Sun Pharmaceutical Industries, today announced that Sun Pharma 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 USS 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.
Shares of the company declined Rs 46.6, or 9.47%, to trade at Rs 445.70. The total volume of shares traded was 797,103 at the BSE (9.32 a.m., Monday).