Rosuvastatin Clopidogrel and Aspirin Capsules

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Rosuvastatin, clopidogrel, and aspirin capsules are fixed-dose combination (FDC) medications used for the prevention of serious cardiovascular events such as heart attacks and strokes. This “triple therapy” combines a cholesterol-lowering statin with two antiplatelet agents

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Description

Rosuvastatin, Clopidogrel & Aspirin Capsules

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular and hematological therapeutics. We provide high-purity Rosuvastatin (10 mg / 20 mg), Clopidogrel (75 mg) & Aspirin (75 mg) Capsules, manufactured in WHO–GMP certified advanced pelletization facilities. This “High-Intensity Triple Cardiovascular Shield” is a massive-volume, premium export to cardiology centers, catheterization labs, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the ultimate, life-saving compliance intervention for Acute Coronary Syndrome (ACS) and aggressive post-stent thrombosis prevention.


Product Overview

This formulation combines three of the most critical cardiovascular APIs in the world: Rosuvastatin Calcium (a high-intensity, hydrophilic lipid-lowering statin), Clopidogrel Bisulfate (a thienopyridine ADP receptor inhibitor), and Aspirin / Acetylsalicylic Acid (a cyclooxygenase inhibitor).

The “Aggressive Plaque & Clot” Specialist:

  • Mechanism 1 (Rosuvastatin – High-Intensity Plaque Stabilization): Rosuvastatin competitively and selectively inhibits HMG-CoA reductase in the liver. It is considered one of the most potent statins available, drastically lowering LDL (“bad”) cholesterol while significantly raising HDL (“good”) cholesterol. Crucially for post-heart attack patients, it physically stabilizes vulnerable atherosclerotic plaques in the coronary arteries, preventing them from rupturing.
  • Mechanism 2 (Aspirin – COX-1 Inhibition): Aspirin irreversibly binds to the Cyclooxygenase-1 (COX-1) enzyme inside platelets, completely blocking the production of Thromboxane A2 (TXA2) to prevent primary platelet clumping.
  • Mechanism 3 (Clopidogrel – P2Y12 Blockade): Clopidogrel irreversibly binds to the P2Y12 ADP receptors on the platelet surface, shutting down a completely separate, complementary pathway of platelet aggregation.
  • The “Polypill” Synergy: Following a heart attack or the placement of a coronary stent (PCI), clinical guidelines mandate Dual Antiplatelet Therapy (DAPT) alongside high-intensity Statin therapy. By combining all three into a single capsule, this formulation guarantees maximum patient adherence, drastically reducing the rate of fatal secondary cardiovascular events.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Tri-Isolated Pellets, packed strictly in moisture-proof Alu-Alu blisters.

Active IngredientStrength & FormatRelease Profile Function
Rosuvastatin Calcium USP/BP10 mg or 20 mg (Film-Coated Pellets)High-intensity secondary prevention dose for aggressive lipid reduction.
Clopidogrel (as Bisulfate) USP/BP75 mg (Film-Coated Pellets)Standard maintenance dose for P2Y12 ADP receptor blockade.
Aspirin (Acetylsalicylic Acid) USP/BP75 mg (Enteric-Coated Pellets)Low-dose COX-1 inhibitor, strictly coated to prevent direct gastric mucosal erosion.
ExcipientsMethacrylic Acid Copolymer / HypromelloseEnteric Coating Polymer / Protective API Barriers

*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 Code3004.90.99 (Medicaments containing other active substances)
CAS Numbers147098-20-2 (Rosuvastatin) / 113665-84-2 (Clopidogrel) / 50-78-2 (Aspirin)
Dosage FormCapsules containing API-isolated Pellets
PackagingAlu-Alu Blister (CRITICAL). Absolutely essential to protect against moisture-induced salicylic acid hydrolysis and degradation of the Rosuvastatin and Clopidogrel.
StorageStore below 25°C in a dry place. Protect strictly from Light and Moisture.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Tri-Chemical Isolation Engineering: Aspirin degrades rapidly into salicylic and acetic acids when exposed to microscopic moisture, which will aggressively destroy both the Clopidogrel and Rosuvastatin APIs if they come into physical contact. Our encapsulation technology isolates all three drugs utilizing distinct polymer film-coatings and enteric-coatings before placing them inside the single gelatin shell. This guarantees zero chemical cross-reactivity over the product’s shelf life.
  • Precise Assay Control: Strict high-performance liquid chromatography (HPLC) testing is performed on every batch to ensure free salicylic acid and statin degradation impurities remain well below pharmacopeial limits, guaranteeing cardiovascular safety.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of critical ischemic events:

  • Acute Coronary Syndrome (ACS): Unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI).
  • Post-Stent Implantation (PCI): Prevention of devastating in-stent thrombosis following the placement of bare-metal or drug-eluting stents in patients requiring aggressive lipid control.
  • Secondary Prevention: Prevention of atherothrombotic events in patients with a history of recent myocardial infarction or stroke.

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist):

  • Administration: Taken orally, once daily, with or without food.
  • Standard Adult Maintenance Dose: One capsule daily.
  • 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 chemically degrade the other two APIs.

Safety Warnings (CRITICAL):

  • 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.
  • Myopathy & Rhabdomyolysis: Rosuvastatin, particularly at higher doses, carries a risk of severe skeletal muscle toxicity. Patients must immediately report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.
  • Renal Toxicity Caution: Unlike Atorvastatin, Rosuvastatin is partially excreted by the kidneys. High doses should be used with caution in patients with severe renal impairment.
  • CYP2C19 Poor Metabolizers (Clopidogrel): Patients with genetic variants making them “poor metabolizers” will not effectively convert Clopidogrel to its active form, leaving them at high risk for fatal cardiovascular events.

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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