Artesunate Tablets

Description

Artesunate Tablets (50mg / 100mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Artesunate Tablets in India. This Artemisinin derivative is a potent antimalarial drug, critical for the treatment of uncomplicated and severe Malaria caused by Plasmodium falciparum. We produce high-stability tablets designed to withstand tropical supply chains. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and NGO tenders.

2. Product Specifications

3. Manufacturing Artesunate Tablets

We divide our operations to ensure specialized focus.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Artesunate is chemically unstable and can break down (hydrolyze) if exposed to humidity. To prevent this, we manufacture in Dehumidified Suites (RH < 40%). We use Moisture-Barrier Blister Packaging (Alu-Alu or PVDC) to ensure the tablets remain stable and potent even in the hot, humid climates of Africa and Southeast Asia where malaria is endemic.
• The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Artesunate Tablets. We supply National Malaria Control Programs and global health NGOs. We are experienced in supplying both mono-therapy tablets and ACT (Artemisinin-based Combination Therapy) kits.

4. Quality Assurance

• Related Substances: We monitor for the breakdown product Dihydroartemisinin to ensure the drug has not degraded during production.
• Dissolution: We test how the tablet releases the drug. Rapid release is vital to quickly reduce the “parasite load” in the patient’s blood.
• Assay: We confirm the potency to ensure effective parasite clearance.

5. Why Use Artesunate Tablets?

This drug is one of the fastest-acting antimalarials available.

• Mechanism: It produces free radicals (reactive oxygen species) inside the malaria parasite. These radicals damage the parasite’s proteins and membranes, killing it rapidly.
• Effect: It clears parasites from the blood faster than Chloroquine or Quinine.

Key Indications:

• Uncomplicated Malaria: Treatment of P. falciparum malaria (usually in combination with Amodiaquine, Mefloquine, or SP).
• Severe Malaria (Step-down): Oral follow-up treatment after the patient has received injectable Artesunate for severe malaria.

6. Export and Regulatory Support

• Dossier: We offer CTD and ACTD formats.
• Certificates: We supply the Free Sale Certificate (FSC) and COPP.
• Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

Q: Who manufactures Artesunate Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

Q: Is this Monotherapy or Combination?
A: This page describes Artesunate Tablets (Monotherapy). However, WHO recommends using it in combination (ACT) to prevent resistance. We can supply the partner drugs (Amodiaquine/SP) as well.

Q: What is the shelf life?
A: Our stabilized formulation offers a 24 to 36-month shelf life depending on the packaging used.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 4 mg/kg body weight once daily for 3 days (usually combined with another antimalarial).
• Administration: Swallow whole with water. Can be taken with food to reduce nausea.
• Adherence: Completing the full 3-day course is critical to prevent the infection from returning.

9. Side Effects and Precautions

• Common Side Effects: Dizziness, headache, nausea, and vomiting (often difficult to distinguish from malaria symptoms).
• Hemolysis: Rare cases of delayed hemolysis (breakdown of red blood cells) can occur weeks after treatment.
• Pregnancy: Generally considered safe in the 2nd and 3rd trimesters. Use in the 1st trimester only if the benefit outweighs the risk.

10. Storage Instructions

• Store below 30°C in a dry place.
• Critical: Protect from moisture and heat.
• Keep out of reach of children.