Description
Rivaroxaban Tablets (2.5 mg / 10 mg / 15 mg / 20 mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, hematological, and critical-care therapeutics. We provide ultra-high-purity, kinetically controlled Rivaroxaban Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Direct Oral Anticoagulant (DOAC) / Factor Xa Inhibitor” is a massive-volume, highly lucrative export to cardiology centers, orthopedic surgical wards, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for the prevention of stroke and the treatment of severe deep vein thrombosis (DVT).
Product Overview
This formulation contains Rivaroxaban, a highly targeted, next-generation blood thinner that provides highly predictable anticoagulation, fundamentally changing how physicians manage stroke risk and venous thromboembolism (VTE).
The “Factor Xa Direct Inhibitor” Specialist:
- Mechanism (The Coagulation Cascade Blockade): Blood clotting is a complex cascade of enzymes activating one another. At the exact intersection of the “intrinsic” and “extrinsic” clotting pathways sits a critical enzyme called Factor Xa. Factor Xa is responsible for converting prothrombin into thrombin (which then creates the fibrin clot). Rivaroxaban acts as a highly precise chemical lock, directly binding to and shutting down Factor Xa. Without Factor Xa, thrombin generation violently halts, and the dangerous blood clot cannot form or expand.
- The “Warfarin-Sparing” Revolution: For decades, patients on Warfarin required constant, stressful blood tests (INR monitoring) to ensure their blood wasn’t too thin or too thick, and they had to avoid eating green vegetables (Vitamin K). Rivaroxaban provides a highly stable, predictable level of blood thinning. It requires zero routine blood monitoring and has no dietary restrictions, drastically improving patient compliance and quality of life.
- Surgical & Cardiac Versatility: Because of its rapid onset of action, it is heavily prescribed by orthopedic surgeons immediately following knee or hip replacements to prevent fatal lung clots (Pulmonary Embolism), and by cardiologists to prevent strokes in patients with irregular heartbeats (Non-Valvular Atrial Fibrillation).
Product Composition & Strength
We supply this product as a Precision-Engineered Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of the potent DOAC molecule.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Rivaroxaban INN/Ph.Eur. | 2.5 mg | Vascular Dose: Co-administered with Aspirin to prevent major cardiovascular events in CAD/PAD. |
| Rivaroxaban INN/Ph.Eur. | 10 mg | Surgical Prophylaxis: Prevention of DVT following knee or hip replacement surgery. |
| Rivaroxaban INN/Ph.Eur. | 15 mg / 20 mg | Global Clinical Standard: Treatment of acute DVT/PE and stroke prevention in Atrial Fibrillation. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Hypromellose / Sodium Lauryl Sulfate / Magnesium Stearate | Diluent / Superdisintegrant / Surfactant (Engineered for optimal solubilization and synchronized gastrointestinal absorption) |
*Pack Sizes: 10×10 Alu-Alu Blisters or 14/28/30-Tablet Blisters (Optimized specifically for strict chronic cardiology and acute post-op dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Anticoagulants/Cardiovascular) |
| CAS Number | 366789-02-8 |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Protects the high-value formulation from environmental humidity, UV degradation, and cross-contamination across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Potent API & Dose Uniformity Engineering: Rivaroxaban is a highly potent molecule where a fraction of a milligram difference can cause either a fatal blood clot or catastrophic internal bleeding. Formulating the 2.5 mg and 10 mg strengths requires elite geometric blending and high-shear granulation to ensure absolute content uniformity, guaranteeing every patient receives the precise, life-saving dose.
Therapeutic Indications (Human Use)
Indicated for the targeted prevention and treatment of severe thromboembolic disorders:
- Non-Valvular Atrial Fibrillation (NVAF): Reduction in the risk of stroke and systemic embolism.
- DVT & PE Treatment: Treatment of Deep Vein Thrombosis and Pulmonary Embolism, and reduction in the risk of recurrence.
- Post-Operative Prophylaxis: Prophylaxis of DVT in patients undergoing knee or hip replacement surgery.
- Coronary / Peripheral Artery Disease (CAD/PAD): (2.5 mg dose specifically) to reduce the risk of major cardiovascular events.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist/Surgeon Guidelines):
- DVT/PE Treatment: Initially 15 mg twice daily for 21 days, followed by 20 mg once daily.
- NVAF Stroke Prevention: 20 mg once daily with the evening meal.
- Administration (THE BIOAVAILABILITY RULE – CRITICAL): The 15 mg and 20 mg tablets MUST be taken with food. Taking these higher doses on an empty stomach drastically reduces their absorption by over 30%, risking clinical failure. The 2.5 mg and 10 mg tablets can be taken with or without food.
- Crushed Administration: For patients unable to swallow whole tablets, the tablet may be crushed and mixed with applesauce, followed immediately by food (for 15mg/20mg doses).
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Premature Discontinuation): Premature discontinuation of any oral anticoagulant, including Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events (stroke, heart attack).
- BLACK BOX WARNING (Spinal/Epidural Hematoma): Patients treated with Rivaroxaban who are receiving neuraxial anesthesia (spinal/epidural) or undergoing spinal puncture are at an extreme risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.
- Bleeding Risk: As a potent blood thinner, it can cause severe, sometimes fatal, major bleeding (gastrointestinal or intracranial). A specific reversal agent (Andexanet alfa) exists but is highly expensive and often unavailable in emerging markets; therefore, bleeding management relies on withholding the drug and supportive care.
- Drug Interactions (CYP3A4 & P-gp): Rivaroxaban is cleared by both the CYP3A4 enzyme and the P-glycoprotein (P-gp) transporter. Co-administration with combined P-gp and strong CYP3A4 inhibitors (like Ketoconazole or Ritonavir) will drastically increase blood levels, leading to fatal bleeding.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for post-operative wards in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.










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