GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Primaquine Phosphate Tablet USP 15mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Primaquine Phosphate USP
Equivalent to Primaquine...........................7.5mg
Excipients.....................q.s.
Colour: Ponceau 4 R
b) Primaquine Phosphate Tablet USP 15mg
Each film coated tablet contains:
Primaquine Phosphate USP
Equivalent to Primaquine............................15mg
Excipients...................... q.s.
Colour: Fast green FCF
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dosage: As directed by the Physician
Adult dosage should not exceed 1 tablet daily for 14 days.
Discontinue promptly if signs suggestive of hemolytic anemia occur (ie, darkening of urine, marked fall of hemoglobin, of erythrocyte count).
Attach dispensing label as per end county.
Primaquine Phosphate Tablets 15mg Technical Specification:
| Product Name: | Primaquine Phosphate Tablets USP |
| Brand Name: | Generic |
| Strength: | 7.5mg, 15mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antimalarial |
| Indication: | Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Primaquine Phosphate Tablet USP 7.5mg
B) Primaquine Phosphate Tablet USP 15mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Primaquine Phosphate Tablet USP 7.5mg
Each film coated tablet contains:
Primaquine Phosphate USP
Equivalent to Primaquine……………….7.5mg
Excipients…………………………………….q.s.
Colour: Ponceau 4 R
B) Primaquine Phosphate Tablet USP 15mg
Each film coated tablet contains:
Primaquine Phosphate USP
Equivalent to Primaquine…………….15mg
Excipients……………………………………q.s.
Colour: Fast green FCF
THERAPEUTIC INDICATIONS:
Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia. Specifically it is used for malaria due to Plasmodium vivax and Plasmodium ovale along with other medications and for prevention if other options cannot be used.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician
Adult dosage should not exceed 1 tablet daily for 14 days.
Discontinue promptly if signs suggestive of hemolytic anemia occur (ie, darkening of urine, marked fall of hemoglobin, of erythrocyte count).
Attach dispensing label as per end county.
Introduction to Primaquine Phosphate Tablets 15mg and Its Global Importance
Primaquine Phosphate Tablets 15mg play a crucial role in the treatment and prevention of malaria relapse—a life-threatening parasitic disease transmitted by mosquito bites. It belongs to the class of antiprotozoal medicines that act on dormant liver-stage parasites (hypnozoites) of Plasmodium vivax and Plasmodium ovale, effectively preventing recurrence after initial treatment.
Taj Pharma, the well-known Primaquine Phosphate Tablets 15mg manufacturer in India, assures unmatched quality, purity, and consistency in every batch. The medicine works by killing the residual malaria-causing parasites in red blood cells and liver tissue, preventing relapse and reducing transmission.
Malaria continues to affect millions globally, particularly across Africa, Asia, and Latin America, making Primaquine a cornerstone medicine for malaria elimination efforts supported by WHO, UNICEF, and Global Fund initiatives.
With over two decades of experience, Taj Pharma Ltd, headquartered in Vapi, Gujarat, India, has established itself as one of the most trusted Primaquine Phosphate Tablets 15mg manufacturers, exporters, and suppliers, catering to global pharmaceutical distributors, tender buyers, and PCD franchise partners.
Uses, Benefits, and Administration
Primaquine Phosphate Tablets 15mg are antiparasitic medicines used both for treatment and prevention of malaria. The drug prevents the relapse of malaria by eliminating dormant parasites that remain in the liver even after the primary infection has been treated with blood schizonticides such as chloroquine or artemisinin-based combinations.
Therapeutic Benefits:
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Treats and prevents relapse of malaria (Plasmodium vivax and P. ovale)
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Reduces malaria transmission by killing gametocytes
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Effective against dormant liver-stage parasites
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Used as part of the WHO-approved combination malaria therapy
Administration and Dosage Guidelines:
Primaquine Phosphate Tablets 15mg should be taken with food to minimize stomach upset. Follow the exact dosage and duration prescribed by your doctor.
Do not skip doses and complete the full treatment course even if symptoms improve.
Important Note:
Do not double the dose to make up for a missed dose. If a dose is missed, take it as soon as possible or resume the next scheduled dose.
Safety and Precautions
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Avoid using Primaquine if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as it can cause hemolysis.
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Inform your doctor about any anemia, liver issues, or metabolic disorders.
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Use with caution during pregnancy or lactation.
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Regular blood tests may be required for patients on long-term therapy.
