Granules India Share Price In Focus After Tentative USFDA Approval For ADHD Drug

Granules India share price is in the spotlight today after its US subsidiary, Granules Pharmaceuticals Inc., received tentative approval from the US Food and Drug Administration (USFDA) for an ADHD treatment.

The stock had ended the previous session slightly higher, gaining 0.3% to close at ₹583.3 per share.

Details of the USFDA Approval

The USFDA has given tentative approval to Granules’ abbreviated new drug application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets, which are used to treat attention deficit hyperactivity disorder (ADHD).

The medicine will be manufactured at the company’s facility in Chantilly, Virginia. According to IQVIA data, the US market for this drug is estimated to be around $172 million for the 12 months ending November.

Currently, the market has only one approved generic and one authorised generic, which could give Granules a good opportunity once final approval is received.

Management commentary

Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said the tentative approval supports the company’s strategy of building a portfolio of complex and differentiated generic medicines. He added that ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the US.

USFDA Inspection At Hyderabad Unit

In a separate update, Granules India informed that its Hyderabad facility received a USFDA Form 483 with 5 observations after an inspection conducted from December 15 to December 19, 2025.

The company clarified that these observations are related to procedural issues and do not involve data integrity or product safety concerns.

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Granules India Share Price Performance

As of market open on Monday, December 22, 2025, Granules India share price (NSE: GRANULES) was trading at around ₹581.70 on the NSE, slightly below its previous close of ₹583.40. The stock opened the day at ₹585.00 and moved within a range of ₹580.90 to ₹589.20 during early trade. Over the past year, the stock has touched a 52-week high of ₹621.10 and a 52-week low of ₹422.00.

Conclusion

Granules India’s tentative USFDA approval for an ADHD drug is a positive development that strengthens its presence in the central nervous system segment. While regulatory observations remain to be addressed, the company’s focus on complex generics and US compliance continues to support its long-term growth plans.

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