Phenylbutazone

Rheumatic immune diseases are chronic and highly prevalent diseases, and there is a long-term rigid clinical demand for anti-inflammatory and analgesic drugs. Phenylbutazone is a pyrazolone non-steroidal anti-inflammatory drug. It reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and at the same time inhibits the chemotaxis and aggregation of leukocytes and the release of lysosomal enzymes in the inflammatory response, thus exerting strong anti-inflammatory and analgesic effects, and also promoting the excretion of uric acid. It is mainly used clinically to treat joint inflammations such as rheumatoid arthritis, rheumatoid arthritis and ankylosing spondylitis. It can also be used for short-term analgesia in acute gout attacks and symptomatic treatment of some intractable high fever symptoms. The applicable population is mainly patients with medium and chronic rheumatic immune diseases.As a classic anti-inflammatory drug that has been on the market for many years, the global market size of phenylbutazone is approximately US$120 million. Due to the stable prescription habits formed in clinical practice, the growth rate has maintained at around 2.1% in recent years. At present, the market supply is dominated by generic drugs. China is the world's main producer of phenylbutazone API, with production capacity accounting for about 68% of the global total. In addition to meeting the needs of domestic preparation enterprises, more than 40% of the production capacity is used for export to supply the global market. With the implementation of the centralized volume-based procurement policy, the cost control requirements for APIs have increased after the price of downstream preparations has decreased, and the market share of API suppliers with compliant production qualifications and stable production capacity is gradually increasing.The original research enterprise of phenylbutazone is Novartis, and the original research brand name is Butazolidin. Its core compound patent expired globally in 1975. At present, the marketed original research dosage forms mainly include 100mg tablets and 50mg/ml injections, both of which have been included in the FDA reference preparation catalog. For the domestic market, 12 phenylbutazone APIs have obtained CDE registration numbers so far, 8 of which are in status A and can be used for association with domestic preparation declarations. The domestically approved phenylbutazone preparations include tablets and enteric-coated capsules, and multiple generic drugs have passed the consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest information)CATO can provide a full range of phenylbutazone impurity reference standards, covering dozens of types such as production process impurities and degradation impurities. Most products are in sufficient stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of different stages such as API R&D, quality research, and registration declaration.

作为上市多年的经典抗炎药物，保泰松的全球市场规模约为1.2亿美元，因临床已形成稳定的处方习惯，近年增速维持在2.1%左右。目前市场供应以仿制药为主，国内是全球主要的保泰松原料药生产地，产能占全球的68%左右，除满足国内制剂企业需求外，超过40%的产能用于出口供应全球市场。随着集中带量采购政策落地，下游制剂价格下降后对原料药成本控制要求提升，具备合规生产资质、产能稳定的原料药供应商市场份额正逐步提升。

保泰松的原研企业为诺华制药，原研商品名为Butazolidin，其核心化合物专利已于1975年全球到期。目前已上市的原研剂型主要包括100mg片剂及50mg/ml注射液，两种剂型均已被列入FDA参比制剂目录。国内方面，目前已有12个保泰松原料药获得CDE登记号，其中8个状态为A，可关联国内制剂申报使用；国内已批准上市的保泰松制剂包括片剂及肠溶胶囊，已有多个仿制药通过一致性评价。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技可提供保泰松全系列杂质标准品，覆盖生产过程杂质、降解杂质等数十种类型，大部分产品库存充足，现货产品16:00前下单即可当天发货，所有产品均符合中国药典、FDA等多法规体系要求，可充分满足原料药研发、质量研究、注册申报等不同阶段的需求。