Atropine

In the field of ophthalmic clinical and first-aid medications, atropine, as a classic anticholinergic drug, has a clear mechanism of action and a wide range of application scenarios. It competitively blocks the binding of acetylcholine to M cholinergic receptors, relaxes a variety of smooth muscles, inhibits glandular secretion, dilates pupils, increases intraocular pressure, and induces cycloplegia, while also stimulating the respiratory center. In clinical practice, low-concentration atropine eye drops are currently the only topical medication confirmed by evidence-based medicine to delay the progression of myopia in children, while high-concentration atropine is widely used in scenarios such as first aid for organophosphorus poisoning, treatment of iridocyclitis, and mydriasis before ophthalmic surgery, covering multiple groups of people including children and adolescents in the myopia prevention and control group, patients receiving emergency and critical care treatment, and patients with ophthalmic diseases.

The global atropine market size has maintained a steady growth trend in recent years. In 2023, the overall market size has exceeded 1.2 billion US dollars, among which the compound annual growth rate in the field of myopia prevention and control exceeds 18%. In terms of the domestic market, with the continuous release of demand for children's myopia prevention and control, the market growth rate of atropine-related preparations is significantly higher than the global average. In 2023, the total scale of hospital preparations and compliant marketed varieties has reached nearly 1.5 billion yuan. In the current competitive landscape, domestic generic drugs occupy most of the market for grassroots first-aid and routine ophthalmic medications. Myopia prevention and control preparations are currently dominated by hospital preparations, and there is no officially approved low-concentration atropine marketed variety, so the relevant R&D track is highly competitive.

The original research enterprise of atropine is Abbott Laboratories, and the original research trade name is Isopto Atropine. The compound patent in the US market expired in 1973. The main dosage forms of the original research include injections of 0.5mg/ml and 1mg/ml, as well as eye drops and eye ointments of 0.5% and 1%, which have been included in the FDA Reference Listed Drug Catalog and also included in the *China Catalog of Chemical Drugs*. At present, more than 30 domestic enterprises have obtained CDE registration numbers (status A) for atropine API, and multiple dosage forms such as atropine injection, eye ointment and eye drops have been approved for marketing as domestic generic drugs. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for atropine API, covering the reference materials required for the whole research path including synthesis process impurities and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the research needs of various links such as API R&D, quality research, and compliant declaration.