文拉法辛

The global prevalence of depression has continued to rise in recent years, and drugs with both antidepressant and anxiolytic effects have long been a clinical rigid demand in clinical treatment. Venlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) class of antidepressant. It increases the concentration of the two neurotransmitters in the synaptic cleft by simultaneously inhibiting their reuptake. Compared with traditional single-channel antidepressants, it has a faster onset of action, and has definite efficacy in patients with severe depression, depression accompanied by anxiety symptoms, and people with generalized anxiety disorder. It can also be used for the treatment of social anxiety disorder and panic disorder in adults, and is a first-line recommended drug for the full-course treatment of depressive disorders at present.

In 2023, the domestic market size of antidepressants has exceeded 11 billion yuan, among which SNRI drugs account for more than 35% of the market. As a classic variety of SNRI class, venlafaxine maintains a stable annual growth rate of around 8%. At present, generic drugs account for more than 90% of the domestic market, and more than 20 enterprises have obtained the approval documents for venlafaxine preparations. Venlafaxine extended-release capsules were included in the fifth batch of national centralized drug procurement, with an average price reduction of more than 70% for winning bids. While the accessibility at the primary level has been greatly improved, it has also driven the continuous increase in the demand for upstream active pharmaceutical ingredients.

The original research enterprise of venlafaxine is Pfizer, and the original research trade name is "Effexor". The expiration date of its core compound patent in the United States is 2008, and the core compound patent in China expired in 2006. The mainstream dosage forms of the original research include venlafaxine hydrochloride extended-release capsules (75mg, 150mg) and conventional tablets (25mg, 50mg). The original research extended-release capsules have been included in the Catalogue of Listed Drugs in China as reference preparations, and are also listed in the FDA Reference Preparations Catalogue. Up to now, there are nearly 30 registration numbers of venlafaxine hydrochloride on the API registration platform of China CDE, among which more than 20 are in A status. Dozens of venlafaxine preparation varieties have been approved for marketing in China, covering multiple dosage forms such as extended-release capsules, extended-release tablets and conventional tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

For the needs of pharmaceutical research and quality control related to venlafaxine, CATO provides a full set of impurity reference standards for this API. Most of the products support spot supply, and spot products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in the whole process of R&D and production scenarios such as registration and declaration, and quality inspection.