Dexlansoprazole Capsules Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 30 mg and 60 mg
Reference Brands: Dexilant(US & EU)
Category:
Gastrointestinal Drugs
Dexlansoprazole is a proton pump inhibitor that blocks gastric acid secretion by irreversibly inhibiting the H+/K+ ATPase enzyme in stomach cells. Its dual-release formulation provides prolonged acid suppression, reducing GERD symptoms, promoting mucosal healing, and improving quality of life for patients with acid-related gastrointestinal disorders.
Dexlansoprazole Capsules is available in Capsules
and strengths such as 30 mg and 60 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, Dexlansoprazole 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) |
Dexlansoprazole 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:
Dexlansoprazole capsules, marketed as Dexilant, are approved in the US by the FDA and in the EU via EMA for GERD, erosive esophagitis, and Zollinger-Ellison syndrome. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data 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. Proper regional adherence supports swift approval, safe medication use, and global availability, helping millions worldwide effectively manage acid-related disorders.
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