Tretinoin

In the fields of dermatology and oncology treatment, tretinoin is the core representative of retinoid drugs. It regulates gene expression by binding to intracellular retinoic acid receptors. On the one hand, it can regulate the proliferation and differentiation of epidermal cells, inhibit the activity of sebaceous glands, and reduce melanin production; on the other hand, it can induce the differentiation and apoptosis of tumor cells and inhibit the proliferation of malignant cells. In clinical practice, topical dosage forms are widely used in the treatment of acne vulgaris, psoriasis, ichthyosis and keratosis abnormality skin diseases, while oral dosage forms have become the first-line induction therapy for acute promyelocytic leukemia (APL), covering a huge clinical demand group ranging from patients with common skin diseases to patients with hematological tumors.

The global market size of tretinoin preparations was approximately USD 1.87 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at 4.2%. The growth drivers mainly come from the rising prevalence of skin diseases such as acne, the popularization of hematological tumor treatment regimens, and the demand for off-label use related to anti-aging in the medical aesthetic field. In the domestic market, generic drugs dominate. Topical preparations have been included in multiple batches of local centralized procurement, and the winning bid prices are 40%-60% lower than those of the original research drugs. The upstream API supply is concentrated in pharmaceutical enterprises in China and India. At present, more than 10 domestic enterprises have obtained production approvals for tretinoin APIs, with sufficient production capacity to meet the needs of downstream preparations and exports.

The original research enterprise of tretinoin is Roche, with the original trade name "Tretinoin". The global patent of the original oral preparation expired in 2008, and the core patent of the topical preparation expired even earlier before 2000. The original marketed dosage forms include 10mg oral capsules, as well as topical creams/gels with concentrations of 0.025%, 0.05% and 0.1%. Among them, multiple dosage forms have been included in the FDA Reference Listed Drug Catalog, and relevant original research products and generic preparations that have passed the consistency evaluation have also been included in the *Catalog of Reference Listed Drugs for Chemical Drugs* in China. At present, there are 8 registration entries of tretinoin APIs on the domestic CDE API registration platform, 5 of which are in "A" status and can be used for associated review. The number of domestic approved oral and topical tretinoin preparation varieties has exceeded 30. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs related to tretinoin, CATO provides a full set of impurity reference standards for this API, which can fully cover all scenario-based quality control needs such as related substance inspection and content determination. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support pharmaceutical enterprises in preparation R&D, consistency evaluation and daily production quality inspection.