Scopolamine

Cholinergic receptor antagonists are classic categories in the fields of perioperative medication and digestive system disease treatment. As a representative M-cholinergic receptor blocker among them, scopolamine can competitively inhibit the binding of acetylcholine to receptors, suppress glandular secretion, relieve smooth muscle spasm, and simultaneously have central sedative effects. In clinical practice, it can be used as pre-anesthetic medication to reduce respiratory tract secretions, relieve pain caused by gastrointestinal spasm, prevent and treat motion sickness, and can also be used for the rescue of organophosphorus poisoning. The applicable population covers surgical patients, patients with digestive tract diseases and people with high incidence of motion sickness.

According to public market data, the domestic market size of scopolamine-related preparations in 2023 was approximately RMB 1.27 billion, and the compound annual growth rate in the recent 3 years has maintained at around 4.2%. At present, the domestic market is dominated by generic drug supply, and the manufacturers are concentrated in North China and East China. Among them, dosage forms such as scopolamine butylbromide injection and scopolamine hydrobromide patch have been included in multiple batches of provincial centralized procurement, and the winning bid prices have dropped by 48% on average, further promoting the improvement of clinical accessibility.

The original research enterprise of scopolamine is Daiichi Sankyo Co., Ltd. of Japan, and the original trade name is "Buscopan" (scopolamine butylbromide). Its core compound patent expired globally in 2001. At present, the dosage form of the original research drug approved in China is mainly scopolamine butylbromide injection with the specification of 20mg/1ml, which has been included in the *Catalogue of Marketed Drugs in China* as the reference listed drug. As of the retrieval time point, there have been 43 domestic scopolamine-related active pharmaceutical ingredients obtained CDE registration numbers, among which 21 are in status A (already used in marketed preparations), and the corresponding approved preparation varieties cover multiple dosage forms such as injections, patches, oral solutions, etc. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for scopolamine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet various technical needs of pharmaceutical enterprises in impurity research, quality control and generic drug consistency evaluation.