Lincomycin

Gram-positive bacterial infection is a common type of infection in clinical practice. When patients are allergic to penicillins and cephalosporins, the selection of safe and effective alternative drugs has long been the focus of clinical attention. Lincomycin belongs to the lincosamide class of antibacterial drugs. It inhibits the elongation of peptide chains by binding to the 50S subunit of bacterial ribosomes, thereby blocking bacterial protein synthesis. It has good antibacterial activity against *Staphylococcus aureus*, Streptococcus, anaerobes, etc. It is mainly used clinically for the treatment of respiratory tract infections, skin and soft tissue infections, female reproductive tract infections, abdominal infections, etc. It is especially suitable for the selection of anti-infective regimens for patients with penicillin allergy, and is a commonly used antibacterial drug category in primary medical institutions.

At present, the annual global market size of lincomycin API exceeds 1,200 tons. China is the world's largest producer and exporter of lincomycin, with its production capacity accounting for more than 90% of the global total. The industry concentration is relatively high, and leading enterprises have obvious advantages in production capacity. Driven by the improvement of the accessibility of antibacterial drugs at the primary level and the growth of veterinary anti-infective demand, the global demand for lincomycin has maintained a compound annual growth rate of about 4.2% in the past three years. After the implementation of domestic centralized procurement, the dosage of the preparation side has increased steadily, further driving the steady expansion of the demand for upstream APIs. At present, there are more than 30 domestic preparation enterprises that have passed the consistency evaluation, and the stability of upstream API supply has become one of the core competitive elements for downstream enterprises.

The original research enterprise of lincomycin is Pfizer, and the original research brand name is Lincocin. The core compound patent expired globally in 1972. At present, the mainstream dosage forms include injection, capsule and oral solution, and common specifications are 0.6g/2ml for injection, 250mg/500mg for capsule. The original research product has been included in the FDA Reference Listed Drug Catalog. The lincomycin preparation varieties already marketed in China cover multiple dosage forms such as injections and oral preparations. The CDE API Registration Platform shows that there are more than 15 domestic lincomycin API registration numbers, most of which are in activated status, which can meet the needs of associated review for domestic preparation production. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of lincomycin impurity reference standards, which can meet the impurity research requirements under different production processes. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API and preparation enterprises in quality research and consistency evaluation work.