Tazarotene

The recurrent attacks of chronic skin diseases such as psoriasis and acne not only affect the appearance of patients, but also bring long-term psychological burden. For a long time, there has been an urgent clinical need for topical treatment options with both efficacy and safety. Tazarotene is a third-generation polyaromatic retinoid for topical use. It selectively binds to retinoic acid receptor β/γ in the skin, regulates the differentiation and proliferation of keratinocytes, and inhibits the release of inflammatory factors. It can improve the symptoms of erythema and scales in vulgaris psoriasis, and also act on the links of comedones and inflammatory lesions in mild to moderate vulgaris acne. It is one of the core drugs for topical dermatological treatment at present, and its applicable population covers adolescents over 12 years old and adult patients who meet the indications.

The global market size of tazarotene related preparations has maintained steady growth in recent years. The overall size in 2023 is about USD 420 million, with China's market accounting for about 12%, and the annual compound growth rate maintained at about 7%. The growth momentum mainly comes from the increase in the number of patients with acne and psoriasis and the improvement of the clinical penetration rate of topical retinoid drugs. In terms of competitive landscape, the current domestic preparation market is still dominated by original research products and leading generic pharmaceutical enterprises. After the implementation of centralized procurement of topical preparations, cost control and quality compliance of APIs have become the core considerations for generic pharmaceutical enterprises in supply chain layout, and the demand for upstream APIs continues to rise.

The original research enterprise of tazarotene is Leo Pharma of Germany, and the original research trade name is Tazorac®. The core compound patent of tazarotene expired in the United States in 2008, and the compound patent in China has expired. At present, the approved original research dosage forms include gels and creams with concentrations of 0.05% and 0.1%. The relevant dosage forms have been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs*. At present, a number of tazarotene APIs have been approved for marketing and registration on the domestic API registration platform, all with the status of A. Meanwhile, tazarotene gel and cream preparations of many domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full series of tazarotene impurity reference standards, covering all common types such as synthesis process impurities and degradation impurities. Most products have sufficient in-stock inventory, and in-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs of pharmaceutical enterprises in the whole process of API quality research, preparation stability investigation and registration declaration.