Alanyl Glutamine

In the metabolic support therapy for critically ill patients, glutamine, as the core nutritional substrate for intestinal mucosal barrier repair, has long been limited in application due to the clinical pain point of poor water solubility that prevents direct intravenous administration. Alanyl glutamine is an enteral nutrition amino acid derivative, which can be rapidly decomposed into glutamine and alanine after entering the human body. It not only solves the problem of instability of glutamine aqueous solution, but also supplements essential nutrition for patients in a state of high catabolism. Its indications mainly include patients receiving parenteral nutrition who have gastrointestinal mucosal injury caused by severe surgery, trauma, infection, radiotherapy and chemotherapy. It is an important component of clinical nutrition support regimens.

At present, the global market size of alanyl glutamine is approximately USD 780 million, of which the Chinese market accounts for nearly 42%, and the compound growth rate in the past three years has remained at 8.2%. The growth momentum mainly comes from the expansion of intensive care unit beds and the improvement of the standardization of tumor nutrition therapy. The competition landscape is characterized by the dominance of generic drugs. Nearly 30 domestic enterprises have obtained preparation approvals, the localization rate of active pharmaceutical ingredients (APIs) exceeds 90%, and the production cost is more than 60% lower than that of imported original research products. Driven by the volume-based procurement policy, the terminal price of preparations has dropped by more than 75%, further expanding the coverage in primary medical institutions.

The original research enterprise is Fresenius Kabi, with the brand name Dipeptiven®. Its core compound patent expired in China as early as 2007, and the core patents in the European and US markets expired in 2008 and 2009 respectively. The dosage form approved for the original research product is injection, with common specifications of 50ml:10g and 100ml:20g. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by China's NMPA, and is also listed in the FDA Reference Preparation Catalogue. At present, more than 20 domestic enterprises have obtained A status for their alanyl glutamine APIs through CDE registration, and both imported and domestic preparation products have been approved and marketed for many years. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for alanyl glutamine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the sample requirements of pharmaceutical enterprises in the whole process of quality research, stability study and declaration and registration.