Nebivolol Hydrochloride Tablets (2.5 mg / 5 mg / 10 mg / 20 mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-hypertensive, and endothelial-healing therapeutics. We provide ultra-high-purity, kinetically precise Nebivolol Hydrochloride Film-Coated / Uncoated Tablets (2.5 mg / 5 mg / 10 mg / 20 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Third-Generation Nitric Oxide-Donating Beta-Blocker” is an ultra-high-value, premium export to cardiology centers, specialized hypertension clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for Essential Hypertension and stable Chronic Heart Failure (CHF).
Product Overview
This highly advanced formulation utilizes a perfectly balanced racemic mixture of two distinct enantiomers, delivering an unparalleled, dual-action hemodynamic profile that dramatically lowers blood pressure without the paralyzing side effects of legacy beta-blockers.
The “Nitric Oxide & Cardioselective” Specialist:
- Mechanism 1 (The Ultra-Selective Cardiac Shield): The d-nebivolol enantiomer is one of the most highly selective Beta-1 adrenergic blockers in clinical existence. It specifically targets the receptors in the heart, slowing the resting heart rate and reducing the force of contraction. This drastically lowers the heart’s oxygen demand and completely shields the myocardium from the toxic effects of massive adrenaline spikes, which is a life-saving mechanism in chronic heart failure.
- Mechanism 2 (The Nitric Oxide Vasodilation): Unlike any other beta-blocker, the l-nebivolol enantiomer actively stimulates the L-arginine/Nitric Oxide (NO) pathway in the endothelial lining of the blood vessels. This forces the arteries to physically relax and widen (vasodilation), profoundly dropping peripheral vascular resistance and lowering blood pressure through an entirely secondary mechanism.
- The “Quality of Life” Advantage (CRITICAL COMPLIANCE): Older beta-blockers frequently cause extreme fatigue, icy hands and feet, and severe Erectile Dysfunction (ED) by constricting peripheral blood flow. Nebivolol’s unique NO-donating properties actively maintain rich, healthy blood flow to the extremities and reproductive organs, resulting in near-perfect clinical compliance, especially in younger, active male patients.
Product Composition & Strength
We supply this product as a Precision-Blended, Low-Dose Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or high-density PVC/PVDC blister strips to ensure the absolute chemical stability of the hydrochloride salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Nebivolol (as HCl) Ph.Eur./USP | 2.5 mg / 5 mg | Global Hypertension Standard: Base therapeutic unit for the continuous, highly tolerated management of essential hypertension. |
| Nebivolol (as HCl) Ph.Eur./USP | 10 mg / 20 mg | Advanced Cardiac Standard: High-dose maintenance therapy for refractory hypertension and specialized heart failure protocols. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Croscarmellose Sodium / Hypromellose / Polysorbate 80 / Magnesium Stearate | Diluent / Superdisintegrant / Wetting Agent / Lubricant (Engineered specifically to ensure rapid, predictable gastric dissolution while protecting the delicate racemic balance of the API) |
*Pack Sizes: 10×10 Blisters or 28/30-Tablet Calendar Packs (Optimized specifically for strict, high-compliance 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/Beta-Blockers) |
| CAS Number | 152520-56-4 (Nebivolol Hydrochloride) |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | High-Density PVC/PVDC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light and Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Racemic Micro-Dose Geometric Blending: Nebivolol is a precise 50:50 racemic mixture of d-nebivolol and l-nebivolol. If this delicate balance is disrupted during manufacturing, the dual-action mechanism is completely lost. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols to blend the highly potent, low-dose (2.5 mg) API uniformly throughout the excipient matrix. This is rigorously verified by high-frequency chiral HPLC testing to guarantee absolute enantiomeric purity and content uniformity in every single tablet.
Therapeutic Indications (Human Use)
Indicated for the comprehensive, next-generation management of severe cardiovascular dysfunction:
- Essential Hypertension: Treatment of high blood pressure as monotherapy or in combination with other antihypertensive agents.
- Chronic Heart Failure (CHF): Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients (≥ 70 years).
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist Guidelines):
- Hypertension: Typically 5 mg once daily. The full blood-pressure-lowering effect becomes evident after 1 to 2 weeks of treatment.
- Chronic Heart Failure (TITRATION IS MANDATORY): Must be initiated at a microscopic dose of 1.25 mg (half of a 2.5 mg tablet) once daily, strictly increasing every 1 to 2 weeks under close cardiac monitoring, up to a maximum of 10 mg daily, to prevent sudden acute heart failure exacerbation.
- Administration: Can be taken with or without food. Should be taken at the same time each day.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Abrupt Cessation): Severe exacerbation of angina, occurrence of myocardial infarction, and dangerous ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of beta-blockers. The dose MUST be gradually tapered over 1 to 2 weeks.
- Severe Bradycardia & Heart Block: Nebivolol significantly slows the heart. It is strictly contraindicated in patients with severe bradycardia (< 60 bpm), second or third-degree heart block, cardiogenic shock, or uncompensated heart failure.
- CYP2D6 Poor Metabolizers: Nebivolol is heavily metabolized by the CYP2D6 enzyme. Patients who are “poor metabolizers” will achieve blood concentrations nearly 5 times higher than normal, drastically increasing the risk of severe bradycardia. Dose adjustments are required.
- Bronchospasm Risk: While highly selective for Beta-1 receptors in the heart, high doses can “spill over” and block Beta-2 receptors in the lungs, potentially triggering severe asthma attacks or COPD exacerbations.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Cardiology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular and Racemic Formulations. Whether you are looking for a reliable Government Tender Supplier for hypertension clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.