Ketorolac

Pain is the fifth vital sign, and the management of moderate to severe perioperative pain directly affects the quality of patients' postoperative recovery. Non-steroidal anti-inflammatory analgesics are the core component of multimodal analgesia. Ketorolac is a pyrrolidine carboxylic acid class non-steroidal anti-inflammatory drug, which reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase, and has both potent analgesic and moderate anti-inflammatory effects. Its analgesic efficacy is comparable to that of moderate doses of opioids, and it has no risks of respiratory depression and addiction. Clinically, it is mainly used for the short-term relief of moderate to severe postoperative pain, acute renal colic, cancer pain, etc. The applicable population covers adult surgical patients and acute pain patients intolerant to opioids, and it is a key variety in the clinical analgesic ladder regimen to replace or reduce the use of opioids.

The global ketorolac market size has maintained steady growth in recent years. The overall market size in 2023 was approximately USD 420 million, of which the Chinese market accounted for about 18%, with a compound annual growth rate maintained at around 6%. As the compound patent has long expired, the market is dominated by generic drugs. Domestic manufacturers are concentrated in East China and North China. Injections are the mainstream dosage form for clinical use, accounting for 87% of the overall market share. They have been included in the centralized procurement catalogs of multiple provinces, and the highest drop in the winning bid price compared with the original research drug has reached 91, and clinical accessibility has been greatly improved.

The original research enterprise of ketorolac is Syntex, a subsidiary of Roche, and the original research trade name is Toradol. Its US compound patent expired in 1999, and all core patents in China have expired. The main dosage forms of the original research drug include 1ml:30mg injection and 10mg oral tablet, among which the injection has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (29th Batch)*. As of now, there are 12 registration numbers of ketorolac tromethamine API on the API registration platform of China CDE, 8 of which are in Status A and can be used for associated review. More than 30 ketorolac tromethamine injections and oral preparations have been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of ketorolac impurity reference standards, covering the whole research chain including starting materials, intermediates, and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of Chinese Pharmacopoeia and relevant FDA regulations, and can fully meet the use needs of different scenarios such as API registration and declaration, quality research, and stability investigation.