Sunday, 17 February 2019

Zydus gets tentative USFDA approval for acid reflux capsules

22 January 2019 | News

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

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The company has received the tentative approval from the 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 of the filing process in FY 2003-04.

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