SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Granules India gets USFDA’s approval for Esomeprazole Magnesium Delayed-Release Capsules

19 Oct 2023 Evaluate

Granules India has received US Food & Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Granules now have a total of 62 ANDA approvals from the USFDA (60 final and 2 tentative approvals). The current annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 Million, according to MAT Jul 2023, IQVIA/IMS Health.

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

889.55 8.40 (0.95%)
10-Jul-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma. Inds. 1935.25
Dr. Reddys Labs. 1245.50
Cipla 1438.75
Zydus Lifesciences 1150.50
Lupin 2496.05
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: