Description

Chloroquine Phosphate Tablets (250mg / 500mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Chloroquine Phosphate Tablets in India. Chloroquine is a classic 4-Aminoquinoline Antimalarial drug that has served as the backbone of malaria treatment for decades. Beyond its antiparasitic role, it possesses significant immunomodulatory properties, making it a valuable Disease-Modifying Antirheumatic Drug (DMARD) for Rheumatoid Arthritis and Lupus Erythematosus.

We offer Contract Manufacturing (Third Party) services for this essential medicine. Chloroquine has a notoriously bitter taste. Our WHO-GMP certified facility in Mumbai utilizes advanced Film Coating Technology to effectively mask the bitterness, ensuring patient compliance, especially in pediatric populations. Healthy Inc manages the export logistics, supplying government malaria control programs, NGOs, and hospital formularies across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Fighting parasites with precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: The active ingredient is intensely bitter. We use a specialized polymer coating (Opadry) that remains intact in the mouth but dissolves rapidly in the stomach. This is crucial for preventing children from spitting out the medication.

  • Dissolution Efficiency: To ensure rapid parasitic clearance, our tablets are engineered to disintegrate quickly, releasing the drug for immediate absorption into the bloodstream.

  • High-Volume Capacity: As a staple for national health programs, we maintain high-speed compression lines capable of producing millions of tablets to meet tender requirements efficiently.

• The Exporter: Healthy Inc

  • Bulk Tenders: We are experienced in supplying bulk packs (1000s jars) for institutional use and cost-effective blister packs for retail distribution in endemic regions.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency is strictly within 93-107% of the label claim.

• Dissolution: Tested in 0.1N HCl to verify rapid release (>75% in 45 mins).

• Impurity Profiling: We strictly monitor for degradation products to ensure safety and stability.

5. Why Use Chloroquine?

The trusted defender against malaria.

• Mechanism: Chloroquine enters the malaria parasite (Plasmodium) inside the red blood cell. It interferes with the parasite’s ability to digest hemoglobin. Specifically, it prevents the parasite from converting toxic heme into non-toxic hemozoin. The buildup of toxic heme kills the parasite.

• Key Indications:

  • Malaria: Treatment and prophylaxis of malaria caused by susceptible strains of P. vivax, P. malariae, P. ovale, and P. falciparum.

  • Amebiasis: Treatment of extra-intestinal amebiasis (liver abscess).

  • Autoimmune Diseases: Rheumatoid Arthritis and Discoid/Systemic Lupus Erythematosus (SLE) due to its anti-inflammatory effects.

     

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Chloroquine Tablets?

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

• Q: Is it Resochin?

  A: Resochin is the brand name (Bayer). We manufacture the Generic Equivalent (Chloroquine Phosphate).

• Q: Does it affect the eyes?

  A: Yes. Long-term use (usually for arthritis/lupus) can cause Retinopathy (damage to the retina). Regular eye exams are mandatory for long-term users.

• Q: Is it safe for pregnancy?

  A: Yes. It is generally considered safe for the treatment and prevention of malaria in pregnant women.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Malaria Treatment (Adults): Initial 1000mg (600mg base), followed by 500mg (300mg base) after 6 hours, then 500mg daily for 2 days. Total dose: 2500mg in 3 days.

• Malaria Prophylaxis: 500mg (300mg base) once weekly, on the same day each week. Start 1-2 weeks before travel.

• Amebiasis: 1000mg (600mg base) daily for 2 days, then 500mg daily for 2-3 weeks.

• Administration: Take with food or milk to minimize gastric irritation.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, diarrhea, abdominal cramps.

• CNS: Headache, dizziness, sleep disturbances.

• Ocular: Blurred vision, difficulty focusing. Irreversible Retinal Damage with prolonged high doses.

• Cardiac: QT prolongation and arrhythmias (rare but serious).

• Contraindications: Retinal or visual field changes, known hypersensitivity.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.