Marksans Pharma gets USFDA nod for heartburn drug

Written By :  Ruchika Sharma
Contributed By :  Dr. Kamal Kant Kohli
Published On 2025-08-08 06:40 GMT   |   Update On 2025-08-08 06:40 GMT
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MumbaiMarksans Pharma Limited's wholly owned subsidiary, Marksans Pharma Inc., has received final approval from the U.S. Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets, 20 mg (OTC).

This product is bioequivalent to the reference listed drug (RLD), Prilosec Delayed-Release Tablets, 20 mg (OTC), of AstraZeneca Pharmaceuticals LP, NDA - 021229.
Omeprazole is used to treat heartburn and certain other conditions caused by too much acid in the stomach.

Read also: Marksans Pharma arm gets marketing authorization for Oxybutynin hydrochloride 2.5mg/5ml Oral Solution in UK

Marksans Pharma Limited, headquartered at Mumbai, India, is engaged in Research, Manufacturing & 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 product portfolio spreads over major therapeutic segments of CVS, CNS, Anti-diabetic, Pain Management, Gastroenterological and Antiallergies. The company is marketing these products globally.

Read also: Marksans Pharma arm adds Metformin Hydrochloride 500mg/ 5 ml Oral Solution to growing list of UK approved medicines

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