Nortropine

In the clinical medication for central nervous system diseases and peripheral nervous system diseases, the synthesis of anticholinergic and analgesic drugs is often supported by key intermediates. Nortropine (norscopolamine), as the core mother nucleus structure of tropane alkaloids, is a key synthetic raw material for a variety of clinically essential drugs such as anisodamine, tiotropium bromide, and glycopyrrolate bromide. It has a tropane ring structure itself, and different functional groups can be introduced through structural modification to derive preparation products with different pharmacological activities such as antispasmodic, anti-asthmatic, and glandular secretion inhibition, ultimately benefiting patient groups in multiple therapeutic fields such as chronic obstructive pulmonary disease, peptic ulcer, and anesthesia adjuvant medication.

The global market size of tropane APIs exceeded US$1.2 billion in 2023. Among them, the annual demand for nortropine as a core upstream intermediate exceeds 280 tons, and the annual compound growth rate is maintained at around 7.2%. The growth momentum mainly comes from the market expansion of downstream COPD medications and ophthalmic antispasmodic medications. At present, the global production capacity is mainly concentrated in China and India. Domestic enterprises, relying on their cost and process advantages, account for more than 65% of the global supply share. Part of the demand in the high-end market still relies on imports at present. With the iteration of domestic synthesis processes, the space for domestic substitution is continuously releasing.

Nortropine is a general pharmaceutical intermediate, with no exclusive original research enterprise or corresponding trade name. As of October 2024, there are 6 registration numbers of domestic nortropine on the API registration platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, among which 3 have been activated to A status, which can be used in association with domestic preparation declarations. Domestic approved and marketed preparation products such as tiotropium bromide and racemic anisodamine all require nortropine as the starting material. At present, no original research imported nortropine API has been registered in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of nortropine impurity reference standards. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They are compliant with multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the impurity research needs of pharmaceutical enterprises in the whole process from process R&D to registration and declaration.