Mumbai-Based Pharma Giant Marksans Pharma Triumphs with USFDA Nod for Esomeprazole Magnesium Capsules
In an exciting development, Mumbai-based pharmaceutical powerhouse Marksans Pharma proudly announced on Tuesday that it has secured the highly coveted final approval from the United States Food and Drug Administration (USFDA). This milestone achievement came through its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, now available over-the-counter (OTC).
Esomeprazole, the potent active ingredient found in these capsules, plays a crucial role in the treatment of a variety of stomach and esophagus-related ailments, including acid reflux and ulcers. By effectively reducing the production of stomach acid, it provides much-needed relief from uncomfortable symptoms such as heartburn, difficulties in swallowing, and persistent coughing.
What sets this medication apart is its remarkable ability to heal acid-induced damage to the stomach and esophagus, thereby preventing the formation of ulcers. Furthermore, it holds the promise of reducing the risk of developing oesophageal cancer. Esomeprazole belongs to the esteemed class of drugs known as proton pump inhibitors (PPIs), renowned for their efficacy in managing gastrointestinal distress.
It’s worth noting that this revolutionary product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed-Release Capsules, 20 mg (OTC), manufactured by AstraZeneca Pharmaceuticals LP.
The manufacturing of this groundbreaking product will take place at Marksans Pharma’s state-of-the-art formulation manufacturing facility located in the picturesque setting of Goa, India.
Marksans Pharma, a trailblazer in the realm of pharmaceuticals, is actively engaged in cutting-edge research, precision manufacturing, and strategic marketing of generic pharmaceutical formulations on a global scale. The company proudly operates with a worldwide footprint, boasting manufacturing facilities not only in India but also in the United States and the United Kingdom.
About Marksans Pharma:
Marksans Pharma ships its products to European, Latin American, African, and Oceanic markets. In the realm of research and development, the company’s R&D center is located in Goa and is dedicated to pioneering new drug discovery in the fields of chemistry, pharmacokinetics, pharmacology/molecular biology, toxicology, and associated expertise and support domains.
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