Recently, Qilu Pharmaceutical entered the administrative examination and approval stage with duloxetine hydrochloride enteric-coated capsules for imitation of category 4 applications. Duloxetine is an antidepressant with a total sales of 1.2 billion yuan in China's public medical institutions and physical pharmacies in cities in China in 2019. According to data from Minai.com, there are currently 4 psychostimulants in Qilu that have been reported for production/approved for clinical use.
Duloxetine is a selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor developed by Eli Lilly and is mainly used clinically to treat depression.
Sales of duloxetine in Chinese public medical institutions and physical pharmacies in cities in China
According to data from Meinenet, in recent years, duloxetine's domestic market scale has continued to expand, and the growth rate has remained at double digits. In 2019, China's urban public hospitals, county-level public hospitals, urban community centers, township health centers (Chinese public medical institutions), and China's urban physical pharmacies totaled 1.2 billion yuan in sales, of which capsules accounted for more than 50%.
The application status of consistency evaluation of duloxetine hydrochloride enteric-coated capsules
At present, 12 companies have submitted supplementary applications for the consistency evaluation of duloxetine hydrochloride enteric-coated capsules or submitted them for production under the new classification. The products of 6 companies have passed or are deemed to have passed the consistency evaluation, and Qilu Pharmaceutical's products have entered the administrative approval stage.
Qilu Pharmaceutical has reported production/approved clinical psych stimulant
In the field of psychostimulants, in addition to duloxetine hydrochloride enteric-coated capsules, Qilu Pharmaceutical has also applied for listing of one type 3 generic drug, one type 2 modified new drug, and two new drugs that have been approved for clinical use.
Source: Minei.com database, the official website of the State Food and Drug Administration
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