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Maintain protective measures against mosquito bites to prevent reinfection—use repellents, bed nets, and wear light-colored clothing after sunset.
Possible Side Effects
Like all medicines, Primaquine Phosphate Tablets 15mg may cause minor side effects, which are usually temporary and mild:
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Nausea or vomiting
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Headache
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Dizziness
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Rash or itching
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Abdominal discomfort
Consult your doctor immediately if you experience severe or persistent side effects.
Global Demand and Market Outlook
The global demand for Primaquine Phosphate Tablets 15mg continues to rise due to the growing emphasis on malaria eradication programs worldwide. India, being a major WHO-prequalified source for essential medicines, is one of the largest exporters of Primaquine formulations.
Taj Pharma’s expertise in large-scale manufacturing, regulatory compliance, and consistent product quality makes it a preferred partner for government tenders, NGOs, and global importers.
In-Depth Information for Importers, Exporters, and Buyers
Regulatory Documentation Provided by Taj Pharma
Taj Pharma provides complete regulatory and quality documentation to ensure seamless registration and import approvals across global markets:
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WHO-GMP Certificate
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COPP (Certificate of Pharmaceutical Product)
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Certificate of Analysis (COA)
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Free Sale Certificate (FSC)
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CTD/ACTD Dossier
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Stability Data (as per ICH guidelines)
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Batch Manufacturing Records
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COA & Specifications Sheet
Custom Packaging and Labeling
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Export packaging designed for high humidity and tropical climates
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Alu-Alu / Blister / Bottle packaging options
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Multilingual labeling (English, French, Spanish, Arabic)
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Custom branding for private-label buyers
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Tamper-evident seals and moisture-proof protection
Shelf-Life, Storage, and Dosage Form
-
Shelf-life: 24 to 36 months from the date of manufacture
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Storage: Store below 30°C in a cool, dry place, away from sunlight
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Dosage form: Film-coated tablet (15mg)
Export Certifications and Compliance
All batches of Primaquine Phosphate Tablets 15mg are manufactured under WHO-GMP, ISO 9001:2015, and EU-GMP standards. Taj Pharma complies with international regulatory frameworks including:
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ICH Q7A & WHO TRS guidelines
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Schedule M (Indian GMP)
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PIC/S standards for global distribution
Target Export Markets
Taj Pharma has built a strong export footprint across malaria-endemic countries in Africa, Asia, the Middle East, and Latin America.
Top 20 Export Destinations for Taj Pharma Primaquine Phosphate Tablets 15mg
USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia
Taj Pharma’s consistent regulatory support and logistics network make it a trusted pharmaceutical exporter in both public and private healthcare markets.
Why Taj Pharma is the Most Trusted Primaquine Phosphate Tablets 15mg Manufacturer in India
1. WHO-GMP and ISO Certified Manufacturing Facilities
Taj Pharma’s state-of-the-art manufacturing plant in Vapi, Gujarat complies with WHO-GMP, ensuring strict adherence to international quality standards and Good Manufacturing Practices.
2. Quality Assurance and Purity Guarantee
Each batch undergoes rigorous in-process checks, analytical testing, and stability studies to maintain the highest quality and purity levels.
3. Affordable Pricing for Global Health Programs
Taj Pharma supports international malaria control programs by offering cost-effective Primaquine Phosphate Tablets 15mg without compromising quality.
4. Global Presence and Reliable Supply Chain
With robust logistics and an established distribution network, Taj Pharma ensures timely delivery and steady supply to over 40 countries worldwide.
5. Expertise in Regulatory Submissions
Taj Pharma provides complete regulatory dossiers (CTD/ACTD formats), facilitating fast registration in countries across Africa, Asia, and Latin America.
6. Sustainability and Ethical Manufacturing
Taj Pharma upholds eco-friendly, ethical manufacturing practices, ensuring environmental compliance, worker safety, and product sustainability.
