Sodium aminosalicylate

The complexity of clinical treatment regimens for multidrug-resistant tuberculosis has always been a difficulty that urgently needs to be broken through in the field of public health, and sodium aminosalicylate is precisely an indispensable second-line anti-tuberculosis drug in such combined treatment regimens. As a salicylic acid derivative, it competitively inhibits the p-aminobenzoic acid synthesis process of Mycobacterium tuberculosis and interferes with its folic acid metabolism, thereby specifically inhibiting the proliferation of mycobacteria. It is often clinically used in combination with first-line anti-tuberculosis drugs such as isoniazid and streptomycin, mainly for the treatment of pulmonary tuberculosis and extrapulmonary tuberculosis patients who are resistant to first-line drugs, and can also be used for adjuvant treatment of tuberculous meningitis, which can effectively reduce the transmission risk of drug-resistant strains.

At present, the global stock of multidrug-resistant tuberculosis patients exceeds 500,000 cases, and China is one of the countries with a high burden of multidrug-resistant tuberculosis, with about 65,000 new cases annually, driving the market demand for sodium aminosalicylate to remain stable at an annual supply scale of more than one ton. The patent of this drug has been in the public domain for many years. The domestic supply of API is mainly dominated by local enterprises, the overall market competition pattern is relatively scattered, and there is no absolute monopoly manufacturer. At the same time, this drug has been included in the National Essential Drug List, the demand coverage of primary medical institutions continues to increase, and the requirements for supply chain stability are further improved.

The original research enterprise of sodium aminosalicylate is Takeda Pharmaceutical Company Limited of Japan, with the original trade name PAS-Na, and the core compound patent expired as early as before 1950. At present, the commonly used clinical dosage forms include oral tablets, enteric-coated capsules and injections, with common specifications of 0.5g/tablet and 2g/ampoule. Its oral immediate-release dosage forms and injections have all been included in the Chinese Catalog of Reference Preparations for Chemical Drugs. At present, the sodium aminosalicylate APIs of a number of domestic enterprises have obtained Class A status through CDE registration, and multiple domestic varieties of the corresponding oral preparations and injections have been approved for marketing. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for sodium aminosalicylate API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for relevant pharmaceutical enterprises in API quality research and consistency evaluation work.