Rosuvastatin & Clopidogrel Capsules

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Rosuvastatin and clopidogrel capsules are fixed-dose combination (FDC) medications used for the secondary prevention of cardiovascular events like heart attacks and strokes. They are typically available in strengths such as 10 mg/75 mg or 20 mg/75 mg.

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Description

Rosuvastatin & Clopidogrel 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) Capsules, manufactured in WHO–GMP certified advanced pelletization facilities. This “High-Intensity, Aspirin-Free Cardiovascular Shield” is a massive-volume export to cardiology centers, catheterization labs, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive compliance intervention for Acute Coronary Syndrome (ACS) and post-stent patients who cannot tolerate Aspirin therapy.


Product Overview

This formulation combines two of the most critical cardiovascular APIs in modern medicine: Rosuvastatin Calcium (a high-intensity, hydrophilic lipid-lowering statin) and Clopidogrel Bisulfate (a thienopyridine ADP receptor inhibitor).

The “Aspirin-Free Plaque & Clot” Specialist:

  • Mechanism 1 (Rosuvastatin – High-Intensity Plaque Stabilization): Rosuvastatin competitively inhibits HMG-CoA reductase in the liver. As one of the most potent statins globally, it drastically lowers LDL cholesterol while stabilizing vulnerable, lipid-rich atherosclerotic plaques in the coronary arteries, physically preventing them from rupturing and triggering an infarction.
  • Mechanism 2 (Clopidogrel – P2Y12 Blockade): Clopidogrel irreversibly binds to the P2Y12 ADP receptors on the platelet surface, shutting down a major pathway of platelet aggregation and preventing life-threatening thrombosis inside coronary stents.
  • The “GI-Sparing” Clinical Advantage: Standard post-heart attack protocols demand a statin plus Aspirin and Clopidogrel. However, long-term Aspirin use frequently causes severe, sometimes fatal, gastrointestinal bleeding. For patients with a history of peptic ulcers, extreme bleeding risks, or NSAID hypersensitivity, cardiologists drop the Aspirin and rely exclusively on Clopidogrel alongside a high-intensity statin. This dual-capsule guarantees perfect patient adherence for this highly specific, vulnerable demographic.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Dual-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.
ExcipientsMethacrylic Acid Copolymer / HypromelloseProtective API Coating Barriers (Ensures API isolation)

*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)
Dosage FormCapsules containing API-isolated Pellets
PackagingAlu-Alu Blister (CRITICAL). Absolutely essential to protect both the Rosuvastatin and Clopidogrel from moisture-induced degradation.
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.

  • Dual-Chemical Isolation Engineering: Even without Aspirin, Rosuvastatin and Clopidogrel can interact and degrade if exposed to microscopic moisture within the capsule shell. Our encapsulation technology isolates both drugs utilizing distinct polymer film-coatings before placing them inside the 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 statin degradation impurities remain well below pharmacopeial limits, guaranteeing absolute cardiovascular safety.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of critical ischemic events, particularly in Aspirin-intolerant patients:

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

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 chemically degrade the APIs in the gastric environment.

Safety Warnings (CRITICAL):

  • Bleeding Risk: While safer for the stomach than Aspirin-inclusive regimens, Clopidogrel still significantly increases the risk of bleeding. It should be discontinued 5 to 7 days prior to elective surgery.
  • Myopathy & Rhabdomyolysis: Rosuvastatin carries a dose-dependent risk of severe skeletal muscle toxicity. Patients must immediately report any unexplained muscle pain, tenderness, or weakness.
  • 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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