Description

Nicoumalone Tablets (Acenocoumarol 0.5mg – 4mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Nicoumalone (Acenocoumarol) Tablets in India. This is a potent Oral Anticoagulant (blood thinner) belonging to the coumarin class (Vitamin K Antagonist). It is a Narrow Therapeutic Index (NTI) drug, meaning small differences in dose or blood concentration can lead to therapeutic failure (clotting) or serious adverse drug reactions (bleeding).

We offer Contract Manufacturing (Third Party) services for this critical cardiovascular medicine. Unlike Warfarin, Nicoumalone has a shorter half-life, allowing for quicker dosage adjustments. Our WHO-GMP certified facility in Mumbai utilizes advanced blending technologies (Geometric Dilution) to ensuring the micro-dose active ingredient is perfectly distributed in every tablet. Healthy Inc manages the export logistics, supplying hospitals and cardiology centers across Europe, Africa, CIS countries, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Manufacturing NTI drugs requires zero tolerance for weight variation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: Since the dose is extremely low (as low as 0.5mg), we use Geometric Mixing and High-Shear Granulation to ensure the active ingredient is homogeneously distributed. A variance of even 10% could alter a patient’s INR (clotting time) dangerously.

  • Hardness & Friability: We compress tablets to a specific hardness that allows them to be split easily (as dosage is often adjusted by half-tablets) without crumbling.

  • Dedusting: Strict dedusting protocols are used to prevent cross-contamination, as Nicoumalone is a potent substance.

• The Exporter: Healthy Inc

  • Supply Chain: We understand the critical nature of anticoagulants. We ensure “Just-in-Time” delivery for tenders to ensure maximum shelf life upon arrival.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards for NTI drugs:

• Assay: We strictly control the potency within tight limits (often 95-105% rather than the standard 90-110%) to ensure clinical stability.

• Dissolution: We test for consistent release profiles to ensure predictable absorption in the patient.

• Related Substances: We monitor for impurities to ensure safety over the 3-year shelf life.

5. Why Use Nicoumalone?

It prevents life-threatening blood clots.

• Mechanism: It inhibits the enzyme vitamin K epoxide reductase, which stops the liver from recycling Vitamin K. Without Vitamin K, the blood cannot produce clotting factors II, VII, IX, and X.

• Key Indications:

  • Deep Vein Thrombosis (DVT): Treatment and prevention of clots in the legs.

  • Pulmonary Embolism (PE): Prevention of clots traveling to the lungs.

  • Atrial Fibrillation: Prevention of stroke in patients with irregular heartbeats.

  • Heart Valve Replacement: Essential for patients with mechanical heart valves to prevent clot formation on the valve.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Nicoumalone Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India with NTI-grade precision.

• Q: Is Nicoumalone the same as Warfarin?

  A: They are in the same class (coumarins) and work similarly, but they are different chemicals. Nicoumalone has a shorter half-life (8-11 hours) compared to Warfarin (36-42 hours), meaning it clears from the body faster if bleeding occurs.

• Q: Does the patient need monitoring?

  A: Yes. Patients must have their INR (International Normalized Ratio) checked regularly to ensure the blood is not too thin (risk of bleeding) or too thick (risk of clotting).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dosage: Highly individualized. Dosage is adjusted based on the patient’s Prothrombin Time (PT) and INR.

• Induction: Usually 2mg to 4mg initially, then adjusted.

• Administration: Take at the same time every day.

9. Side Effects and Precautions

• Hemorrhage (Bleeding): The most common side effect. Signs include nosebleeds, bleeding gums, bruising, or dark stools.

• Skin Necrosis: Rare but serious reaction (calciphylaxis).

• Dietary Interactions: Foods high in Vitamin K (spinach, kale, broccoli, cabbage) can make the drug less effective. Patients should maintain a consistent diet.

• Pregnancy: Contraindicated. It can cause birth defects (fetal warfarin syndrome).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly out of reach of children.