Granules shares rise 5% on US FDA nod for ADHD treatment drug

The stock has rallied 86 per cent in the past three months as compared to 13.5 per cent rise in the S&P BSE Sensex

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.

Granules now has a total of 30 ANDA approvals from the US FDA out of which 28 are final approvals and 2 tentative approvals.

According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had US sales of approximately $556 million for the most recent twelve months ending in July 2020.

Granules India's stock hit a record high of Rs 384 on Thursday. In the past three months, it has rallied 86 per cent, as compared to 13.5 per cent rise in the S&P BSE Sensex.

On August 22, Granules India had announced that its subsidiary company Granules Pharmaceuticals Inc had received approval from the US Food & Drug Administration (US FDA) for Ramelteon Tablets 8 mg, a bioequivalent to the reference listed drug product (RLD), Rozerem Tablets, 8 mg, of Takeda Pharmaceuticals USA.

"Ramelteon Tablets are used for the treatment of insomnia characterised by difficulty with sleep onset. Ramelteon Tablets had US sales of approximately $33 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health," it said.

At 09:21 am, the stock was trading 2 per cent higher at Rs 367 on the BSE, against 0.18 per cent gain in the Sensex. A combined 696,000 equity shares have changed hands on the counter on the NSE and BSE, so far.