Tafluprost

Glaucoma is the world's leading irreversible blinding eye disease, and most patients have the typical characteristic of elevated intraocular pressure. The core goal of clinical treatment is to control intraocular pressure stably for a long time to delay optic nerve damage. Tafluprost is a prostaglandin F2α analog, which increases the outflow of aqueous humor through the uveoscleral pathway by activating FP receptors. Compared with traditional intraocular pressure lowering drugs, it has a stronger hypotensive effect, longer duration of action, and lower incidence of adverse reactions such as ocular irritation. At present, it is the first-line local treatment drug for patients with primary open-angle glaucoma and ocular hypertension, and can also be used in combination therapy scenarios where other hypotensive drugs have poor efficacy.

The global market size of anti-glaucoma drugs has maintained steady growth in recent years. In 2023, the overall market size was approximately USD 7.8 billion, of which prostaglandin analogs accounted for more than 45%. Tafluprost, with its advantage of medication compliance, has a growth rate significantly higher than the average level of the category. In terms of the domestic market, tafluprost eye drops have been included in the National Medical Insurance Catalog. In 2023, the domestic hospital sales volume exceeded RMB 1.2 billion, with a compound annual growth rate of 22% in the past three years. At present, the original research products still account for more than 65% of the domestic preparation market. With the successive approval of generic drugs, market competition has gradually intensified, and the demand for upstream API has continued to rise.

The original research enterprise of tafluprost is Santen Pharmaceutical of Japan, and the original trade name is Tapros. The expiration date of its core compound patent in major markets such as Japan and the United States is 2027, and the Chinese compound patent expired in 2023. The main dosage form approved by the original research is eye drops, with a specification of 0.0015% (2.5ml:37.5μg). This dosage form has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and also included in the FDA Reference Preparations Catalogue. Up to now, the tafluprost APIs of a number of domestic enterprises have obtained A status through CDE registration, and the tafluprost generic preparations of more than ten other enterprises have been approved for marketing. (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 tafluprost API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the needs of pharmaceutical enterprises for impurity reference standards in all links of drug research and development, quality research and production quality control.