Granules India announced its US subsidiary has received marketing approval from the U.S. Health Regulator (FDA) for DexmethylphenidateHCI extended-release capsules for the treatment of attention-deficit hyperactivity disorder. Granules' capsule product is bioequivalent to the reference listed drug (RLD), Focalin™ XR.

The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia.

Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2tentative approvals).

Powered by Capital Market - Live News

The counter trades near its all time high of Rs 383.70 hit on 10 September 2020. The stock is up 306% from its 52-week low of Rs 93 touched on 15 October 2019.

Granules India before market hours today said its US based subsidiary has received marketing approval for Dexmethylphenidate HCl extended-release capsules for the treatment of attention-deficit hyperactivity disorder (ADHD) from the US Health Regulator (FDA). Granules' capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.

The drug will be manufactured at its manufacturing facility in Chantilly, Virginia. According to IQVIA Health, Dexmethylphenidate HCI ER Capsules had US sales of approximately $556 million for the most recent twelve months ending in July 2020 (As per IQVIA MAT July 2020).

Commenting on the development, Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals Inc. said the approval of Dexmethylphenidate XR is a good addition to the company's portfolio. It will be launching the product in the US market soon.

Granules is a vertically integrated pharmaceutical company, headquartered in Hyderabad, India. It produces Finished Dosages (FDs), Pharmaceutical Formulation intermediates (PFls) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice.

Powered by Capital Market - Live News

Granules India in a regulatory filing announced that Ramelteon tablets are bioequivalents to the reference listed drug product (RLD), Rozerem tablets of Takeda Pharmaceuticals U.S.A., Inc. Ramelteon tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.

Granules said has a total of 29 ANDA approvals from US FDA (27 final approvals and 2 tentative approvals). According IQVIA Health, Ramelteon Tablets had a US sales of approximately $33 million MAT for the most recent twelve months ending in June 2020.

Granules India is a growing pharmaceutical manufacturing company. It produces Finished Dosages (FDs), Pharmaceutical Formulation intermediates (PFls) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice.

Powered by Capital Market - Live News

Granules India announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India for Ramelteon Tablets, 8 mg. It is bioequivalent to the reference listed drug product (RLD), Rozerem Tablets, 8 mg, of Takeda Pharmaceuticals U.S.A., Inc. Ramelteon Tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.

Granules now has a total of 29 ANDA approvals from US FDA (27 Final approvals and 2 tentative approvals).

Ramelteon Tablets had U.S. sales of approximately $33 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health.

Rozerem® is a trademark of Takeda Pharmaceutical Company

Powered by Capital Market - Live News