Granules India, has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application(ANDA) filed by Uspharam Windlas LLc for Prasugrel tablets, used for treatment of heart diseases.
According to a statement by Granules, it has an exclusive tie up with USpharma to market and distribute four drugs of the latter, including Prasugrel (5 mg and 10 mg).
As per the release,”The approved ANDA is the bio-equivalent to the reference listed drug product (RLD) Effient tablets 5 mg and 10 mg of Eli Lilly and Company.”
