Cyclopentolate

In the clinical scenarios of mydriatic optometry and fundus examination, anticholinergic ciliary muscle paralytic drugs are core medications to ensure the accuracy of examinations. As a representative variety among such drugs, cyclopentolate achieves the dual effects of rapid mydriasis and cycloplegia by blocking the response of the iris sphincter and ciliary muscle to acetylcholine. Compared with traditional atropine and tropicamide, it has a shorter onset time (usually reaching the maximum effect in 20 to 30 minutes) and a faster recovery rate (accommodation function basically recovers in 6 to 24 hours). It is the preferred short-acting mydriatic drug for children's refractive error screening and adult fundus lesion examination, especially suitable for patient groups who need to complete the examination quickly and are unwilling to suffer from long-term blurred vision.

The global market size of cyclopentolate preparations has maintained steady growth in recent years. In 2023, the market size was approximately USD 130 million, with a compound annual growth rate of around 4.2%. The growth momentum mainly comes from the increased penetration rate of children's ophthalmic screening and the expanded demand for middle-aged and elderly people's fundus examination. In terms of the domestic market, the currently approved and marketed cyclopentolate preparations are dominated by imported original research products and a small number of domestic generic drugs, and the supply of active pharmaceutical ingredients (APIs) has been in a relatively tight state for a long time. In the past three years, the annual growth rate of the sales volume of cyclopentolate eye drops at the terminal of domestic public medical institutions has exceeded 12%, and the unmet clinical demand has promoted the continuous expansion of the market space of upstream APIs and related supporting consumables.

The original research enterprise of cyclopentolate is Novartis, and the original research brand name is "Cyclogyl". Its core compound patent in the US market expired in 1999. At present, the main dosage form approved for the original research product is eye drops, with conventional specifications of 0.5% and 1%. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. According to the information on the domestic API registration platform, there is currently no Class A registration number of cyclopentolate API submitted by domestic enterprises, and only the original research-related API holds an overseas DMF number. The domestic approved and marketed preparations are dominated by the original research imported cyclopentolate eye drops, and the number of approved domestic generic preparations is small. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for cyclopentolate API, covering all categories such as synthesis process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet various test needs of API R&D, quality research and generic drug consistency evaluation.