Galanthamine

Alzheimer's disease, as a neurodegenerative disease with high incidence in the elderly population, has long faced the dilemma of limited effective drug options in clinical treatment. The clinical application of galantamine provides an important treatment path in this field. This drug belongs to the second-generation acetylcholinesterase inhibitor, with a dual mechanism of action combining reversible inhibition of cholinesterase and allosteric regulation of nicotinic acetylcholine receptors. It can improve the cognitive function of patients by increasing the level of acetylcholine in the central nervous system, and is a first-line drug for mild and moderate Alzheimer's disease. Meanwhile, it can also be used for the treatment of neuromuscular conduction disorder diseases such as myasthenia gravis and sequelae of poliomyelitis, and the applicable population covers patients of all ages who meet the indications.

The global market size of galantamine preparations was approximately USD 870 million in 2023. Driven by the continuous increase in the number of Alzheimer's disease patients worldwide, it is expected to maintain a steady growth at a compound annual growth rate of 3.2% from 2024 to 2030. In terms of the Chinese market, the sales of galantamine at public medical institution terminals exceeded RMB 320 million in 2023, with a compound growth rate of 7.8% in the past five years, which is higher than the global average. In the current competitive landscape, in addition to the original research products, more than 15 domestic enterprises have obtained the approval documents of galantamine preparations. The market share of domestic manufacturers in the API segment has exceeded 80%. After winning the bid in centralized procurement, the price has stabilized, and the substitution effect of generic drugs is gradually released.

The original research enterprise of galantamine is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, with the original brand name "Razadyne/Liyilin". Its core compound patent expired globally in 2008, and the preparation patent in China also expired in 2010. The main dosage forms approved for the original product include oral tablets, oral solutions and sustained-release capsules, with specifications covering 4mg, 8mg, 16mg and 24mg sustained-release dosage forms. The relevant dosage forms have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Currently, there are 11 galantamine API registration entries on China's CDE API Registration Platform, among which 9 are registered by domestic manufacturers and 2 are imported registrations. 8 of the entries are in the registration status of "A" (activated). The domestically approved galantamine preparation varieties cover multiple dosage forms such as tablets, capsules, injections and oral solutions. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of galantamine impurity reference standards. Most of the products are available in stock. For spot orders placed before 16:00, delivery can be made on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API R&D, quality research and consistency evaluation work.