Acetylcholine

Nerve signal transduction is the core link to maintain human physiological functions. As a core member of endogenous neurotransmitters, acetylcholine belongs to cholinergic parasympathomimetic drugs. By activating the two types of cholinergic receptors M and N, it exerts both muscarinic and nicotinic effects, and can regulate smooth muscle contraction, glandular secretion, cardiovascular tone and signal transmission at neuromuscular junctions. In clinical practice, its active pharmaceutical ingredient (API) is mainly used as a medicinal active ingredient for the production of preparations related to the rescue of atropine poisoning during the perioperative period, intraocular pressure reduction for glaucoma, and symptomatic treatment of postoperative gastrointestinal or bladder smooth muscle paralysis. It can also be used as a core tool drug for neuroscience research, and is suitable for patients and scientific research scenarios that require rapid regulation of cholinergic pathway function.

At present, the global market size of acetylcholine API is approximately USD 120 million, and the compound annual growth rate from 2023 to 2029 is expected to remain at 4.2%. The demand growth mainly comes from the stable demand in the fields of ophthalmic preparations, perioperative medication and scientific research consumables. In the domestic market, due to the simple structure and mature synthesis process of this compound, the competitive landscape is dominated by local generic pharmaceutical enterprises, with no patent barrier restrictions. The combined market share of the top three manufacturers accounts for approximately 62%, the overall supply is stable, and the annual price fluctuation range is below 5%.

There is no exclusive original research enterprise for acetylcholine. As an endogenous natural compound, it was first discovered by physiologists and artificially synthesized. Its medicinal preparation was first approved for marketing by the FDA in 1938. At present, there are 3 registration entries of acetylcholine API on the domestic CDE API registration platform, 2 of which are in Class A status and can be used for associated preparation declaration. The domestically approved acetylcholine preparations marketed include acetylcholine for injection and acetylcholine eye drops, both of which have been included in the domestic reference preparation catalogue. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for acetylcholine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API manufacturers in quality research, impurity calibration, and application document preparation.