Granules India shares jump as USFDA grants tentative approval with 180-day exclusivity for ADHD drugGranules India shares jump as USFDA grants tentative approval with 180-day exclusivity for ADHD drug

Introduction

Leading pharmaceutical firm receives tentative FDA approval for generic DYANAVEL XR tablets with 180-day exclusivity, targeting ADHD treatment in the U.S. market worth approximately USD 41 million.

Also Read: Lords Mark Industries hits 5% upper circuit after achieving major milestone with 150+ US FDA approvals

Share price movement of Granules India

On January 8, 2026, Granules India Ltd opened at ₹612.50, up 0.03% from its previous close of ₹612.45. The stock reached a high of ₹621.50 (1.50%) and a low of ₹599.45 (-2.13%). By 12:28 PM, it traded at ₹609.50, a -0.48% decrease, with a market cap of ₹14,790.66 crore.

Granules Pharma Gets FDA Approval

Granules Pharmaceuticals, Inc., a subsidiary of Granules India Limited, received tentative approval from the U.S. FDA for generic Amphetamine Extended-Release Tablets, equivalent to DYANAVEL XR®, in 5 mg to 20 mg strengths.

The FDA granted 180-day exclusivity to the Granules ANDA. The product is indicated for ADHD treatment and has an estimated U.S. market size of approximately USD 41 million.

This marks the second recent tentative approval for Granules Pharmaceuticals. Earlier, approval was received for generic ADZENYS XR-ODT® tablets, strengthening its presence in the complex generic ADHD drug market.

Stock performance of Granules India for Period of 1 week, 6 months, and 1 year

Granules India Ltd delivered a -1.33% return over the past week, 30.3% over the past six months, and 0.42% over the past one year.

Also Read: Trident to acquire MyTrident, set to add new wholly owned subsidiary

Shareholding pattern of Granules India

Particulars	Sep 2025	Jun 2025	Mar 2025
Promoter	38.80%	38.80%	38.80%
FII	14.10%	13.20%	15.10%
DII	17.90%	23.50%	22.50%
Public	29.20%	24.40%	23.60%

About Granules India

Granules India Ltd (NSE: GRANULES), incorporated in 1991, is a vertically integrated pharmaceutical company producing APIs, PFIs, FDs, and peptides with global presence in over 80 countries.

Stay Ahead with the Latest Stock Market Updates – Click Here

Disclaimer: The above article is written for educational purposes, and the companies’ data mentioned in the article may change with respect to time. The securities quoted are exemplary and are not recommendatory.

FAQs