Description
Amlodipine & Enalapril Maleate Tablets
Healthy Inc is a specialized global supplier and exporter of high-stability Fixed-Dose Combination (FDC) cardiovascular therapies. We provide premium Amlodipine (as Besylate) & Enalapril Maleate Tablets, sourced from WHO–GMP certified solid dosage facilities. This essential “Dual-Action” antihypertensive is a primary export to cardiology centers, diagnostic clinics, and Ministry of Health tenders in Africa, LATAM, and Southeast Asia, offering a synergistic approach to managing moderate to severe hypertension.
Product Overview
This formulation combines a Calcium Channel Blocker (CCB) with an Angiotensin-Converting Enzyme (ACE) Inhibitor. This combination is clinically preferred for its ability to target two distinct physiological pathways, resulting in enhanced vasodilation and reduced cardiac workload.
The “Hemodynamic Balance” Specialist:
- Amlodipine (The Peripheral Vasodilator): A long-acting dihydropyridine CCB that inhibits the influx of calcium ions into vascular smooth muscle. It acts primarily on the peripheral arteries, reducing total peripheral resistance and lowering systemic blood pressure.
- Enalapril Maleate (The RAAS Modulator): A prodrug that is bioactivated into Enalaprilat. It blocks the enzyme responsible for creating Angiotensin II. By inhibiting this potent vasoconstrictor, it promotes systemic vasodilation and reduces the secretion of aldosterone, thereby decreasing sodium and water retention.
- Synergy and Tolerability: Enalapril helps counteract the activation of the sympathetic nervous system and the renin-angiotensin system that can sometimes occur with Amlodipine monotherapy. Furthermore, ACE inhibitors like Enalapril are known to reduce the incidence of Amlodipine-induced peripheral edema.
Product Composition & Strength
We supply this product as Film Coated Tablets to protect the Enalapril Maleate from moisture-induced degradation and to ensure the physical integrity of the combination.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Amlodipine (as Besylate) BP/USP | 5 mg / 10 mg | Calcium Channel Blocker (CCB) | |
| Enalapril Maleate BP/USP | 5 mg / 10 mg / 20 mg | ACE Inhibitor | |
| Excipients | Q.S. | Sodium Stearyl Fumarate / Lactose | Lubricant & Stabilizer |
*Available in common ratios like 5/5mg, 5/10mg, and 10/20mg. Pack Sizes: 10s, 14s, 28s, or 30s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Cardiovascular Medicaments) |
| Dosage Form | Tablet (Film Coated) |
| Packaging | Alu-Alu Blister (Strictly required for Enalapril stability) |
| Storage | Store below 25°C. Protect from moisture and light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Stability Excellence: Enalapril Maleate is prone to hydrolysis and cyclization in the presence of certain lubricants like Magnesium Stearate. We utilize Sodium Stearyl Fumarate and low-moisture excipients to prevent the formation of the “Diketopiperazine” impurity, ensuring long-term stability.
- Validation: Every batch undergoes rigorous dissolution testing to ensure that the release profiles of both Amlodipine and Enalapril meet USP/BP standards for immediate-release FDCs.
Therapeutic Indications (Human Use)
Indicated for the management of hypertension:
- Primary Hypertension: For patients not adequately controlled on monotherapy with CCBs or ACE inhibitors.
- Cardiovascular Protection: To reduce the risk of stroke and myocardial infarction in hypertensive patients with multiple risk factors.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist):
- Route: Oral.
- Standard Dose: One tablet daily.
- Administration: Should be taken at the same time each day. Consistency is vital to maintain steady-state blood pressure control.
Safety Warnings:
- Pregnancy Warning: BOXED WARNING: ACE inhibitors like Enalapril can cause fetal injury or death if used during pregnancy. Discontinue immediately if pregnancy is detected.
- Renal Function: Monitor serum creatinine and potassium levels, as Enalapril can cause hyperkalemia, especially in patients with kidney impairment.
- Cough: A persistent dry cough may occur in some patients due to the ACE inhibitor component.
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
