Artesunate+Amodiaquine Tablet 25mg+67.5mg

Artesunate+Amodiaquine Tablet 25mg+67.5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Artesunate+Amodiaquine Tablet 25mg+67.5mg
  
• Artesunate+Amodiaquine Tablet 50mg+135mg
• Artesunate+Amodiaquine Tablet 100mg+270mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

•  a) Artesunate+Amodiaquine Tablet 25mg+67.5mg
  Each bilayer tablet contains:
  Artesunate.…………………………….25mg
  Amodiaquine HCL…………………………….67.5mg
  Excipients…………………………………. q.s.
  Colours: Quinoline Yellow
• b) Artesunate+Amodiaquine Tablet 50mg+135mg
  Each bilayer tablet contains:
  Artesunate.…………………………….50mg
  Amodiaquine HCL…………………………….135mg
  Excipients…………………………………. q.s.
  Colours: Sunset Yellow
• c) Artesunate+Amodiaquine Tablet 100mg+270mg
  Each bilayer tablet contains:
  Artesunate.…………………………….100mg
  Amodiaquine HCL…………………………….270mg
  Excipients…………………………………. q.s.
  Colours: Quinoline Yellow Lake

THERAPEUTIC INDICATIONS:

• ARTESUNATE AMODIAQUINE WINTHROP is indicated for the treatment of uncomplicated cases of malaria due to Plasmodium falciparum strains which are susceptible to amodiaquine as well as to artesunate.

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
  

STORAGE & DOSAGE:

• Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage: As directed by the Physician.

🧪 Introduction to Artesunate+Amodiaquine Tablet 25 mg+67.5 mg

Artesunate+Amodiaquine Tablet 25 mg+67.5 mg is a fixed-dose combination used to treat uncomplicated malaria caused by Plasmodium falciparum strains susceptible to both artesunate and amodiaquine. It leverages the rapid parasiticidal action of artesunate with the longer-acting antiprotozoal effects of amodiaquine. Widely adopted by national malaria control programs in Africa, Asia, and the Middle East, this formulation is crucial in combatting drug-resistant malaria and reducing disease burden.

The global demand for this combination has surged, especially in high-incidence countries like Nigeria, Kenya, Ghana, and Ivory Coast. Bulk procurement by governmental and NGO-led public health initiatives underscores its life-saving role. Taj Pharma, a leading Artesunate+Amodiaquine Tablet 25 mg+67.5 mg manufacturer in India, has positioned itself to fulfill this need with assurance of quality, scale, and affordability.

 In-Depth Details for Importers, Exporters & Buyers

✅ Regulatory Documentation Provided

Taj Pharma supplies full regulatory dossiers essential for global market entry:

• WHO-GMP and ISO certifications

• Certificate of Pharmaceutical Product (COPP)

• Complete CTD-formatted dossiers

• Compliance documents (e.g., stability data, CoA, free-sale certificates)

📦 Custom Packaging & Labeling

Options include:

• Blister packs, strip packs, HDPE bottles

• Country-specific language inserts

• Customized packaging adhering to destination labeling regulations

• Private-labeling solutions ideal for PCD Pharma Franchise partners

⌛ Shelf-life, Storage & Dosage Form

• Shelf-life: 24–36 months

• Storage: Room temperature (20–25 °C), protect from moisture

• Dosage Form: Oral, film‑coated tablet; convenient for mass distribution

🌍 Export Certifications

Supports global compliance with:

• WHO‑GMP

• EU‑GMP (on request)

• COPP & CTD dossier for ease of registration

• Potential for US FDA Type II DMF or Indian Drug Master File (upon request)

🚚 Target Countries & Export Markets

Taj Pharma’s tablets are deployed across regions fighting malaria, including:

• Africa: Nigeria, Kenya, Ghana, Tanzania, Zambia

• Asia: Bangladesh, Sri Lanka, Myanmar, Cambodia, Vietnam

• Middle East: Iraq, UAE, Saudi Arabia, Jordan

• Latin America: Colombia, Peru, Ecuador

• Eastern Europe & Central Asia: Ukraine, Uzbekistan

With precise cold-chain logistics and export support, Taj Pharma ensures timely delivery with full documentation.

