Dextromethorphan

As a commonly used drug in the field of central antitussive therapy, dextromethorphan is a morphinan derivative. It exerts antitussive effect by inhibiting the cough center of the medulla oblongata. Its antitussive potency is equivalent to or slightly stronger than that of codeine, and it has no analgesic effect, does not inhibit respiration at therapeutic doses, and no addiction or tolerance has been found after long-term application. It is mainly used clinically to relieve dry cough symptoms caused by upper respiratory tract infection, acute and chronic bronchitis, bronchial asthma and other diseases. Its applicable population covers adults and children over 2 years old, and it is one of the core choices of clinical over-the-counter antitussive drugs at present.

The global dextromethorphan market size has maintained steady growth in recent years. The market size was approximately USD 420 million in 2023, with a compound annual growth rate maintained at around 3.5%. In terms of the domestic market, dextromethorphan preparations are common components of cold and antitussive drugs. The total annual sales in public medical institutions and the retail market exceed RMB 1.5 billion, of which compound preparations account for more than 80%. At present, domestic generic drug enterprises dominate the market, with the share of original research products being less than 10%. More than 30 enterprises have had their dextromethorphan related preparations pass the consistency evaluation. The winning bid price of relevant varieties in centralized procurement is about 60% lower than that of the original research products, and the accessibility has been significantly improved.

The original research enterprise of dextromethorphan is Roche, and the original research trade name is Dextromethorphan Hydrobromide, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Solution (trade name: Huifeining). The core compound patent expired globally in 1987. The original research dosage forms marketed in China mainly include oral solutions and sustained-release suspensions, with the common specification being 100ml containing 100mg of dextromethorphan. The original research products have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA. At present, there are more than 60 domestic marketing authorization application numbers for dextromethorphan active pharmaceutical ingredients, among which more than 20 are in status A (approved for use in marketed preparations). The approved and marketed preparations cover more than 10 dosage forms such as tablets, capsules, oral solutions and granules. (Data as of December 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for dextromethorphan, most of which are in stock. For spot orders placed before 16:00, delivery can be made on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API manufacturers for quality research, impurity control and registration declaration.