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Protamine Sulfate bulk supplier for pharma manufacturers

Protamine Sulfate 10 mg/mL, 50 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 10 mg/mL, 50 mg/mL

Reference Brands: Generic formulations marketed under different names

Category: Critical Care

Protamine Sulfate is a Critical Care product available as Injection in strengths 10 mg/mL, 50 mg/mL. It corresponds to the reference brand Generic formulations marketed under different names. Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Protamine sulfate is a specialized medication used to reverse and neutralize the anticoagulant effects of heparin. It acts as a specific antagonist to heparin-induced anticoagulation by forming a stable complex with heparin, effectively restoring normal blood clotting. Protamine sulfate is a highly basic, polycationic, low-molecular-weight protein, originally derived from salmon sperm, and is also available in recombinant forms for pharmaceutical use. Its unique mechanism makes it an essential agent in critical care and surgical settings where rapid heparin reversal is required.

Clinically, protamine sulfate is used in cases of heparin or low molecular weight heparin overdose, during cardiovascular surgeries such as cardiopulmonary bypass, and in obstetric procedures when heparin anticoagulation must be neutralized. It is administered intravenously, with the dosage and infusion rate carefully calculated based on the amount of heparin to be reversed and the patient’s clinical condition.

While highly effective, protamine sulfate must be used cautiously due to potential adverse effects such as hypotension, bradycardia, and rare severe allergic reactions. With careful monitoring, protamine sulfate provides rapid and reliable reversal of anticoagulation, making it a critical tool for healthcare teams managing patients in surgery, critical care, and emergency settings.

Protamine Sulfate — third party manufacturing & bulk supply

Protamine Sulfate 10 mg/mL, 50 mg/mL 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Indicative minimum order quantity

Protamine Sulfate is supplied as Injection — an injectable dosage form, so the indicative MOQ is 50,000 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 Protamine Sulfate listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Protamine sulfate is used to reverse the anticoagulant effects of heparin, especially during surgeries, dialysis, or in cases of heparin overdose, restoring normal blood clotting.

Protamine sulfate is a mixture of low molecular weight, highly basic proteins derived from salmon sperm or other fish sources, formulated as a sterile solution for intravenous use.

Protamine sulfate is marketed primarily as a generic product. The historical brand name is Protamine.

Protamine sulfate is manufactured by multiple pharmaceutical companies worldwide as a generic injectable solution.

The generic name is protamine sulfate.

Protamine (historical), most commonly available as generic protamine sulfate.

Protamine sulfate is manufactured in the USA, EU, and other countries by licensed pharmaceutical companies specializing in sterile injectable medications.

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