Duloxetine

The global prevalence of mental illnesses such as depression and generalized anxiety disorder is increasing year by year, and the clinical demand for antidepressants with both good tolerability and multiple indications continues to rise. Duloxetine belongs to the class of serotonin and norepinephrine reuptake inhibitors (SNRIs), which can simultaneously increase the concentrations of these two neurotransmitters in the synaptic cleft and has the dual effects of central analgesia and mood regulation. It is not only used for the treatment of adult depression and generalized anxiety disorder, but also can improve somatic symptoms such as diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain, making it one of the core medications in the current field of combined treatment of psychiatry and pain.

The global duloxetine market has maintained stable growth for a long time. In 2023, the overall market size exceeded 1.8 billion US dollars, and the terminal sales in China's public medical institutions have exceeded 1.5 billion yuan. With the improvement of the diagnosis and treatment rate of mental illnesses and the further promotion of pain indications, it is expected that the domestic market will maintain a compound annual growth rate of about 6% in the next five years. At present, generic drugs account for more than 85% of the domestic market, and duloxetine preparations from nearly 30 enterprises have been approved for marketing. The winning bid price in centralized procurement has dropped by more than 70% compared with the original research drug, further promoting the clinical accessibility of the drug, and the supply demand for upstream API has also continued to expand.

The original research manufacturer of duloxetine is Eli Lilly and Company (US), with the original research trade name "Cymbalta". Its core US compound patent expired in 2013, and its Chinese compound patent expired in 2020. The main dosage forms approved for the original research product include enteric-coated capsules (30mg, 60mg) and enteric-coated tablets (20mg, 30mg, 60mg). The original research enteric-coated preparations have been included in the China Listed Drug Catalogue and are also included in the FDA Reference Listed Drug Catalogue. As of now, there are more than 20 duloxetine API registration numbers on the API registration platform of China's CDE, most of which have obtained A status through joint evaluation and approval with preparations, and multiple domestic enterprises have obtained marketing approval for duloxetine enteric-coated preparations and enteric-coated tablets. (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 duloxetine API, which can cover the whole process of quality research needs from API R&D to registration and declaration. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, which can effectively reduce the impurity research cost and time input of customers.