Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries including its subsidiaries has received final approval from US FDA 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. As per IQVIA, Ganirelix Acetate Injection, 250 mcg/0.5 mL had annual sales of approximately $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.

Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.