Description
Sulphadiazine Tablets (500 mg)
Healthy Inc is a specialized global supplier of high-stability sulfonamide therapies. We provide premium Sulphadiazine Tablets, manufactured in WHO–GMP certified antimicrobial units. As a vital anti-infective with excellent cerebrospinal fluid (CSF) penetration, this product is a primary export for neurological clinics, infectious disease centers, and Ministry of Health (MOH) tenders in Africa, Southeast Asia, and the Middle East.
Product Overview
Sulphadiazine is a short-acting sulfonamide antibiotic. It is specifically engineered to inhibit the synthesis of dihydrofolic acid in susceptible bacteria and protozoa, providing a potent bacteriostatic effect across a wide range of pathogens.
The “Blood-Brain Barrier” Specialist:
- Mechanism of Action: Sulphadiazine acts as a competitive antagonist of para-aminobenzoic acid (PABA). By inhibiting the enzyme dihydropteroate synthase, it prevents the synthesis of folic acid, which is essential for the production of bacterial purines and DNA.
- Superior Distribution: Unlike many other sulfonamides, Sulphadiazine achieves high concentrations in the Cerebrospinal Fluid (CSF), making it a frontline choice for cerebral infections and toxoplasmosis of the central nervous system.
- Clinical Versatility: It remains a cornerstone for Rheumatic Fever prophylaxis and is frequently used in combination with pyrimethamine for the synergistic treatment of parasitic infections.
Technical & Manufacturing Specifications
Formulated for high chemical purity and optimized dissolution profiles.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Sulphadiazine BP / USP / IP |
| Dosage Form | Uncoated or Film-Coated Tablets |
| Standard Strength | 500 mg |
| HS Code | 3004.20.19 (Other Antibiotics) / 2935.90.90 |
| Packaging | Alu-Alu Blister or Secure HDPE Containers |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Crystalluria Prevention Engineering: Sulphadiazine has a tendency to form crystals in acidic urine. Our formulation process ensures rapid disintegration and consistent particle size to facilitate optimal absorption and minimize renal complications.
- Impurity Profile Monitoring: We maintain strict controls on related substances and heavy metals through validated HPLC and Atomic Absorption Spectroscopy, ensuring the highest safety for long-term prophylactic use.
- Stability Validation: Every batch is validated for Climatic Zone IVb, ensuring potency and physical integrity in high-temperature export markets.
Therapeutic Indications & Clinical Symptoms
- Toxoplasmosis: Treatment of Toxoplasma gondii infections, particularly in immunocompromised patients (often co-administered with pyrimethamine).
- Rheumatic Fever Prophylaxis: Prevention of recurrent streptococcal infections in patients with a history of rheumatic heart disease.
- Nocardiosis: Management of systemic infections caused by Nocardia species.
- Meningococcal Carrier State: Elimination of Neisseria meningitidis from the nasopharynx in specialized clinical scenarios.
Dosage & Administration
- General Infection: 2 g to 4 g initially, followed by 2 g to 4 g daily in 3 to 6 divided doses.
- Hydration Protocol: Patients must maintain high fluid intake (at least 1.5 to 2 liters daily) to ensure adequate urinary output and prevent crystal formation.
- Safety Note: Contraindicated in patients with severe renal failure, porphyria, or known hypersensitivity to sulfonamides.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to NGO Health Missions and Ministry of Health Tenders. We offer Third Party Manufacturing for Sulphadiazine with full CTD Dossier and COPP support. Our logistics network ensures secure, high-volume supply to Nigeria, Vietnam, Kenya, and Brazil, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
