Aciclovir

As a classic nucleoside antiviral drug, acyclovir selectively inhibits herpes virus DNA polymerase and blocks the viral DNA replication process, serving as a basic medication for anti-herpes virus infections. Its indications cover labial herpes, genital herpes and viral encephalitis caused by herpes simplex virus infection, chickenpox and herpes zoster caused by varicella-zoster virus, as well as the prevention and control of cytomegalovirus infection in immunodeficient patients. Its applicable population covers ordinary patients, people with low immune function and people with special infection exposure, making it an indispensable variety in the clinical anti-infective medication system.

At present, the global market size of acyclovir API is approximately USD 420 million, with a compound annual growth rate maintained at around 3.7%, and the demand is rigid and stable. China is the world's largest producer and exporter of acyclovir API, with production capacity accounting for more than 75% of the global total production capacity. The concentration of leading manufacturers is relatively high, and the market share of the top five enterprises accounts for more than 60%. In terms of the domestic market, acyclovir oral preparations have been included in multiple rounds of national centralized procurement, and the winning bid price has dropped by more than 70%, which promotes the further concentration of upstream API demand in compliant production capacity. API manufacturers with a complete impurity control system and compliance with the pharmacopoeia standards of multiple countries have significant competitive advantages.

The original research enterprise of acyclovir is GlaxoSmithKline, with the original brand name "Zovirax (舒维疗)", and the core compound patent expired globally in 1997. The main dosage forms approved for the original research include tablets (200mg, 400mg, 800mg), injections (500mg/vial), creams (5%) and eye ointments (3%). Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. At present, more than 30 domestic enterprises have obtained CDE registration numbers (status A) for acyclovir APIs, and multiple domestic enterprises have been approved to market full-dosage preparations including oral, external and injectable ones, with sufficient overall supply. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of acyclovir impurity reference standards, covering all quality control dimensions such as related substances, residual solvents and elemental impurities, and the products simultaneously meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia, FDA and EP. Most impurities are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard needs of API enterprises in the whole process of process research and development, quality research and compliance declaration.