Domperidone

As a commonly used prokinetic drug in clinical practice, domperidone is a peripheral dopamine receptor antagonist. It can block the dopamine D2 receptor in the gastrointestinal tract, enhance the tension of the lower esophageal sphincter, promote gastric emptying, and coordinate the movement of the stomach and duodenum. Meanwhile, it cannot cross the blood-brain barrier and cause adverse reactions in the central nervous system. Its clinical indications include abdominal distension, belching, nausea and vomiting caused by functional dyspepsia, and it can also be used for vomiting symptoms caused by organic, infectious or dietary factors. It is applicable to adults and children aged over 12 years old with body weight ≥ 35kg, and is a commonly used basic drug in primary diagnosis and treatment of gastroenterology.

At present, the global market size of domperidone exceeds 1.8 billion US dollars, and the domestic market size is about 2.3 billion yuan. In recent years, with the increasing prevalence of functional gastrointestinal diseases, the compound annual growth rate has remained at about 4.2%. The domestic market is dominated by generic drugs, and more than 20 preparation enterprises have passed the consistency evaluation. In 2022, domperidone tablets were included in the seventh batch of national centralized drug procurement, with an average price reduction of 68% for winning bids, which greatly compressed the profits of intermediate circulation links. The supply stability and cost control of upstream API have become the core competitive elements for downstream preparation enterprises.

The original research enterprise of domperidone is Janssen Pharmaceutica N.V. of Belgium, and the original research trade name is "Motilium". Its core compound patent expired globally in 1999. The mainstream dosage forms of the original research include 10mg oral tablets and 10mg/ml oral suspension, among which the 10mg tablets have been included in the Reference Listed Drug Catalogue of China marketed drugs, and are also included in the FDA Reference Listed Drug Catalogue. According to the domestic API registration platform, 26 enterprises have obtained A-status registration for domperidone API so far. The approved domperidone preparations cover tablets, suspensions, suppositories and other dosage forms, with sufficient market supply. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for domperidone API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various technical needs of preparation enterprises for impurity research, quality consistency evaluation and daily release testing.