Granules India rises post USFDA approval for its US arm's ANDA

The shares of Granules India gained over 2.5 per cent after its subsidiary received USFDA approval for amphetamine sulfate tablets.

The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India Limited, for amphetamine sulfate tablets USP 5 mg and 10 mg.

The drug is the bioequivalent to the reference listed drug product (RLD) Evekeo tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC. Amphetamine sulfate is a central nervous system stimulant used to treat sleep disorder, increase attention, decrease impulsiveness and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD).

The stock of the company on Tuesday opened at Rs. 90 against Monday’s close of Rs.89.60. At 14:34 hours, it was trading at Rs.91.75, 2.40 per cent higher than its previous close. The stock hit an intra-day high of Rs 92 and intra-day low of Rs. 89.15. Its 52-week high was Rs. 123 and 52-week low was Rs. 79 on the BSE.