Granules India Limited has informed the Exchange regarding a press release dated December 22, 2025, titled "Granules Pharmaceuticals Inc. Receives FDA Tentative Approval for Generic Amphetamine Extended-Release Orally Disintegrating Tablets (ADZENYS XR-ODT®)".
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Awaiting price reaction for this filing.
Granules India Limited's US subsidiary, Granules Pharmaceuticals Inc., has received tentative approval from the US FDA for its generic version of Amphetamine Extended-Release Orally Disintegrating Tablets, which is the generic equivalent of the branded drug ADZENYS XR-ODT®. This product is used in the treatment of ADHD (Attention Deficit Hyperactivity Disorder). Tentative approval means the FDA has found the generic version to be safe and effective, but final approval and market launch may be delayed due to existing patent or exclusivity rights held by the brand owner. The tentative approval paves the way for Granules to enter the US generic market once those barriers are cleared.
Positive for long-term growth as it strengthens Granules' US generics pipeline, but immediate revenue impact is limited until final approval and launch. May modestly boost investor sentiment around the company's regulatory track record.