Acenocoumarol

Thromboembolic disorders such as deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF) continue to pose significant risks to cardiovascular health worldwide. Proper anticoagulation is essential in both preventing and treating these conditions. Acenocoumarol, a vitamin K antagonist, remains a time-tested oral anticoagulant widely used in clinical practice, particularly where monitorable, dose-adjustable therapy is preferred.

BluepillExpress, a WHO-GMP-certified pharmaceutical manufacturing company, specializes in the third-party production of Acenocoumarol tablets tailored for private-label distribution, hospital procurement, export markets, and regulatory registration. With a strong reputation in cardiovascular and hematologic therapeutic segments, BluepillExpress ensures quality, regulatory readiness, and consistency in every batch delivered.

What is Acenocoumarol?

Acenocoumarol is an oral anticoagulant that belongs to the coumarin class of vitamin K antagonists. It functions by inhibiting the enzyme vitamin K epoxide reductase, leading to reduced synthesis of active clotting factors II, VII, IX, and X in the liver. By suppressing the production of these clotting factors, Acenocoumarol reduces the blood’s ability to form clots, effectively lowering the risk of thrombosis and embolic complications.

Its efficacy, predictable pharmacodynamics, and adjustability via INR (International Normalized Ratio) monitoring make it an essential anticoagulant, especially in long-term therapy, post-surgical care, and atrial fibrillation cases.

Therapeutic Class

• Oral Anticoagulant (Vitamin K Antagonist)
• Blood Thinner / Antithrombotic
• Cardiovascular and Hematologic Therapy

Key Benefits of Acenocoumarol

1. Effective Thrombosis Prevention and Treatment

Acenocoumarol is used for the prophylaxis and treatment of venous and arterial thromboembolic disorders, including DVT, PE, and stroke prevention in atrial fibrillation.

2. Well-Established Safety and Efficacy Profile

Clinically validated for long-term anticoagulation, particularly in patients not suitable for newer agents or requiring dose adjustability.

3. INR-Based Dose Personalization

Allows healthcare providers to tailor anticoagulant intensity by monitoring INR, thereby minimizing the risk of bleeding while maintaining efficacy.

4. Suitable for Cost-Conscious Markets

More economical than NOACs (Novel Oral Anticoagulants), making it ideal for public health programs, tenders, and developing markets.

5. Flexible Strength Options

BluepillExpress offers a range of tablet strengths to support precise dosing and patient-specific therapy.

Indications

Acenocoumarol is indicated for:

• Prophylaxis and treatment of venous thrombosis (e.g., DVT)
• Prevention of pulmonary embolism
• Prevention of thromboembolic events in patients with atrial fibrillation
• Prophylaxis in patients with prosthetic heart valves
• Prevention of strokes in patients at high cardiovascular risk
• Treatment of thromboembolic complications of myocardial infarction

Its use is often continued for weeks to months, depending on the patient’s condition and underlying risk factors.

Available Dosage Forms and Strengths

BluepillExpress offers Acenocoumarol tablets in multiple strengths to support precise dose titration:

• Acenocoumarol 0.5 mg tablets
• Acenocoumarol 1 mg tablets
• Acenocoumarol 2 mg tablets
• Acenocoumarol 4 mg tablets

Formulations are manufactured using pharma-grade APIs with validated bioavailability, designed to meet USP, BP, IP, or Ph.Eur standards.

Each tablet is film-coated for ease of administration and enhanced shelf-life, with color-coded tablets available for better dosage distinction (upon request).

Dosage and Administration

Initial Dosage (Adults):

• Typically 2–4 mg orally once daily for the first 2 days

Maintenance Dose:

• Adjusted based on INR; usual range is 1–8 mg/day

INR Monitoring:

• Initial monitoring every 2–3 days
• Maintenance monitoring once every 1–4 weeks

Special Populations:

• Lower starting doses for elderly patients, liver impairment, or malnutrition

Important Notes:

• Tablets should be taken at the same time each day
• Frequent INR monitoring is essential
• Drug and dietary interactions must be considered, especially with vitamin K-rich foods

Pharmacokinetics

• Absorption: Rapid and nearly complete oral absorption
• Bioavailability: ~100%
• Onset of action: 24–48 hours
• Half-life: ~8–11 hours
• Metabolism: Hepatic (CYP2C9)
• Excretion: Primarily via urine as metabolites

The pharmacokinetic profile supports once-daily dosing with an excellent balance between efficacy and controllability.

Manufacturing Capabilities

BluepillExpress operates state-of-the-art manufacturing facilities that comply with WHO-GMP standards, capable of producing large volumes of anticoagulant formulations.

Facility Highlights:

• Automated granulation and compression lines
• Precision tablet press machines for dose accuracy
• Film-coating and color-coding stations for strength differentiation
• Automated blister packing and labeling units
• Cleanrooms under ISO Class 8 compliance
• In-house analytical and microbiological labs

Our facilities support low to high batch volumes, catering to private-label brands, institutional supply, and bulk exports.

Packaging and Labeling

Packaging ensures dose stability, patient safety, and regulatory compliance, with multiple options based on partner needs.

Primary Packaging:

• Blister packs (Alu-Alu or PVC)
• HDPE bottles with desiccants (for institutional supply)

Secondary Packaging:

• Customized cartons with multilingual artwork
• Leaflets with dosage adjustment tables and INR monitoring guidance
• Barcoding, serialization, and QR coding (as required)
• Tamper-evident packaging for exports

Packaging can be customized to meet the standards of ROW, CIS, Africa, Asia, and other global regions.

Quality Assurance and Compliance

All products undergo rigorous QA and QC testing, with full traceability and compliance to regulatory standards.

Certifications:

• WHO-GMP
• ISO 22000:2018
• Indian FDA manufacturing license
• Regulatory files compliant with CTD/ACTD structure

Quality Control Tests:

• Uniformity of content and weight
• Dissolution and disintegration
• Related substances and degradation profile
• Microbial limit testing
• Real-time and accelerated stability studies

Each batch is released with a Certificate of Analysis (CoA) and accompanied by a Batch Manufacturing Record (BMR).

Regulatory Documentation Support

BluepillExpress provides all essential documentation for regulatory filing, registration, and tender submission.

Available Documents:

• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• CTD/ACTD dossier (Modules 1–5)
• Stability Data (Real-time and Accelerated)
• MSDS (Material Safety Data Sheet)
• Label and packaging artwork files

We assist with submission strategies, artwork reviews, and dossier adaptation based on market-specific guidelines.

Export and Logistics

We support international clients with end-to-end logistics, ensuring safe, timely, and regulatory-compliant shipment.

• Shipping by air, sea, or courier
• Packaging for temperature and humidity stability
• Support for EXW, FOB, CIF, and DDP terms
• Documentation support for import customs clearance
• Palletized packaging for bulk shipments

Our export team ensures that your Acenocoumarol products reach their destination efficiently and with all necessary compliance.

Minimum Order Quantity and Lead Time

Product Type	MOQ	Lead Time
Acenocoumarol Tablets	100,000 tablets	20–25 working days
Custom Packaging and Branding	50,000 tablets	25–30 working days
Sample Batches	20–50 packs	7–10 working days

Lead times vary based on packaging, documentation, and market registration status.

Market Demand and Growth Potential

The demand for oral anticoagulants like Acenocoumarol remains strong in:

• Developing countries with limited access to NOACs
• Government tenders and public health programs
• Post-surgical care and long-term thromboembolic prevention
• Institutional hospital supply chains
• Pharmacies and e-pharmacy platforms

Given its affordability, proven track record, and monitoring flexibility, Acenocoumarol continues to be a cornerstone drug in anticoagulation therapy worldwide.

Ideal Business Partners

We collaborate with:

• Cardiovascular and hematology-focused pharmaceutical companies
• Government procurement bodies and NGOs
• Generic product marketers and tender bidders
• Hospital pharmacy chains and distributors
• Exporters targeting ROW and semi-regulated markets
• Digital and e-commerce pharmacy platforms

Whether you’re launching a branded anticoagulant line or supplying a hospital tender, BluepillExpress ensures quality, scale, and reliability.

Why Choose BluepillExpress?

• WHO-GMP and ISO-certified production facilities
• Expertise in cardiovascular and hematology segments
• Regulatory-ready formulations with full dossier support
• Flexible batch sizes, private label options, and low MOQs
• Timely production and global logistics coordination
• Trusted by clients across 30+ countries

Conclusion

Acenocoumarol remains a vital anticoagulant therapy for preventing and treating life-threatening thromboembolic events. Its affordability, efficacy, and monitorability make it the preferred choice in both public and private healthcare settings.

BluepillExpress offers you a dependable, regulatory-compliant, and cost-effective third-party manufacturing solution for Acenocoumarol tablets. We bring unmatched quality, flexibility, and end-to-end support to help you succeed in the global anticoagulant market.