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Haisco Compound Amino Acid Injection (18AA-Ⅶ) passed the consistency evaluation of generic drugs

 Last Update: 2021-08-02
 Source: Internet
 Author: User

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On July 21, Haisco issued an announcement stating that its wholly-owned subsidiary, Liaoning Haisco Pharmaceutical Co.

Basic situation of drugs

Drug name: Compound Amino Acid Injection (18AA-Ⅶ)

Acceptance number: CYHB2050315

Notification number: 2021B02260

Drug approval number: National Medicine Standard H20103264

Dosage form: injection

Specification: 200ml: 20.

Application matter: Evaluation of consistency of quality and efficacy of generic drugs

Registration Classification: Chemicals

Review conclusions: According to the "Drug Administration Law of the People's Republic of China", "Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No.

It is reported that the compound amino acid injection (18AA-Ⅶ) developed by the company obtained a drug registration approval document issued by the State Drug Administration (batch number: 2010S00702) in June 2010

Compound amino acid injection (18AA-Ⅶ) is used to supplement the energy and nutrients required for the body's daily physiological functions

The company's compound amino acid injection (18AA-Ⅶ) approved this time through the consistency evaluation has two packaging forms, which are packaged in a soda lime glass infusion bottle and packaged in a three-layer co-extruded infusion bag with an external barrier bag

The company carried out the consistency evaluation study of compound amino acid injection (18AA-Ⅶ), and the selected reference preparation was "Aminic® Infusion (Japanese)/AMINIC® (English)" which was marketed by the original research institute in Japan.

The company is the first domestic company to pass the consistency evaluation of the quality and efficacy of generic drugs for compound amino acid injection (18AA-VII)

According to data from Meinenet, the sales of compound amino acid injection (18AA-VII) in urban public and county-level public hospitals in 2020 will be approximately RMB 793 million

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