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Cardiovascular

Clopidogrel

Plavix®

Clopidogrel is a thienopyridine antiplatelet agent that irreversibly inhibits the P2Y12 ADP receptor on platelets, reducing thrombotic events.

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Product Details

Dosage FormOral Tablet (Film-Coated)
Strength75 mg, 300 mg
StorageStore at 25°C.
CategoryCardiovascular
AvailabilityAvailable for Transfer

Indication

Reduction of atherothrombotic events in recent MI/stroke, established PAD, or ACS (with aspirin).

Mechanism of Action

Prodrug requiring hepatic CYP2C19 activation. The active metabolite irreversibly blocks the P2Y12 ADP receptor on platelet surface, inhibiting ADP-mediated platelet activation and aggregation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Clopidogrel includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Clopidogrel Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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