Granules Pharmaceuticals Inc, a wholly owned subsidiary of Granules India Limited, has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application covering Amphetamine Extended-Release Orally Disintegrating Tablets. The approval applies to multiple dosage strengths—3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg—which are the generic equivalents of ADZENYS XR-ODT®. The product will be manufactured at the company’s facility in Chantilly, Virginia.
The medication is prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and addresses a US market estimated at approximately USD 172 million, based on IQVIA data. At present, the market has only one approved generic and one authorised generic, offering Granules a favourable entry opportunity upon final approval.
Dr Krishna Prasad Chigurupati, Chairman and Managing Director, said the tentative approval aligns with the company’s strategy to expand its portfolio of complex and differentiated generics, particularly within the central nervous system therapeutic space. He added that Granules remains focused on improving access to high-quality and affordable treatments across global markets. The approval further enhances Granules’ US generics pipeline and reflects its continued investments in advanced dosage forms and patient-centric drug delivery technologies.
Founded in 1991 and headquartered in Hyderabad, Granules India Limited is a vertically integrated pharmaceutical company with operations spanning APIs, PFIs, finished dosages, and peptide CDMO services. The company operates 11 manufacturing facilities across India, the United States, and Switzerland, and supplies products to over 300 customers in more than 80 countries. Granules holds regulatory approvals from major global agencies including the USFDA, EU GMP, EDQM, WHO, TGA, and KFDA.
