Orbifloxacin

In the field of livestock and poultry farming, bacterial infection has always been one of the core risks affecting breeding efficiency and the safety of animal-derived food. As a third-generation quinolone antibacterial agent exclusively for animals, orbifloxacin blocks bacterial DNA replication by inhibiting the activities of bacterial DNA gyrase and topoisomerase IV, and has strong killing effects on Gram-positive bacteria, Gram-negative bacteria and mycoplasma. Clinically, it is mainly used for the prevention and treatment of respiratory, digestive, and urogenital tract infections in livestock and poultry such as pigs, cattle and chickens, and can also be used for skin and soft tissue infections in companion animals. It is an important broad-spectrum antibacterial option in the prevention and control system of livestock and poultry diseases.

The global market size of veterinary quinolone active pharmaceutical ingredients was approximately USD 1.27 billion in 2023, and the compound annual growth rate is expected to be 4.2% by 2028. Among them, orbifloxacin, due to its positioning as an animal-exclusive agent, avoids the policy restrictions on antibacterial agents shared by humans and animals, and its market growth rate is higher than the average level of the细分 category. At present, the global production capacity is mainly concentrated in China and India, and the number of domestic approved manufacturers is less than 10, so the market competition pattern is relatively concentrated. With the continuous improvement of the large-scale rate of livestock and poultry farming and the increasingly strict specifications for the use of antibacterial agents, the demand for compliant and approved orbifloxacin active pharmaceutical ingredients still has room for steady growth.

The original research enterprise of orbifloxacin is Daiichi Sankyo Co., Ltd. of Japan, and the original trade name is Orbiflox. The core compound patent expired globally in 2008. The main approved dosage forms include tablets, injections and oral solutions, with common specifications of 25mg, 50mg and 100mg. The original preparation has been included in the FDA Veterinary Reference Preparation Catalog. Up to now, there is no orbifloxacin preparation marketed domestically in China, and no valid and listed orbifloxacin API registration number has been found on the CDE API registration platform. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for orbifloxacin, and most of the products support spot supply. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the quality research, registration and declaration, and daily testing of veterinary drug R&D and manufacturing enterprises.