Propacetamol

In the clinical management of moderate to severe postoperative pain, the rational use of non-opioid analgesics is the core direction to reduce the risk of adverse reactions. As a prodrug of paracetamol, propacetamol belongs to the antipyretic and analgesic intravenous preparation. Its mechanism of action is that after entering the human body, it is rapidly hydrolyzed by plasma esterase into paracetamol, which reduces the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase in the central nervous system. It has dual effects of antipyretic and analgesic, and has no adverse reactions such as respiratory depression and gastrointestinal injury caused by opioids. It is mainly suitable for patients with short-term postoperative analgesia, fever and pain who cannot be administered orally, and is a commonly used alternative drug in the surgical perioperative analgesia pathway.

At present, the global market size of propacetamol is about 320 million US dollars, and the compound annual growth rate from 2023 to 2028 is expected to be 4.7%. The growth momentum mainly comes from the steady increase in the global surgical volume and the expansion of demand for non-opioid drugs in perioperative analgesia regimens. In terms of the domestic market, propacetamol has been included in the Class B medical insurance catalogs of many provinces and cities. In 2023, the terminal sales of domestic public medical institutions exceeded 1.2 billion yuan. There are more than 15 enterprises with approved generic preparations. Driven by the centralized procurement policy, the price of preparations has dropped by more than 80% compared with the initial stage of the original research launch, and the stability of upstream API supply has become the core element of cost control for preparation enterprises.

The original research enterprise of propacetamol is French UPSA Laboratory, with the original brand name "Propafan", and the core compound patent expired in major global markets in 2009. The original marketed dosage form is injection, with specifications of 1g and 2g, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. According to the domestic API registration platform, there are currently 7 domestic API enterprises that have obtained Class A registration numbers, and the registration applications of another 3 enterprises are under review. More than 30 varieties of propacetamol for injection have been approved in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for propacetamol API. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard requirements of the whole process of API R&D, quality research and declaration.