USFDA approval granted for Esomeprazole Magnesium Capsules: Granules

With this recent approval, Granules now boasts an impressive total of 62 ANDA approvals from the USFDA.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

USFDA approval

In a significant stride towards providing effective healthcare solutions, Granules India Limited has achieved USFDA approval.

The US Food & Drug Administration (USFDA) recently granted its seal of approval to the abbreviated new drug application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP in both 20mg and 40mg formulations.

This breakthrough is a testament to Granules’ unwavering commitment to advancing pharmaceuticals and ensuring patient well-being.

A Closer Look at Esomeprazole Magnesium Capsules

Esomeprazole Magnesium capsules play a pivotal role in managing a spectrum of gastrointestinal conditions. The capsules are specifically designed for:

  1. Short-term treatment of heartburn and related symptoms associated with Gastroesophageal Reflux Disease (GERD).
  2. Reducing the risk of gastric ulcers associated with nonsteroidal anti-inflammatory drugs (NSAID) in adults at risk of developing such ulcers.
  3. Eradicating helicobacter pylori to lower the risk of duodenal ulcer recurrence, often in combination with amoxicillin and clarithromycin.
  4. Providing long-term relief for pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

This wide-ranging utility underscores the versatility and effectiveness of Esomeprazole Magnesium capsules.

Equivalent Excellence

Granules’ Esomeprazole Magnesium Delayed-Release Capsules stand out for being not only bioequivalent but also therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20mg and 40mg, manufactured by AstraZeneca Pharmaceuticals LP.

This equivalence underscores the quality and efficacy of Granules’ product, ensuring patients receive the best care possible.

A Track Record

With this recent approval, Granules now boasts an impressive total of 62 ANDA approvals from the USFDA.

Among these, 60 are final approvals and two are tentative. This impressive track record is a testament to Granules’ dedication to pushing boundaries in pharmaceutical innovation.

Market Impact

The Esomeprazole Magnesium Capsules, now USFDA-approved, are poised to make a significant impact in the pharmaceutical market.

The current annual market for these capsules in the United States is estimated to be around $168 million, according to data from July 2023 by IQVIA/IMS Health.

This promising figure underscores the potential for Granules’ product to address a critical healthcare need.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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