Description

Nevirapine Tablets (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 Nevirapine Tablets in India. Nevirapine is a widely used Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) for the treatment of HIV-1 Infection. It is a cornerstone of antiretroviral therapy (ART) in low-to-middle-income countries due to its efficacy and proven role in preventing Mother-to-Child Transmission (PMTCT) of HIV during childbirth.

We offer Contract Manufacturing (Third Party) services for this essential ARV. Nevirapine requires strict adherence to dissolution standards to ensure bioavailability. Our WHO-GMP certified facility in Mumbai utilizes advanced granulation and compression technologies to produce tablets that meet global pharmacopoeial standards. Healthy Inc manages the export logistics, supplying HIV treatment programs, NGOs, and Ministries of Health across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Bioavailability and safety are the priorities.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Rapid Dissolution: Nevirapine is practically insoluble in water. We use Micronized API and specific disintegrants to ensure the tablet breaks down and dissolves rapidly in the stomach, ensuring the drug reaches therapeutic levels in the blood quickly.

  • Content Uniformity: We use high-precision blending and compression equipment to ensure that every tablet contains exactly 200mg of the active ingredient, which is critical for preventing viral resistance caused by under-dosing.

  • Stability: We formulate the tablet to be stable in tropical zones (Zone IVb), ensuring efficacy even in hot and humid climates common in our export markets.

• The Exporter: Healthy Inc

  • Secure Packaging: We use high-density polyethylene (HDPE) bottles with induction sealing and silica gel desiccants to protect the tablets from moisture during long-term storage and distribution.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for degradation products and related substances to ensure safety over the 3-year shelf life.

5. Why Use Nevirapine?

It is effective and essential for PMTCT.

• Mechanism: It binds directly to the Reverse Transcriptase enzyme of the HIV-1 virus (at a site distinct from nucleosides). This blocks the enzyme’s ability to copy the viral RNA into DNA, preventing the virus from replicating.

• Key Indications:

  • HIV-1 Infection: Combination treatment (with Zidovudine/Lamivudine or Tenofovir) for adults and children.

  • PMTCT: Prevention of Mother-to-Child Transmission (single dose given to mother at onset of labor and to infant after birth) in resource-limited settings.

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 Nevirapine Tablets?

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

• Q: Why is there a “Lead-in” dose?

  A: Nevirapine can cause a rash. To reduce this risk, patients start with one tablet daily for 14 days (Lead-in). If no rash occurs, they increase to the full dose (one tablet twice daily).

• Q: Can it cure HIV?

  A: NO. It suppresses the virus but does not cure the infection. Patients must take it for life.

• Q: Does it damage the liver?

  A: Yes. Hepatotoxicity (liver damage) is a known risk, especially in the first few weeks. Regular liver function tests are required.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Lead-in Phase: 200mg once daily for the first 14 days.

• Maintenance Phase: 200mg twice daily (only if no severe rash/liver issues occurred during lead-in).

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

9. Side Effects and Precautions

• Skin Rash: Black Box Warning: Severe, life-threatening skin reactions (Stevens-Johnson Syndrome) can occur. Discontinue immediately if severe rash develops.

• Hepatotoxicity: Black Box Warning: Severe liver toxicity can occur. Monitor liver enzymes (ALT/AST) frequently, especially in the first 18 weeks.

• CD4 Count: Higher risk of side effects in women with CD4 > 250 and men with CD4 > 400.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep container tightly closed.