Granules India Receives USFDA Tentative Approval for Generic ADHD Medication

Granules India Ltd has announced a regulatory milestone for its US subsidiary after receiving tentative approval from the US Food and Drug Administration.

The approval relates to a generic version of an ADHD medication and strengthens the company’s presence in the US generics market. The development was disclosed through a regulatory filing on Thursday.

Details of the USFDA Approval

Granules India stated that its wholly owned subsidiary, Granules Pharmaceuticals, Inc, has received tentative approval from the USFDA for its abbreviated new drug application (ANDA). 

The approval covers amphetamine extended-release tablets intended for the treatment of attention deficit hyperactivity disorder (ADHD).

The tablets have been approved in strengths of 5 mg, 10 mg, 15 mg, and 20 mg.

Reference Listed Drug and Market Opportunity

The approved product is the generic equivalent of DYANAVEL XR. According to the company, the ADHD treatment segment targeted by this product has an estimated market size of around $41 million, offering scope for commercial opportunity once final approval is granted.

Eligibility for 180-Day Exclusivity

Granules India highlighted that the ANDA has been found eligible by the USFDA for 180-day marketing exclusivity. This exclusivity period can allow the company to market the generic product with limited competition for a defined timeframe, subject to regulatory conditions.

Company Commentary on the Development

In its filing, Granules India noted that the approval reflects its expanding capabilities in developing and commercialising complex and differentiated generic products for the US market. The company views this as part of its broader strategy to strengthen its product portfolio in regulated markets.

Granules India Share Price Performance

Shares of Granules India Limited were trading slightly lower during afternoon trade on January 8. At around 3:10 PM, the stock was priced at ₹608.00, down ₹2.95 or 0.48%. The stock opened at ₹613.90 and moved between an intraday high of ₹621.80 and a low of ₹599.75. The previous close stood at ₹610.95.

Read More: NALCO Shares Fall on Jan 8, 2026 After Four-Day Rally Amid Weakness in Metals.

Conclusion

The tentative USFDA approval for Granules India’s generic ADHD medication marks a regulatory step forward for the company’s US operations. While commercialisation will depend on final approval, the development adds to Granules India’s growing pipeline of products in the regulated generics space.

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