Pralidoxime Chloride

Organophosphorus pesticide poisoning is a common acute and critical illness in clinical practice. After poisoning, cholinesterase activity is inhibited, and massive accumulation of acetylcholine can cause fatal consequences such as respiratory failure. Pralidoxime chloride is a specific antidote belonging to the cholinesterase reactivator class. It binds to the phosphoryl group in phosphorylated cholinesterase to restore the activity of inhibited cholinesterase, and at the same time can directly bind to free organophosphorus to form non-toxic substances that are excreted from the body. It is the core medication for the treatment of acute organophosphorus poisoning, applicable to all types of organophosphorus poisoning patients caused by ingestion through the digestive tract, respiratory tract, or skin contact, and is often used in combination with atropine to improve the success rate of treatment.

As an essential variety in the emergency rescue drug catalogue, the market demand for pralidoxime chloride is stable at around 300 million yuan per year. In recent years, with the improvement of the emergency system in primary medical institutions, the market size has maintained a steady growth of around 4% per year. In terms of the competitive landscape, there are less than 10 domestic preparation manufacturers, and the concentration of API supply is relatively high. Due to the rigid clinical demand and strict price control of this variety, there are few new entrants, and the overall supply pattern remains stable for a long time.

The original research enterprise of pralidoxime chloride is Abbott Laboratories in the United States, with the original trade name Protopam Chloride, and its core compound patent expired in the 1980s. The main dosage form approved for the original research product is injection, with a specification of 1g/2mL, which has been included in the FDA Reference Listed Drug Catalogue. In China, at present, the pralidoxime chloride APIs of 6 enterprises have obtained A status through CDE registration, and all the approved preparation varieties are pralidoxime chloride injections, among which 3 specifications have been included in the *Catalogue of Reference Listed Drugs of Chemical Preparations*. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for generic drug R&D and quality control of pralidoxime chloride, CATO provides a full set of impurity reference standards for this API, covering the entire research path including synthetic process impurities, degradation impurities, etc. Most of the impurity reference standards are available from stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of various R&D scenarios such as impurity qualitative and quantitative research and stability investigation.