Mesalazine

Inflammatory bowel disease (IBD) is a type of chronic intestinal disease with recurrent attacks, and the global patient population has exceeded 10 million. Mesalazine, a 5-aminosalicylic acid anti-inflammatory drug, is currently the first-line drug for the induction and maintenance treatment of mild to moderate ulcerative colitis. Its mechanism of action is to locally act on the colonic mucosa, inhibit the synthesis of inflammatory factors, and scavenge oxygen free radicals, thereby alleviating inflammation of the intestinal mucosa. It is not only suitable for improving the symptoms of active ulcerative colitis, but also can be used for long-term maintenance treatment in the remission period to reduce the risk of disease recurrence, and is a basic therapeutic drug recommended in clinical pathways.

At present, the global mesalazine market size is stable at around US$2.5 billion, with a compound annual growth rate of approximately 3.2%. The growth rate of the Chinese market is higher than the global average, with the compound annual growth rate remaining at around 6%. The market pattern is characterized by the coexistence of original research drugs and generic drugs. There are more than 20 domestic generic drug manufacturers, and oral preparations and suppositories are the mainstream dosage forms. With the implementation of the centralized procurement policy, the price of oral immediate-release dosage forms has dropped by more than 70%, which has greatly improved the accessibility for patients and also driven the continuous rise in the demand for upstream API.

The original research manufacturer of mesalazine is Falk Pharma GmbH in Germany, and the brand name of the original research product is Pentasa. Its core compound patent expired globally in 2007, and the preparation patent in China also expired in 2010. The main dosage forms approved for the original research product include sustained-release tablets, suppositories and enema solutions, among which the common specification of sustained-release tablets is 0.5g, and that of suppositories is 1g. This original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also included in the reference preparation catalogue of the FDA. Up to now, more than 30 Chinese enterprises have obtained A status for their mesalazine API through CDE registration. The domestically approved mesalazine preparation varieties cover all dosage forms such as sustained-release tablets, enteric-coated tablets, suppositories and enemas, which can fully meet the clinical medication needs. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of mesalazine impurity reference standards, which fully cover all categories such as impurities from the synthesis process and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the full-process needs such as API R&D, quality research and compliance declaration.