Chloroquine Phosphate Tablets

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 4-aminoquinoline antimalarial used for malaria caused by chloroquine-sensitive parasites and for certain other approved indications. We offer contract manufacturing services for this established medicine. Because Chloroquine has a strongly bitter taste, suitable film or sugar coating can be used to improve palatability. Healthy Inc manages export logistics for institutional and international markets.

2. Product Specifications

3. Manufacturing Technology

• The Manufacturer: Healthy Life Pharma Pvt. Ltd. Controlled granulation, compression and coating processes are used according to the validated formulation. Film or sugar coating can help mask the characteristic bitter taste and improve patient acceptability.
• Dissolution & Release: Formulation parameters are controlled to meet applicable pharmacopoeial dissolution requirements.
• The Exporter: Healthy Inc. Retail and institutional packaging configurations can be supplied according to tender, registration and destination-market requirements.

4. Quality Assurance

• Assay: Potency is verified against the applicable approved pharmacopoeial or product specification.
• Dissolution: Finished tablets are tested according to the applicable compendial or registered dissolution method.
• Impurity Profiling: Specified impurities and degradation products are monitored during batch release and stability testing.

5. Why Use Chloroquine?

Chloroquine concentrates in the parasite’s acidic digestive vacuole and interferes with heme detoxification, contributing to parasite death in chloroquine-sensitive malaria.

Key Indications:

• Malaria: Treatment or prophylaxis only where the infecting malaria species and local resistance patterns remain susceptible to Chloroquine.
• Extra-intestinal Amebiasis: May be used in selected cases according to approved prescribing information and specialist guidance.
• Other Uses: Any rheumatologic use should follow current local clinical guidance; hydroxychloroquine is commonly preferred for many chronic rheumatologic indications because treatment choices and safety profiles differ.

6. Export and Regulatory Support

• Dossier Support: CTD and ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to commercial and regulatory requirements.

7. Frequently Asked Questions

Q: Who manufactures Chloroquine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Chloroquine Phosphate Tablets in India.

Q: Is this the same active ingredient as branded Chloroquine products?
A: The active ingredient is Chloroquine Phosphate. Brand equivalence, interchangeability and registration depend on the specific formulation, strength and destination-market requirements.

Q: Can Chloroquine affect the eyes?
A: Retinal toxicity is an important risk with prolonged or high cumulative exposure. Patients receiving long-term therapy require appropriate ophthalmic monitoring according to clinical guidance.

Q: Can Chloroquine be used during pregnancy?
A: Use during pregnancy depends on the indication, malaria susceptibility, individual risk-benefit assessment and current treatment guidelines. Medical supervision is required.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Malaria Treatment: Regimens depend on patient age/weight, whether dosing is expressed as Chloroquine base or Chloroquine Phosphate salt, parasite species and local resistance patterns. Use the approved local treatment guideline.
• Malaria Prophylaxis: Chloroquine should be used only for travel to areas with chloroquine-sensitive malaria and according to current travel-medicine guidance.
• Administration: Taking the medicine with food may reduce gastrointestinal upset. Follow the prescribed schedule exactly.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, abdominal discomfort or diarrhea can occur.
• CNS: Headache, dizziness and other neurologic effects may occur.
• Ocular: Visual disturbances and retinal toxicity are important concerns, particularly with prolonged exposure.
• Cardiac: Chloroquine can prolong cardiac repolarization and may increase the risk of serious arrhythmias, especially with other QT-prolonging medicines or relevant cardiac/electrolyte risk factors.
• Resistance: Chloroquine should not be relied upon for malaria in regions or species with known chloroquine resistance.

10. Storage Instructions

• Store below 25°C in a dry place.
• Protect from light and moisture.
• Keep out of reach of children.