Sibutramine

As an appetite suppressant drug that was once widely used, sibutramine is a serotonin and norepinephrine reuptake inhibitor. By inhibiting the reuptake of these two neurotransmitters by the central nervous system, it enhances satiety, reduces food intake, and increases the basal metabolic rate. It was initially approved for obese patients who cannot effectively lose weight through diet control and exercise intervention. The applicable population includes adult patients with BMI ≥ 30kg/㎡, or BMI ≥ 27kg/㎡ accompanied by weight-related complications such as hypertension, diabetes, and dyslipidemia. Subsequent clinical studies have found that it has significant cardiovascular risks, which can increase the incidence of adverse events such as non-fatal myocardial infarction, stroke, and cardiac arrest. At present, most countries around the world, including China, have stopped its clinical use for weight loss indications, and only some regions have included it in the strict control category of special medical scenarios.

The compliant market size of sibutramine worldwide has shrunk extremely, with the transaction volume of regular pharmaceutical distribution channels being less than 10 million US dollars, showing a year-on-year downward trend. The current market demand is mainly concentrated in the gray industrial chain of illegal addition. According to public monitoring data, about 12%-18% of the illegal weight-loss products sold in the domestic market have the situation of illegal addition of sibutramine, which is a category of illegal addition that is the key target of crackdown by the drug regulatory authorities. On the compliant production side, only a small number of pharmaceutical enterprises retain the production qualification of active pharmaceutical ingredients for special purposes such as law enforcement testing and reference standard preparation, and there is no public information related to generic drug centralized procurement.

The original research enterprise of sibutramine is Abbott, and the original research trade name is Meridia. Its core compound patent in the United States expired in 2021, and the expiration date of its compound patent in China is 2023. The main dosage form approved for the original research is oral capsule, with specifications of 5mg, 10mg and 15mg. It was once included in the FDA Reference Listed Drug Catalog, and later a global withdrawal was initiated in 2010 due to safety issues. At present, there are no approved sibutramine preparation products on the market in China, and there is no API registration number in valid marketing status on the CDE API registration platform. Only reference standards for testing can be circulated in accordance with special regulatory requirements. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sibutramine, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They comply with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of reference standards in scenarios such as drug regulatory testing, drug R&D, and quality control.