Oxytetracycline

As a classic tetracycline antibacterial drug, oxytetracycline inhibits protein synthesis by reversibly binding to the 30S subunit of bacterial ribosomes and blocking peptide chain elongation, and has broad-spectrum antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, Rickettsia, Mycoplasma and Chlamydia. At present, it is mainly used clinically for the treatment of scrub typhus, brucellosis, mycoplasma pneumonia, chlamydial infection and other diseases, and is also widely used in the prevention and control of bacterial diseases in the field of livestock, poultry and aquaculture. It is a commonly used antibacterial API with both clinical value and economic value in the fields of public health, agriculture and animal husbandry.

The current global market size of oxytetracycline API is approximately USD 1.27 billion, with a compound annual growth rate maintained at around 3.2%. The demand growth mainly comes from the primary medical scenarios in developing countries and the veterinary antibacterial drug market. China is the world's largest producer and exporter of oxytetracycline, with its production capacity accounting for more than 85% of the global total production capacity. Domestic manufacturers are mainly large veterinary drug and chemical pharmaceutical enterprises in North China and Northeast China. The products are exported to nearly 100 countries and regions such as Southeast Asia, Latin America and Africa. In addition, the stability of API procurement demand for human oxytetracycline preparations has continued to increase after the implementation of centralized procurement.

The original research enterprise of oxytetracycline is Pfizer, and the original research trade name is Terramycin. The core compound patent expired globally in 1992. At present, the main commercially available dosage forms include tablets (0.125g, 0.25g), capsules (0.25g) and powder for injection. The original research preparation has been included in the FDA Reference Listed Drug Catalog. Up to now, more than 30 domestic enterprises have obtained A status identification for their oxytetracycline APIs through CDE registration, and more than 200 approval documents for oxytetracycline tablets and oxytetracycline capsules have been approved for marketing at the human preparation level. (Data as of December 2024, please refer to the official CDE website for the latest information)

In response to the demand for oxytetracycline-related quality research and compliance declaration, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises for qualitative and quantitative research on process impurities, stability tests and registration declaration.