Phenoxymethylpenicillin

Bacterial infectious diseases have long threatened the health of people of all ages. Penicillin antibiotics are a classic clinical choice for dealing with such infections. Penicillin V belongs to β-lactam oral penicillins, which exerts bactericidal effect by inhibiting the synthesis of bacterial cell walls, and has high sensitivity to Gram-positive bacteria such as Streptococcus hemolyticus and Streptococcus pneumoniae. It is mainly used clinically to treat mild to moderate respiratory tract infections, scarlet fever, erysipelas and prevent the recurrence of rheumatic fever. Compared with injectable penicillins, the convenience of oral administration is more suitable for sequential therapy and long-term prophylactic medication of community-acquired infections, and the applicable population covers adult and pediatric patients without a history of penicillin allergy.

At present, the global market size of penicillin V preparations maintains a steady growth trend. In 2023, the global market size was approximately USD 1.87 billion, and the compound annual growth rate is expected to be approximately 4.2% by 2028. For the domestic market, the demand in the primary medical market continues to be released. In 2023, the domestic market size of penicillin V preparations was approximately RMB 1.26 billion. At present, the competitive landscape is dominated by generic drugs. After the implementation of centralized procurement, the terminal price has dropped significantly, and the penetration rate in primary medical institutions has increased year by year, driving the steady rise in demand for upstream API.

The original developer of penicillin V is Boehringer Ingelheim of Germany, with the original brand name of "Abbocillin-VK", and its core compound patent expired globally in 1999. The main dosage forms of the original drug include tablets and granules, with common specifications of 125mg, 250mg and 500mg. The original preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs of Chemical Drugs* of China. According to the domestic API registration platform, 6 enterprises have obtained A-status registration numbers for penicillin V API, and more than 12 domestic penicillin V preparation varieties have been approved for marketing, covering two dosage forms of tablets and granules. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for penicillin V API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the needs of impurity traceability.