Marksans Pharma Ltd has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC). This product, which is bioequivalent to the reference listed drug (RLD) Nexium 24 HR Delayed-Release Capsules, 20 mg (OTC) by AstraZeneca Pharmaceuticals LP, is used to treat stomach and esophagus issues such as acid reflux and ulcers.
Esomeprazole works by reducing stomach acid production, and alleviating symptoms such as heartburn, swallowing difficulties, and coughing. It aids in healing acid-related damage to the stomach and oesophagus, helps prevent ulcers, and is anticipated to contribute to oesophagal cancer prevention. Esomeprazole belongs to the class of drugs known as proton pump inhibitors (PPIs).
The capsule will be manufactured at the company’s formulation manufacturing facility in Goa, India.
Marksans Pharma Ltd, headquartered in Mumbai, is engaged in research, manufacturing, and marketing of generic pharmaceutical formulations in global markets. The company’s manufacturing facilities in India, the US, and the UK are approved by leading regulatory agencies, including USFDA, UKMHRA, and Australian TGA.
Shares of the company were down by 0.86 per cent at Rs 109 at 11.40 am on the BSE.