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( 03 Dec 2018)
Sun Pharma gets USFDA nod for Ganirelix Acetate injection

Drug maker Sun Pharmaceutical Industries Ltd., said that it has,” received final approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Ganirelix Acetate Injection, 250 mcg/0.5 mL. The generic version is therapeutic equivalent to Organon’s Ganirelix Acetate Injection, 250 mcg/0.5 mL,” in a filing to Bombay Stock Exchange.

“As per IQVIA, Ganirelix Acetate Injection, 250 mcg/0.5 mL had annual sales of approximately US$ 67 million in the US for the 12 months ended September 2018. The commercialization of this product in the US market is expected in Q4FY19,” the company further added.

The shares of the company were trading at Rs. 442.45 apiece, low at 49.85 points or 10.13 per cent, on the BSE at 09: hours.