Benfotiamine

Diabetic peripheral neuropathy is a common complication caused by long-term hyperglycemia, and more than half of diabetic patients will develop symptoms such as limb numbness, pain and hypoesthesia, which seriously affect their quality of life. Benfotiamine, as a derivative of fat-soluble vitamin B1, belongs to the neurotrophic active pharmaceutical ingredients. Its mechanism of action breaks through the absorption limitation of ordinary water-soluble vitamin B1. It can be efficiently absorbed by the human body through passive diffusion, and rapidly converted into biologically active thiamine pyrophosphate in cells, reducing the production of advanced glycation end products and improving the energy metabolism and conduction function of nerve tissues. It is mainly used clinically for the treatment of diabetic peripheral neuropathy, and can also be used for the adjuvant treatment of nervous system diseases such as polyneuritis and Wernicke's encephalopathy related to vitamin B1 deficiency. The applicable population covers patients with diabetic neurological complications of various disease courses and people with vitamin B1 absorption disorders.

At present, the global market size of benfotiamine is approximately USD 230 million, with a compound annual growth rate maintained at around 5.8%. The core growth drivers come from the continuous rise in the global prevalence of diabetes and the increasing demand for the management of neuropathy complications. China is the main producer of benfotiamine API in the world, with its production capacity accounting for more than 65% of the total global production capacity. The domestic market size has exceeded RMB 320 million, among which the supply of generic drug-related raw materials dominates. The approved oral preparations have been included in the local medical insurance catalogs of some provinces, and the clinical application penetration rate is increasing year by year.

The original research enterprise of benfotiamine is Takeda Pharmaceutical Company Limited of Japan, and the original brand name is Benfotiamine. Its core compound patent expired in the 1980s. At present, the main dosage forms approved for the original research are tablets, with specifications including 50mg and 100mg. The original research tablet of this product has been listed as a reference preparation in the Japanese Orange Book, and is also included in the Reference Listed Drug Catalogue by the FDA. According to the domestic API registration database, nearly 20 enterprises have obtained A-status registration numbers for their benfotiamine APIs. The approved preparations on the market are mainly oral tablets, and there is no approval record for imported original research preparations. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of benfotiamine impurity reference standards, which can meet the qualitative and quantitative requirements of impurities under different production processes. The products also meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are available from stock. Spot orders submitted before 16:00 can be shipped on the same day, which can quickly respond to the reference standard requirements of API enterprises in the whole process of R&D, registration and production.