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23 Dec 2025
Admin
News Article

Granules Pharma Secures US FDA Tentative Approval for ADHD Generic

Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received tentative approval from the US FDA for its amphetamine extended-release orally disintegrating tablets.

This product is the generic equivalent of Adzenys XR-ODT, used in the treatment of attention deficit hyperactivity disorder (ADHD).

What the FDA Tentative Approval Covers?

The approval applies to multiple strengths, improving dosing flexibility and patient compliance.

Approved strengths include:

3.1 mg
6.3 mg
9.4 mg
12.5 mg
15.7 mg
18.8 mg

The product will be manufactured at Granules’ US-based facility in Chantilly, Virginia.

Why This Approval Matters?

The current US market is limited, with:

Only one approved generic
One authorized generic

This creates a favourable competitive window for Granules once final approval is granted.

For patients, this means:

Greater access to ADHD treatment
Increased affordability
More supply reliability

Strategic Focus on CNS and Complex Generics

Granules continues to build its portfolio around complex and differentiated generic products, especially in central nervous system (CNS) therapies.

Commenting on the milestone, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, said the approval reinforces Granules’ long-term strategy in CNS medicines.

ADHD remains one of the most commonly diagnosed neurodevelopmental disorders in the United States, affecting millions globally.

Strengthening Granules’ US Generics Portfolio

This tentative approval highlights Granules’ continued investments in:

Complex dosage forms
Patient-friendly delivery technologies
Value-driven healthcare solutions

It also strengthens the company’s position as a reliable supplier in the US generics market.

About Granules India Limited

Founded in 1991, Granules India Limited is a vertically integrated pharmaceutical company headquartered in Hyderabad.

The company operates best-in-class manufacturing facilities and focuses on:

Operational excellence
Quality-driven manufacturing
Global customer partnerships

Granules remains committed to improving patient access through high-quality, affordable medicines worldwide.

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