Neomycin

Aminoglycoside antibiotics are an important branch of clinically used drugs for anti-Gram-negative bacterial infections. As a representative variety among them, neomycin exerts a broad-spectrum antibacterial effect by binding to the 30S subunit of bacterial ribosomes, inhibiting bacterial protein synthesis and destroying the integrity of cell membranes. It is mostly used clinically for preoperative preparation for intestinal infections and adjuvant treatment of hepatic encephalopathy, and can also be prepared into topical preparations to treat skin and mucosal infections caused by sensitive bacteria. The oral dosage form is rarely absorbed into the systemic circulation, with outstanding safety advantages, and is a commonly used drug in primary medical institutions and dermatology departments.

In recent years, the global neomycin market size has been stable at around USD 320 million, with a compound annual growth rate of approximately 2.8%. The demand growth mainly comes from the expansion of the animal health field and the topical preparation market. China is the main production capacity supplier of neomycin, accounting for more than 75% of the global total output. The leading production enterprises are concentrated in North China and East China. The existing preparation varieties have been included in the National Essential Medicines List, the winning price in centralized procurement is 62% lower than that of the original research drug, and the domestic substitution rate has exceeded 90%.

The original research enterprise of neomycin is Pfizer, with the original research brand name "Neobiotic". The core compound patent expired globally in 1969. Commonly used clinical dosage forms include tablets (0.1g, 0.25g), ointments (0.5%), and eye drops (0.5%). Among them, the 0.5% ointment and 0.25g tablet have been included in the China Listed Medicines Catalog as reference preparations. Up to now, the CDE API Registration Platform has publicly announced 12 neomycin API registration information, of which 8 are in status A (approved for joint evaluation with preparations), and 27 domestic enterprises have been approved to produce neomycin-related preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of neomycin impurity reference standards, covering a total of 17 kinds of synthesis process impurities and degradation impurities. 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 comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can meet the needs of the whole process of API R&D, quality research and registration declaration.