Clopidogrel

Clopidogrel is a widely prescribed antiplatelet medication used to reduce the risk of heart attack, stroke, and other serious cardiovascular events. As a third-party manufacturer, we specialize in producing high-quality Clopidogrel tablets for pharmaceutical brands, distributors, and healthcare organizations worldwide. Our facilities are designed to meet international standards, ensuring consistent efficacy, safety, and compliance with regulatory guidelines.

About Clopidogrel

Clopidogrel belongs to the thienopyridine class of antiplatelet agents. It works by inhibiting the ADP receptor (P2Y12) on platelets, preventing their aggregation. This action helps keep blood flowing smoothly through arteries and reduces the risk of clot formation, particularly in patients with a history of heart attack, stroke, or peripheral arterial disease.

Typical dosage forms include Clopidogrel 75 mg and 300 mg tablets. The 75 mg dose is commonly used for daily maintenance therapy, while the 300 mg tablet is often administered as a loading dose during acute coronary syndrome treatment.

Why Choose Us as Your Third-Party Manufacturer?

1. GMP-Certified Facilities

We operate state-of-the-art manufacturing units accredited with WHO-GMP and ISO certifications. Our facilities adhere strictly to Current Good Manufacturing Practices (cGMP), ensuring every batch of Clopidogrel meets the highest standards of quality and purity.

2. Advanced Manufacturing Technology

Our production lines feature high-speed tablet compression, automated granulation systems, and precision coating technology, enabling us to produce Clopidogrel tablets with uniform weight, content, and dissolution profiles. Our investments in technology guarantee scalability and consistency.

3. Comprehensive Quality Control

We maintain a robust quality assurance system, with in-house analytical laboratories equipped with HPLC, UV spectrophotometers, and dissolution testers. Each batch undergoes rigorous testing for:

• Assay and potency
• Impurities and related substances
• Uniformity of dosage units
• Dissolution and disintegration
• Microbiological purity

Only batches that pass these stringent tests proceed to packaging and dispatch.

4. Customizable Packaging

We offer flexible packaging solutions, including:

• Alu-Alu or blister packs
• Bottles of varying sizes
• Bulk packing for hospitals or institutional supply
• Printed or neutral cartons as per client branding requirements

We also provide multilingual labeling services, meeting local market and regulatory demands.

5. Regulatory Compliance

Our regulatory team has extensive experience in preparing dossiers in CTD/eCTD formats for product registrations worldwide. We support partners in filing regulatory submissions in markets like Europe, Asia, Africa, Latin America, and CIS countries.

6. Competitive Pricing

We leverage economies of scale and process optimization to offer competitive rates without compromising on quality. Whether you are a startup or an established pharmaceutical company, our pricing model can help you achieve higher profitability in your markets.

Applications and Therapeutic Uses

Clopidogrel is a cornerstone therapy in cardiology, recommended by leading guidelines for:

• Prevention of myocardial infarction (heart attack)
• Secondary prevention after ischemic stroke
• Management of acute coronary syndromes (ACS), including unstable angina and non-ST elevation myocardial infarction (NSTEMI)
• Post-percutaneous coronary intervention (PCI) with stent placement to prevent stent thrombosis
• Peripheral arterial disease-related clot prevention

Our third-party manufactured Clopidogrel tablets deliver reliable therapeutic outcomes, helping your customers improve patient adherence and long-term health.

Manufacturing Process Overview

1. Raw Material Procurement
   All active pharmaceutical ingredients (API) and excipients are sourced from certified vendors with valid Drug Master Files (DMFs) and Certificates of Analysis (COAs).
2. Granulation
   Using wet or dry granulation techniques, we prepare uniform granules to ensure optimal flowability and compressibility.
3. Compression
   High-speed rotary tablet presses produce tablets with accurate weight and hardness, minimizing batch variation.
4. Coating
   Our film-coating technology ensures tablets have excellent stability, easy swallowing, and protection from moisture and light.
5. Packaging
   Tablets are packed under controlled conditions to preserve potency and shelf life, with tamper-evident seals and serialization if required.
6. Quality Assurance and Release
   Comprehensive batch records and certificates are provided with every shipment, ensuring traceability and compliance.

Advantages for Your Brand

• Fast Turnaround: Reduced lead times thanks to optimized production planning.
• Low Minimum Order Quantities (MOQs): Suitable for startups or market testing.
• Full Support: From formulation development to final delivery.
• Confidentiality: Strict non-disclosure agreements (NDAs) to protect your intellectual property and brand identity.

Documentation Provided

We offer a complete set of documents for your regulatory and marketing needs, including:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Stability data (long-term and accelerated studies)
• Batch Manufacturing Records (BMR)
• Product Specifications and Method of Analysis

Shelf Life and Storage

Our Clopidogrel tablets have a shelf life of 24 to 36 months, depending on packaging configuration. Recommended storage conditions are below 25°C in a dry, dark place.

Private Label and Contract Manufacturing Options

We understand that every client has unique needs. Whether you need Clopidogrel under your own brand name (private labeling) or require custom specifications such as specific tablet shapes, colors, or coatings, our team can tailor the production process to your requirements.

Sustainability and Responsibility

Our manufacturing processes are designed to minimize environmental impact, with:

• Wastewater treatment plants to prevent chemical pollution
• Energy-efficient equipment
• Responsible sourcing of raw materials
• Commitment to eco-friendly packaging materials upon request

Global Logistics Support

We handle all aspects of international shipping, including:

• Export documentation
• Customs clearance
• Temperature-controlled transportation if required

Our reliable logistics network ensures timely delivery to your warehouse or directly to your distributors, minimizing delays and maximizing your market competitiveness.

Conclusion

Partnering with us for third-party manufacturing of Clopidogrel gives you access to high-quality production, regulatory expertise, and flexible business models tailored to your brand’s needs. Whether you are looking to expand your cardiovascular portfolio or launch a new line of antiplatelet products, our comprehensive services can help you achieve your goals with confidence and speed.