Protamine Sulfate manufacturer - Scrianen

                                                                         Protamine  Sulfate  manufacturer - Scrianen

Protamine sulfate is a well-established pharmaceutical active ingredient widely used as a heparin antagonist in clinical practice, particularly in cardiovascular surgery and hemodialysis. Due to its biological origin and clinical importance, the manufacturing of protamine sulfate requires strict quality control, validated processes, and full regulatory compliance.

Our factory is a qualified and experienced manufacturer of protamine sulfate API, operating in accordance with international pharmaceutical standards. The production process starts from carefully selected raw materials of controlled origin, followed by a series of extraction, purification, and refinement steps designed to ensure high purity, consistent potency, and excellent safety performance. Advanced purification technologies are applied to remove impurities and endotoxins, meeting pharmacopeial requirements.

The entire manufacturing process is carried out under a GMP-compliant quality management system, with well-defined process controls, in-process testing, and comprehensive batch records. Each batch of protamine sulfate is subject to rigorous quality testing, including identity, assay, impurities, endotoxin levels, and microbiological control, before release.

With stable production capacity, reliable supply, and strong technical expertise, our factory is committed to providing high-quality, compliant protamine sulfate API to global pharmaceutical partners. We continuously invest in process optimization and quality improvement to meet evolving regulatory and customer requirements, making us a trusted and eligible manufacturer in the international market.

Protamine  Sulfate  manufacturer