Description

Nelfinavir Tablets (250mg / 625mg)

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 Nelfinavir Mesylate Tablets in India. Nelfinavir is a potent Protease Inhibitor (PI) used in combination with other antiretroviral agents for the treatment of HIV-1 Infection. It works by preventing the HIV virus from multiplying, helping to lower the viral load and increase CD4 cell counts in adults and children.

We offer Contract Manufacturing (Third Party) services for this critical antiretroviral (ARV) drug. Nelfinavir requires high doses to be effective, leading to large tablet sizes. Our WHO-GMP certified facility in Mumbai utilizes advanced high-shear granulation and compression technologies to produce high-load tablets that remain swallowable and disintegrate effectively. Healthy Inc manages the export logistics, supplying HIV/AIDS treatment programs, NGOs, and government tenders across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

High drug load and absorption are the challenges.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • High-Load Formulation: Nelfinavir tablets contain a large amount of active ingredient (up to 625mg). We use specialized binders and super-disintegrants to ensure the tablet is robust enough to handle but breaks down rapidly in the stomach.

  • Bioavailability Enhancement: The drug absorption is significantly food-dependent. We formulate the tablet to dissolve efficiently in the presence of gastric fluids, ensuring consistent uptake when taken with meals.

  • Coating: We apply a smooth Film Coating to mask the bitter taste of the mesylate salt and make the large tablet easier to swallow.

• The Exporter: Healthy Inc

  • Moisture Protection: Nelfinavir Mesylate is hygroscopic. We use desiccants (silica gel) inside our HDPE bottles and induction sealing to prevent moisture ingress during storage in humid climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 30 minutes.

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

• Impurity Profiling: We rigorously monitor for degradation products (Mesylate esters) to ensure long-term safety.

5. Why Use Nelfinavir?

It is a reliable component of “HAART” (Highly Active Antiretroviral Therapy).

• Mechanism: It binds to the active site of the HIV-1 Protease enzyme. This prevents the enzyme from cutting the viral protein precursors into functional pieces. The result is the production of immature, non-infectious viral particles that cannot infect new cells.

• Key Indications:

  • HIV-1 Infection: Treatment of HIV in adults and children (aged 2+), usually combined with nucleoside analogues (like Zidovudine/Lamivudine).

• Advantage: Unlike some other protease inhibitors, Nelfinavir typically does not require “boosting” with Ritonavir, simplifying the regimen for some patients.

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 Nelfinavir Tablets?

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

• Q: Must I take it with food?

  A: YES. Taking Nelfinavir with a meal increases absorption by 2-3 times. Taking it on an empty stomach will result in low drug levels and treatment failure.

• Q: Does it cause diarrhea?

  A: Yes. Diarrhea is the most common side effect. It can often be managed with over-the-counter anti-diarrheal medicines (like Loperamide) and usually improves over time.

• Q: Can it cure HIV?

  A: NO. There is currently no cure for HIV. Nelfinavir helps control the virus, allowing the immune system to recover and preventing AIDS.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1250mg (two 625mg tablets) twice daily OR 750mg (three 250mg tablets) three times daily.

• Pediatrics (2-13 years): 20-30 mg/kg per dose, three times daily.

• Administration: Take with a meal. Swallow whole. Do not crush (bitter taste).

9. Side Effects and Precautions

• Gastrointestinal: Diarrhea (very common), nausea, flatulence.

• Metabolic: New onset diabetes, hyperglycemia, and redistribution of body fat (“buffalo hump” or lipodystrophy).

• Hemophilia: Increased bleeding risks in hemophiliacs.

• Interactions: Significant drug interactions (CYP3A4 inhibitor). Consult a doctor before taking other meds (Simvastatin, Amiodarone, etc. are contraindicated).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep bottle tightly closed with desiccant.