Citalopram

Depression is a mental disease with a high global burden. Selective serotonin reuptake inhibitors (SSRIs) are the first-line medication regimen in clinical treatment, and citalopram is a variety with outstanding tolerance performance in this category. Its mechanism of action is to highly selectively inhibit the reuptake of serotonin by the presynaptic membrane, prolong and enhance the pharmacological effect of serotonin, thereby exerting an antidepressant effect. It has minimal impact on receptors such as norepinephrine and dopamine. Compared with traditional tricyclic antidepressants, it has a lower risk of cardiovascular adverse reactions. This drug is suitable for the treatment of various types of depression and panic disorder, and is especially suitable for long-term use in elderly depressed patients with underlying diseases.

At present, the global market size of antidepressants has exceeded 15 billion US dollars, of which SSRIs account for nearly 40%. As a mature variety, although citalopram has entered the middle and late stages of its product life cycle, its global annual sales are still stable at around 700 million US dollars. In terms of the domestic market, the overall size of citalopram preparations is about 1.2 billion yuan, with a compound annual growth rate maintained at around 4%. At present, generic drugs from more than 20 enterprises have been approved for marketing, of which 7 specifications have passed the consistency evaluation. The average price reduction in provincial centralized procurement exceeds 60%, and the accessibility at the primary level has been greatly improved.

The original research enterprise of citalopram is Lundbeck Pharma from Denmark, and the original trade name is "Cipramil". Its core compound patent expired globally in 2003, and the compound patent in China also terminated in 2003. The original marketed dosage form is tablets, with specifications of 20mg and 40mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. Up to now, there are 32 citalopram API registration information on the API registration platform of China CDE, of which 20 are in the status of "A" (already used in marketed preparations). A number of domestic enterprises have obtained approval for the marketing of citalopram tablets and citalopram oral solutions. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of citalopram quality research and production quality control, CATO can provide a full set of impurity reference standards for this API, covering all categories of research needs such as synthetic process impurities and degradation impurities. Most of the products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support impurity qualitative and quantitative research as well as consistency evaluation declaration work.