Erythromycin

As a representative variety of classic macrolide antibiotics, erythromycin reversibly binds to the 50S subunit of bacterial ribosomes to inhibit bacterial protein synthesis, and has good antibacterial activity against Gram-positive bacteria, some Gram-negative bacteria and atypical pathogens. It is widely used clinically for respiratory tract infections, skin and soft tissue infections, and genitourinary system infections caused by sensitive bacteria, and is also an alternative treatment option for patients with penicillin allergy. It covers applicable populations of all age groups including children and adults, and occupies an irreplaceable fundamental position in the primary anti-infective treatment system.

Currently, the global market size of erythromycin API is approximately USD 1.2 billion, with a CAGR maintained at around 3.2%. China is the world's largest producer and exporter of erythromycin, with its production capacity accounting for more than 85% of the global total. The domestic market pattern presents the characteristic of head concentration, with the total market share of the TOP 3 enterprises exceeding 70%. As the centralized procurement policy continues to cover oral antibiotic varieties, the demand of downstream preparation enterprises for cost-effective and compliant APIs has been steadily increasing, and API registration and impurity compliance have become the core competitive barriers for suppliers.

The original developer of erythromycin is Pfizer, with the original brand name Erythrocin, and the core compound patent expired globally in 1985. At present, the mainstream marketed dosage forms include tablets (0.125g, 0.25g), capsules (0.25g), powder for injection (0.25g, 0.3g) and ointments, etc. The original product has been included in the FDA Reference Listed Drug Catalog, and the domestic reference preparation is included in the *Catalog of Chemical Reference Standards*. Up to now, there are 32 valid erythromycin registration numbers on the API registration platform of China CDE, among which 18 are in A status (approved for use in marketed preparations), and there are more than 200 erythromycin oral, injection and external preparation varieties approved in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of erythromycin impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully satisfy the needs of the whole process of API R&D, quality research and compliance declaration.