Propantheline bromide

Paroxysmal abdominal pain and colic caused by gastrointestinal spasm are among the most common reasons for consultation in gastroenterology outpatient clinics. Such symptoms are usually directly related to excessive contraction of gastrointestinal smooth muscle and vagus nerve excitation, and conventional antispasmodic drugs are often accompanied by obvious adverse reactions such as dry mouth and palpitations. Propantheline bromide is a synthetic quaternary ammonium anticholinergic drug, which can selectively block M cholinergic receptors on gastrointestinal smooth muscle, inhibit gastrointestinal peristalsis and reduce gastric acid secretion at the same time. It is not easy to cross the blood-brain barrier and has mild central adverse reactions. It is clinically mainly used for adjuvant treatment of gastric and duodenal ulcers, relief of pain caused by gastrointestinal spasm, and also for relieving smooth muscle irritation symptoms caused by gastritis and pancreatitis. The applicable population covers adults and adolescent patients who need to control gastrointestinal symptoms.

At present, the global market size of anticholinergic antispasmodic drugs is about US$1.9 billion, with a compound annual growth rate of about 3.7%, among which the gastrointestinal antispasmodic细分领域 accounts for more than 42%. As a commonly used basic antispasmodic drug in clinical practice, generic propantheline bromide occupies an absolute dominant position in the market. The annual sales volume at the terminal of domestic public medical institutions is stable at around RMB 120 million. In recent years, with the increase in the allocation rate of commonly used digestive drugs in primary medical institutions, the demand growth rate has remained in the range of 4% to 5%. Domestic manufacturers are mainly generic pharmaceutical companies, there are no imported original research preparations sold in China, the supply of APIs has basically been localized, and it has not been included in the national centralized volume procurement scope.

The original research enterprise of propantheline bromide is Bayer, with the original trade name Pro-Banthine. The compound patent in the US market expired in 1989, and the core crystal form patent expired in 1993. The main dosage form approved for the original research is tablet, with a specification of 15mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, but has not been included in the reference preparation scope of the Chinese Listed Drug Catalog. As of the retrieval time point, there are a total of 6 registration records of propantheline bromide APIs on the domestic API registration platform, among which 3 are in status A (already used in marketed preparations). A total of 22 domestic pharmaceutical companies have been approved to produce propantheline bromide tablets, all with an approved specification of 15mg. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for propantheline bromide, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can meet the R&D and production needs of the whole process such as generic drug consistency evaluation, quality research, and release testing.