Shares of Granules India rallied Five p.c to Rs 378 at the BSE on Friday after the corporate introduced that its US subsidiary has won advertising and marketing approval from the America Health Regulator (FDA) for Dexmethylphenidate HCl extended-release pills for the remedy of attention-deficit hyperactivity dysfunction. Granules’ tablet product is bioequivalent to the reference indexed drug (RLD), Focalin XR, it mentioned.

The drug shall be manufactured on the Granules production facility in Chantilly, Virginia, Granules mentioned in an alternate submitting.

Granules now have a complete of 30 ANDA approvals from America FDA out of which 28 are ultimate approvals and a pair of tentative approvals.

According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had US gross sales of roughly $556 million for the latest 12 months finishing in July 2020.

Granules India’s inventory hit a document top of Rs 384 on Thursday. In the previous 3 months, it has rallied 86 p.c, as in comparison to 13.Five p.c upward thrust within the S&P BSE Sensex.

On August 22, Granules India had introduced that its subsidiary corporate Granules Pharmaceuticals Inc had won approval from America Food & Drug Administration (US FDA) for Ramelteon Tablets eight mg, a bioequivalent to the reference indexed drug product (RLD), Rozerem Tablets, eight mg, of Takeda Pharmaceuticals USA.

“Ramelteon Tablets are used for the treatment of insomnia characterized 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 mentioned.

At 09:21 am, the inventory was once buying and selling 2 p.c upper at Rs 367 at the BSE, in opposition to 0.18 p.c acquire within the Sensex. A mixed 696,000 fairness stocks have modified arms at the counter at the NSE and BSE, up to now.

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