Bromhexine

In response to the problem of sticky sputum obstruction caused by lower respiratory tract infections, chronic bronchitis and other diseases, there has been a long-term lack of treatment options with both expectorant efficiency and safety in clinical practice. The advent of bromhexine has filled this gap in clinical demand. As a mucolytic expectorant, it acts on the mucus-secreting cells of the bronchial glands, cleaves the acidic mucopolysaccharide fibers in sputum, and reduces the sialic acid content of sputum, thereby reducing the viscosity of sputum from the source and making sticky sputum easier to cough up. This drug is indicated for adults and children with acute and chronic bronchitis, asthma, bronchiectasis and other conditions accompanied by sticky sputum that is difficult to cough up, and can also be used for the prevention and treatment of postoperative pulmonary complications. It is a commonly used basic expectorant in clinical respiratory departments.

At present, the global bromhexine market size is stable at around USD 1.2 billion, with a steady compound annual growth rate of 3.2%, of which the generic drug market accounts for more than 85%. China is the core supplier of bromhexine API in the world, with production capacity accounting for more than 70% of the global total production capacity. Affected by the release of primary medical demand and the normalization of respiratory disease prevention and control in the domestic market, the annual growth rate of terminal sales of preparations has reached 6.7% in the past three years. After the implementation of centralized procurement, the average drop in winning bid prices is 42%, and the market share is further concentrated in leading enterprises with large-scale API production capacity.

The original developer of bromhexine is Boehringer Ingelheim of Germany, with the original brand name "Bisolvon". The core compound patent expired globally in 1983. At present, the original dosage form approved in China is tablet, with the specification of 8mg, which has been included in the *Catalogue of Chemical Reference Preparations (29th Batch)* of China. In terms of API registration, 12 domestic enterprises have obtained CDE registration (status A) for their bromhexine APIs, and the approved preparation dosage forms cover tablets, injections, aerosols and other categories, which can meet the needs of different clinical scenarios. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for bromhexine API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can help pharmaceutical companies efficiently complete the whole process of impurity research, quality standard establishment and registration and declaration, effectively shortening the R&D cycle.