quarter of the current financial year. It has the generic version of Pharmacia & Upjohn Company's Zyvox injection in the same strength.   "The approved product has an estimated market size of $87 million for the twelve months ending June 2016 according to IMS," it said. This latest approval is Aurobindo Pharma’s 36th abbreviated new drug ...

Glenmark Pharma gets tentative USFDA approval for Azelaic Acid Gel

Glenmark currently has 106 products authorised for distribution in the US marketplace and 62 ANDAs pending approval with the USFDA The Dollar Business Bureau : On Tuesday, the Ministry of Finance approved Glenmarks 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 ...