Industry

USFDA approval granted Esomeprazole Magnesium DR Capsules

USFDA approval: The USFDA has granted approval for Esomeprazole capsules, which are to be produced at Marksans Pharma's manufacturing facility at Goa, India.

The Health Master

October 8, 2023

USFDA Drug product Approval — USFDA Approval

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Last Updated on December 24, 2023 by The Health Master

USFDA approval

In a significant milestone, Marksans Pharma has secured final USFDA approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC).

This USFDA approval signifies a crucial step in the journey of regulatory compliance and consulting for the company.

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Understanding Esomeprazole Magnesium Delayed-Release Capsules:

Esomeprazole: A Solution for Stomach and Esophagus Problems

Esomeprazole, the active ingredient in Marksans Pharma’s capsules, is a vital medication aimed at addressing various stomach and esophagus-related issues, including acid reflux and ulcers.

It functions by reducing the production of acid in the stomach, thereby alleviating symptoms like heartburn, swallowing difficulties, and coughing.

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Beyond symptomatic relief, this medication plays a pivotal role in healing acid-induced damage to the stomach and esophagus, as well as in the prevention of ulcers and esophageal cancer.

Categorized as a proton pump inhibitor (PPI), Esomeprazole falls under a class of drugs known for their efficacy in managing acid-related conditions.

Comparative Analysis:

Bioequivalence to Reference Listed Drug (RLD)

Marksans Pharma’s Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC) have been established as bioequivalent to the Reference Listed Drug (RLD), Nexium 24 HR Delayed Release Capsules, 20 mg (OTC), marketed by AstraZeneca Pharmaceuticals LP.

This recognition of bioequivalence underscores the product’s efficacy and safety in delivering therapeutic benefits akin to the well-established reference drug.

Manufacturing Hub:

Goa, India: Pioneering Formulation Manufacturing

The USFDA approval has granted Esomeprazole capsules, which are slated to be produced at Marksans Pharma’s state-of-the-art formulation manufacturing facility located in Goa, India.

This facility stands as a testament to the company’s commitment to adhering to high-quality production standards and regulatory compliance.

A Glimpse into the USFDA Drug Approval Process:

The USFDA drug approval process is a multifaceted journey that pharmaceutical companies embark on to bring their products to market.

Key milestones in this process include:

New Drug Application (NDA) Process: This process involves the submission of comprehensive data on the safety and efficacy of the new drug.
Generic Drug Approval Pathway: Generic drugs, like Marksans Pharma’s Esomeprazole capsules, must demonstrate bioequivalence to the reference drug.
Expedited Programs: The USFDA offers various expedited review programs, such as Fast Track Designation, Breakthrough Therapy Designation, Priority Review Process, and Accelerated Approval Process.
Orphan Drug Designation Process: For drugs targeting rare diseases, this designation offers incentives for development.
Advisory Committee Review: Expert panels evaluate the safety and effectiveness of the drug.
Post-Market Surveillance: Continual monitoring of a drug’s safety and efficacy after it reaches the market

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.