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Esomprazole
API

To guarantee the highest purity and therapeutic efficacy, we adhere to strict global standards

HUMAN API

Esomprazole

Esomeprazole is a critical Active Pharmaceutical Ingredient (API) belonging to the Proton Pump Inhibitors (PPIs) class. As the active (S)-isomer of omeprazole, it offers enhanced efficacy and superior bioavailability in inhibiting gastric acid production. We supply Esomeprazole, typically in its Magnesium Trihydrate or Sodium salt form, ensuring stability and compliance with the highest quality standards for enteric formulations.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
Proton Pump Inhibitor (PPI).
Mechanism of Action:
Irreversibly inhibits the $H^{+}/K^{+}$-ATPase enzyme (the proton pump) in the gastric parietal cells, leading to potent and long-lasting suppression of stomach acid secretion.
Clinical Application:
Treatment of Gastroesophageal Reflux Disease (GERD), gastric and duodenal ulcers, prevention of NSAID-associated ulcers, and management of Zollinger-Ellison syndrome.
Competitive Advantage:
Superior acid control compared to some other PPIs due to its high bioavailability, ensuring reliable therapeutic outcomes.
Enteric-Coated Tablets & Capsules

Standard oral formulations.

We supply the API in the form of ready-to-fill enteric-coated pellets, reducing complex manufacturing steps for pharmaceutical companies.

Injectable Formulations

Sodium salt for Intravenous (IV) injection for acute bleeding or dysphagia.

High water solubility of the Sodium salt, suitable for sterile injectable preparations.

Liquid Formulations

Oral suspensions for pediatric or dysphagia patients.

Optimal stability in pH-adjusted suspension systems.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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