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Esomeprazole manufacturers

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Country of origin : France

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esomeprazole

Capsules, gastro resistant (GR) 20 mg, 40 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #15084

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Esomeprazole Manufacturers

Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Esomeprazole is used for the management of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury to the esophagus. This drug is also used for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs. Esomeprazole is prescribed to treat Zollinger-Ellison syndrome, a condition in which the stomach produces excess acid. This medication is also used to relieve symptoms such as difficulty swallowing, persistent cough and other conditions involving excess stomach acid. Manufacturers market Esomeprazole under the Brand name of Nexium. Esomeprazole is available in the dosage form of Tablet (delayed release), Capsule (delayed release), Injection and Oral Suspension. The tablet, capsule and suspension form are administered orally and the injection is administered Intravenously. Esomeprazole injections are supplied as a freeze-dried powder in a single use vial. Esomeprazole is available in 10 mg, 20 mg, 40 mg, 20 mg/5mL and 40 mg/5mL dosage strengths. Esomeprazole should be taken at least one hour before food. Tablets should be swallowed whole, if patients are unable to swallow 40 mg tablet, two 20 mg tablet may be taken, but 40 mg oral suspension should not be divided into two 20 mg dosage for pediatric patients who are unable to take tablet formulation. The usual recommended adult dose for GERD is 40 mg esomeprazole tablet given once a day orally for 8 weeks and 20 mg or 40 mg I.V. injection administered once a day. For Zollinger-Ellison syndrome, the recommended dose is 40 mg tablet orally twice a day and 20 mg or 40 mg I.V. injection administered once a day. Treatment with I.V injection should be discontinued as soon as the patient can resume oral treatment with esomeprazole. The recommended storage conditions for esomeprazole tablets, capsules and I.V. infusion is to store at 25° C (77° F) with excursions permitted to 15° C to 30° C (59° F - 86° F), protect from sunlight. The reconstituted product should not be refrigerated.

Wholesale Price of Esomeprazole

In the USA, the wholesale price of 20 mg esomeprazole oral delayed-release tablets ranges from $ 73.94 - $ 367.74 for a quantity of 90 tablets and the per-unit cost is available at as low as $ 0.81 The per unit cost of 40 mg esomeprazole oral delayed release capsule ranges from $ 0.82 - $3.54 and for a quantity of 90 tablets, the cost ranges from $ 73.94 - $ 318.45 The wholesale price of 40 mg esomeprazole intravenous powder for injection costs around $ 302.66 - $ 429.50 for a quantity of 10 and the per unit cost ranges from $ 30.27 - $ 42.95

Esomeprazole - Mechanism of Action

Esomeprazole suppresses gastric acid secretion by inhibiting the partial cell membrane H+ K+ ATPase enzyme system. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the H+, K+ ATPase results in an inhibition of gastric acid secretion.

Finding Esomeprazole Manufacturers and Suppliers

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