India’s Zydus Lifesciences receives Final Clearance from US-FDA for Esomeprazole; Product will be manufactured at Moraiya facility

On Thursday, June 8, Indian pharmaceutical company Zydus Lifesciences Limited received final approval from the United States Food and Drug Administration (USFDA) for Esomeprazole Magnesium for Delayed-Release Oral Suspension 20 mg and 40 mg.

Pharmaceutical tablets and capsules are arranged on table in photo illustration
Pharmaceutical tablets and capsules. Meel Bijendra/Agrika/illustration

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Zydus Lifesciences Limited formerly known as Cadila Healthcare Limited was renamed in 2022 and is primarily engaged in manufacturing generic drugs. In addition, Starting in late 2015, Zydus Lifesciences also manufactures generics for hepatitis C treatment after signing a voluntary license agreement with Gilead.

Zydus Lifesciences explains “Esomeprazole is used to treat certain problems of stomach and esophagus like acid reflux and ulcers which works by reducing the amount of acid made in the stomach”. As of April 2023, annual sales in the United States for Esomeprazole Magnesium, 20 mg and 40 mg for Delayed-Release Oral Suspension were US$42 million.

In 2020 Zydus Cadila’s drug Decidustat got US-FDA approval to start clinical trials on cancer patients and Zydus Lifesciences claims Esomeprazole drug helps heal acid damage in stomach and esophagus, prevent ulcers and helps prevent cancer of the esophagus.

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Zydus has 4 manufacturing facilities in India located at Ankleshwar, Vadodara and Ahmedabad to manufacture active pharmaceutical ingredients. The Esomeprazole Magnesium for Delayed-Release Oral Suspension 20 mg and 40 mg products will be manufactured at the group’s manufacturing facility in Moraiya, Ahmedabad (India).

Zydus Lifesciences develops and manufactures a wide range of diagnostics, herbal products, skincare products and other Over-the-counter (OTC) products in India and the company currently holds 370 approvals and has filed 442 Abbreviated new drug applications (ANDAs) since April 2004.

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