Tetracycline

As a representative of classic broad-spectrum antibiotics, tetracycline belongs to tetracycline bacteriostatic agents. It exerts its effect by reversibly binding to the 30S subunit of bacterial ribosomes, blocking the binding of aminoacyl-tRNA to ribosomes and inhibiting bacterial protein synthesis. In addition to antibacterial activity against Gram-positive and Gram-negative bacteria, it can also be used for the treatment of Rickettsia, Mycoplasma, Chlamydia, Spirochete and some protozoan infections. Clinically, it can be used in the combination regimens for scrub typhus, brucellosis, acne, Helicobacter pylori eradication, etc. The applicable population covers adults and patients with specific infections who have no history of tetracycline allergy. It is one of the commonly used drugs in primary clinical and public health prevention and control scenarios.

The global market size of tetracycline API is about 1.2 billion US dollars, with a compound annual growth rate maintained at around 3.2%. The demand mainly comes from the human antibiotic market and the animal health field. China is the world's largest producer of tetracycline API, with production capacity accounting for more than 85% of the global total. Leading manufacturers are concentrated in North China and East China. In addition to meeting domestic clinical demand, more than 60% of the production capacity is supplied for export. After the implementation of centralized procurement, the price of tetracycline-related preparations has dropped by 47%, which further drives the expansion of demand for upstream APIs. Under the tightening environmental protection policies, small and medium-sized production capacity is gradually cleared, and the industry concentration continues to increase.

The original research enterprise of tetracycline is Pfizer, and the original brand name is Achromycin. The core compound patent expired globally in 1975. At present, the main marketed dosage forms include tablets, capsules and injections. The commonly used specifications are 250mg and 500mg for tablets, and 0.5g for injections. The original product has been included in the FDA Reference Listed Drug Catalog. The original preparation has not been imported into China, and the approved domestic preparations are mainly generics. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for tetracycline APIs, which can be legally supplied for domestic preparation production. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for tetracycline API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and fully meet the demand for impurity reference standards in the process of pharmaceutical R&D, quality research and production of pharmaceutical enterprises.