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)
Category: Blood Disorder
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.
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:
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
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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Dabigatran Capsule →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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