Technical Product Specification Table
| Product Name | Primaquine Phosphate Tablets 15mg |
|---|---|
| Active Ingredient | Primaquine Phosphate |
| Strength | 15mg |
| Dosage Form | Oral Tablet |
| Therapeutic Category | Antiprotozoal / Antimalarial |
| Indication | Treatment & prevention of malaria relapse |
| Color | White to off-white |
| Packaging | 10×10 tablets / 100 tablets bottle / export carton |
| Storage | Below 30°C, dry and dark place |
| Shelf Life | 24–36 months |
| Certifications | WHO-GMP, ISO 9001:2015, COPP |
| Regulatory Support | CTD/ACTD Dossier, COA, COPP |
| Manufacturer | Taj Pharmaceuticals Ltd., Vapi, Gujarat, India |
PAN India Manufacturer and Global Exporter
Taj Pharma is a PAN India manufacturer and supplier of Primaquine Phosphate Tablets 15mg, offering products from Mumbai, Maharashtra to Vapi, Gujarat.
They cater to domestic distributors, hospital tenders, and international buyers seeking WHO-GMP certified pharmaceuticals.
Key Variants:
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Primaquine Phosphate Tablets 15mg Manufacturer from Mumbai
-
Primaquine Phosphate Tablets 15mg Manufacturer in Gujarat
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Primaquine Phosphate Tablets 15mg Supplier and Exporter PAN India
-
Primaquine Phosphate Tablets 15mg PCD Pharma Franchise Partner
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Primaquine Phosphate Tablets 15mg at Best Price – Taj Pharma, India
Partner with Taj Pharma Today
If you are an importer, global distributor, or procurement agency, partner with Taj Pharma Ltd for reliable supply of Primaquine Phosphate Tablets 15mg.
Contact Information:
📞 Phone: +91 84484 44095
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
🏭 Address: Taj Pharma Ltd., Vapi, Gujarat, India
With over 20 years of export expertise, regulatory documentation support, and dedicated logistics infrastructure, Taj Pharma remains your most dependable partner for Primaquine Phosphate Tablets 15mg export from India.
Top 20 FAQs
1. What are Primaquine Phosphate Tablets 15mg used for?
They are used to treat and prevent malaria relapse caused by Plasmodium vivax and P. ovale.
2. Who manufactures Primaquine Phosphate Tablets 15mg in India?
Taj Pharma Ltd, a WHO-GMP certified manufacturer based in Vapi, Gujarat.
3. How does Primaquine work?
It destroys dormant malaria parasites in the liver, preventing relapse and reducing disease transmission.
4. What is the dosage of Primaquine?
As prescribed by a doctor—typically once daily after meals.
5. Can Primaquine be taken during pregnancy?
It should be avoided unless the benefit outweighs the risk; consult your physician.
6. Is Primaquine safe for G6PD-deficient individuals?
No, it may cause hemolytic anemia. Always test for G6PD deficiency before use.
7. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, and CTD dossier-ready compliance.
8. Does Taj Pharma export Primaquine globally?
Yes, to more than 40 malaria-endemic countries.
9. What is the shelf life of Primaquine tablets?
Approximately 24–36 months under proper storage.
10. What packaging options are available?
Blister packs, Alu-Alu strips, and export bottles with tamper-evident seals.
11. Can Taj Pharma provide samples?
Yes, samples are available for registration and quality evaluation.
12. Are custom label options available?
Yes, multilingual private-label packaging is available for export clients.
13. Does Taj Pharma support PCD franchise business?
Yes, PCD franchise and third-party manufacturing opportunities are open.
14. How can importers verify certifications?
All regulatory documents are verifiable through the manufacturer’s quality department.
15. Does Primaquine cause drowsiness?
It may cause mild dizziness; avoid driving or operating machinery if affected.
16. Can Primaquine be combined with chloroquine?
Yes, it is often prescribed as part of combination therapy for malaria.
17. What storage conditions are recommended?
Store below 30°C in a dry, cool environment away from direct light.
18. Does Taj Pharma supply to NGOs and global tenders?
Yes, Taj Pharma supplies WHO and government-approved health programs.
19. How to order Primaquine Phosphate Tablets 15mg?
Contact Taj Pharma’s export department with your quantity and destination details.
20. Why choose Taj Pharma over others?
Because of WHO-GMP certification, superior quality, global reach, and affordable pricing.
Taj Pharma stands as India’s leading Primaquine Phosphate Tablets 15mg Manufacturer, Supplier, and Exporter, known for its WHO-GMP-certified manufacturing, quality assurance, and global reliability.
With an unwavering commitment to public health, affordable pricing, and timely delivery, Taj Pharma continues to empower malaria control programs and improve global healthcare access.
Whether you are a government procurement agency, NGO, or international distributor, Taj Pharma Ltd is your trusted partner for sourcing Primaquine Phosphate Tablets 15mg from India.






