Carebastine

In the clinical treatment of allergic diseases such as chronic urticaria and allergic rhinitis, second-generation antihistamines are the core medications for symptom control. As a new type of highly selective H1 receptor antagonist, carebastine exerts long-acting blocking effects on peripheral histamine H1 receptors, thus avoiding common central adverse reactions of traditional antihistamines such as drowsiness and dry mouth. At present, this drug is mainly used for the symptomatic treatment of chronic idiopathic urticaria and seasonal/perennial allergic rhinitis in adults and adolescents aged 12 years and above. Once-daily administration can maintain the efficacy for 24 hours, which greatly improves the medication compliance of patients, and is especially suitable for people who need long-term control of allergic symptoms.

The逐年 increasing prevalence of allergic diseases worldwide drives the continuous expansion of the antihistamine market. Among them, carebastine maintains a steady growth trend in the second-generation antihistamine market segment by virtue of its lower incidence of adverse reactions and better long-acting effect. At present, the overall size of the antihistamine market in the domestic market exceeds RMB 6 billion. Carebastine is still in the market introduction stage, and only a small number of domestic enterprises are engaged in the generic R&D of this variety, so the market competition pattern is relatively loose. In the future, with the improvement of clinical awareness and the launch of generic drugs, its market penetration rate is expected to further expand.

The original research enterprise of carebastine is Merck Group of Germany, and the original trade name is "Allegra". Its core compound patents expired in 2011 in major markets such as the European Union and the United States, and the compound patent in China has also expired. The main dosage forms approved for the original research product include tablets and oral suspensions, with conventional specifications of 120 mg and 180 mg. The original preparation has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *Catalog of Reference Preparations for Chemical Drugs* of China. On the domestic side, there are currently no approved carebastine preparation products on the market, and no valid and in-validity registration number of carebastine API has been published on the API registration platform of CDE. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for carebastine API, and most of the products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for enterprises' API R&D, quality research and generic drug consistency evaluation.