New Delhi: Granules India Limited on Monday said its wholly owned US subsidiary, Granules Pharmaceuticals Inc., has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets, used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The product is the generic equivalent of ADZENYS XR-ODT® and will be manufactured at Granules’ US-based facility in Chantilly, Virginia. The tablets will be available in six strengths — 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg — catering to varied patient requirements.
According to IQVIA estimates, the addressable US market for the product is valued at approximately $172 million. The competitive landscape remains limited, with only one approved generic and one authorised generic currently available, providing Granules a favourable entry opportunity once final approval is received.
The tentative approval is subject to the expiry of applicable patents and exclusivity periods. Once commercialised, the product is expected to further strengthen Granules India’s US generics portfolio and enhance its presence in patient-friendly dosage forms and advanced drug delivery technologies.
Granules India has been steadily increasing investments in complex formulations and value-added generics, with the US market continuing to remain a key growth driver for the company.
