Rivaroxaban API Manufacturer & Supplier in India

Rivaroxaban is an oral, direct Factor Xa inhibitor belonging to the class of novel oral anticoagulants (NOACs). It selectively and reversibly blocks Factor Xa, the pivotal enzyme in the coagulation cascade, thereby inhibiting thrombin generation and clot formation without requiring routine coagulation monitoring. Mediocon Inc manufactures GMP-compliant Rivaroxaban at its state-of-the-art facility in Aurangabad, Maharashtra, India, supplying pharmaceutical manufacturers worldwide with consistent purity and full regulatory documentation.

• Prevention of stroke and systemic embolism in non-valvular atrial fibrillation
• Treatment and secondary prevention of deep vein thrombosis (DVT)
• Treatment and prevention of pulmonary embolism (PE)
• Prophylaxis of DVT following elective hip or knee replacement surgery
• Reduction of cardiovascular events in coronary artery disease and peripheral artery disease

• GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
• Full pharmacopoeial compliance: IP / BP / EP / USP standards
• Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
• Stringent in-process quality control at every manufacturing stage
• HPLC purity testing and spectroscopic identification (IR, NMR)
• Cold-chain and controlled-environment storage facilities available
• Exported to 40+ countries with full regulatory support

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Rivaroxaban — CAS 755037-03-7 (CAS 755037-03-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Rivaroxaban — CAS 755037-03-7 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