SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Granules’ arm secures USFDA’s approval for drug indicated for ADHD treatment

22 Dec 2025 Evaluate

Granules India’s wholly owned subsidiary -- Granules Pharmaceuticals Inc. has secured Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT. 

The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It will be manufactured at the company’s US-based facility located in Chantilly, Virginia. Currently, the market has only one approved generic and one authorised generic, positioning the company favourably to expand access to this critical therapy upon launch. This approval further strengthens the company’s US generics portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

Granules India Share Price

703.55 4.30 (0.61%)
04-May-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1824.10
Dr. Reddys Lab 1287.95
Cipla 1334.85
Zydus Lifesciences 901.65
Lupin 2350.95
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through:

×