Description

Lisinopril 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 Lisinopril Tablets in India. Lisinopril is a potent ACE Inhibitor (Angiotensin-Converting Enzyme Inhibitor) widely used as a first-line therapy for the treatment of Hypertension (High Blood Pressure), Congestive Heart Failure, and to improve survival after a Myocardial Infarction (Heart Attack). It is also critical for protecting the kidneys in diabetic patients (Diabetic Nephropathy).

We offer Contract Manufacturing (Third Party) services for this high-volume cardiovascular drug. Unlike many other ACE inhibitors (like Enalapril), Lisinopril is not a prodrug and acts directly, making it effective even in patients with liver issues. Our WHO-GMP certified facility in Mumbai utilizes advanced direct compression technology to produce tablets with excellent stability and rapid disintegration. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stability and bioavailability are the priorities.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Control: Lisinopril Dihydrate is stable, but the tablet formulation can be sensitive to high humidity. We manufacture in Dehumidified Suites and use Alu-Alu Cold Form Blisters to ensure the drug remains stable in tropical climates (Zone IVb stability).

  • Direct Compression: We use specialized grades of excipients (like Dicalcium Phosphate) that allow for direct compression. This avoids the heat and moisture of wet granulation, preserving the integrity of the active molecule.

  • Content Uniformity: For lower strengths (2.5mg), we use high-precision geometric blending to ensure exact dosing in every tablet.

• The Exporter: Healthy Inc

  • Patient Compliance Packs: We offer “Calendar Blister Packs” (Mon-Sun markings) to help elderly patients track their daily dosage, improving adherence to therapy.

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.

• Related Substances: We strictly monitor for the specific Diketopiperazine impurity (a degradation product) to ensure safety.

5. Why Use Lisinopril?

It relaxes blood vessels to lower pressure.

• Mechanism: It inhibits the ACE enzyme, preventing the body from converting Angiotensin I to Angiotensin II (a potent vasoconstrictor). This relaxes blood vessels (vasodilation) and reduces the secretion of Aldosterone (lowering fluid retention).

• Key Indications:

  • Hypertension: Monotherapy or combined with diuretics (Hydrochlorothiazide).

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

  • Post-MI: Given within 24 hours of a heart attack to improve survival.

  • Diabetic Nephropathy: Protects kidneys from damage caused by high blood pressure and diabetes.

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 Lisinopril Tablets?

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

• Q: Is it Zestril/Prinivil?

  A: Zestril and Prinivil are brand names. We manufacture the Generic Equivalent (Lisinopril), which is bioequivalent and works exactly the same way.

• Q: Why do I have a dry cough?

  A: A Persistent Dry Cough is a common side effect of all ACE inhibitors (due to bradykinin buildup in the lungs). If it becomes unbearable, your doctor may switch you to an ARB (like Losartan).

• Q: Is it safe for pregnancy?

  A: NO. It causes major birth defects (fetotoxicity). Do not take if you are pregnant or planning to become pregnant.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: Start 10mg once daily. Maintenance 20-40mg daily.

• Heart Failure: Start 2.5mg or 5mg once daily.

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

9. Side Effects and Precautions

• Hyperkalemia: Increases potassium levels in the blood. Monitor electrolytes, especially if taking potassium supplements.

• Hypotension: “First-dose hypotension” (dizziness) can occur. Start with a low dose at bedtime.

• Angioedema: Rare but life-threatening swelling of the face/throat. Stop immediately and seek emergency care.

• Renal Function: Monitor serum creatinine.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.