Cefaclor

In the clinical treatment of infectious diseases of the respiratory tract and urinary system, cefaclor is a commonly used second-generation oral cephalosporin. It exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and has good antibacterial activity against a variety of Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae and some Gram-negative bacteria. Clinically, it is mainly used for otitis media, lower respiratory tract infections, upper respiratory tract infections, urinary tract infections, skin and skin tissue infections, sinusitis, etc. caused by sensitive bacteria. The applicable population covers adults and children who meet the medication indications. Due to its good oral absorption and low incidence of adverse reactions, it has become a common choice for the treatment of community-acquired infections.

At present, the global market size of oral cephalosporins maintains steady growth, among which cefaclor accounts for about 6% of the segmented market share by virtue of its mature clinical application foundation. In terms of the domestic market, the annual sales of cefaclor preparations exceed 2 billion yuan, the overall competitive landscape is dominated by generic drugs, and cefaclor has been included in the national centralized procurement catalog. The winning bid price has dropped by an average of 65% compared with that before the centralized procurement, which has greatly improved the accessibility of medication for patients. At present, the domestic supply of API is mainly dominated by local enterprises, with the top 3 enterprises accounting for more than 70% of the domestic market share, and the overall supply system is mature and stable.

The original research enterprise of cefaclor is Eli Lilly and Company in the United States, and the original trade name is "Ceclor". Its core compound patent expired globally in 1999, and all relevant preparation patents in China have also expired. The main dosage forms approved for the original research include capsules (250mg, 500mg), granules (125mg/bag, 250mg/bag), and dry suspensions (125mg/5ml, 250mg/5ml). The original 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, there are more than 30 valid registration numbers of cefaclor API on the API registration platform of China CDE, most of which are in A status and can be associated with domestic preparation applications; there are more than 200 marketed approval numbers of cefaclor preparations in China, covering all mainstream dosage forms such as capsules, granules and dry suspensions. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of cefaclor impurity reference standards. Most of the products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the needs of pharmaceutical enterprises in various R&D and production scenarios such as impurity research, quality standard establishment, and generic drug consistency evaluation.