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Primaquine Phosphate Tablets

Primaquine Tablets

Primaquine Phosphate Tablets IP 2.5 mg
Each Sugar Coated Tablet contains :
Primaquine Phosphate IP
Eq. To Primaquine 2.5 mg

Primaquine Phosphate tablets IP 2.5 mg

EACH FILM COATED TABLET CONTAINS:

Primaquine phosphate IP Equivalent to primaquine 2.5 mg

Primaquine Phosphate Tablets IP 7.5 mg
Each Sugar Coated Tablet contains :
Primaquine Phosphate IP
Eq. To Primaquine 7.5 mg

Primaquine Phosphate tablets IP 7.5 mg

EACH FILM COATED TABLET CONTAINS:

Primaquine phosphate IP , Equivalent to primaquine 7.5 mg

PRIMAQUINE PHOSPHATE TABLETS IP 15 MG

Each film coated Tablet Contains:
Primaquine Phosphate IP equivalent to primaquine 15 mg

Excipients q.s.

Primaquine Phosphate Tablets 2.5 mg
Each Sugar coated Tablet contains:
Primaquine Phosphate BP
Eq. To Primaquine 2.5 mg
Excipients q.s

PRIMAQUINE TABLETS 7.5 MG

Each film coated tablet contains:

Primaquine Phosphate BP – eq. to primaquine BP 7.5 mg
– Redoxide of iron –
– Excipients – QS

Usage: – Treat or prevent malaria

Category: – Antimalarial drugs

Therapeutic category: – Antimalarial

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Description

Primaquine Tablets (2.5mg / 7.5mg / 15mg)

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

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Primaquine Tablets in India. This antimalarial is critical for the “radical cure” of malaria, targeting the dormant liver stages of the parasite to prevent relapse. We produce high-purity coated tablets. Our facility adheres to strict WHO-GMP standards. Therefore, we ensure consistent efficacy for malaria elimination programs. Healthy Inc manages our global exports and government tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Primaquine Tablets | | Generic Name | Primaquine Phosphate USP / BP / IP | | Strength | 2.5mg / 7.5mg / 15mg (Base) | | Dosage Form | Film Coated / Sugar Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Antimalarial (8-Aminoquinoline) | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 1000s Bulk Jar |

3. Manufacturing Primaquine 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. Primaquine has a very bitter taste. Therefore, we use advanced Coating Technology (Sugar or Film) to ensure patient compliance, which is vital since the treatment often lasts 14 days. We also use precision compression to ensure exact dosage in these low-strength tablets (2.5mg to 15mg).

  • The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Primaquine Tablets. We supply national malaria control programs in regions where P. vivax is prevalent. We understand the specific packaging needs for mass administration campaigns (MDA).

4. Quality Assurance We test every batch rigorously.

  • Assay Verification: We use HPLC testing. This confirms the Primaquine content is exact.

  • Dissolution: We test how the tablet releases the drug. Consistent release is vital for clearing the hypnozoites (dormant parasites) from the liver.

  • Impurities: We monitor for degradation products to ensure the drug remains safe over its 3-year shelf life.

5. Why Use Primaquine Tablets? This drug does what other antimalarials cannot: it kills dormant parasites.

  • Mechanism: It acts as a tissue schizonticide. It destroys the hypnozoites (sleeping forms) of the parasite in the liver.

  • Gametes: It also kills gametocytes in the blood, preventing the mosquito from picking up the infection and spreading it to others.

Key Indications:

  • Radical Cure: Prevention of relapse in Plasmodium vivax and Plasmodium ovale malaria.

  • Transmission Blocking: Reducing transmission of Plasmodium falciparum (single dose).

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 Primaquine Tablets?A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

  • Q: Is this used alone?A: No, it is usually given after Chloroquine to kill the liver stages of the parasite.

  • Q: Do you offer the 7.5mg pediatric strength?A: Yes, we manufacture 2.5mg, 7.5mg, and 15mg strengths to cover all age groups.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Radical Cure (Adults): Typically 15mg (base) daily for 14 days.

  • Administration: Take with food to reduce stomach pain and cramping.

  • Timing: Usually started towards the end of the Chloroquine course.

9. Side Effects and Precautions

  • G6PD Deficiency Warning: Primaquine can cause severe hemolysis (destruction of red blood cells) in patients with G6PD deficiency. Patients should be tested before starting therapy.

  • Common Side Effects: Nausea, vomiting, and stomach cramps.

  • Contraindications: Pregnancy (due to risk of hemolysis in the fetus) and severe G6PD deficiency.

10. Storage Instructions

  • Store below 25°C in a dry place.

  • Light Sensitive: Protect from light.

  • Keep out of reach of children.

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