Clopidogrel API Manufacturer & Supplier in India

Clopidogrel is a prodrug P2Y12 ADP receptor antagonist that irreversibly inhibits platelet aggregation. It is one of the most widely prescribed cardiovascular drugs globally, used for prevention of atherosclerotic events including heart attack and stroke in patients with ACS, peripheral arterial disease, or recent stroke. Mediocon Inc supplies pharmaceutical-grade Clopidogrel meeting IP/BP/EP/USP standards.

Key Features

• Irreversible P2Y12 ADP receptor antagonist prodrug
• IP/BP/EP/USP compliant, Assay 99.0% Min.
• Prevents MI, stroke, and vascular death
• Suitable for oral tablet formulations

Applications

• Acute coronary syndrome treatment
• Stroke prevention tablets
• Peripheral arterial disease therapy
• Dual antiplatelet therapy with aspirin

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 Clopidogrel (CAS 113665-84-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Clopidogrel 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