Granules India Limited announced that its US-based subsidiary, Granules Pharmaceuticals Inc., has received tentative approval from the US Food and Drug Administration (USFDA) for a medication used in the treatment of attention deficit hyperactivity disorder (ADHD). The development has drawn attention to the company’s stock, which closed the previous trading session marginally higher at ₹583.3 per share.
Details of the Regulatory Approval
The USFDA granted tentative approval to the company’s abbreviated new drug application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets. The product is indicated for the treatment of ADHD and will be manufactured at Granules’ facility in Chantilly, Virginia.
Based on IQVIA data, the US market size for this product is estimated at approximately $172 million for the 12-month period ending November. At present, the market includes one approved generic product and one authorised generic.
Management Statement
Commenting on the approval, Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, stated that the tentative clearance aligns with the company’s focus on developing complex and differentiated generic formulations. He also noted that ADHD is among the most commonly diagnosed neurodevelopmental disorders in the United States.
USFDA Inspection Update
In a separate disclosure, Granules India reported that its Hyderabad manufacturing unit underwent a USFDA inspection from December 15 to December 19, 2025. Following the inspection, the facility received a Form 483 with five observations. The company clarified that the observations pertain to procedural matters and do not relate to data integrity or product safety.
Summary
Granules India’s US subsidiary has obtained tentative USFDA approval for an ADHD medication to be manufactured in Virginia. The company also disclosed that its Hyderabad facility received a Form 483 with five procedural observations after a recent USFDA inspection, with no data integrity or product safety issues reported.
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