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Protamine Sulfate bulk supplier for pharma manufacturers

Protamine Sulfate 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 available in Injection and strengths such as 10 mg/mL, 50 mg/mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Protamine Sulfate is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Protamine Sulfate can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

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.

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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.

Yes, Protamine Sulfate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Protamine Sulfate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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