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Esomeprazole Magnesium Dihydrate API

Cas Number : 217087-10-0
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Regulatory Documentation
CEP/USDMF
Category
Commercially available/Generic APIs
Therapeutical Use
Anti-Ulcer
Gastro-Intestinal
Disorder Treatment

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About Esomeprazole Magnesium Dihydrate API

Esomeprazole Magnesium Dihydrate API has been developed at Minakem’s French facility in Dunkerque (formerly AstraZeneca’s legacy facility) for over 10 years.
Esomeprazole Magnesium Dihydrate API CAS number is 217087-10-0

From a regulatory perspective, Minakem offers:

  • An American DMF (Drug Master File) #34026
  • A European DMF (CEP 2015-086)

Minakem’s Esomeprazole Magnesium Dihydrate API brings:

  • Annual production capacity over 200 MT
  • Micronised grade to facilitate your formulation
  • Strong OTIF reliability
  • Always a safety stock available

Therapeutical Class and Mechanism of Action

Esomeprazole magnesium is a proton pump inhibitor (PPI), used primarily in the treatment of gastroesophageal reflux disease (GERD), gastric ulcers, and other conditions related to excess stomach acid production.

Esomeprazole magnesium works by inhibiting the proton pump (H+/K+ ATPase) in the parietal cells of the stomach.
This enzyme is responsible for the final step in the production of gastric acid. The mechanism involves the following:

  • Inhibition of Acid Secretion
  • Reduction of Gastric Acid Production
  • Symptom Relief and Healing

About Minakem Dunkerque’s Expertise

Minakem Dunkerque has been manufacturing Active Pharmaceutical Ingredients (APIs) for over 30 years. The site, formerly AstraZeneca’s legacy API facility, is dedicated to the production of esomeprazole, omeprazole, and budesonide APIs.

The site has extensive expertise in manufacturing large quantities of APIs and micronizing them. It also manufactures corticosteroids, including Budesonide API.

Strategically located in the heart of Europe, near the Dunkerque and Antwerpen harbors, the site exports more than 50% of its production globally.

About Minakem’s Network

Minakem Dunkerque collaborates daily with Minakem’s other European facilities, leveraging their complementary expertises in solid engineering, analytics, global regulatory affairs, and other capabilities to enhance competitiveness.

Minakem brings over 40 years of experience in developing, scaling up, registering Drug Master Files (DMFs), and manufacturing complex Active Pharmaceutical Ingredients (APIs), including chiral small molecules, steroids, and highly potent APIs (HPAPIs)—primarily used in oncology treatments.

As supply chain performance becomes increasingly critical to customers’ success, Minakem focuses on delivering:

  • Safe products for patients,
  • High On-Time-In-Full (OTIF) performance,
  • Robust quality support, and
  • Innovative solutions to address customers’ unexpected market demands.

More data

Esomeprazole Magnesium Dihydrate API’s data are available on

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Esomeprazole Magnesium Dihydrate API additional data are available on

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Get in touch Esomeprazole Magnesium Dihydrate API

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