Last Updated on October 15, 2024 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:
- Short-term treatment of heartburn and related symptoms associated with Gastroesophageal Reflux Disease (GERD).
- Reducing the risk of gastric ulcers associated with nonsteroidal anti-inflammatory drugs (NSAID) in adults at risk of developing such ulcers.
- Eradicating helicobacter pylori to lower the risk of duodenal ulcer recurrence, often in combination with amoxicillin and clarithromycin.
- 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.
USFDA Approval: USFDA Approval granted for Apremilast Tablets
USFDA tentative approval granted for Apalutamide tablets
USFDA approval granted for this inflammatory bowel disease drug
USFDA Approved Weight Loss Drugs: A Comprehensive Guide
European regulator warns EU, UK about fake Ozempic Injection
NABL certification procedure for Laboratories
Phytopharmaceuticals: A New Era in Natural Medicine for Indian Pharma
Formaldehyde in Hair Products: USFDA Proposed Ban
Drug recall: These OTC Drugs and Medical Devices recalled
USFDA issued OAI Status to Biocon Subsidiary
USFDA Approval: USFDA Approval granted for Apremilast Tablets
Drug recall: Sun Pharma subsidiary recalls this Anti-depression drug
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Drug recall: This Nasal Spray recalled due to Microbial Contamination
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