Why Taj Pharma is the Most Trusted Manufacturer/Supplier/Exporter

🏭 State-of-the-Art Manufacturing

• Modern WHO-GMP facility in Vapi, Gujarat

• Advanced equipment: blister lines, coating units, stability chambers

• Robotics and automated systems reduce contamination risk

💰 Affordable Pricing & Quality Assurance

• Economies of scale allow very low-cost bulk pricing

• In‑house labs perform rigorous QA/QC: dissolution, content assay, microbial testing

• Full traceability with batch-coded GS1 barcodes

🌐 Global Presence & Supply Chain Support

• Distribution in 20+ countries

• Dedicated export managers with language support

• Just‑in‑time inventory and courier partnerships for speedy fulfilment

🌍 Top 20 Export Countries

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

These nations rely on WHO‑GMP manufacturer India companies like Taj Pharma to sustain malaria-control efforts.

Technical Product Specification

📞 Contact Taj Pharma Today

For high-quality Artesunate+Amodiaquine Tablet 25 mg+67.5 mg Manufacturer in India, reach out to Taj Pharma. Seize the opportunity for bulk purchase, custom labeling, and access to PCD Pharma Franchise programs.

📧 Email: info@tajpharma.com
📱 Call/WhatsApp: +91 84484 44095 / +91 7400009975
🌐 Website: www.tajpharmaindia.com

Let Taj Pharma be your dependable global partner in antimalarial solutions today.

Top 20 FAQs

1. What is this tablet used for?
Treats uncomplicated Plasmodium falciparum malaria.

2. How does it work?
Artesunate rapidly kills parasites; amodiaquine maintains suppression to prevent resistance.

3. Is prevention a use?
No. Due to side-effect risks, it’s meant only for active treatment, not prophylaxis.

4. What is the dosage schedule?
Standard regimen: once daily for 3 days, per WHO guidelines.

5. Side effects?
May include nausea, vomiting, headache; rare but serious are agranulocytosis or liver toxicity.

6. Who should not take it?
Patients with severe malaria, hepatic/renal impairment, or known allergies.

7. Storage guidelines?
Store at 20–25 °C; avoid humidity and heat.

8. Shelf life?
24–36 months from manufacturing date.

9. Is Taj Pharma certified?
Yes – WHO-GMP, COPP, ISO 9001, EU-GMP (optional).

10. Can I private-label?
Absolutely – custom packaging and blister options are available.

11. What documentation is provided?
Dossier (CTD), CoA, stability data, Free Sale Certificate, GMP certificate.

12. Is it available PAN-India?
Yes – dispatches from Vapi, Gujarat, to all Indian states including Mumbai.

13. Do they export to Africa/Asia/Middle East?
Yes – across Nigeria, Kenya, Bangladesh, UAE, Saudi Arabia, etc.

14. Is sample supply available?
Yes, upon request for evaluation and regulatory filings.

15. Payment terms?
Flexible terms include T/T, L/C, and other global financing options.

16. Does Taj Pharma offer logistics support?
Yes – includes shipping, customs clearance, and documentation.

17. Are there shelf-substitutes available?
Generic fixed doses are made per buyer’s target market specs.

18. Can this be used in children?
Dose depends on weight; must follow WHO dosing chart and medical oversight.

19. Are there resistance issues?
Combination therapy helps reduce resistance; dosing must be completed fully.

20. Is there PCD Pharma Franchise support?
Yes – Taj Pharma offers exclusive marketing rights and product support.

In an era where malaria remains a significant global challenge, Taj Pharma stands as a reliable, quality-focused Artesunate+Amodiaquine Tablet 25 mg+67.5 mg Manufacturer in India. Their robust product quality, global reach, regulatory compliance, and flexible business models (PCD, private label, bulk supply) make them the ultimate partner for international buyers and healthcare programs. Choose Taj Pharma to secure safe, effective, and cost-efficient malaria treatment for your markets.