Moxifloxacin

Respiratory tract infection is a highly prevalent infectious disease in clinical practice, and the rising drug resistance of pathogenic bacteria has always been a difficulty in treatment. Quinolones have become the core medication choice due to their broad antibacterial spectrum and high oral bioavailability. Moxifloxacin is a fourth-generation fluoroquinolone antibacterial agent. It blocks bacterial DNA replication by inhibiting bacterial DNA gyrase and topoisomerase IV, and has coverage capacity against Gram-positive bacteria, Gram-negative bacteria, anaerobes and atypical pathogenic bacteria. It is clinically mainly used for the treatment of adult community-acquired pneumonia, acute bacterial sinusitis, acute exacerbation of chronic bronchitis, complicated abdominal infection and other diseases. Due to its low metabolic burden on liver and kidney functions, it also has relatively high medication safety in the elderly infected population.

In the domestic respiratory quinolone market, moxifloxacin is an antibacterial drug variety ranking among the top three in sales. In 2023, its sales at the terminal of domestic public hospitals exceeded 4.8 billion yuan, and the compound growth rate in the past three years has remained at 6.2%. After the implementation of centralized procurement, the substitution rate of generic drugs has exceeded 85%. At present, more than 30 domestic enterprises have obtained approval for moxifloxacin preparations, and the supply pattern of API presents a coexistence situation of original research manufacturers, large domestic generic pharmaceutical enterprises and characteristic API enterprises. With the improvement of infection diagnosis and treatment capacity of primary medical institutions, the medication demand in the sinking market still has an annual growth space of about 10%.

The original research enterprise of moxifloxacin is Bayer Group, and the original research trade name is "Avelox". The expiration time of its core compound patent in China is 2013. The main dosage forms approved by the original research include moxifloxacin hydrochloride tablets (0.4g) and moxifloxacin hydrochloride and sodium chloride injection (250ml: 0.4g moxifloxacin and 2.0g sodium chloride). Both original research preparations have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA reference preparation catalogue. Up to now, more than 20 marketing registration numbers of moxifloxacin API can be queried on the CDE platform, and more than 20 domestic manufacturers have obtained approval for the marketing of moxifloxacin oral and injection preparations. (Data as of September 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for moxifloxacin API. Most products support spot supply. Spot orders placed before 16:00 can be delivered on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in various scenarios such as API quality research, consistency evaluation and stability investigation.