Description

Quinine Sulphate Tablets (300mg / 600mg)

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 Quinine Sulphate Tablets in India. Quinine is the original and historically most significant Antimalarial alkaloid derived from Cinchona bark. While newer drugs exist, Quinine remains a critical life-saving rescue treatment for Chloroquine-resistant Plasmodium falciparum malaria and severe/complicated malaria cases.

We offer Contract Manufacturing (Third Party) services for this essential medicine. Quinine is notorious for its extremely bitter taste and light sensitivity. Our WHO-GMP certified facility in Mumbai utilizes advanced film-coating technologies to effectively mask the taste, ensuring patient compliance—a major challenge in oral quinine therapy. Healthy Inc manages the export logistics, supplying hospitals and infectious disease centers across Africa, Southeast Asia, and South America.

2. Product Specifications

3. Manufacturing Technology

Taste masking and stability are the primary production goals.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Quinine is one of the most bitter substances known. We apply a robust Sugar Coating or Flavor-Enhanced Film Coating (Opadry) to completely seal the tablet core. This prevents the tablet from dissolving on the tongue and causing gagging or vomiting.

  • Photosensitivity Protection: Quinine degrades and discolors when exposed to light. We use opaque coating materials and light-resistant packaging to ensure the product remains white and potent.

  • Dissolution: Despite the thick coating for taste masking, we optimize the core disintegration to ensure the drug releases rapidly (>85% in 45 mins) once it reaches the stomach acid.

• The Exporter: Healthy Inc

  • Bulk & Blister: We supply both Bulk Jars for hospital dispensing and Blister Packs for retail, using high-density materials to protect against the tropical sun and humidity common in malaria-endemic zones.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Dihydroquinine Limit: Quinine naturally contains Dihydroquinine (a related alkaloid). We strictly monitor this impurity to ensure it stays within the pharmacopoeial limit (usually < 10%).

• Dissolution: We test release profiles to ensure bioavailability is not compromised by the taste-masking coat.

5. Why Use Quinine?

It is the reliable “Backstop” for resistant malaria.

• Mechanism: It interferes with the parasite’s ability to digest hemoglobin. It blocks the crystallization of hemozoin (a toxic byproduct of hemoglobin digestion), leading to the accumulation of cytotoxic heme which kills the parasite.

• Key Indications:

  • Complicated Malaria: Treatment of multi-drug resistant P. falciparum malaria.

  • Nocturnal Leg Cramps: (Off-label/Second-line) Used for the treatment of severe, persistent night leg cramps when non-pharmacological treatments fail.

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 Quinine Sulphate Tablets?

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

• Q: Is it safe for pregnancy?

  A: It is generally considered acceptable for treating Malaria in pregnancy (benefit outweighs risk), but is CONTRAINDICATED for treating leg cramps in pregnancy.

• Q: Why do my ears ring?

  A: This is called “Cinchonism” (tinnitus, headache, nausea, disturbed vision). It is a common side effect of therapeutic doses of Quinine. It usually resolves after stopping the drug.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Malaria Treatment: 600mg every 8 hours for 5-7 days (often combined with Doxycycline or Clindamycin).

• Leg Cramps: 200mg to 300mg at bedtime.

• Administration: Swallow whole with water and food to minimize stomach upset. Do not crush or chew (extremely bitter).

9. Side Effects and Precautions

• Cinchonism: Tinnitus (ringing in ears), headache, nausea, and blurred vision.

• Hypoglycemia: Quinine stimulates insulin release. Monitor blood sugar, especially in pregnant women.

• Cardiac: Risk of QT prolongation. Use with caution in heart patients.

• Hematologic: Rare but serious risk of thrombocytopenia (low platelets). Stop immediately if unexplained bruising/bleeding occurs.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Crucial).