Allantoin

Impaired skin barrier is the common pathological basis of multiple skin diseases, ranging from daily dryness and desquamation, mild sunburn to atopic dermatitis and refractory ulcer wounds. The clinical management of such conditions always requires a balance between mildness and repair efficiency. Allantoin is an imidazolidine skin protectant, which can achieve wound repair by promoting epithelial cell proliferation and accelerating granulation tissue formation. Meanwhile, it can inhibit the release of inflammatory factors, enhance the hydration capacity of the stratum corneum, and relieve uncomfortable symptoms such as skin itching and burning. In addition to dermatological medications, it is also widely used in compound preparations for mucosal protection, suitable for skin-sensitive populations such as children and the elderly, and can also be used as an auxiliary component in the combined treatment of chronic wounds.

The current global market size of allantoin active pharmaceutical ingredients (APIs) is approximately USD 180 million, with a compound annual growth rate maintained at around 4.2%. The demand growth mainly comes from three tracks: over-the-counter dermatological drugs, pharmaceutical excipients and functional skincare products. China is the core global supplier of allantoin, with its production capacity accounting for more than 65% of the global total. The industry concentration is relatively high, and the combined market share of the top 3 enterprises exceeds 40%. Due to mature preparation processes and no core patent restrictions, the domestic price of allantoin APIs has remained stable for a long time. In the past three years, the fluctuation of the bid prices of allantoin-containing compound preparations involved in centralized procurement has not exceeded 10%, and the upstream supply system is very complete.

Allantoin is a general-purpose pharmaceutical raw material, with no clear originator enterprise or exclusive trade name, and all relevant compound patents have expired. At present, the domestically approved allantoin single-agent preparations are mainly creams, with common specifications of 10g:0.1g and 20g:0.2g. A number of products have been included in the National Essential Medicines List, and have also been included by the FDA as OTC skin protectant reference listed drugs. As of now, there are 12 allantoin API registration entries on the CDE API Registration Platform, of which 8 are in Status A, which can be directly associated with preparation applications, and another 3 registration numbers in Status I are under the review stage. The cumulative number of marketed allantoin-containing preparation varieties in China exceeds 30. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for allantoin APIs. Most products support spot supply, and spot orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in API quality research, preparation declaration and routine production quality control.