Shares of Granules India rallied 5 per cent to Rs 378 on the BSE on Friday after the company announced that its US subsidiary has received marketing approval from the US Health Regulator (FDA) for Dexmethylphenidate HCl extended-release capsules for the treatment of attention-deficit hyperactivity disorder. Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR, it said.
The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia, Granules said in an exchange filing.
The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia, Granules said in an exchange filing.
Granules now has a total of 30 ANDA approvals from the US FDA out of which 28 are final approvals