Granules’ arm secures USFDA’s approval for drug indicated for ADHD treatment

22 Dec 2025 Evaluate

Granules India’s wholly owned subsidiary -- Granules Pharmaceuticals Inc. has secured Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT. 

The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It will be manufactured at the company’s US-based facility located in Chantilly, Virginia. Currently, the market has only one approved generic and one authorised generic, positioning the company favourably to expand access to this critical therapy upon launch. This approval further strengthens the company’s US generics portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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