Ambroxol

Chronic respiratory diseases are highly prevalent globally. Patients often face clinical risks of airway obstruction and aggravated infection due to thick sputum and difficulty in sputum excretion, and there is always an urgent clinical demand for drugs with both mucolytic and airway protective effects. Ambroxol is a mucolytic expectorant. It breaks the acidic glycoprotein fibers in sputum to reduce sputum viscosity, promotes the ciliary beating of airway epithelium to enhance the self-purification ability of the respiratory tract, and can also synergistically increase the concentration of antibiotics in airway tissues. In addition to expectorant treatment for acute and chronic bronchitis, bronchial asthma, bronchiectasis, pulmonary tuberculosis and other diseases, it is also applicable to the preventive treatment of postoperative pulmonary complications, as well as the treatment of respiratory distress syndrome in premature infants and neonates, covering all age groups including adults and children.

The global ambroxol market size has been close to 1.5 billion US dollars, with an annual compound growth rate maintained at around 3%. China is the largest ambroxol consumer market in the world, accounting for more than 40% of the total market. As this variety is mature in clinical application, it has been included in the National Class A Medical Insurance Catalogue and the National Essential Medicines Catalogue. The domestic preparation market is dominated by generic drugs, with more than 30 enterprises having passed the consistency evaluation. The price of the public medical institution market has dropped significantly under the influence of the centralized drug procurement policy, but the demand in the retail and primary medical markets remains stable. On the API supply side, domestic manufacturers dominate, with production capacity accounting for more than 70% of the global total production capacity.

The original developer of ambroxol is Boehringer Ingelheim, and the original brand name is "Mucosolvan". The core compound patent of the original drug expired in 2005 in major global markets. The originally marketed dosage forms include oral solution, tablets, injection, sustained-release capsules, etc. Common specifications cover 15mg/2ml injection, 30mg tablets, 60mg sustained-release capsules, 30mg/5ml oral solution, etc. The original preparation has been included in the Catalogue of Marketed Drugs in China as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalogue. Up to now, more than 50 ambroxol API registration numbers have been publicized on the API Registration Platform of China Center for Drug Evaluation (CDE), among which more than 30 are in status A (usable in marketed drugs). The domestically approved ambroxol preparation varieties have covered all common dosage forms. (Data as of October 2024, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for ambroxol API. Most products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of drug regulatory regulations of multiple countries including the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of the whole process of API research and development, quality research, declaration and registration, etc.