Description

Amlodipine and Lisinopril 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 Lisinopril Tablets in India. This is a powerful Antihypertensive Combination therapy that brings together two distinct mechanisms of action to lower blood pressure more effectively than either drug alone. It combines Amlodipine (a Calcium Channel Blocker) with Lisinopril (an ACE Inhibitor).

We offer Contract Manufacturing (Third Party) services for this Fixed-Dose Combination (FDC). This formulation is particularly valuable because the addition of Lisinopril can help counteract the peripheral edema (ankle swelling) often associated with Amlodipine monotherapy, improving patient tolerance. Our WHO-GMP certified facility in Mumbai utilizes precise blending technologies to ensure content uniformity of both active ingredients. Healthy Inc manages the export logistics, supplying this essential cardiovascular medicine to markets in the USA, Europe, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Creating a stable dual-action tablet requires strict environmental controls.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Compatibility: While generally compatible, we ensure optimal excipient selection to prevent the degradation of Lisinopril (which can form diketopiperazine) and ensure the stability of Amlodipine Besylate.

  • Content Uniformity: Both drugs are potent. We use High-Shear Granulation and Geometric Mixing to ensure that the ratio of Amlodipine to Lisinopril is exact in every single tablet, preventing blood pressure fluctuations.

  • Compression: We compress tablets to specific hardness parameters to ensure they are durable for shipping but disintegrate rapidly in the stomach for consistent absorption.

• The Exporter: Healthy Inc

  • Packaging: Lisinopril can be sensitive to moisture. We predominantly use Alu-Alu Cold Form Blisters or PVDC-coated PVC to provide a high barrier against humidity, ensuring the product remains stable in tropical export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

• Dissolution: We test the release profile to confirm that >80% of both drugs release within 30 minutes.

• Related Substances: We strictly monitor for specific impurities like Amlodipine impurity A and Lisinopril diketopiperazine to guarantee safety.

5. Why Use Amlodipine + Lisinopril?

It offers superior BP control with fewer side effects.

• Mechanism:

  • Amlodipine: Relaxes the muscles in the blood vessel walls (vasodilation), allowing blood to flow more easily.

  • Lisinopril: Blocks the ACE enzyme, preventing the body from producing Angiotensin II (a substance that tightens blood vessels) and reducing salt/water retention.

• Key Advantages:

  • Synergy: The combination lowers BP more than increasing the dose of just one drug.

  • Reduced Side Effects: Lisinopril helps dilate veins, which can reduce the fluid leakage (edema) caused by Amlodipine’s dilation of arteries.

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 Lisinopril Tablets?

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

• Q: Is this safer than taking them separately?

  A: It is more convenient (one pill instead of two) and often tolerated better. The combination is a standard therapy for patients not controlled on monotherapy.

• Q: Can this cause a cough?

  A: Yes, because it contains Lisinopril (an ACE inhibitor), some patients may develop a dry, persistent cough. If this occurs, a doctor may switch the patient to an ARB combination.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily.

• Titration: Treatment is usually started with lower strengths and titrated up based on blood pressure response over 2-4 weeks.

• Administration: Can be taken with or without food.

9. Side Effects and Precautions

• Common Side Effects: Dizziness, headache, dry cough (ACE inhibitor effect), and swelling of ankles (though less than Amlodipine alone).

• Hyperkalemia: Lisinopril can increase potassium levels. Monitor electrolytes regularly.

• Pregnancy: Black Box Warning: Drugs acting on the renin-angiotensin system (like Lisinopril) can cause injury and death to the developing fetus. Do not use in pregnancy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.