Aminophylline

Chronic airway diseases have long ranked among the top global chronic diseases in terms of prevalence, and bronchodilators have always been the core medication option in clinical treatment. Aminophylline is a xanthine bronchodilator. By inhibiting phosphodiesterase activity, increasing the concentration of intracellular cyclic adenosine monophosphate, and antagonizing adenosine receptors at the same time, it has multiple effects of relaxing bronchial smooth muscle, enhancing diaphragm contractility, and exerting mild anti-inflammatory action. It is routinely used in clinical practice to relieve wheezing symptoms of bronchial asthma and chronic obstructive pulmonary disease, and can also be used for the treatment of wheezing caused by cardiogenic pulmonary edema. It covers patients with airway diseases of different age groups including adults and children, and is one of the standing medications in primary medical institutions.

Aminophylline is a mature product that has been on the market for many years. The annual sales in the terminal market of domestic public medical institutions are stable in the range of RMB 1.2 billion to RMB 1.5 billion, and the growth rate has maintained at around 2% in the past three years, with significantly rigid market demand. The competitive landscape is dominated by generic drugs, with more than 40 domestic manufacturers. After the implementation of centralized procurement of preparations, the stability of raw material supply and the level of impurity control have become the core competitive factors for enterprises, and the demand for supporting impurity reference standards that meet the pharmacopoeia standards of multiple countries continues to rise.

The original research enterprise of aminophylline is Takeda Pharmaceutical Company Limited, and the original brand name is Asmalon. The core compound patent expired before 1985, and there is no core patent restriction at present. The main dosage forms that have been marketed in China include conventional tablets, sustained-release tablets and injections, and common specifications include 100mg tablets and 2ml:0.25g injections, etc. The original research sustained-release tablets have been included in the FDA Reference Listed Drug Catalog, and the aminophylline preparations included in the domestic Reference Listed Drug Catalog are mainly domestic products that have passed the consistency evaluation. As of September 2024, the CDE API Registration Platform has included more than 30 aminophylline API registration numbers, of which more than 20 are in Status A, which can be legally associated with preparation declarations. More than 30 aminophylline preparation varieties have been approved for marketing in China. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of aminophylline impurity reference standards, which fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day, which can fully meet the testing needs of pharmaceutical enterprises in different scenarios such as API quality research and preparation consistency evaluation.