Description

Amlodipine and Enalapril Maleate Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Amlodipine and Enalapril Maleate Tablets in India. This is a synergistic Antihypertensive Combination designed to provide superior blood pressure control compared to monotherapy. It combines Amlodipine (a long-acting Calcium Channel Blocker) with Enalapril Maleate (an ACE Inhibitor).

We offer Contract Manufacturing (Third Party) services for this effective Fixed-Dose Combination (FDC). The addition of Enalapril helps to blunt the reflex tachycardia and peripheral edema that can sometimes occur with Amlodipine alone. Our WHO-GMP certified facility in Mumbai utilizes advanced formulation techniques to stabilize the moisture-sensitive Enalapril component. Healthy Inc manages the export logistics, supplying this essential cardiovascular medicine to pharmacy chains and government health programs across Latin America, CIS countries, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stabilizing ACE inhibitors in combination requires strict environmental control.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Stability Control: Enalapril Maleate is highly sensitive to moisture and heat; it can degrade into the inactive impurity Diketopiperazine (DKP). We manufacture in Low-Humidity Suites (< 35% RH) and strictly control the water content of excipients to prevent this degradation.

  • Content Uniformity: Both active ingredients are potent. We use High-Shear Granulation and Geometric Dilution to ensuring a homogenous blend, guaranteeing that every tablet delivers the exact prescribed dose.

  • Compatibility: We select specific lubricants and binders (avoiding alkaline substances) that do not react with the Enalapril salt.

• The Exporter: Healthy Inc

  • High-Barrier Packaging: Due to Enalapril’s moisture sensitivity, we strongly recommend Alu-Alu Cold Form Blisters for tropical markets. This ensures the product remains stable and effective throughout its shelf life.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We simultaneously quantify both Amlodipine and Enalapril using HPLC to ensure 100% label claim (90-110%).

• Dissolution: We test the release profile to confirm that both drugs release rapidly and consistently.

• Impurity Profiling: We strictly monitor for Enalaprilat and Diketopiperazine impurities to ensure the drug remains safe and potent.

5. Why Use Amlodipine + Enalapril?

It provides “Balanced” blood pressure control.

• Mechanism:

  • Amlodipine: Relaxes arterial muscles (vasodilation), lowering peripheral resistance.

  • Enalapril: Blocks the formation of Angiotensin II, preventing vasoconstriction and reducing sodium retention.

• Key Advantages:

  • Reduced Edema: Enalapril dilates veins (venodilation), which helps drain the fluid accumulation in the ankles often caused by Amlodipine (which primarily dilates arteries).

  • Renal Protection: ACE inhibitors like Enalapril offer protective benefits for the kidneys, especially in diabetic patients.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Amlodipine Enalapril Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Can this cause a cough?

  A: Yes, Enalapril is an ACE Inhibitor, which can cause a dry, tickly cough in about 10-15% of patients. If intolerable, doctors may switch to an ARB combination.

• Q: Is it safe for kidneys?

  A: Generally, yes. It can protect kidneys in diabetics, but it should not be used in patients with severe bilateral renal artery stenosis.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily.

• Titration: Dosage is adjusted based on patient response.

• Administration: Can be taken with or without food.

9. Side Effects and Precautions

• Common Side Effects: Dizziness, headache, dry cough, and fatigue.

• Hyperkalemia: Enalapril can raise potassium levels. Avoid potassium supplements unless prescribed.

• Angioedema: Rare but serious swelling of the face/throat. Stop immediately if this occurs.

• Pregnancy: Contraindicated. ACE inhibitors can cause fetal injury.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture.