Qilu Pharmaceutical Duloxetine Hydrochloride Enteric-coated Capsules Will Pass Consistency Evaluation

Recently, Qilu Pharmaceutical entered the administrative examination and approval stage with duloxetine hydrochloride enteric-coated capsules for imitation of category 4 applications.

Source: official website of the State Food and Drug Administration

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

Source: Minet database

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.

Application status of consistency evaluation of duloxetine hydrochloride enteric-coated capsules

Source: Meinenet MED2.

At present, 12 companies have submitted supplementary applications for the consistency evaluation of duloxetine hydrochloride enteric-coated capsules or submitted for production under the new classification.

Qilu Pharmaceutical has reported production/approved clinical psychostimulant

Source: Meinenet MED2.

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 have been approved for clinical use.

Source: Minei.