Granules India Limited announced that its wholly owned subsidiary Granules Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its second generic ADHD medication within weeks. The latest approval, announced on January 8, 2026, covers generic Amphetamine Extended-Release Tablets with 180-day exclusivity, marking a significant milestone in the company's central nervous system therapeutic expansion.

Latest FDA Approval with Market Exclusivity

The recent tentative approval covers generic Amphetamine Extended-Release Tablets in four strengths, positioning it as the generic equivalent of DYANAVEL XR. The FDA has determined that Granules' ANDA is eligible for 180-day exclusivity, providing the company with a competitive advantage in this specialized market segment.

Previous ADHD Drug Approval

Granules previously received tentative approval on December 22, 2025, for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT. This earlier approval covers six different strengths and targets a significantly larger market opportunity.

Strategic Market Positioning

Both products are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), positioning Granules to serve different segments of this therapeutic market. The combined market opportunity of approximately USD 213.00 million demonstrates the company's strategic focus on high-value, complex generic formulations with limited competition.

Management Commentary and Strategic Vision

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, emphasized that having a product eligible for 180-day exclusivity strongly validates Granules' long-term strategy of building a differentiated portfolio of complex generics. He highlighted that this achievement reinforces the company's commitment to strengthening its presence in the central nervous system therapeutic space while enhancing value creation in the U.S. generics market.

The consecutive approvals within weeks demonstrate Granules' expanding capabilities in complex formulation development and regulatory execution, reinforcing the company's ability to identify, develop, and progress technically challenging products that deliver meaningful differentiation and long-term value in the U.S. generics market.

Granules India Limited has announced that its wholly-owned subsidiary, Granules Life Sciences Private Limited (GLS), has successfully concluded a Good Manufacturing Practices (GMP) and Prior Approval Inspection by the U.S. Food and Drug Administration (FDA). The inspection resulted in five procedural observations, with no concerns raised regarding data integrity or product safety standards.

Inspection Timeline and Scope

The FDA inspection was conducted from December 15 to 19, 2025, at the Granules Life Sciences facility located in Hyderabad (FEI: 3030495702). The inspection focused on the facility engaged in manufacturing PFI Finished Dosages, representing a comprehensive evaluation of the company's pharmaceutical manufacturing operations.

Inspection Outcome

The inspection concluded with five observations related to procedural requirements. None of these observations are associated with data integrity or product safety issues, which are among the most critical areas evaluated during pharmaceutical inspections.

Company Response and Commitment

Granules India has committed to addressing the observations promptly and will submit its response to the US FDA within the stipulated timeframe. This approach demonstrates the company's dedication to maintaining regulatory compliance and addressing any procedural improvements identified during the inspection.

Regulatory Significance

The completion of the FDA inspection with only procedural observations reflects positively on Granules Life Sciences' manufacturing standards and quality control processes. The absence of data integrity or product safety issues is particularly significant, as these areas represent core regulatory requirements that directly impact product quality and patient safety in pharmaceutical manufacturing operations.