Shares of Granules India Ltd. gave up early gains on Thursday, January 8, despite its US-based subsidiary receiving tentative approval from the US drug regulator with 180-day exclusivity for a drug that treats attention deficit hyperactivity disorder (ADHD).

FDA Approval Details

The company's wholly-owned subsidiary Granules Pharmaceuticals Inc. has received the US Food and Drug Administration's tentative approval for its abbreviated new drug application for generic Amphetamine Extended-Release Tablets. The approval covers multiple strengths including 5mg, 10mg, 15mg and 20mg formulations, serving as the generic equivalent of DYANAVEL XR.

Additional ADHD Portfolio Expansion

Granules announced on December 22 that it had received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets in six different strengths: 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg and 18.8mg. This drug serves as the generic equivalent of ADZENYS XR-ODT, also for ADHD treatment.

Strategic Market Position

"Having a product that is eligible for 180-day exclusivity, Granules strongly validates our long-term strategy of building a differentiated portfolio of complex generics," said Krishna Prasad Chigurupati, the chairman and managing director of Granules India.

The 180-day exclusivity period provides Granules with a significant competitive advantage, allowing the company to be among the first to market these generic ADHD treatments before other competitors can enter.

Stock Performance

Shares of Granules India are currently trading little changed on Thursday at ₹611.90. The stock has remained flat over the last 12 months, showing minimal movement despite the regulatory achievements in the ADHD treatment segment.

Granules India has officially scheduled an Extraordinary General Meeting (EGM) for January 22, 2026 at 11:30 AM IST through video conferencing to seek shareholder approval for its comprehensive ₹1,762.50 crore fundraising initiative through preferential allotment.

EGM and Voting Details

The pharmaceutical company has announced detailed procedures for the upcoming EGM, with remote e-voting commencing from January 19, 2026 (9:00 AM IST) and concluding on January 21, 2026 (5:00 PM IST). Shareholders holding shares as of the cut-off date of January 15, 2026 will be eligible to participate in the voting process.

Convertible Warrants Issuance

The board has approved the issuance of up to 2.50 crore convertible warrants at ₹585.00 per warrant, targeting both promoter group and non-promoter investor categories. The warrants are convertible into equivalent equity shares within 18 months from allotment date.

Equity Shares Component

The company will also issue 51.28 lakh fully paid-up equity shares exclusively to non-promoter investors at ₹585.00 per share, raising ₹300.00 crores. The equity shares will be distributed among nine institutional investors including 360 ONE Equity Opportunity Fund, Public Sector Pension Investment Board, and other fund houses.

Investor Allocation and Fund Utilization

The convertible warrants will be allocated among five investors, with Mrs. Chigurupati Uma Devi (Promoter) receiving the majority allocation of 2.49 crore warrants, resulting in a post-issue holding of 12.51%. The fundraising proceeds will be utilized for funding business operations, vendor payments, and general corporate purposes.

Regulatory Compliance and Approvals

The fundraising initiative is subject to regulatory approvals and shareholder consent. The relevant date for the preferential issue under SEBI ICDR Regulations is December 23, 2025. The company has appointed a monitoring agency to oversee the utilization of proceeds exceeding ₹100 crores as per regulatory requirements.

Shareholders can access the complete EGM notice and related documents on the company's website at granulesindia.com. The initiative represents a strategic capital raising approach combining multiple instruments to strengthen the pharmaceutical company's financial position for organic and inorganic growth opportunities.