Dabigatran Capsule bulk supplier for pharma manufacturers

Dabigatran Capsule 75 mg, 110 mg, and 150 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 75 mg, 110 mg, and 150 mg

Reference Brands: Pradaxa(EU & US)

Dabigatran is a direct thrombin inhibitor that prevents clot formation by blocking thrombin's role in converting fibrinogen to fibrin. It effectively reduces stroke risk in atrial fibrillation, treats and prevents deep vein thrombosis and pulmonary embolism, with benefits including oral administration, predictable effects, and no routine blood monitoring.

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Product Description: Dabigatran, marketed as Pradaxa, is approved in the US by the FDA and in the EU via EMA authorization. Regulatory approval requires a detailed dossier demonstrating safety, efficacy, manufacturing quality, and stability data. In the US, FDA approval involves a comprehensive submission, while the EU approval follows centralized or national procedures. Both regions emphasize pharmacovigilance and clinical data to ensure product compliance. For expert guidance on dossier preparation, regulatory strategies, and market entry, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for successful approval, market access, and ensuring patient safety worldwide with dabigatran capsules.

Dabigatran Capsule — third party manufacturing & bulk supply

Dabigatran Capsule 75 mg, 110 mg, and 150 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

Dabigatran Capsule 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 Dabigatran Capsule 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

Dabigatran Capsule is listed as Capsules in 75 mg, 110 mg, and 150 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

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