THD NewsDesk, Mumbai: The announcement of the USFDA’s approval for Dexmethylphenidate HCI release capsules, used in the treatment of ADHD (attention-deficit hyperactivity disorder) has hiked the shares of Granules India by 5%. The shares have rallied to Rs. 378 on the BSE on Friday, the 12th of September.
The Granule-capsule has come to be known as a bioequivalent to Focalin XR (a reference listed drug, RLD). The manufacturing of the drug will be executed in Chantilly, Virginia, at the Granules manufacturing facility, as per the data of an exchange filing.
The total count of ANDA approvals from the US FDA for Granules now has come to 30. 28 of the 30 are reported as final approvals while 2 remain tentative.
Granules India’s stock hit the highest of RS. 384 on Thursday. Stocks surged 86% in the past three months, as compared to 13.5% in the S&P BSE Sensex. With a 2% lead at Rs. 367 on the BSE, the stock was trading at 0.18% in the Sensex.
The company’s subsidiary ‘Granules Pharmaceuticals Inc’ was granted the US FDA approval for Ramelten Tablets 8mg, a bioequivalent of Rozerem Tablets, 8mg (reference listed drug, Takeda Pharmaceuticals, USA) just recently, on the 22nd of August.
“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,” said the report. “A total of 696,000 equity shares have changed hands on the counter on the NSE and BSE, so far.”
