Salicylic acid

In the clinical treatment system of dermatology, salicylic acid is a classic active ingredient of the keratolytic category. By dissolving the intercellular binding substances in the stratum corneum, it exerts the effects of loosening and exfoliating excessively accumulated keratin and unclogging blocked hair follicle ducts, and also has the auxiliary effects of broad-spectrum bacteriostasis and anti-inflammation. It is widely used in clinical treatment of skin diseases such as acne vulgaris, seborrheic dermatitis, psoriasis, clavus, and mild superficial fungal infections, covering all applicable groups from children to adults, and is one of the core raw materials for topical skin preparations.

The global market size of salicylic acid API has maintained steady growth in recent years. The market size was approximately USD 420 million in 2023, and is expected to reach USD 580 million by 2028, with a compound annual growth rate of approximately 6.7%. The market competition pattern presents obvious concentration characteristics. China is the core supplier of salicylic acid API in the world, with its production capacity accounting for more than 70% of the global total production capacity. The products of leading domestic manufacturers cover multiple application scenarios such as medicinal, cosmetic, and industrial grades. In addition to meeting the demand of domestic preparation production, more than 40% of the output is exported to markets such as Europe, America, and Southeast Asia, making China the core support of the global salicylic acid supply chain.

As a classic medicinal raw material, salicylic acid has no clear single original research enterprise. At present, the domestically approved and marketed salicylic acid preparations cover a variety of dosage forms such as cream, ointment, lotion, patch, and solution, among which salicylic acid ointment, salicylic acid and phenol patch, etc. have been included in the National Medical Insurance Catalog. As of October 2024, there are 17 registration entries of salicylic acid API on the CDE API Registration Platform, among which 8 are in status A, which can be directly used for domestic preparation declaration by association. The salicylic acid DMFs of multiple domestic enterprises have obtained certifications from international regulatory authorities such as FDA and EDQM. (Data is as of October 2024, please refer to the official CDE website for the latest information)

In response to the demand for salicylic acid-related impurity research and quality control, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios such as R&D declaration and daily quality testing of preparation enterprises.