Bupropion

In the clinical treatment of mental disorders, the selection of antidepressants has always centered on the balance between efficacy and safety. As a core variety of atypical antidepressants, bupropion belongs to aminoketone derivatives, and its mechanism of action is different from that of traditional SSRI drugs. It exerts effects by inhibiting the reuptake of dopamine and norepinephrine, while having minimal impact on the reuptake of 5-hydroxytryptamine. It can not only effectively improve the core symptoms of depression, but also reduce common adverse reactions of antidepressants such as sexual dysfunction and weight gain. In addition to monotherapy or combination therapy for adult depression, it is also approved for the prevention of seasonal affective disorder and as an adjuvant smoking cessation therapy for nicotine addiction, especially suitable for patient groups who are intolerant to the adverse reactions of SSRI drugs.

The global bupropion market size has maintained steady growth in recent years. In 2023, the overall market size exceeded 1.8 billion US dollars, with generic drugs accounting for more than 90%. In the Chinese market, the terminal sales of public medical institutions exceeded 1.2 billion yuan in 2023, with a compound annual growth rate remaining at around 8%. In terms of the domestic competitive landscape, more than 10 enterprises have been approved for bupropion preparations at present, among which sustained-release dosage forms are the mainstream in the market, accounting for more than 75%. After the implementation of centralized procurement, the price of preparations has dropped by more than 60%, driving the continuous increase in demand for upstream API. At present, the domestic API supply is dominated by local enterprises, with imported API accounting for less than 10%.

The original developer of bupropion is GlaxoSmithKline, with the original brand name Wellbutrin. It was first approved in the United States in 1985. The patent of the original sustained-release dosage form expired around 2008, and the compound patent expired even earlier in 2001. In terms of dosage forms, the original approved products include conventional tablets and sustained-release tablets, with common specifications of 75mg, 150mg and 300mg. This variety has been included in the FDA Reference Listed Drug Catalogue, and the reference listed drug marketed in China is the 150mg sustained-release tablet of GlaxoSmithKline. At present, there are more than 15 registration entries of bupropion API on China's CDE API Registration Platform, most of which are in A status, and multiple varieties of bupropion sustained-release tablets and conventional tablets have been approved for marketing in China. (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 bupropion API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products comply with multiple regulations including Chinese Pharmacopoeia and FDA, which can fully meet the multi-scenario needs of API enterprises such as quality research, stability study and registration declaration, and provide reliable support for quality control throughout the product life cycle.