Granules spurts after USFDA nod for ADHD drug

Granules India gained 4.68% to Rs 378 after the pharmaceutical company announced that its US subsidiary has received marketing approval from the USFDA for Dexmethylphenidate HCI extended-release capsules.

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.

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