Promethazine

As a classic variety of first-generation antihistamines, promethazine exerts its pharmacological effect by competitively blocking histamine H1 receptors, and also has central sedative, antiemetic and anti-motion sickness effects. In clinical practice, it is not only used for the treatment of common allergic diseases such as allergic rhinitis, urticaria and food allergy, but also can be used as an adjuvant drug to relieve postoperative nausea and vomiting, prevent and treat motion sickness. It is also often used in combination with analgesic drugs to enhance the anesthetic and sedative effect, and its applicable population covers adults and child patients who meet the dosage specifications, making it a standing drug in primary medical institutions and emergency scenarios.

The domestic promethazine market is generally in a stable and mature development stage. At present, the annual market size is about 320 million yuan, and the compound growth rate in the past 3 years has maintained at about 2.1%. The competition landscape is dominated by domestic generic drugs, with the localization rate exceeding 95%. There are more than 40 approved preparation manufacturers at present, and the supply of active pharmaceutical ingredients is mainly concentrated in 6 license-holding enterprises in East China and South China. After the implementation of centralized procurement, the terminal price of this variety of preparations has dropped by about 47%, further promoting the improvement of clinical penetration.

The original research enterprise of promethazine is Sanofi, and the original research trade name is Phenergan. Its core compound patent expired globally in 1987. The main dosage forms approved for the original research include tablets (12.5mg, 25mg) and injections (25mg/1ml, 50mg/2ml). The original research preparations have been included in the FDA Reference Listed Drug Catalog, and no imported original research preparations have been approved for marketing in China. Up to now, there are 12 domestic registration numbers of promethazine active pharmaceutical ingredients, 8 of which are in A status and can be directly associated with preparation declarations. The domestically approved promethazine preparations cover three major categories: tablets, injections and syrups. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of promethazine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D needs of pharmaceutical enterprises such as active pharmaceutical ingredient quality research, stability study and preparation of application documents.