Methoxyphenamine

Bronchial asthma is a chronic inflammatory airway disease with more than 300 million patients worldwide. Its recurrent wheezing and shortness of breath symptoms seriously affect patients' quality of life. Methoxyphenamine belongs to β-adrenergic receptor agonist class of anti-asthmatic drugs. It selectively stimulates the β2 receptors on bronchial smooth muscle, relaxes airway smooth muscle and relieves bronchospasm. Meanwhile, it can inhibit the release of allergic mediators such as histamine and reduce congestion and edema of airway mucosa. It is often clinically formulated into compound preparations with other drugs for the symptomatic treatment of cough, expectoration and wheezing symptoms caused by bronchial asthma, asthmatic bronchitis and other respiratory diseases, and the applicable population covers adults and children over 5 years old.

At present, the market demand for methoxyphenamine is growing steadily. In 2023, the sales volume of compound methoxyphenamine preparations at the terminal of domestic public medical institutions exceeded 1.2 billion yuan, and the compound growth rate in the past three years has remained at around 8%. In terms of competitive landscape, the preparation market is dominated by the original imported products, accounting for about 65%. In recent years, domestic generic drugs have gradually seized market share through consistency evaluation. The active pharmaceutical ingredients (APIs) have basically achieved domestic supply, with about 10 domestic manufacturers, sufficient production capacity and significant cost advantages.

The original developer of methoxyphenamine is Astellas Pharma of Japan, with the original brand name "Asmeton". Its core compound patent expired in the 1990s. The main dosage form approved in China is compound methoxyphenamine capsule, with the specification that each capsule contains 12.5 mg of methoxyphenamine hydrochloride, 7 mg of noscapine, 25 mg of aminophylline and 2 mg of chlorpheniramine maleate. It has been included in the China Listed Drug Catalogue as a reference preparation. At present, the methoxyphenamine hydrochloride APIs of 5 domestic enterprises have completed registration with the Center for Drug Evaluation (CDE) and obtained the A status label, and the compound methoxyphenamine capsules of more than 7 enterprises have been approved for marketing, among which 3 have passed the consistency evaluation. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of methoxyphenamine impurity reference standards. The R&D process strictly complies with the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. The products have complete structural confirmation and accurate purity calibration, which can fully meet the whole process requirements of API R&D, quality research and routine release testing. Most impurity reference standards are in stock regularly. Orders submitted before 16:00 can be arranged for delivery on the same day, which effectively shortens the R&D waiting cycle and provides stable supply chain support for the project advancement of pharmaceutical enterprises.