Description

Lamivudine, Zidovudine & Nevirapine Tablets (150mg + 300mg + 200mg)

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 Lamivudine, Zidovudine, and Nevirapine Tablets in India. This Triple Fixed-Dose Combination (FDC) simplifies HIV-1 treatment by combining three essential antiretroviral drugs into a single tablet. It is widely used as a First-Line regimen in many national health programs across Africa and Asia.

We offer Contract Manufacturing (Third Party) for this high-volume ARV formulation. Our WHO-GMP certified facility in Mumbai uses advanced manufacturing processes to ensure the stability of all three active ingredients in one matrix. Healthy Inc manages the complex supply chain for global tenders and NGO procurement, ensuring timely delivery of life-saving medicines.

2. Product Specifications

3. Manufacturing Triple FDC Tablets

Combining three drugs requires precise formulation science to prevent interaction and degradation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  We use a robust Wet Granulation process to ensure uniform distribution of the potent actives. Since Nevirapine is hydrophobic (hard to dissolve), we use specific solubilizers to ensure bioequivalence. We apply a protective Film Coating to mask the bitter taste of the drugs and protect Zidovudine from light degradation. This ensures patient compliance, which is critical for HIV treatment success.

• The Exporter: Healthy Inc

  Healthy Inc specializes in the export of ARVs. We use HDPE Bottles with Induction Sealing and heavy-duty desiccants to protect the tablets from humidity during sea freight to tropical destinations. We provide complete logistical support for Ministry of Health tenders and bulk procurements.

4. Quality Assurance

We adhere to strict testing protocols for multi-component formulations:

• Dissolution: We simultaneously test the release profile of all three drugs to ensure they dissolve at the correct rate in the stomach.

• Impurities: We strictly monitor for degradation products (like Thymine) and process-related impurities to ensure safety over the 3-year shelf life.

• Assay: We confirm that every tablet contains exactly 100% of the label claim for all three ingredients.

5. Why Use This Triple FDC?

It improves adherence by reducing the “pill burden.”

• Mechanism:

  • Lamivudine & Zidovudine (NRTIs): Block the reverse transcriptase enzyme by mimicking DNA building blocks.

  • Nevirapine (NNRTI): Directly binds to and disables the reverse transcriptase enzyme.

  • Synergy: Together, they powerfully suppress viral replication and increase CD4 cell counts.

• Key Indications:

  • HIV-1 Infection: Treatment of HIV-1 infection in adults and adolescents.

  • Simplified Regimen: Replaces the need to take separate bottles of medicines, improving patient compliance.

6. Export and Regulatory Support

We support our partners with comprehensive regulatory files:

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

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

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

7. Frequently Asked Questions

• Q: Who manufactures this Triple FDC?

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

• Q: Can a patient start this tablet immediately?

  A: usually, patients start with a “Lead-in” period (separate Nevirapine) for the first 14 days to check for allergic reactions before switching to this convenient FDC.

• Q: Is this WHO pre-qualified standard?

  A: We manufacture according to WHO-GMP standards and follow the pharmacopoeial monographs (USP/IP) strictly.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet twice daily (every 12 hours).

• Precaution: Patients should not switch to this fixed-dose combination until they have tolerated the first 14 days of Nevirapine treatment without rash.

• Administration: Can be taken with or without food.

9. Side Effects and Precautions

• Skin Rash: Nevirapine can cause severe skin rashes (Stevens-Johnson Syndrome). Discontinue immediately if severe rash occurs.

• Anemia: Zidovudine can cause low red blood cells. Regular monitoring is needed.

• Hepatotoxicity: Monitor liver function, as Nevirapine can cause liver stress.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep the bottle tightly closed.