Butamirate

As a representative variety in the field of non-addictive central antitussive drugs, butamirate is an antitussive API with dual peripheral and central effects. Its mechanism of action combines three effects: inhibiting the cough center, relaxing bronchial smooth muscle, and local anesthesia. Its antitussive potency is about twice that of codeine, and it has no respiratory depression or addiction potential. It is clinically mainly used 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 1 year old, and it is especially suitable for patient groups who cannot tolerate opioid antitussives.

The global market size of butamirate is approximately USD 230 million, with a compound annual growth rate of 4.7% in the past three years. The core growth drivers are the rising prevalence of chronic respiratory diseases and the clinical replacement demand for non-addictive antitussives. The current market is dominated by generic drug supplies. Europe, India and China are the three major global production areas of APIs. Among them, China-produced butamirate API accounts for about 38% of the global supply share by virtue of its cost and quality advantages. In terms of the domestic market, this variety has not yet been included in the national centralized volume-based procurement, the clinical demand is stable, and the enthusiasm for generic drug development is continuously rising.

The original research enterprise of butamirate is Boehringer Ingelheim of Germany, and the original research brand name is Sinecod. Its core compound patent expired worldwide in 1999, and there is no valid core patent restriction at present. The main dosage forms of the original research products on the market include oral solutions, tablets and drops, and the common specifications are 10 mg/tablet and 50 mg/5 ml solution. This variety has been included in the FDA Reference Listed Drug Catalog. At present, no original research preparation has been approved for import in China, and there is no imported API registration number corresponding to the original research on the API registration platform. Three domestic enterprises have obtained CDE registration numbers for butamirate API, among which 2 are in Status A, which can be associated with domestic preparation declarations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for butamirate API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They are compliant with multiple regulations including Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in API quality research, consistency evaluation and registration declaration.