Description

Lopinavir and Ritonavir Tablets (200mg + 50mg)

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 Lopinavir and Ritonavir Tablets in India, producing high-quality Antiretroviral (ARV) medicines for the management of HIV-1 infection. This fixed-dose combination acts as a boosted Protease Inhibitor (PI), which is a critical component of Second-Line HIV Therapy recommended by the WHO.

We offer Contract Manufacturing (Third Party) for this complex formulation using advanced Heat-Stable technology, ensuring the tablets do not require refrigeration. Our WHO-GMP certified facility in Mumbai adheres to strict global standards to support government tenders and NGO programs in Africa, SE Asia, and Latin America. Healthy Inc manages the specialized logistics required for ARV exports.

2. Product Specifications

3. Manufacturing Lopinavir + Ritonavir

Producing this ARV requires advanced solubility enhancement technology.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Ritonavir and Lopinavir are poorly soluble drugs. We utilize Hot Melt Extrusion (HME) technology to create a solid dispersion. This ensures that the drug dissolves properly in the body for maximum absorption. Unlike older formulations that required refrigeration, our Heat-Stable Matrix allows the tablets to be stored at room temperature, which is vital for distribution in tropical climates.

• The Exporter: Healthy Inc

  Healthy Inc manages the global supply chain with a focus on compliance. We understand the urgency of ARV supplies. We pack the bottles with high-grade silica gel desiccants to prevent moisture ingress, which can destabilize the amorphous nature of the drug. We facilitate bulk shipments for large-scale HIV treatment programs.

4. Quality Assurance

We perform rigorous testing to ensure viral load suppression efficacy:

• Polymorph Screening: We test Ritonavir to ensuring it remains in the active crystal form (Form I/II stability).

• Dissolution Profiling: We verify that the drug releases consistently to maintain therapeutic blood levels.

• Impurities: We strictly monitor for degradation products to ensure safety over the shelf life.

5. Why Use Lopinavir + Ritonavir?

It is a “gold standard” boosted protease inhibitor.

• Mechanism: Lopinavir blocks the HIV protease enzyme, preventing the virus from multiplying. Ritonavir inhibits the liver enzyme (CYP3A4) that breaks down Lopinavir, effectively “boosting” the levels of Lopinavir in the blood.

• Key Indications:

  • HIV-1 Infection: Treatment of adults, adolescents, and children with HIV-1 infection in combination with other antiretroviral agents.

  • Post-Exposure Prophylaxis (PEP): Sometimes used in occupational exposure scenarios.

6. Export and Regulatory Support

We support National Health Programs with full documentation:

• Dossier Support: We provide CTD and ACTD Dossiers for fast 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 Lopinavir Ritonavir Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using heat-stable technology.

• Q: Do these tablets need refrigeration?

  A: No, our modern formulation is stable at room temperature (up to 30°C), making logistics easier.

• Q: Is this a generic for Kaletra?

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

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Adult Dose: Two tablets (Total 400mg/100mg) twice daily.

• Administration: Should be swallowed whole and not chewed, broken, or crushed. Can be taken with or without food.

9. Side Effects and Precautions

• Common Side Effects: Diarrhea (very common), nausea, vomiting, and high cholesterol/triglycerides.

• Interactions: Ritonavir is a potent CYP3A4 inhibitor. It interacts with many drugs including statins, sedatives, and anti-arrhythmics. Always check interactions.

• Warnings: Monitor liver function tests and lipid profiles regularly.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep the bottle tightly closed.