Sun Pharma gets ANDA approval

India’s top pharma company, Sun Pharma received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for the generic version of Generic Ganirelix Acetate injection, 250 mcg/0.5 ml.

Ganirelix Acetate injection is indicated for the inhibition of premature Luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. The injection had an annual sales of around US$67 million in the US for the 12 months ended September 2018.

Sun Pharma plans to commercialize the drug in the US market by Q4FY19. Ganirelix Acetate injection is a ready-to-use solution intended for subcutaneous administration. Each sterile, pre-filled syringe contains 250 µg/0.5 ml of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol and water for injection adjusted to pH 5.0.

On Monday, the shares of Sun Pharma opened at Rs. 467.00 per share, and hit a high and low of Rs. 467.00 per share and Rs. 441.95 per share, respectively. At 9:58 am, the stock was trading at Rs. 450.90 per share, down 8.41 per cent.