Description

Rosuvastatin & Fenofibrate Tablets (10 mg / 160 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, lipid-regulating, and metabolic therapeutics. We provide ultra-high-purity, kinetically synchronized Rosuvastatin Calcium (10 mg / 20 mg) & Micronized Fenofibrate (160 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual-Action Lipid Complete Modulator” is a massive-volume, premium export to cardiology centers, diabetology clinics, 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 severe Mixed Dyslipidemia and the prevention of cardiovascular disease in diabetic patients.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes the two most powerful lipid-altering agents in modern medicine, delivering a comprehensive strike against every facet of a corrupted lipid profile (High LDL, High Triglycerides, and Low HDL).

The “Diabetic Dyslipidemia & Pancreatitis” Specialist:

• Mechanism 1 (The LDL Crusher – Rosuvastatin 10mg): Rosuvastatin is the most potent statin available. It aggressively inhibits the HMG-CoA reductase enzyme in the liver, the primary pathway the body uses to manufacture cholesterol. By starving the liver of cholesterol, the liver is forced to pull massive amounts of LDL (“bad” cholesterol) out of the bloodstream to survive, violently dropping systemic LDL levels and halting the buildup of arterial plaque.
• Mechanism 2 (The Triglyceride Incinerator – Fenofibrate 160mg): Massive triglyceride levels thicken the blood and can trigger fatal acute pancreatitis. Fenofibrate acts as a highly selective PPAR-alpha agonist. It genetically commands the body to produce an enzyme called Lipoprotein Lipase, which literally shreds and incinerates triglycerides in the blood while simultaneously boosting the production of ApoA-I and ApoA-II, raising the protective HDL (“good” cholesterol).
• The Synergy of “The Deadly Triad”: Type 2 Diabetics frequently suffer from “The Atherogenic Triad” (High LDL, High TGs, Low HDL). Taking a statin alone leaves the dangerous triglycerides untouched. This specific FDC targets the entire triad simultaneously, offering complete cardiovascular protection in a single daily dose.

Product Composition & Strength

We supply this product as a Precision-Engineered Bilayer or Matrix Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly sensitive Rosuvastatin calcium salt.

*Pack Sizes: 10×10 Alu-Alu Blisters or 3×10 Unit-Dose Blisters (Optimized specifically for high-compliance 30-day chronic cardiology dispensing regimens).

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.

• Advanced API Micronization Engineering: Standard, un-micronized Fenofibrate is practically insoluble in water and absorbs terribly in the human gut. Our facilities utilize advanced high-speed air-jet milling to “micronize” the Fenofibrate powder, violently crushing the API particles into microscopic fractions. This massively increases the surface area, guaranteeing peak gastrointestinal solubilization and clinical bioequivalence even in patients with compromised digestion.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe, complex metabolic and lipid disorders:

• Mixed Dyslipidemia (Type IIb): Treatment of patients with highly elevated LDL cholesterol accompanied by dangerously elevated Triglycerides and low HDL cholesterol.
• Diabetic Dyslipidemia: Routine cardiovascular prophylaxis in patients with Type 2 Diabetes who exhibit the atherogenic lipid triad.
• Severe Hypertriglyceridemia (Type IV, V): Targeted therapy to rapidly lower massive triglyceride loads to prevent acute, fatal pancreatitis.

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Standard Adult Dosing: One tablet (e.g., 10 mg/160 mg) taken orally once daily.
• Administration (THE MEALTIME RULE): To maximize the absorption of the highly lipophilic Fenofibrate component, the tablet should ideally be taken with a main meal. Taking it on an empty stomach can significantly reduce the triglyceride-lowering effect. Tablets must be swallowed whole.
• Renal Impairment: Fibrates are heavily excreted by the kidneys. This FDC is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min).

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX EQUIVALENT (Myopathy & Rhabdomyolysis): Combining any statin with a fibrate significantly amplifies the risk of severe muscle toxicity (myopathy) and rhabdomyolysis (muscle breakdown causing acute kidney failure). Patients must be explicitly instructed to report any unexplained muscle pain, tenderness, or weakness immediately.
• Severe Hepatotoxicity: Both APIs can stress the liver. Transaminase (AST/ALT) levels must be monitored before starting therapy and periodically thereafter. The drug must be stopped if liver enzymes exceed 3x the upper limit of normal.
• Gallstone Formation (Cholelithiasis): Fenofibrate vastly increases the excretion of cholesterol into the bile, which can lead to the rapid formation of gallstones. If gallstones are detected via ultrasound, the medication must be discontinued.
• Warfarin Interaction: Fenofibrate powerfully potentiates the effects of coumarin-type anticoagulants (like Warfarin), drastically increasing the risk of catastrophic bleeding. Warfarin doses must be immediately reduced and INR closely monitored.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular and Metabolic Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for diabetes clinics 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.