Esomeprazole Magnesium Capsules Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 20 mg, 40 mg
Reference Brands: Nexium(US & EU)
Category:
Gastrointestinal Drugs
Esomeprazole capsules are proton pump inhibitors (PPIs) that irreversibly block gastric acid secretion by inhibiting the H+/K+ ATPase enzyme in stomach cells. They effectively treat GERD, ulcers, and Zollinger-Ellison syndrome, providing relief from acid reflux, promoting mucosal healing, and preventing complications caused by excess stomach acid.
Esomeprazole Magnesium Capsules is available in Capsules
and strengths such as 20 mg, 40 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Esomeprazole Magnesium Capsules is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Esomeprazole Magnesium Capsules can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Esomeprazole capsules, marketed as Nexium, are approved in the US by the FDA and in the EU via EMA for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality information for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance supports swift approval, safe use, and global availability of esomeprazole capsules, helping manage acid-related disorders worldwide effectively.
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