Description

Lamivudine and Zidovudine Tablets (150mg + 300mg)

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 and Zidovudine Tablets in India, producing essential Antiretroviral (ARV) medicines for the management of HIV-1 infection. This fixed-dose combination (FDC) contains two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and is a cornerstone of First-Line and Second-Line HIV Therapy protocols recommended by the WHO.

We offer Contract Manufacturing (Third Party) services for this product, supporting global HIV/AIDS treatment programs. Our WHO-GMP certified facility in Mumbai adheres to strict quality controls to ensure the stability and efficacy of this life-saving medication. Healthy Inc manages the specialized export logistics, supplying NGOs, hospitals, and government health ministries across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Lamivudine + Zidovudine Tablets

Producing ARV combinations requires precise formulation stability.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Zidovudine is sensitive to light and moisture. We utilize a Film Coating process (Opadry) to protect the tablet core from degradation. We use robust granulation techniques to ensure the uniform distribution of both active ingredients, preventing segregation during compression. This ensures that every tablet delivers the precise 150mg/300mg ratio required for viral suppression.

• The Exporter: Healthy Inc

  Healthy Inc ensures compliance with international export regulations for ARVs. We use high-density polyethylene (HDPE) bottles with desiccants or high-barrier blisters to maintain stability in tropical climates. We are experienced in managing Global Tender requirements and providing the necessary documentation for rapid customs clearance.

4. Quality Assurance

We perform rigorous testing to ensure safety and efficacy:

• Dissolution: We test the release rate of both drugs to ensure bioequivalence to the innovator product.

• Related Substances: We strictly monitor for Thymine and other degradation impurities to ensure patient safety over the shelf life.

• Assay: We confirm the potency of both Lamivudine and Zidovudine stays within tight limits (90-110%).

5. Why Use Lamivudine + Zidovudine?

This dual-NRTI backbone is effective in suppressing viral load.

• Mechanism: Both drugs mimic the building blocks of DNA (nucleosides). When the HIV virus tries to copy its genetic material using the enzyme “Reverse Transcriptase,” these drugs insert themselves into the chain and terminate the process, stopping viral replication.

• Key Indications:

  • HIV-1 Infection: Treatment of HIV infection in combination with other antiretrovirals (like Efavirenz or Nevirapine).

  • Prevention: Used in Post-Exposure Prophylaxis (PEP) protocols.

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

7. Frequently Asked Questions

• Q: Who manufactures Lamivudine Zidovudine Tablets?

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

• Q: Is this the generic for Combivir?

  A: Yes, this is the generic equivalent of Combivir.

• Q: Can this be used for children?

  A: This strength is generally for adults and adolescents. Pediatric formulations are different.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

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

• Administration: Can be taken with or without food.

• Adherence: Strict adherence to dosing is critical to prevent drug resistance.

9. Side Effects and Precautions

• Common Side Effects: Nausea, headache, fatigue, and muscle pain.

• Anemia: Zidovudine can cause bone marrow suppression leading to severe anemia. Regular blood tests (Hemoglobin) are required.

• Lactic Acidosis: A rare but serious condition associated with NRTIs.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.