Dexlansoprazole Capsules 30 mg and 60 mg 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.
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.
Dexlansoprazole Capsules — third party manufacturing & bulk supply
Dexlansoprazole Capsules 30 mg and 60 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Dexlansoprazole Capsules listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Dexlansoprazole Capsules →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
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