Sulfasalazine

As a classic immunomodulator with more than half a century of clinical application, sulfasalazine is an azo complex of sulfonamide antibacterial agents and 5-aminosalicylic acid. After oral administration, it is decomposed into 5-aminosalicylic acid and sulfapyridine under the action of intestinal microorganisms. The former exerts an anti-inflammatory effect by inhibiting the synthesis of prostaglandins, while the latter has antibacterial activity and delays the absorption of the former in the intestinal tract. This drug is currently a first-line basic medication for rheumatic immune diseases such as ankylosing spondylitis and rheumatoid arthritis. Meanwhile, it is also recommended by guidelines for the induction of remission and maintenance treatment of mild to moderate ulcerative colitis. The applicable population covers adult patients with chronic inflammatory bowel disease and patients with active rheumatic immune diseases. For some special indications in children, the dosage should be adjusted under the guidance of a doctor.

At present, the global market size of sulfasalazine is approximately USD 320 million, with an annual compound growth rate maintained at around 2.8%. The growth momentum mainly comes from the rising prevalence of inflammatory bowel disease and the release of long-term medication demand for rheumatic immune diseases. In terms of the domestic market, this variety has been included in the National Medical Insurance Class A Catalog, and is also a variety of the third batch of national centralized drug procurement. After winning the bid in the centralized procurement, the price of the preparation has dropped by more than 70%, and the downstream clinical dosage has increased significantly. At present, the annual domestic demand for the API is stable at around 180 tons, and the main suppliers are local generic pharmaceutical enterprises, with a relatively scattered competitive landscape.

The original research enterprise of sulfasalazine is Pfizer, and the original research trade name is Sulfazine. The core compound patent expired globally around 1980. At present, the mainstream dosage forms include oral tablets and suppositories. The common specifications of tablets are 250mg and 500mg. The original research 500mg tablet has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China for the time being. According to the domestic API registration platform, 12 enterprises have obtained A-status registration numbers for sulfasalazine API after approval by the CDE. The corresponding domestically approved preparation varieties include three categories: tablets, suppositories and enteric-coated tablets, with more than 20 manufacturing enterprises. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for sulfasalazine, most of which are in stock. In-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.