Granules Pharmaceuticals Gains FDA Tentative Approval for ADHD Drug
Filing Summary
Granules Pharmaceuticals Inc., a subsidiary of Granules India Limited, has received tentative approval from the U.S. FDA for its generic Amphetamine Extended-Release Orally Disintegrating Tablets, equivalent to ADZENYS XR-ODT®. The product, intended for ADHD treatment, will be manufactured at Granules’ facility in Chantilly, Virginia. The market for this drug is valued at approximately USD 172 million. Currently, there is only one approved generic and one authorized generic in the market. This development aligns with Granules’ strategy to expand its CNS therapeutic portfolio.
Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets. These tablets are the generic equivalent of ADZENYS XR-ODT® and will be available in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and will be manufactured at Granules’ facility in Chantilly, Virginia.
The estimated market size for this ADHD treatment is approximately USD 172 million, according to IQVIA (IMS Health). Currently, the market has only one approved generic and one authorized generic. This positions Granules Pharmaceuticals favorably to expand access to this critical therapy upon launch. The tentative approval is part of Granules’ strategic focus on expanding its portfolio of complex and differentiated generics.
The scope of the approval includes the production of the drug at Granules’ U.S.-based facility. The product is designed to treat ADHD, a commonly diagnosed neurodevelopmental disorder in the United States. The approval underscores Granules’ commitment to improving patient access by delivering high-quality, affordable medications across global markets. The company continues to invest in complex dosage forms and patient-friendly delivery technologies.
The tentative approval from the FDA is a significant step for Granules Pharmaceuticals in enhancing its presence in the central nervous system (CNS) therapeutic area. The company aims to leverage this approval to strengthen its U.S. generics portfolio. The approval aligns with Granules’ ongoing investments in value-driven healthcare solutions.
The timeline for the product’s market launch will depend on the final approval from the FDA. Granules Pharmaceuticals will continue to work closely with regulatory authorities to ensure compliance and readiness for market entry. The manufacturing facility in Chantilly, Virginia, is equipped to meet the production requirements for the approved drug.
Granules India Limited is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company is involved in the manufacturing of the entire pharmaceutical value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Granules India distributes its products to over 300 customers in regulated and semi-regulated markets, with a presence in more than 80 countries. The company operates 11 manufacturing facilities, with regulatory approvals from multiple international agencies.