GENERIC NAME OF THE MEDICINAL PRODUCT:
Artesunate+Amodiaquine Tablet 25mg+67.5mg
Artesunate+Amodiaquine Tablet 50mg+135mg
Artesunate+Amodiaquine Tablet 100mg+270mg
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
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
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
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.
Dosage: As directed by the Physician.
Artesunate+Amodiaquine Tablet 50mg+135mg Technical Specification:
| Product Name: | Artesunate+Amodiaquine Tablet |
| Brand Name: | Generics |
| Strength: | (25mg+67.5mg), (50mg+135mg), (100mg+270mg) |
| Dosage Form: | Tablet (Bilayer) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antimalarial |
| Indication: | 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. |
| 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. |
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 50mg+135mg
Artesunate+Amodiaquine Tablet 50mg+135mg is a widely used fixed-dose antimalarial combination for treating uncomplicated Plasmodium falciparum malaria. Artesunate acts swiftly by producing free radicals within the malarial parasite that destroy it, while amodiaquine enhances the treatment effect by accumulating toxic heme in the parasite, killing it.
This formulation is not recommended for prophylaxis, especially due to the potential hepatotoxic effects of amodiaquine. It is, however, critical in global malaria eradication programs, particularly across Africa, Southeast Asia, and South America.
As global malaria cases persist, the demand for reliable treatment solutions like Artesunate+Amodiaquine Tablet 50mg+135mg is on the rise. This presents an opportunity for bulk buyers, NGOs, health ministries, and pharmaceutical franchises seeking affordable, high-quality antimalarials.
In-Depth Details for Importers, Exporters & Buyers
Regulatory Documentation Provided
Taj Pharma provides complete, export-ready regulatory compliance documents:
- WHO-GMP, ISO 9001:2015 certifications
- Certificate of Pharmaceutical Product (COPP)
- Dossier in CTD/ACTD formats
- Stability data & batch CoAs
- Free Sale Certificate (FSC)
Custom Packaging & Labeling
Taj Pharma supports:
- Customized packaging in blisters, HDPE bottles, or foil packs
- Country-specific artwork and multilingual inserts
- Private labeling and PCD Pharma Franchise support
Shelf-Life, Storage & Dosage Form
- Shelf Life: 24-36 months
- Storage: Below 25°C, dry place, away from light
- Dosage Form: Oral film-coated tablet
Export Certifications
Taj Pharma’s manufacturing complies with:
- WHO-GMP & EU-GMP standards
- COPP for global registration
- ICH guidelines on stability & impurity profiles
- CTD dossiers for streamlined registration
Target Countries & Export Markets
Taj Pharma actively exports to:
- Africa: Nigeria, Ghana, Kenya, Tanzania, Uganda
- Asia: Myanmar, Sri Lanka, Bangladesh, Cambodia, Vietnam
- Middle East: Iraq, UAE, Saudi Arabia
- Latin America: Colombia, Peru, Ecuador
- Eastern Europe: Ukraine, Georgia, Uzbekistan
Why Taj Pharma is the Most Trusted Manufacturer/Supplier/Exporter
State-of-the-Art Manufacturing Facilities
Taj Pharma’s WHO-GMP certified facility in Vapi, Gujarat, India features:
- Automated tablet compression & coating lines
- Controlled environment packaging zones
- In-house QC and stability chambers
Affordable Pricing & Quality Assurance
- Competitive bulk pricing without compromising on quality
- Fully validated processes and GMP-compliant practices
- Robust QA/QC: Dissolution, microbial, and assay testing
Global Presence & Logistics
- PCD Pharma Franchise across PAN India
- Supply chain partners for global logistics and cold chain
- Rapid fulfillment and documentation support
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
Technical Product Specification
| Parameter | Details |
|---|---|
| Product Name | Artesunate+Amodiaquine Tablet 50mg+135mg |
| Strength | Artesunate 50mg + Amodiaquine 135mg |
| Dosage Form | Oral, Film-Coated Tablet |
| Indication | Uncomplicated P. falciparum malaria |
| Packaging Options | Blister, HDPE Bottle, Custom packs |
| Storage Conditions | Below 25°C, dry and dark conditions |
| Shelf Life | 24 – 36 months |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
| Export Certifications | WHO-GMP, COPP, CTD Dossier |
| Dossier Format | CTD / ACTD |
| HS Code | 30049099 |
| MOQ | As per buyer’s requirement |
Call to Action for Buyers & Distributors
Looking for a WHO-GMP certified Artesunate+Amodiaquine Tablet 50mg+135mg manufacturer in India?
Partner with Taj Pharma, the trusted supplier and exporter from Vapi, Gujarat.
📞 Contact Us Today:
- Email: info@tajpharma.com
- Phone/WhatsApp: +91 74000 09975 / +91 84484 44095
- Website: www.tajpharmaindia.com
Ensure safe, effective malaria treatment for your market – bulk orders, PCD franchise & private labeling supported.
Top 20 FAQs
1. What is Artesunate+Amodiaquine Tablet 50mg+135mg used for?
Treatment of uncomplicated Plasmodium falciparum malaria.
2. How does it work?
Artesunate kills parasites via free radicals; amodiaquine disrupts parasite heme metabolism.
3. Is this combination suitable for prevention?
No. Due to hepatotoxic risks, it’s only used for treatment.
4. What is the dosage duration?
Standard 3-day course, once daily.
5. Any major side effects?
Common: headache, dizziness, vomiting; Rare: hepatitis, neutropenia.
6. Who should avoid it?
Patients with liver disease, severe malaria, or hypersensitivity.
7. Is it safe during pregnancy?
Not recommended during the first trimester unless essential.
8. How should it be stored?
Cool, dry place below 25°C, away from sunlight.
9. Can I drive after taking it?
May cause dizziness. Avoid driving until you know how it affects you.
10. What happens if I miss a dose?
Take it as soon as possible. Do not double dose.
11. Does Taj Pharma provide private-label options?
Yes. Custom branding and packaging available.
12. Is WHO-GMP certified product available?
Yes. Taj Pharma facilities are WHO-GMP approved.
13. Can I get samples for registration?
Yes. Samples are available for evaluation purposes.
14. Do they export to Africa and Asia?
Yes. Taj Pharma has clients in 20+ malaria-endemic countries.
15. What are the payment terms?
Flexible terms: LC, TT, advance, as per agreement.
16. Is technical documentation shared?
Yes. Dossier, stability data, CoAs and COPP are provided.
17. How fast is delivery?
Dispatch within 2–10 days depending on order size and documentation.
18. Can this be used in children?
Weight-based dosing applies. Pediatric supervision required.
19. Is it available PAN India?
Yes. Taj Pharma supplies across India and internationally.
20. Can it be used for severe malaria?
No. IV treatment is preferred for severe malaria cases.
Taj Pharma remains the most reliable Artesunate+Amodiaquine Tablet 50mg+135mg Manufacturer in India, offering cost-effective, high-quality, WHO-GMP certified solutions for malaria treatment worldwide.
With a proven track record in global exports, regulatory readiness, and PCD franchise offerings, Taj Pharma is your trusted partner in delivering antimalarial solutions at scale.
