Description

Dabigatran Etexilate Capsules / Tablets (75 mg / 110 mg / 150 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, hematology, and targeted Direct Oral Anticoagulant (DOAC) therapeutics. We provide ultra-high-purity, kinetically stabilized Dabigatran Etexilate Mesylate Capsules (75 mg / 110 mg / 150 mg), manufactured in WHO–GMP certified, strictly humidity-controlled, advanced pellet-coating facilities. This “Direct Thrombin Inhibitor” is a massive-volume, premium export to cardiology networks, stroke prevention centers, orthopedic surgical wards, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, INR-free intervention for the prevention of stroke in Atrial Fibrillation and the treatment of Deep Vein Thrombosis (DVT).

Product Overview

This highly advanced formulation operates as a highly specific, molecular saboteur of the human coagulation cascade. Unlike older drugs like Warfarin that deplete vitamin K over several days, Dabigatran provides instant, predictable blood-thinning power without the need for constant, agonizing dietary restrictions or routine blood monitoring.

The “Direct Thrombin Inhibitor & DOAC” Specialist:

• Mechanism 1 (The Factor IIa Blockade): Dabigatran is a potent, competitive, and reversible direct inhibitor of Thrombin (Factor IIa). Thrombin is the master enzyme in the clotting cascade responsible for converting soluble fibrinogen into the insoluble fibrin strands that form a blood clot. By physically binding to the active site of thrombin, Dabigatran instantly paralyzes the enzyme, halting the formation of lethal clots in the heart and deep veins.
• Mechanism 2 (The Warfarin Replacement Paradigm): Warfarin is highly unpredictable, interacting with dark green vegetables and countless other drugs, requiring patients to undergo weekly INR blood tests. Dabigatran delivers a flat, highly predictable pharmacokinetic response. It frees millions of cardiovascular patients from the “Warfarin Clinic” and severe dietary restrictions.
• Mechanism 3 (The Prodrug & Tartaric Acid Dynamic): Dabigatran etexilate is a prodrug. To be absorbed in the intestines, it absolutely requires a highly acidic microenvironment. Therefore, the active drug is coated onto a core of Tartaric Acid. Once swallowed, the tartaric acid dissolves, creating a localized acid pocket that guarantees the Dabigatran is absorbed perfectly, regardless of the patient’s natural stomach acid levels.

Product Composition & Strength

We supply this product as a Precision-Blended, Tartaric Acid-Cored Pellet Formulation, packed exclusively in highly specialized, moisture-blocking Alu-Alu blister strips with integrated desiccants to ensure the absolute chemical survival of the intensely hygroscopic prodrug.

*Pack Sizes: 10×10 Specialized Alu-Alu Blisters or Heavy-Gauge HDPE Bottles with Desiccant Caps (Optimized specifically for absolute moisture defense).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Tartaric Acid Pellet Engineering & Moisture Defense (CRITICAL COMPLIANCE): Dabigatran is one of the most complex oral solids to manufacture. If a generic manufacturer fails to perfectly separate the tartaric acid core from the API using polymer barriers, the drug destroys itself on the shelf. Our cardiovascular suites utilize advanced Wurster fluid-bed processors operating under strict dehumidification (RH < 20%) to build these multi-layered pellets flawlessly. We guarantee absolute pharmacokinetic bioequivalence and uncompromising shelf-life stability.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized lifelong management of thromboembolic disorders:

• Non-Valvular Atrial Fibrillation (NVAF): To reduce the risk of stroke and systemic embolism in patients with NVAF.
• Deep Vein Thrombosis (DVT) & Pulmonary Embolism (PE): For the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrence.
• Post-Operative Prophylaxis: Prevention of DVT/PE following major orthopedic surgeries (e.g., hip or knee replacement).

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Standard NVAF Dosing: 150 mg taken orally twice daily (BID).
• The “Do Not Open” Mandate (CRITICAL): Capsules MUST be swallowed completely whole with a full glass of water. Opening, breaking, or chewing the capsule destroys the controlled-release mechanism and increases the absorption of Dabigatran by 75%, instantly triggering a massive, potentially fatal overdose and severe internal bleeding.
• The Pill-Box Warning: Patients MUST NOT store Dabigatran in weekly pill organizers. The drug must remain in its original moisture-proof blister or bottle until the exact moment of ingestion.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Premature Discontinuation): Stopping Dabigatran prematurely without bridging to another anticoagulant massively increases the risk of stroke and thrombotic events.
• BLACK BOX WARNING (Spinal/Epidural Hematoma): Patients receiving neuraxial anesthesia (spinal/epidural) while on Dabigatran are at high risk of developing epidural hematomas, which can result in long-term or permanent paralysis.
• Severe Gastrointestinal Bleeding & Dyspepsia: Because of the tartaric acid core, Dabigatran frequently causes severe dyspepsia (heartburn/indigestion) and carries a higher risk of major gastrointestinal bleeding compared to Warfarin.
• Reversal Agent Availability: In the event of catastrophic, life-threatening bleeding, Dabigatran is one of the only DOACs with a highly specific, rapidly acting intravenous reversal agent available globally (Idarucizumab).

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Cardiology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Direct Oral Anticoagulants (DOACs), Tartaric Acid Pellet Formulations, and Extreme Moisture-Barrier Packaging. Whether you are looking for a reliable Government Tender Supplier for stroke prevention programs in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.