Thioctic acid

Diabetic peripheral neuropathy is a common complication caused by long-term hyperglycemia. More than half of diabetic patients with a disease course of over 10 years will develop symptoms such as limb numbness, pain and hypoesthesia, which seriously affect their quality of life. Lipoic acid is a derivative of B vitamins. As a potent antioxidant, it can scavenge free radicals, reduce oxidative stress injury, improve nerve conduction velocity, and enhance glucose utilization efficiency. In clinical practice, it is mainly used to improve paresthesia caused by diabetic peripheral neuropathy, and is also widely used in adjuvant therapy of liver diseases and cardiovascular diseases, as well as antioxidant-related nutritional supplementation scenarios. Its applicable population covers patients with diabetic complications, patients with chronic diseases related to oxidative damage, etc.

The global lipoic acid market size was approximately USD 380 million in 2023, and it is expected to grow at a compound annual growth rate of 5.2% to USD 490 million by 2028. China is the core supplier of lipoic acid API in the world, with its production capacity accounting for more than 90% of the global total production capacity. The industry concentration is relatively high, and the top 3 enterprises account for nearly 70% of the domestic API production capacity. On the preparation side, lipoic acid has been included in the provincial centralized procurement catalogs of multiple provinces at present, with an average price reduction of over 60% for the selected products. Downstream preparation enterprises have a continuously rising demand for APIs with high cost-effectiveness and compliant standards.

The original research enterprise of lipoic acid is Germany's Stada Arzneimittel AG, with the original research trade name of Thiogamma. The core compound patent of lipoic acid expired around 2002 in major markets such as Europe and the United States. The main dosage forms approved for the original research product are injection and oral immediate-release dosage forms, among which the specification of injection is 12ml:300mg, and the specification of oral dosage form is 600mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Listed Drugs for Chemical Drugs* of China. At present, more than 30 domestic enterprises have obtained A status for their lipoic acid APIs through CDE registration, and the approved and marketed preparation varieties cover multiple dosage forms such as injection, tablets and capsules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of lipoic acid impurity reference standards, which comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet various reference standard requirements in the stages of API production, preparation R&D and quality research.