Bacitracin

In the clinical treatment of skin, eye and soft tissue infections caused by drug-resistant Gram-positive bacteria, polypeptide antibiotics have always been an important option for topical medication. Bacitracin is a typical polypeptide antibacterial agent, which exerts a bactericidal effect through the dual mechanisms of inhibiting the synthesis of mucopeptide in bacterial cell walls and damaging the permeability of cell membranes. It has remarkable antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus and Streptococcus. Clinically, it is mainly used in the form of topical external preparations for the prevention and treatment of superficial infections, and can also be used as a feed additive for epidemic prevention in livestock and poultry breeding. The applicable population covers patients with local infections of all age groups, with no special age restriction.

The current global bacitracin market size is approximately USD 320 million, with an annual compound growth rate maintained at around 3.1%. The growth momentum mainly comes from the expanding demand in the veterinary drug sector and the stable demand in the topical external preparation market. China is the world's largest producer of bacitracin active pharmaceutical ingredients (APIs), with its production capacity accounting for more than 75% of the total global production capacity. The concentration of domestic manufacturers is relatively high, with the top three enterprises accounting for over 60% of the total production capacity, and their products are mainly exported to North America, Southeast Asia and the European market. The market size of human-use bacitracin preparations is relatively small. At present, the relevant preparations already marketed in China are mainly compound external ointments and eye ointments, which are not included in the scope of national centralized volume-based procurement, and the market competition is relatively mild.

The original developer of bacitracin is Pfizer Inc. of the United States, with the original trade name Bacitracin. The core compound patent expired in 1960, and there is no valid core patent at present. The main dosage forms of the original product are external ointment and eye ointment of 500 units/g, which have been included in the FDA Reference Listed Drug Catalogue, but not included in the Catalogue of Marketed Drugs in China. As of September 2024, there are a total of 8 bacitracin API registration entries on the API registration platform of China's Center for Drug Evaluation (CDE), among which 3 are in status A (approved for use in marketed preparations). A number of domestically manufactured preparations such as bacitracin ointment and bacitracin eye ointment have been approved for marketing. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of bacitracin impurity reference standards, which can meet the quality control requirements of the whole process from R&D and declaration to mass production. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide reliable material basis support for enterprises' impurity research and quality standard establishment.