Chloramphenicol

In response to the clinical treatment needs of multi-drug resistant bacterial infections, amphenicol antibiotics have always been an important supplement to the anti-infective drug system. As a classic representative of this class of drugs, chloramphenicol reversibly binds to the 50S subunit of bacterial ribosomes, inhibits peptide chain elongation and thus blocks protein synthesis, and has broad-spectrum antibacterial activity against Gram-negative bacteria, Gram-positive bacteria, anaerobes, Rickettsia and Chlamydia. Clinically, it is mainly used for typhoid fever, paratyphoid fever, severe anaerobic infection, central nervous system infection and other diseases caused by sensitive bacteria, and can also be used as a topical drug to treat superficial infections of the eyes and ears. It is an indispensable alternative drug in primary medical care and drug-resistant bacterial infection prevention and control scenarios.

The global market size of chloramphenicol API is stable at around USD 420 million, with a compound annual growth rate of approximately 2.3%, and the demand is mainly concentrated in the fields of generic drug production, animal health and topical preparations. China is the world's largest producer and exporter of chloramphenicol API, with production capacity accounting for more than 85% of the global total. The annual production capacity of leading enterprises all exceeds 1,000 tons, with significant cost advantages, and product supply covers nearly 100 countries and regions such as Europe, America and Southeast Asia. In terms of the domestic market, chloramphenicol preparations have been included in the National Essential Medicines List, with stable primary procurement demand, and the consumption scale of topical dosage forms has shown a slow upward trend in recent years.

The original research enterprise of chloramphenicol is Pfizer, with the original brand name Chloromycetin, and the core compound patent has expired. The main dosage forms currently on the market include tablets (0.25g), capsules (0.25g), injections (2ml:0.25g), eye ointments (1%) and ear drops (0.25%), etc. A number of original research and international mainstream generic products have been included in the FDA Reference Listed Drug Catalog. In China, as of now, more than 30 enterprises have obtained A status for their chloramphenicol APIs through CDE registration, which can be supplied to domestic preparation manufacturers; meanwhile, multiple dosage forms including tablets, capsules, injections and topical preparations have been approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for chloramphenicol API. Related products simultaneously meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock. Stock orders placed before 16:00 can be shipped on the same day, which can efficiently meet the reference standards use needs of pharmaceutical enterprises in the whole process of R&D, quality research and consistency evaluation.