Bethanechol

Postoperative urinary retention and gastrointestinal flatulence are common complications in surgery and postpartum conditions. If not handled in time, they are likely to cause secondary problems such as urinary tract infection and intestinal paralysis, while cholinergic drugs are the core treatment option for such disorders. As an M cholinergic receptor agonist, bethanechol chloride can selectively act on the smooth muscles of the gastrointestinal tract and urinary tract. By promoting the rhythmic contraction of smooth muscles, it can rapidly improve symptoms such as dysuria and abdominal distension without affecting heart rate and blood pressure. Clinically, it is mainly used for non-obstructive urinary retention after surgery and childbirth, as well as digestive system disorders such as gastric atony and gastric retention. The applicable population covers postoperative surgical patients, postpartum women and some patients with functional gastrointestinal diseases.

At present, the global market size of bethanechol chloride is about USD 230 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at 4.2%. The demand growth mainly comes from the popularization of primary surgical diagnosis and treatment scenarios and the increase in postoperative rehabilitation needs of elderly patients. In terms of the domestic market, this drug is a commonly used low-cost drug. At present, 8 domestic enterprises have obtained preparation approval documents. The supply of API is mainly from local manufacturers, and the overall competitive pattern is relatively stable. It has not been included in the scope of national centralized volume procurement, and the procurement of medical institutions is mainly based on online listing and price negotiation.

The original research enterprise of bethanechol chloride is Merck & Co., Inc. (US), with the original brand name Urecholine. Its core compound patent expired in 1986, and there is no core patent restriction worldwide at present. The main dosage form of the original product is tablet, with specifications including 5mg, 10mg, 25mg and 50mg. It has been included in the FDA Reference Listed Drug Catalog, and the original product has not been included as a reference listed drug in China. In terms of domestic API registration, as of now, there are 3 registration numbers of bethanechol chloride API on the CDE platform, 2 of which are marked as "A" in status, which can be legally supplied to preparation manufacturers. A number of domestic enterprises have obtained approval for the marketing of bethanechol chloride tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for bethanechol chloride API. Most products are in stock. For in-stock products, orders placed 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 fully meet various needs of API manufacturers such as quality research, consistency evaluation and routine release testing.