Description
Sacubitril & Valsartan Tablets (50 mg / 100 mg / 200 mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, heart failure, and critical-care therapeutics. We provide ultra-high-purity, kinetically synchronized Sacubitril & Valsartan Film-Coated Tablets (24mg/26mg, 49mg/51mg, 97mg/103mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This first-in-class “Angiotensin Receptor-Neprilysin Inhibitor (ARNI)” is a highly lucrative, premium export to cardiology centers, specialized heart failure clinics, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-prolonging intervention to drastically reduce cardiovascular death and hospitalizations in patients with chronic heart failure.
Product Overview
This revolutionary Fixed-Dose Combination masterfully synchronizes a neprilysin inhibitor prodrug with a highly potent Angiotensin II Receptor Blocker (ARB), delivering a paradigm-shifting, dual-pathway strike against the downward spiral of heart failure.
The “ARNI & Cardiac Remodeling” Specialist:
- Mechanism 1 (The Neurohormonal Booster – Sacubitril): The failing heart releases protective proteins called natriuretic peptides (NP) to lower blood pressure, excrete sodium (natriuresis), and protect the heart muscle. However, an enzyme called neprilysin constantly destroys these protective peptides. Sacubitril aggressively inhibits neprilysin, allowing these life-saving peptides to surge, vigorously defending the heart from fluid overload and strain.
- Mechanism 2 (The RAAS Blocker – Valsartan): Simultaneously, the body’s Renin-Angiotensin-Aldosterone System (RAAS) overreacts to heart failure, producing Angiotensin II, which constricts blood vessels and damages the heart tissue. Valsartan aggressively blocks the Angiotensin II (AT1) receptor, shutting down this destructive vasoconstriction and preventing maladaptive cardiac remodeling (the physical thickening and stiffening of the heart wall).
- The Synergy & Superiority: Clinical trials (like PARADIGM-HF) proved that this dual ARNI mechanism is vastly superior to standalone ACE inhibitors (like Enalapril) in reducing the risk of sudden cardiac death and heart failure hospitalizations, making it the supreme foundational therapy for HFrEF.
Product Composition & Strength
We supply this product as a Precision-Engineered Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the sensitive dual-molecule complex.
| Active Ingredient | Strength (Total Dose) | Primary Clinical Function |
|---|---|---|
| Sacubitril / Valsartan INN/Ph.Eur. | 24 mg / 26 mg (50 mg Total) | Starting dose for patients with severe renal impairment, hepatic impairment, or those not currently taking an ACEi/ARB. |
| Sacubitril / Valsartan INN/Ph.Eur. | 49 mg / 51 mg (100 mg Total) | Standard Initiation Dose: For patients switching from standard doses of ACE inhibitors or ARBs. |
| Sacubitril / Valsartan INN/Ph.Eur. | 97 mg / 103 mg (200 mg Total) | Target Maintenance Dose: Maximum adult therapy for optimal mortality reduction in heart failure. |
| Excipients | Microcrystalline Cellulose / Crospovidone / Colloidal Silicon Dioxide / Magnesium Stearate | Diluent / Superdisintegrant / Glidant (Engineered for immediate gastric dissolution and synchronized dual-absorption) |
*Pack Sizes: 14×2 or 28-Tablet Alu-Alu Blisters (Optimized specifically for strict twice-daily chronic cardiology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Cardiovascular/Heart Failure) |
| CAS Numbers | 149709-62-6 (Sacubitril) / 137862-53-4 (Valsartan) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Protects the highly sensitive, hygroscopic formulation from environmental humidity and hydrolytic degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect 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.
- Advanced Co-Crystal / Supramolecular Engineering: Formulating Sacubitril and Valsartan is exceptionally complex, as they must be delivered in a highly specific ratio to ensure bioequivalence. Our facilities utilize elite pharmaceutical engineering to formulate the active ingredients perfectly, guaranteeing the identical pharmacokinetic release profile required to match the innovator brand and provide reliable, life-saving cardiovascular output.
Therapeutic Indications (Human Use)
Indicated for the targeted management of severe cardiovascular dysfunction:
- Heart Failure (HFrEF): To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
- Note: It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Standard Adult Dosing: The recommended starting dose is 49 mg/51 mg twice daily. The dose should be doubled every 2 to 4 weeks to the target maintenance dose of 97 mg/103 mg twice daily, as tolerated by the patient.
- Administration: Can be taken with or without food. Tablets must be swallowed whole.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Fetal Toxicity): When pregnancy is detected, discontinue this medication immediately. Drugs that act directly on the renin-angiotensin system can cause profound injury, massive malformations, and death to the developing fetus.
- The 36-Hour Washout Rule (CRITICAL FATAL ANGIOEDEMA RISK): Sacubitril/Valsartan is strictly contraindicated with ACE inhibitors. If a patient is switching from an ACE inhibitor (like Ramipril or Lisinopril) to this drug, there MUST be a 36-hour washout period between the last dose of the ACEi and the first dose of the ARNI. Taking them together will cause massive, life-threatening angioedema (swelling of the face, throat, and airway).
- Hypotension: Because it is a powerful vasodilator, it can cause severe, symptomatic low blood pressure, especially in patients who are volume-depleted from diuretics.
- Hyperkalemia & Renal Impairment: Can cause dangerous spikes in serum potassium and reversible decreases in renal function. Serum potassium and creatinine must be monitored routinely.
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 Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for cardiology wards 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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