Dabigatran API Manufacturer & Supplier in India

Dabigatran etexilate is a prodrug that is rapidly converted to Dabigatran, a direct, reversible inhibitor of thrombin, used in prevention of stroke and systemic embolism in atrial fibrillation, and treatment/prevention of DVT and pulmonary embolism. Mediocon Inc supplies pharmaceutical-grade Dabigatran meeting IP, BP, EP, and USP standards.

Key Features

• Analgesic, antipyretic & anti-inflammatory
• USP/BP/IP compliant quality
• Widely used in cardiovascular therapy
• Suitable for tablet and effervescent formulations

Applications

• Stroke prevention in non-valvular AF
• Deep vein thrombosis (DVT) treatment
• Pulmonary embolism prevention
• Post-surgical thromboprophylaxis

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Dabigatran (CAS 211914-51-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Dabigatran is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries