Cefotiam

Bacterial infection has always been the core response area of clinical anti-infective treatment. With balanced coverage of Gram-positive bacteria and Gram-negative bacteria and lower nephrotoxicity, the second-generation cephalosporins have become a common choice for the treatment of moderate community and nosocomial infections. As a representative variety of the second-generation injectable cephalosporins, cefotiam exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and has good antibacterial activity against common pathogenic bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli and Klebsiella species. It is clinically mainly used for the treatment of pneumonia, bronchitis, biliary tract infection, peritonitis, urinary tract infection, post-surgical or traumatic infection and sepsis caused by sensitive bacteria, applicable to adult and pediatric patients with sensitive bacterial infections, and is widely used in the departments of respirology, general surgery, urology and others.

At present, the global market size of cefotiam is stable at around US$1.5 billion, and the Chinese market is the main growth contributing region, with a compound growth rate of 4.2% in the past three years. The core driving factors are the improved accessibility of anti-infective drugs in primary medical institutions and the standardized application of perioperative infection prevention. In terms of the competitive landscape, the domestic preparation market has formed a situation where both the originator and generic drugs are supplied. As of 2024, more than 20 enterprises have obtained the approval documents for generic cefotiam for injection, and this variety has been included in multiple batches of national centralized volume-based procurement, with an average price reduction of 69% for the winning bids compared with the maximum declared price. The API supply side is dominated by domestic local manufacturers, with sufficient overall production capacity, which can fully meet the incremental market demand after centralized procurement.

The originator enterprise of cefotiam is Takeda Pharmaceutical Company Limited, with the originator brand name "Pansporin", and its core compound patent expired globally in 2003. The main dosage form approved for the originator is cefotiam hydrochloride for injection, with specifications including 0.5g and 1.0g. The originator dosage form has been included in the China Listed Drug Catalogue as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalogue. In terms of domestic API registration, as of now, 11 registration numbers of cefotiam hydrochloride API have been approved, all with the status of A, which can meet the requirements of associated review, and more than 30 varieties of cefotiam for injection preparations have been approved for marketing in China. (Data as of September 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefotiam impurity reference standards. Most products support spot supply, and spot orders paid before 16:00 can be dispatched on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of various R&D and production scenarios such as API quality research, impurity profile analysis, and generic drug consistency evaluation.