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Zydus Cadila gets USFDA’s tentative approval for Esomeprazole Capsules
Jan-21-2019

Zydus Cadila has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Esomeprazole Magnesium Delayed-Release Capsules (US RLD - NEXIUM). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

Esomeprazole belongs to the group of medicines termed as proton pump inhibitors. Esomeprazole reduces the amount of acid secreted by the stomach. The drug is used to treat the symptoms of gastroesophageal reflux disease, to reduce the risk of stomach ulcers in some people taking pain medicines, treat patients with stomach infection (Helicobacter pylori) along with certain antibiotics and long-term treatment of conditions where stomach makes too much acid.

The group now has 247 approvals and has so far filed over 330 ANDAs since the commencement ofthe filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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