Dexlansoprazole Capsules bulk supplier for pharma manufacturers

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)

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.

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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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Dexlansoprazole Capsules is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.

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Frequently Asked Questions

Dexlansoprazole Capsules is listed as Capsules in 30 mg and 60 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Dexlansoprazole Capsules is referenced against Dexilant(US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.