Glutathione

The continuous rise in diagnosis and treatment needs related to metabolic diseases and oxidative damage has increasingly highlighted the clinical value of endogenous antioxidant active substances. Glutathione is a tripeptide antioxidant API, which binds harmful substances such as free radicals and heavy metals in the body through sulfhydryl groups to maintain cellular redox homeostasis. Meanwhile, it participates in the tricarboxylic acid cycle and glucose metabolism processes to provide energy support for cells. It is widely used in clinical adjuvant treatment of liver injury, detoxification during radiotherapy and chemotherapy, and prevention and control of oxidative damage to the ocular lens. It can also assist in improving skin pigmentation problems, and the applicable population covers patients with chronic liver disease, people receiving tumor radiotherapy and chemotherapy, elderly groups with high incidence of cataracts and people with medical cosmetology needs.

The global market size of glutathione API has exceeded USD 380 million in 2023, with a compound annual growth rate maintained at around 7.2%. The demand growth mainly comes from three downstream fields: liver disease treatment, dietary supplements and cosmetic raw materials. China is the world's largest producer and exporter of glutathione API, with its production capacity accounting for more than 80% of the global total production capacity. The concentration of leading manufacturers is relatively high, with the top three enterprises together accounting for nearly 65% of the domestic market share. With the upgrading of pharmacopoeia standards and the improvement of downstream compliance requirements, small and medium-sized production capacities are being accelerated to be cleared out.

The original research enterprise of this variety is Kyowa Hakko Kirin Co., Ltd. of Japan, with the original research trade name "Atomolan". The core compound patent expired globally in 2010. The main dosage forms of the original drug include injections (0.6g, 1.2g, 1.5g) and oral tablets (0.1g), which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and also included in the FDA Reference Preparation Catalogue. Up to now, there are more than 30 glutathione API registration numbers on the API Registration Platform of China CDE, among which more than 20 are in A status. Multiple domestic manufacturers have obtained approval for the marketing of glutathione for injection and glutathione tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a complete set of impurity reference standards for glutathione API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable impurity research support for API manufacturers and preparation R&D institutions.