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Sulfadoxine + Pyrimethamine (SP) – tablets bulk supplier for pharma manufacturers

Sulfadoxine + Pyrimethamine (Sp) – Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 500 mg sulfadoxine + 25 mg pyrimethamine; 500 mg + 75 mg

Reference Brands: Generic formulations

Category: Medical Aid

Sulfadoxine inhibits bacterial dihydropteroate synthase, while pyrimethamine blocks dihydrofolate reductase, disrupting folate synthesis in malaria parasites. This combination effectively kills Plasmodium falciparum, providing rapid malaria prophylaxis and treatment. Benefits include high efficacy, synergy against resistant strains, and simplified dosing in endemic regions.

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Product Description: Sulfadoxine + Pyrimethamine (SP) tablets are approved for malaria treatment and prophylaxis in the EU and US, mainly in endemic regions. In the EU, brands like Fansidar are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, approval is limited; primarily used in travel medicine and imported cases, with no specific brand approval. Both regions require detailed dossiers including clinical trial data, quality assurance, and pharmacovigilance plans for approval and safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for sulfadoxine/pyrimethamine, ensuring adherence to European and US standards for safe, effective malaria therapy.

Sulfadoxine + Pyrimethamine (Sp) – Tablets — third party manufacturing & bulk supply

Sulfadoxine + Pyrimethamine (Sp) – Tablets is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Sulfadoxine + Pyrimethamine (Sp) – Tablets is supplied as Tablet — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Sulfadoxine + Pyrimethamine (Sp) – Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Sulfadoxine + Pyrimethamine (SP) – tablets is listed as Tablet in 500 mg sulfadoxine + 25 mg pyrimethamine; 500 mg + 75 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Sulfadoxine + Pyrimethamine (SP) – tablets is referenced against Generic formulations. Reference brands are shown for identification only and remain the property of their respective trademark owners.

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