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On the 17th, Kang Enbei announced that recently, the holding subsidiary Jinhua Kangenbei) received the "Notice of Supplementary Drug Application" approved and issued by the State Food and Drug Administration.
Jinhua Kangenbei produced omeprazole sodium for injection (40mg ) Pass the consistency evaluation of the quality and efficacy of generic drugs
.
Omeprazole Sodium for Injection is a category B product in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List" (Yibaofa [2020] No.
53), which is used as an alternative therapy for the following diseases when oral therapy is not applicable: 12 Digital ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome
.
The indications are: peptic ulcer bleeding, anastomotic ulcer bleeding; acute gastric mucosal damage complicated by stress, and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs; it is also often used to prevent severe diseases (such as cerebral hemorrhage, Severe trauma, etc.
At present, a total of 103 domestic companies hold production approvals for omeprazole sodium (40mg) for injection, and 10 of them have passed the consistency evaluation of this product (including Jinhua Kangenbei)
.
According to data from Minai.
As of the disclosure date of this announcement, Jinhua Kangenbei has invested approximately RMB 3,662,200 in research and development costs for the evaluation of the quality and efficacy of the generic drug for the drug
