Marksans Pharma gets USFDA approval for Esomeprazole Magnesium Capsules

Mumbai-headquartered pharma company Marksans Pharma announced on Tuesday that it has received final 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).

Esomeprazole, the active ingredient in these capsules, is used for treating various stomach and oesophagus-related issues, such as acid reflux and ulcers. It operates by reducing the production of stomach acid, and providing relief from symptoms such as heartburn, swallowing difficulties, and coughing.

Moreover, this medication also heals acid-induced damage to the stomach and oesophagus, preventing ulcers, and is expected to help in reducing the risk of oesophageal cancer. Esomeprazole belongs to the class of drugs known as proton pump inhibitors (PPIs).

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed-Release Capsules, 20 mg (OTC), of AstraZeneca Pharmaceuticals LP.

The product will be manufactured at Marksans Pharma's formulation manufacturing facility in Goa, India.

Marksans Pharma operates in the research, manufacturing, and marketing of generic pharmaceutical formulations in global markets. The company has manufacturing facilities in India, the USA, and the UK.