Artesunate Tablets (only for Export)

Artesunate Tablets

ARTESUNATE TABLETS 25 MG
each uncoated tablet contains:
artesunate IP 25 mg
excipients q.s.

Armax – 50
Artesunate Tablets 50 mg
Each Filmcoated tablet contains:
Artesunate 50 mg

Artesunate Tablets 100 mg
Each uncoated tablet contains:
Artesunate IP 100 mg
Excipients – QS

Artesunate Tablets 150 mg
Each Uncoated tablet contains:
Artesunate 150 mg
Excipients – q.s

Artesunate Tablets 200 mg
Each Filmcoated tablet contains:
Artesunate IP 200 mg

ARTESUNATE TABLETS INT. PH.+PYRIMETHAMINE AND
SULPHADOXINE- AThree Tablets Of
– Each uncoated tablet contains:
– SULFADOXINE IP 500 MG
– Pyrimethamine IP 25 MG
– BThree Tablet Of
– Each Film coated tablet contains:
– Artesunate IP 200 MG

ARTESUNNATE + SULPHADOXINE AND
PYRIMETHAMINE IP COB
Each kit contains:

Artisunate tab+sulphadoxine and Pyrimethamine tab three tab of artesunate 150 mg and two tablets of sulphadoxine and pyrimethamine ip 525 mg CMB

ARTESUNATE + SULPHADOXINE & PYRIMETHAMINE IP-
5 TO 8 YEARS 3 TABLETS OF ARTESUNATE 100MG AND
1 TABLET OF PYRIMETHAMINE AND SULPHADOXINE
TABLETS IP 750 & 37.5MGCMB
EACH KIT CONTAINS

ARTESUNATE + SULPHADOXINE & PYRIMETHAMINE IP – ADULT 15 YEARS & ABOVE [ 3 TABLETS OF ARTESUNATE 200 MG AND 3 TABLET OF PYRIMETHAMINE AND SULPHADOXINE TABLETS IP 500 & 25 MG] CMB

ARTESUNATE + SULPHADOXINE & PYRIMETHAMINE IP – INFANT BELOW 1 YEAR [ 3 TABLETS OF ARTESUNATE 25 MG AND 2 TABLETS OF SULPHADOXINE & PYRIMETHAMINE TABLETS IP 125 & 6.25 MG] CMB Artesunate Tablets + Pyrimethamine & Sulphadoxine Tablets IP Age 1 to 4 Years CMB 3 TABLETS OF ARTESUNATE AND 1 TABLET OF PYRIMETHAMINE & SULPHADOXINE Each Combipack Contains: ARTESUNATE TABLETS 50 MG
Each film coated tablet contains:
ARTESUNATE IP 50 mg

PYRIMETHAMINE AND SULPHADOXINE TABLETS IP

ARTESUNATE TABLETS + PYRIMETHAMINE & SULPHADOXINE TABLETS IP Age 9 to 14 years CMB 3 TABLETS OF ARTESUNATE AND 2 TABLETS OF PYRIMETHAMINE & SULPH

ARTESUNATE TABLETS 150 MG
Each Uncoated tablet contains:
Artesunate 150 mg
Excipients – q.s

PYRIMETHAMINE AND SULPHADOXINE TABLETS IP
Supp Each uncoated tablet contains: Sulphadoxine IP 500 mg
Pyrimethamine IP 25 mg
Excipients – QS

Arsugin M Combipack
Artesunate Tablets + Mefloquine Tablets
a Each Film Coated Tablet Contains:
Artesunate 200 mg
b Each Film Coated Tablet Contains:
Mefloquine Hydrochloride BP
eq. To Mefloquine 250 mg

Arsugin SP Combipack
Artesunate Tablets +
Sulfadoxine and Pyrimethamine Tablets USP
a Each Film Coated Tablet Contains:
Artesunate 200 mg
b Each Uncoated Tablet Contains:
Sulfadoxine USP 500 mg
Pyrimethamine USP 25 mg

Usage: – Treat severe Malaria

Category: – Antimalarial drugs

Therapeutic category: – Antimalarial,

SKU: Artesunate Tablets Categories: , , , , , , Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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 | Parameter | Specification | | :— | :— | | Product Name | Artesunate Tablets | | Generic Name | Artesunate USP / IP / WHO | | Strength | 50mg / 100mg / 200mg | | Dosage Form | Uncoated / Film Coated Tablet | | Standard | USP / IP / WHO Prequalified Standards | | Therapeutic Class | Antimalarial (Artemisinin Derivative) | | Shelf Life | 24 – 36 Months | | Packaging | 1×6 Strip / 1×12 Blister / 1000s Bulk Jar |

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 We test every batch rigorously.

  • 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 We provide complete documentation for registration.

  • 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.

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