On February 13, 2026, the European CEP registration for Polymyxin B Sulfate (Pyrogen-free) API, a product of a key client of Huzhou Shenke Biotechnology Co., Ltd. (HZSKBIO^®) in East China, was officially approved. The client obtained the Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP Certificate) issued by the European Directorate for  the Quality of Medicines & HealthCare (EDQM). 

Relying on its independently developed Pyrogen Detection Kit (MAT Method) (Cat. No.: 1502100) and professional, reliable testing services, Huzhou Shenke Biotechnology Co., Ltd. (HZSKBIO^®) provided critical technical support and quality assurance for the client’s EU registration application of Polymyxin B Sulfate API, backed by profound regulatory expertise, rapid technical response and efficient project management.

About Polymyxin B Sulfate

Polymyxin B Sulfate is a crucial antibiotic API. It is primarily applied to treat severe infections induced by susceptible Gram-negative bacilli, including Acinetobacter baumannii, Klebsiella pneumoniae, Pseudomonas aeruginosa and other strains. Regarded as one of the "last line of defense" drugs against multidrug-resistant bacteria, it holds a pivotal position in the treatment of specific multidrug-resistant bacterial infections.

To date, only four domestic Chinese enterprises have obtained EU CEP registration and certification for this API.

Pyrogen Detection Kit (MAT Method)

Item No.: 1502100