Sodium Gualenate

In the long-term management of digestive system diseases, mucosal repair drugs have always been the core medication option for diseases such as inflammatory bowel disease and chronic gastritis. Sodium azulene sulfonate belongs to the sodium azulene sulfonate class of mucosal protective agents, which can directly act on the inflamed mucosa, and exerts its effect through multiple mechanisms including inhibiting histamine release, promoting the regeneration of mucosal epithelial cells, and enhancing the activity of gastric mucosal defense factors. It can be used alone for the treatment of acute and chronic gastritis, gastric ulcer, and duodenal ulcer, and is often formulated into a compound preparation with L-glutamine. The applicable population covers patients at all stages from adult patients with mild gastrointestinal mucosal injury to patients receiving maintenance treatment for ulcerative colitis, and it has a wide range of clinical application scenarios.

The global market size of digestive system mucosal protective agents exceeded USD 12 billion in 2023, of which compound glutamine drugs account for approximately 11%, with a compound annual growth rate of 4.7% in the past five years. In terms of the domestic market, preparations related to sodium azulene sulfonate have long been in a stage of steady growth in clinical demand. At present, they have been included in the local medical insurance catalogs of multiple provinces, and there are more than 15 manufacturers of generic preparations. Previously, the upstream supply of active pharmaceutical ingredients (APIs) was highly dependent on imports. With the advancement of the domestic generic drug consistency evaluation, the demand for domestic API substitution continues to rise, and the market gap has been close to 30 tons per year in 2024.

The original research enterprise of sodium azulene sulfonate is Kotobuki Pharmaceutical Co., Ltd. of Japan, and the original brand name is Marzulene (a compound preparation with L-glutamine). The core compound patent expired in Japan, European and American markets in 2015, and the compound patent in China expired in 2016. The originally marketed dosage form is mainly granules, with the specification that each bag contains 2 mg of sodium azulene sulfonate and 660 mg of L-glutamine. This compound preparation has been included in the Reference Listed Drugs of the China Listed Drug Catalog. As of now, no domestic enterprise has submitted a marketing registration number for sodium azulene sulfonate on the CDE API registration platform, and all sodium azulene sulfonate-containing preparations approved for marketing in China are domestic generic drugs that have passed the consistency evaluation. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sodium azulene sulfonate, most of which 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 regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the full-process needs of API research and development, quality research and consistency evaluation.