Oxomemazine

In view of clinical symptoms such as intractable pruritus and cough caused by allergic diseases, the clinical application value of second-generation antihistamines continues to be highlighted. Oxomemazine is a phenothiazine H1 receptor antagonist, which can competitively block the binding of histamine to H1 receptors on effector cells, inhibit histamine-mediated capillary dilation, smooth muscle spasm and nerve ending stimulation responses, and has weak central sedative and anticholinergic effects at the same time. It is mainly used clinically to treat allergic rhinitis, urticaria and contact dermatitis, and can also be used to relieve allergic cough and postoperative vomiting. It also has clear applicable evidence in the symptomatic treatment of children's allergy-related symptoms.

At present, the overall global market size of antihistamines has exceeded 9 billion US dollars, of which second-generation non-sedative varieties account for more than 70%. With a lower incidence of adverse reactions of drowsiness, oxomemazine maintains a stable growth in the pediatric allergy medication track, with a global market compound annual growth rate of approximately 4.2% in the past three years. At present, the generic market of this variety is still in a relatively early stage. A small number of generic pharmaceutical enterprises in Europe and India have been approved for marketing, and there is no relevant generic drug application in China, so the overall competitive landscape is relatively loose.

The original research enterprise of oxomemazine is Sanofi, with the original research trade name Phenergan, and its core compound patent expired globally in 1987. The main dosage form approved for the original research is tablet, with the conventional specification of 10 mg per tablet, which has been included in the EU EMA reference preparation catalog. Before the search, no valid DMF registration information of oxomemazine has been found in the API registration database of China CDE, and no relevant preparations of oxomemazine have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of oxomemazine impurity reference standards, which fully cover intermediate impurities, degradation impurities and enantiomeric impurities that may be generated during the synthesis process. Most products are in stock, and in-stock products ordered 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 support enterprises to carry out the whole process of API R&D, registration and declaration, and quality research.

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