Haiscode Fatty Milk Amino Acid (17) Glucose (11%) Injection Approved for Market

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

Basic situation of drugs

Drug name: Fatty Emulsion Amino Acid (17) Glucose (11%) Injection

Acceptance number: CYHB2007289

Certificate Number: 2021B02081

Drug approval number: National Medicine Standard H20217055

Dosage form: injection

Specification: 900ml [fat emulsion injection (20%) 159ml; compound amino acid injection (17) 188ml; glucose injection (11%) 553ml]

Application items: supplementary application-adding drug specifications, etc.

Registration Classification: Chemicals

Evaluation conclusion: According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, this product meets the relevant requirements of drug registration, and it is approved to increase this product by 900ml [fat emulsion injection (20%) 159ml; compound amino acid injection ( 17) 188ml; glucose injection (11%) 553ml] specifications, approved drug approval number

It is reported that the company’s fat milk amino acid (17) glucose (11%) injection was approved by the National Medical Products Administration in March 2018.

In September 2020, the company submitted a supplementary application for increasing specifications to the Drug Evaluation Center of the National Medical Products Administration and was accepted.

The 900ml specification added this time is an effective supplement to the existing 1440ml specification of this product and can meet the clinical needs for small-sized three-chamber bag parenteral nutrition products

According to data from Minai.