Description

Enalapril Tablets (2.5mg / 5mg / 10mg / 20mg)

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 Enalapril Maleate Tablets in India. Enalapril is a widely prescribed Angiotensin-Converting Enzyme (ACE) Inhibitor used as a cornerstone therapy for Hypertension and Congestive Heart Failure. It is clinically proven to improve survival rates in patients with heart failure and asymptomatic left ventricular dysfunction.

We offer Contract Manufacturing (Third Party) services for this essential cardiovascular drug. Enalapril is a prodrug that is sensitive to heat and moisture, prone to degrading into a toxic impurity called diketopiperazine. Our WHO-GMP certified facility in Mumbai utilizes controlled low-humidity manufacturing suites (< 30% RH) and specialized packaging to ensure stability. Healthy Inc manages the export logistics, supplying cardiology centers and government health programs across Latin America, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

preventing degradation for maximum potency.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Stabilization: Enalapril Maleate easily degrades into Enalaprilat and Diketopiperazine (DKP) in the presence of moisture. We use Direct Compression with low-moisture excipients (like Anhydrous Lactose) and strictly control environmental humidity to prevent this reaction.

  • Alu-Alu Packaging: To guarantee stability in tropical climates (Zone IVb), we strongly recommend Cold Form Alu-Alu Blisters, which provide a near-perfect barrier against moisture ingress.

  • Content Uniformity: We ensure precise blending to guarantee that every tablet, from the low 2.5mg dose to the 20mg dose, contains the exact amount of active ingredient.

• The Exporter: Healthy Inc

  • Heart Failure Kits: We can support the packaging of “Heart Failure Management Kits” (Enalapril + Diuretic + Beta Blocker) for chronic disease management programs.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for the specific degradation impurity (Diketopiperazine) to ensure the drug remains effective and safe.

5. Why Use Enalapril?

Protects the heart and kidneys while lowering pressure.

• Mechanism: Enalapril is a prodrug converted in the liver to Enalaprilat. It inhibits the Angiotensin-Converting Enzyme (ACE). This prevents the conversion of Angiotensin I to Angiotensin II (a potent vasoconstrictor). The result is relaxed blood vessels and reduced release of Aldosterone, lowering blood pressure and heart strain.

• Key Indications:

  • Hypertension: Effective reduction of blood pressure as monotherapy or combination.

  • Heart Failure: Reduces the workload on the heart and improves survival.

  • Asymptomatic Left Ventricular Dysfunction: Delays the onset of symptomatic heart failure.

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 Enalapril Tablets?

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

• Q: Is it Vasotec?

  A: Vasotec is the brand name (Merck). We manufacture the Generic Equivalent (Enalapril Maleate).

• Q: Does it cause a cough?

  A: Yes. Like all ACE inhibitors, it can cause a persistent dry cough in some patients due to the accumulation of Bradykinin in the lungs.

• Q: Is it safe for kidneys?

  A: Yes and No. It protects kidneys in diabetics but can worsen kidney function in patients with severe renal artery stenosis. Blood tests are required.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: Start 5mg once daily. Maintenance 10-40mg daily (single or divided doses).

• Heart Failure: Start 2.5mg once or twice daily. Titrate slowly to target 20mg daily.

• Administration: Swallow with water. Can be taken with or without food.

9. Side Effects and Precautions

• Dry Cough: A tickling, non-productive cough.

• Hyperkalemia: Can raise potassium levels. Monitor K+ levels.

• Hypotension: “First-dose effect” causing dizziness. Start low in volume-depleted patients.

• Angioedema: Rare but serious swelling of the face/lips/tongue. Stop immediately.

• Pregnancy: Contraindicated. Can cause fetal injury.

10. Storage Instructions

• Store below 25°C in a dry place.

• Extremely Sensitive to Moisture. Keep in the original blister pack until use.