Composition: Each uncoated tablet contains Nicoumalone IP 2 mg or 4 mg.
Dosage form: Uncoated tablets
Usage: Prevention and treatment of selected harmful blood clots under medical supervision.
Category: Hypertensive / Cardiac Drugs
Therapeutic category: Oral Anticoagulant / Vitamin K Antagonist
SKU: Nicoumalone Tablets
Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations
Nicoumalone Tablets IP is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status requires verification)
Exporter: Healthy Inc (Star Export House status requires verification)
Nicoumalone, also known as acenocoumarol, is a prescription oral anticoagulant belonging to the vitamin K antagonist (VKA) class. It is used for prevention and treatment of selected thromboembolic conditions when clinically appropriate. It is not an antihypertensive medicine.
Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied product information. Manufacturing credentials and commercial availability should be verified before publication.
| Product | Nicoumalone (Acenocoumarol) Tablets IP |
|---|---|
| Strengths | 2 mg and 4 mg (confirmed) |
| Composition | Each uncoated tablet contains Nicoumalone IP 2 mg or 4 mg, respectively |
| Dosage form | Uncoated oral tablet |
| Standard | IP per supplied composition; other standards not confirmed |
| Therapeutic class | Oral anticoagulant / Vitamin K antagonist |
| CAS number | 152-72-7 (acenocoumarol) |
| Other strengths | 0.5 mg, 1 mg and 3 mg appear in general description but are not confirmed in supplied compositions |
| Shelf life / packaging | Confirm against approved stability data and actual pack label |
Low-dose anticoagulant tablet production requires robust blend uniformity, validated compression and contamination-control procedures. Content uniformity and tablet performance must be established through product-specific validation. No particular granulation process, scoring design, or packaging material is confirmed by the supplied composition.
Applicable IP monograph and approved product specifications should govern identity, assay, uniformity of dosage units, dissolution or disintegration, impurities, stability and packaging verification. Do not assume a universal assay limit or 36-month shelf life without supporting data.
Acenocoumarol inhibits vitamin K epoxide reductase, reducing the formation of functional vitamin K-dependent clotting factors II, VII, IX and X. Its anticoagulant effect requires INR monitoring.
Depending on clinical assessment and local approvals, vitamin K antagonists may be used for venous thromboembolism, prevention of stroke in selected atrial fibrillation patients and anticoagulation with mechanical heart valves. Treatment choice varies by indication and patient characteristics.
Product registration, pharmacopoeial compliance, GMP certification, certificate of analysis, certificates of pharmaceutical product, shipping conditions and dossier availability should be confirmed with the manufacturer/exporter for each destination market. WHO-GMP and Star Export House claims are not independently verified here.
Is Nicoumalone the same as warfarin? No. Both are vitamin K antagonists, but they are different medicines and are not dose-for-dose interchangeable.
Why is INR testing necessary? INR helps clinicians adjust therapy to reduce the risk of harmful clotting and bleeding.
Should patients avoid leafy vegetables? Not necessarily. Consistent vitamin K intake is generally preferable to sudden large dietary changes; seek clinician guidance.
Dosing is individualized by the prescribing clinician according to the indication, INR, other medicines, diet and bleeding risk. Take only as directed. Do not double a missed dose or change dose independently. The tablets should only be split when the approved product labeling permits it.
Major risk: bleeding. Seek urgent care for uncontrolled bleeding, black or bloody stools, vomiting blood, severe headache, sudden weakness or head injury while anticoagulated. Serious skin reactions, including skin necrosis, may occur rarely.
Acenocoumarol has important interactions with other medicines, including NSAIDs, antibiotics and some herbal products. It is generally contraindicated during pregnancy because of fetal harm; specialist advice is essential. Patients need clear instructions on INR monitoring and consistent vitamin K intake.
Store in the original, properly closed packaging and follow the temperature and humidity limits on the approved product label. Keep out of sight and reach of children. The proposed below-25°C limit must be verified for this specific product.