AVT Sodium Hyaluronate (HA-SHL) Registration Status changed to A!

Recently, our pharmaceutical injection grade sodium hyaluronate HA-SHL helped sodium hyaluronate eye drops pass the consistency evaluation, and the CDE registration status was changed to A status after the preparation association review. Specific information can be queried in the CDE official website - Registration Information of Raw and Auxiliary packages. The screenshot below is the query result.

Kewpie Corporation is one of the world's largest suppliers of HA (sodium hyaluronate), with a century of fermentation process experience. As the only company to produce HA using both extraction and fermentation methods, Kewpie has been providing a steady supply of high quality HA in various fields for 40 years. HA-SHL is an injection grade sodium hyaluronate raw material produced by fermentation, with a molecular weight range of 1.7 to 2.4 million. According to product requirements, customers can choose the appropriate molecular weight.

HA-SHL is suitable for drugs and three types of medical instruments, drugs can be used as raw materials for sodium hyaluronate eye drops, sodium hyaluronate joint cavity injection and other products, medical instruments can be used for surgical anti-adhesion agent, ophthalmic viscoelastic agent.

Kewpy injection grade sodium hyaluronate has been registered in CDE, and 2 of them have completed drug association review and turned into A state. Compared with similar products, Chewbee HA has four advantages: lower internal toxin (0.001EU/mg), lower impurity protein (0.02%), more precise control of molecular weight (± 100,000), more uniform distribution, and less difference between batches.

According to the Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs (Trial) : The modified API is an approved API, and is generally managed in accordance with medium change. Therefore, whether it is A new drug for approval or a change in the API of a drug for approval, HA-SHL in A state (molecular weight 1.7 to 2.4 million) is a very good choice.

AVT can provide long-term stable pharmaceutical injection grade sodium hyaluronate (CDE has been registered), welcome to inquire!