Mupirocin

As a commonly used clinical drug for the treatment of Gram-positive bacterial skin infections, mupirocin is a topical antibiotic belonging to the aminoacyl-tRNA synthetase inhibitor class. It reversibly binds to the isoleucine binding site of bacterial isoleucyl-tRNA synthetase, blocking the key step of bacterial protein synthesis. Meanwhile, due to its extremely low affinity for human homologous enzymes, it has a relatively high toxicity risk for systemic administration but excellent safety for topical use. Clinically, it is mainly used for the treatment of primary and secondary skin bacterial infections such as impetigo, folliculitis, infected eczema, and infected trauma, and can also be used for the prophylactic eradication of nasal Staphylococcus aureus colonization. Its applicable population covers adults and children over 3 months old, and it is a first-line recommended variety in local medication guidelines for skin infections.

The current global market size of mupirocin is approximately USD 320 million, and the annual sales in the Chinese market exceed RMB 1.2 billion. In recent years, driven by the increase in the consultation rate of skin infections and the growth of drug penetration in primary medical institutions, the overall market maintains an annual growth rate of around 5%. In terms of the competitive landscape, the topical preparation market is dominated by the original research product, which accounts for more than 60% of the market share, while domestic generic drugs occupy the remaining share. On the API supply side, the production capacity of domestic enterprises accounts for more than 70% of the global total, and multiple generic drugs have passed the consistency evaluation. Among them, mupirocin ointment is a variety included in the National Class B Medical Insurance Catalog, with stable prices and relatively rigid clinical demand.

The original research enterprise of mupirocin is GlaxoSmithKline, with the original brand name "Bactroban". The core compound patent of mupirocin in major global markets expired around 2001. Currently, the original research dosage forms approved in China include 2% mupirocin ointment (specifications: 2g/5g/10g) and 2% mupirocin spray, both of which have been included in the China Listed Drug Catalog as reference preparations. In terms of API registration, more than 10 mupirocin API registration information entries can be queried on the CDE platform, among which the registration status of multiple enterprises is "A (approved for use in marketed preparations)". The mupirocin preparations approved for marketing in China cover multiple dosage forms such as ointment, cream, and spray. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for mupirocin API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can meet the reference material use needs of the whole process including API R&D, quality research, and consistency evaluation.