Tropicamide

In the clinical application of ophthalmic examination and mydriatic drugs, anticholinergic agents have always been an indispensable category. As a representative short-acting M receptor blocker, tropicamide has become a conventional medication in ophthalmology outpatient departments by virtue of its clinical advantages of short duration of action and rapid recovery from cycloplegia. Its mechanism of action is to block the M cholinergic receptors of the iris sphincter and ciliary muscle, leading to mydriasis and cycloplegia. Clinically, it is mainly used for the preparation before mydriatic optometry and fundus examination, and can also be used to prevent pseudomyopia in adolescents. The applicable population covers patients of all ages who need to receive ophthalmic examinations and groups for pseudomyopia prevention and control.

At this stage, the global market size of tropicamide-related preparations is approximately USD 320 million, with a compound annual growth rate maintained at around 4.7%. The domestic market size is approximately RMB 370 million, with a growth rate slightly higher than the global average. In terms of competitive landscape, the domestic preparation market is dominated by domestic generic drugs, with a localization rate of more than 85%. Domestic enterprises have achieved independent and controllable supply of API. At present, more than 10 domestic enterprises have obtained the production approval documents for tropicamide API. After the implementation of centralized procurement, the price of related preparations has dropped by 62%, further promoting the increase of clinical medication penetration rate.

The original research enterprise of tropicamide is Japan's Santen Pharmaceutical, with the original brand name "Mydrin-P". The core compound patent expired globally in 2002. At present, the main dosage form of the original marketed product is eye drops, with conventional specifications of 5ml:25mg and 10ml:50mg. This product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, 8 valid A-status tropicamide API registration numbers can be queried on CDE at present, and more than 20 tropicamide eye drop preparations have obtained domestic marketing approval. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of tropicamide impurity reference standards. Most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day. All products comply with multiple regulatory standards such as the Chinese Pharmacopoeia and FDA, and can fully meet the quality control requirements of different scenarios such as API R&D, quality research, and consistency evaluation.