Description

Artesunate + Sulfadoxine & Pyrimethamine Tablets (Combi-Kit)

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 Artesunate + Sulfadoxine & Pyrimethamine (AS+SP) Tablets in India. This product is an Artemisinin-based Combination Therapy (ACT), which is the Gold Standard recommended by the World Health Organization (WHO) for the treatment of uncomplicated Plasmodium falciparum malaria.

We offer Contract Manufacturing (Third Party) for this anti-malarial kit. Because Artesunate is chemically sensitive to the alkaline nature of Sulfadoxine, we typically manufacture this as a Co-Blistered Combi-Kit (separate tablets in the same blister) to ensure maximum stability and shelf-life. Our WHO-GMP certified facility in Mumbai supplies this critical medicine to malaria-endemic regions in Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Manufacturing ACTs requires strict environmental control to prevent degradation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Artesunate Stability: Artesunate is highly sensitive to moisture and hydrolysis (breaking down in water). We process it in Low-Humidity Suites (< 30% RH) and use moisture-protective coating.

  • Segregation: Since Sulfadoxine/Pyrimethamine is alkaline and can destabilize Artesunate if mixed directly, we utilize Co-Blistering Technology. This places the Artesunate tablets and SP tablets in separate pockets within the same blister sheet, ensuring they remain chemically stable while providing a convenient single-dose unit for the patient.

• The Exporter: Healthy Inc

  Healthy Inc manages the supply chain for malaria programs. We use Alu-Alu / Alu-PVC-PVDC Blisters to provide a high barrier against tropical humidity. We are experienced in meeting the stringent requirements of National Malaria Control Programs (NMCP) and NGO tenders.

4. Quality Assurance

We adhere to strict Pharmacopoeial and WHO protocols:

• Dissolution: We test the release rate of Artesunate (fast release) and SP (slower release) to ensure bioequivalence.

• Related Substances: We monitor for Dihydroartemisinin (DHA) and other impurities to ensure the drug retains its potency over 3 years.

• Microbial Limits: Strict bioburden testing is conducted to ensure patient safety.

5. Why Use Artesunate + SP?

This combination combats resistance and ensures a cure.

• Mechanism:

  • Artesunate: Rapidly reduces the parasite biomass (kills 99% of parasites in the first 24 hours).

  • Sulfadoxine & Pyrimethamine: Has a longer half-life; it eliminates the remaining parasites (“mop-up” action) to prevent recrudescence (return of infection).

• Key Indications:

  • Uncomplicated Malaria: Treatment of P. falciparum malaria.

  • Intermittent Preventive Treatment (IPT): SP alone is often used for prevention in pregnancy, but the combination is for acute treatment.

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: Why are there two different types of tablets in the pack?

  A: One is Artesunate (usually yellow or white, round) and the other is SP (usually white, large). They must be taken together as directed to cure malaria completely.

• Q: Can this be used for Chloroquine-resistant malaria?

  A: Yes, this is specifically designed for areas where Chloroquine resistance is high.

• Q: Who manufactures Artesunate SP Kits?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using stability-enhanced packaging.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Regimen: Typically a 3-day course.

  • Day 1: Artesunate + SP

  • Day 2: Artesunate

  • Day 3: Artesunate

  • (Note: Dosage varies by brand and specific kit strength; always follow the package insert).

• Administration: Take with food to improve absorption and reduce nausea.

9. Side Effects and Precautions

• Common Side Effects: Nausea, vomiting, headache, and dizziness.

• Sulfonamide Allergy: Do not use if the patient is allergic to Sulfa drugs (Sulfonamides), as severe skin reactions (Stevens-Johnson Syndrome) can occur.

• Pregnancy: Generally avoided in the first trimester unless the benefit outweighs the risk; safe in 2nd and 3rd trimesters.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep strictly protected from light and moisture.