Granules India arm gets tentative approval from US drug regulator for drug used in treating ADHD
Published on 22/12/2025 08:48 AM
Granules India arm gets tentative approval from US drug regulator for drug used in treating ADHDThe US Food and Drug Administration (USFDA) has given its tentative approval for the company's abbreviated new drug application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in the 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg and 18.8mg strengths. It is the generic equivalent of ADZENYS XR-ODT.By Shloka Badkar December 22, 2025, 8:48:47 AM IST (Published)2 Min ReadShares of Granules India Ltd. are in focus on Monday, December 22, after the company said its wholly-owned subsidiary Granules Pharmaceuticals Inc. received tentative approval from the US drug regulator for tablets to treat attention deficit hyperactivity disorder (ADHD).
The US Food and Drug Administration (USFDA) has given its tentative approval for the company's abbreviated new drug application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in the 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg and 18.8mg strengths. It is the generic equivalent of ADZENYS XR-ODT.
The same will be manufactured in Granules facility in Chantilly, Virginia in the United States.
The product has an estimated market size of around $172 million as per IQVIA (IMS Health) data for the 12-months that ended in November, Granules said.
At present, the market has only one approved generic and one authorised generic, it added.
"The tentative approval of this ANDA reaffirms Granules' strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system therapeutic area. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide," the company's chairman and managing director Krishna Prasad Chigurupati said.
One of Granules India's units in Hyderabad also received a form 483 from the USFDA with five observations, the company disclosed in a separate filing.
Shares of Granules India Ltd. ended the previous session 0.3% up at ₹583.3 apiece. The stock has gained 17.3% in the last six months but has declined 2.4% this year, so far.
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