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 Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets. This development marks a significant milestone in the company's expansion into the central nervous system therapeutic area.

FDA Approval Details

The tentative approval covers six different strengths of the medication, positioning it as the generic equivalent of ADZENYS XR-ODT. The approved product will be manufactured at Granules' U.S.-based facility located in Chantilly, Virginia, demonstrating the company's commitment to maintaining high-quality manufacturing standards in regulated markets.

Market Opportunity and Competitive Landscape

The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and targets an estimated market size of approximately USD 172.00 million according to IQVIA (IMS Health). The current market dynamics present a favorable opportunity for Granules, as there is currently only one approved generic and one authorized generic in this therapeutic segment. This limited competition positions the company advantageously to expand patient access to this critical therapy upon commercial launch.

Strategic Significance

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, emphasized that this tentative approval reaffirms Granules' strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system therapeutic area. He highlighted that ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States, impacting hundreds of millions of people worldwide.

Company Portfolio Enhancement

This approval further strengthens Granules' U.S. generics portfolio and underscores the company's continued investments in several key areas. The tentative approval represents another step in Granules India's commitment to improving patient access to essential medications while expanding its footprint in specialized therapeutic areas.

The company's focus on complex generics and differentiated products continues to drive its growth strategy in regulated markets, particularly in the United States where it maintains manufacturing capabilities and regulatory expertise.

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.