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Registered Three DMFs for Sodium Hyaluronate

2012.05.07

Registered Three DMFs for Sodium Hyaluronate

Sodium hyaluronate (code name: HA-EP1.8and HA-EP3.0), which is from fermentation, and is intended for themanufacture of intra-ocular preparations or intra-articular preparations, has respectively acquired the Type II Drug Master File registration number #024507 & #024508, issued by US FDA in December 20, 2010. HA-EP0.5 which is intended for the manufacture of oral preparations, had acquired the Type II Drug Master File registration number #026039 in May7,2012.

About DMF:

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder.

DMFs are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND (