Marksans Pharma bags USFDA nod for Esomeprazole Magnesium Delayed Release Capsules
Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux and ulcer).
Mumbai: Marksans Pharma Limited has announced that the Company has received final approval from US Food & Drugs Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC).
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed-Release Capsules, 20mg (OTC), of AstraZeneca Pharmaceuticals LP.
Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux and ulcer). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers and is expected to help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).
The product will be manufactured at the Company's formulation manufacturing facility in Goa, India.
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Marksans Pharma Limited, headquartered in Mumbai, India, is engaged in Research, Manufacturing and marketing of generic pharmaceutical formulation in the global markets. The company's manufacturing facilities located in India, USA and UK are approved by several leading regulatory agencies including USFDA, UKMHRA and Australian TGA. The company's robust product portfolio spreads over major therapeutic segments of CVS, CNS, Antidiabetic, Pain Management, Gastroenterological and Anti-allergies. The company is marketing these products globally.
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