Dimefline

Central respiratory depression is a common critical complication in clinical anesthesia, intensive care and other scenarios, which can directly endanger patients' lives in severe cases. As a classic central stimulant respiratory system drug, dimefline directly excites the medullary respiratory center, significantly improves the sensitivity of the respiratory center to carbon dioxide, and then rapidly enhances the respiratory amplitude and increases pulmonary ventilation. It is mainly clinically used for central respiratory failure and respiratory depression caused by excessive anesthesia and hypnotic drugs, as well as factors such as infection and trauma, and can also be used for respiratory insufficiency associated with chronic obstructive pulmonary disease. Its applicable population covers patients of all ages with respiratory depression who need to improve ventilation function. It has rapid onset of action and clear awakening effect, and is a standing first-aid drug in emergency and ICU departments.

At present, the domestic market size of central respiratory stimulants is about 1.2 billion yuan, and the compound annual growth rate in the past three years has maintained at about 4.2%. With the advantages of flexible administration and controllable adverse reactions, dimefline accounts for nearly 18% of the share in this market segment. The overall competition pattern of this variety is stable. The market share of the original research product is less than 5%, and domestic generic drugs are the main force of clinical supply. At present, more than 12 domestic enterprises have been approved to produce dimefline preparations. After centralized procurement, the terminal price of its injection has dropped by about 62%, and the clinical accessibility has been greatly improved.

The original research enterprise of dimefline is Japan Organo Pharmaceutical Co., Ltd., and the original research trade name is "リカミン" (English name: Recamin). Its core compound patent expired globally around 1990. The main dosage form approved for the original research product is injection, with the specification of 2ml:8mg, and this product is not included in the reference preparation scope of the Chinese Listed Drugs Catalogue. According to the domestic API registration platform, at present, the dimethrine APIs of 3 domestic enterprises have been approved for marketing and activated the A-status registration number, and the DMF registrations of another 2 enterprises are under review. A number of dosage forms such as dimethrine hydrochloride injection and dimethrine hydrochloride for injection have been approved for marketing in China. (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 dimefline API, covering the full research chain requirements such as process impurities and degradation impurities. Most of the products are in stock. Orders for in-stock products paid before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of API manufacturers and preparation R&D institutions in scenarios such as quality research and stability investigation.