Sun Pharma Receives US FDA Approval For Generic Ganirelix Acetate Injection

Deepthi | Myequity news | Date : 03-12-2018 10:30:00 IST

Sun Pharmaceutical Industries Ltd. 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 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.

About Sun Pharmaceutical Industries Ltd.:

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. It provides high-quality, affordable medicines trusted by customers and patients in over 100 countries across the world. Sun Pharma's global presence is supported by 42 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities.

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