Description
Clopidogrel & Aspirin Capsules
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular and hematological therapeutics. We provide high-purity Clopidogrel (75 mg) & Aspirin (75 mg) Capsules, manufactured in WHO–GMP certified advanced pelletization facilities. This “Dual Antiplatelet Therapy (DAPT)” combination is a mandatory, massive-volume export to cardiology centers, catheterization labs, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the absolute gold-standard, life-saving intervention for Acute Coronary Syndrome (ACS) and post-stent thrombosis prevention.
Product Overview
This formulation contains two highly synergistic antiplatelet agents: Clopidogrel Bisulfate (a thienopyridine ADP receptor inhibitor) and Aspirin / Acetylsalicylic Acid (a cyclooxygenase inhibitor).
The “Dual-Pathway Thrombosis” Specialist:
- Mechanism 1 (Aspirin – COX-1 Inhibition): Aspirin irreversibly binds to and acetylates the Cyclooxygenase-1 (COX-1) enzyme inside platelets. This completely blocks the production of Thromboxane A2 (TXA2), a potent chemical signal that normally causes platelets to stick together and blood vessels to constrict.
- Mechanism 2 (Clopidogrel – P2Y12 Blockade): Clopidogrel is a prodrug that, once metabolized by the liver, irreversibly binds to the P2Y12 class of ADP receptors on the platelet surface. This prevents the activation of the GPIIb/IIIa receptor complex, shutting down a completely separate, complementary pathway of platelet aggregation.
- The DAPT Synergy: While Aspirin alone is effective, coronary stents (bare-metal or drug-eluting) are highly recognized as “foreign bodies” by the blood, triggering massive clotting cascades. Blocking both the TXA2 and ADP pathways simultaneously (DAPT) exponentially reduces the risk of in-stent restenosis and fatal myocardial infarctions compared to monotherapy.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule containing Isolated Dual-Technology Pellets or Mini-Tablets, packed strictly in moisture-proof Alu-Alu blisters.
| Active Ingredient | Strength & Format | Release Profile Function |
|---|---|---|
| Clopidogrel (as Bisulfate) USP/BP | 75 mg (Film-Coated Pellets) | Standard maintenance dose for P2Y12 ADP receptor blockade. |
| Aspirin (Acetylsalicylic Acid) USP/BP | 75 mg (Enteric-Coated Pellets) | Low-dose COX-1 inhibitor, coated to prevent direct gastric mucosal erosion. |
| Excipients | Methacrylic Acid Copolymer / Microcrystalline Cellulose | Enteric Coating Polymer / Diluent Core |
*Pack Sizes: 10×10 Alu-Alu Blisters or 10×15 Alu-Alu Blisters (optimizing for 30-day monthly cardiology dispensing).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Cardiology Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Numbers | 113665-84-2 (Clopidogrel Bisulfate) / 50-78-2 (Aspirin) |
| Dosage Form | Capsules containing API-isolated Pellets |
| Packaging | Alu-Alu Blister (CRITICAL). Absolutely essential to protect against moisture-induced salicylic acid hydrolysis and degradation. |
| Storage | Store below 25°C in a dry place. Protect strictly 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.
- Chemical Isolation Engineering: Aspirin degrades rapidly into salicylic acid and acetic acid when exposed to microscopic moisture, which in turn destroys the Clopidogrel API. Our encapsulation technology isolates both drugs utilizing distinct polymer coatings (often enclosing the Aspirin in an enteric coat and the Clopidogrel in a protective film) before placing them inside the single gelatin shell. This guarantees zero chemical cross-reactivity during its 24-month shelf life.
- Precise Assay Control: Strict high-performance liquid chromatography (HPLC) testing is performed on every batch to ensure free salicylic acid levels remain well below pharmacopeial limits, guaranteeing cardiovascular safety.
Therapeutic Indications (Human Use)
Indicated for the management of critical ischemic events:
- Acute Coronary Syndrome (ACS): Unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI), including patients managed medically and those managed with percutaneous coronary intervention (PCI).
- Post-Stent Implantation: Prevention of devastating in-stent thrombosis following the placement of bare-metal stents (BMS) or drug-eluting stents (DES).
- Secondary Prevention: Prevention of atherothrombotic events in patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist):
- Administration: Taken orally, once daily, with or without food.
- Standard Adult Maintenance Dose: One capsule (75 mg / 75 mg) daily. (Note: Initial ACS presentation often requires a higher “loading dose” of Clopidogrel—usually 300 mg to 600 mg—administered separately).
- Swallowing Protocol (CRITICAL): The capsule must be swallowed whole with a glass of water. DO NOT CRUSH OR CHEW THE CAPSULE. Destroying the protective pellet coatings will cause the Aspirin to erode the stomach lining and degrade the Clopidogrel.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Clopidogrel – CYP2C19 Poor Metabolizers): Clopidogrel is a prodrug requiring activation by the liver enzyme CYP2C19. Patients with genetic variants making them “poor metabolizers” will not effectively convert the drug, remaining at high risk for fatal cardiovascular events.
- Major Bleeding Risk: Dual antiplatelet therapy significantly increases the risk of major, sometimes fatal, bleeding (particularly gastrointestinal or intracranial hemorrhages). It is contraindicated in patients with active pathological bleeding (e.g., peptic ulcer or intracranial hemorrhage).
- PPI Interaction: Concurrent use of strong CYP2C19 inhibitors (specifically the proton pump inhibitors Omeprazole or Esomeprazole) drastically reduces the clinical efficacy of Clopidogrel. Pantoprazole is generally considered the safer alternative if a PPI is required to prevent GI bleeding.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. 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 government procurement 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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