Description
Enalapril Maleate Tablets
Healthy Inc is a specialized global supplier and exporter of “Gold Standard” cardiovascular agents. We provide high-purity Enalapril Maleate Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Heart Failure Specialist” ACE Inhibitor is a top export to cardiology institutes, government hypertension programs, and pharmacy chains in Africa, LATAM, and Southeast Asia, recognized worldwide for its proven ability to extend survival in heart failure patients.
Product Overview
This formulation contains Enalapril Maleate, a prodrug of the active ACE inhibitor Enalaprilat.
The “Survival Extension” Specialist:
- Prodrug Activation: Enalapril is inactive until swallowed. It is rapidly absorbed and hydrolyzed by the liver into its active form, Enalaprilat. This mechanism ensures a smoother, more gradual onset of action compared to Captopril, reducing the risk of “first-dose hypotension.”
- Mechanism: It inhibits Angiotensin-Converting Enzyme (ACE), blocking the conversion of Angiotensin I to Angiotensin II. This results in:
- Vasodilation: Relaxing blood vessels to lower blood pressure.
- Preload/Afterload Reduction: Significantly reducing the workload on a failing heart.
- Heart Failure Efficacy: Clinical trials (SOLVD, CONSENSUS) established Enalapril as the benchmark drug for reducing mortality and hospitalization in chronic heart failure.
- Renal Defense: It slows the progression of kidney disease in diabetics by reducing intraglomerular pressure.
Product Composition & Strength
We supply this product as Uncoated Tablets (scored for titration). The wide range of strengths allows for the “Start Low, Go Slow” dosing strategy essential for heart failure.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Enalapril Maleate USP/BP | 2.5 mg | Heart Failure Initiation |
| Enalapril Maleate USP/BP | 5 mg | Hypertension Initiation |
| Enalapril Maleate USP/BP | 10 mg | Maintenance Dose |
| Enalapril Maleate USP/BP | 20 mg | High Strength |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 14s, 28s (Calendar Pack), or Bulk HDPE Jars of 1000s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Oral) |
| Packaging | Alu-Alu Blister (Moisture Sensitive) |
| Storage | Store below 25°C. Protect from Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Salt Stability: Enalapril degrades into diketopiperazine if exposed to moisture or heat. We use the stable Maleate salt and process it in low-humidity zones, packaging it exclusively in high-barrier Alu-Alu blisters to ensure it remains within specification (USP/BP) for 24-36 months.
- Dissolution Profile: Our formulation matches the release profile of the innovator (Vasotec), ensuring the liver receives the drug at the optimal rate for conversion to Enalaprilat.
Therapeutic Indications (Human Use)
Indicated for the management of cardiovascular conditions:
- Essential Hypertension: Treatment of mild to severe high blood pressure (monotherapy or with thiazides).
- Congestive Heart Failure (CHF): Adjunctive therapy to digitalis and diuretics to improve survival and reduce symptoms.
- Asymptomatic Left Ventricular Dysfunction (LVD): Prophylaxis in clinically stable patients to delay the onset of symptomatic heart failure.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist):
- Route: Oral.
- Hypertension: Initial 5 mg daily. Maintenance 10 mg to 40 mg daily (single or divided doses).
- Heart Failure (Critical Titration):
- Week 1: 2.5 mg once daily (monitored for hypotension).
- Week 2-4: Gradually increased to 10 mg or 20 mg daily in two divided doses.
- Goal: Reach the “target dose” of 20 mg daily for maximum survival benefit.
- Renal Impairment: Start with 2.5 mg if Creatinine Clearance is < 30 ml/min.
Safety Warnings:
- ACE Inhibitor Cough: A persistent, dry, tickly cough is a common class effect.
- First-Dose Hypotension: Severe drop in blood pressure may occur after the first dose, especially in patients taking diuretics. Start low.
- Hyperkalemia: Increases potassium levels. Monitor electrolytes, especially if used with Spironolactone.
- Pregnancy (Black Box): Contraindicated. Can cause fetal injury and death (oligohydramnios).
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 OSD (Oral Solid Dosage) forms, 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.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
