Granules shares gain over 5% on U.S. FDA nod for ADHD generic capsules

Granules India receives FDA approval for generic ADHD drug, expanding portfolio and reinforcing presence in treatment space.

Generic drugmaker Granules has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Attention Deficit Hyperactivity Disorder (ADHD) drug Lisdexamfetamine Dimesylate Capsules in multiple strengths.

The generic drug product is bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, of Takeda Pharmaceuticals U.S.A., Inc., Granules India said on the U.S. FDA approval of the ANDA of subsidiary Granules Pharmaceuticals Inc. (GPI).

The parent company’s shares closed 5.49% higher on Thursday (January 30, 2025) at ₹564.40 on the BSE. U.S. FDA had in December 2024 approved Granules’ Lisdexamfetamine Dimesylate Chewable Tablets. “With the latest approval, we are reinforcing our presence in the ADHD treatment space and strengthening our portfolio of complex generics,” CMD Krishna Prasad Chigurupati said.

Lisdexamfetamine Dimesylate is indicated for treatment of ADHD in adults and children above six years as well as for moderate to severe binge eating disorder (BED) in adults. Granules India now holds 69 ANDA approvals, with 38 secured under its name and the rest under GPI.

EU certificate for Vizag plant

On Wednesday (Jan. 29), Granules India’s said its active pharmaceutical ingredients and finished dosages unit in Anakapally, Visakhapatnam, has received EU GMP certificate. This followed the EU (National Centre For Public Health And Pharmacy, Hungary) Authority audit of the facility (Unit V) in November. The facility manufactures APIs and formulations of oncology and non-oncology products.