Securities code: 000597 securities abbreviation: Northeast Pharmaceutical Group Co.Ltd(000597) Announcement No.: 2022-009
Northeast Pharmaceutical Group Co.Ltd(000597)
Announcement on subsidiary obtaining drug registration certificate
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records
Misleading statements or material omissions.
Recently, Northeast Pharmaceutical Group Co.Ltd(000597) (hereinafter referred to as “the company”) is a wholly-owned subsidiary of Northeast China
Shenyang No.1 Pharmaceutical Co., Ltd. (hereinafter referred to as “No.1 pharmaceutical”) of China Pharmaceutical Group received the notice of the State Drug Administration
The drug registration certificate approved and issued by the bureau is hereby announced as follows:
1、 Basic information of registration certificate
Generic name of drug: carboprost tromethamine injection
Drug name
English name / Latin name: carboproject tromethamine injection
Main ingredients: carboprost aminobutanol
Application items of dosage form injection drug registration (domestic production)
Specification 1ml: 250 μ G (calculated by carboprost) registered classification chemical drugs 4 categories
Drug registration Standard No.: ybh17152021 drug validity period: 36 months
Package specification: 10 pieces / box of prescription drugs / over-the-counter drugs
Name: Northeast Pharmaceutical Group Co.Ltd(000597) Group Shenyang first pharmaceutical Co., Ltd
Listing Permit Holder
Address: No. 8, Kunming Lake Street, Shenyang Economic and Technological Development Zone
Name: Northeast Pharmaceutical Group Co.Ltd(000597) Group Shenyang first pharmaceutical Co., Ltd
manufacturing enterprise
Address: No. 8, Kunming Lake Street, Shenyang Economic and Technological Development Zone
Drug approval No.: gyzz h20223039 drug approval No.: valid until January 29, 2027
2、 Other relevant information of drugs
Carboprost tromethamine injection was prepared by Pfizer
It is developed and first listed. Its trade name is hemabate (xinmupei), which is mainly applicable to 13 days of pregnancy
Postpartum hemorrhage caused by abortion from weeks to 20 weeks and uterine contraction relaxation ineffective by conventional treatment.
3、 Impact on the company
The company is the first manufacturer of carboprost aminobutriol API approved by CDE in China. This time, it obtained the drug registration certificate of carboprost aminobutriol injection, which enriched the company’s product pipeline in the field of Gynecology, further consolidated the company’s industrial chain advantage in the integration of raw materials and preparations, and was conducive to improving the company’s market competitiveness, Its listing and sales will have a positive impact on the improvement of the company’s future performance.
As the production and sales of drugs are affected by factors such as changes in the market environment, there is a certain degree of uncertainty. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Northeast Pharmaceutical Group Co.Ltd(000597) board of directors February 18, 2022
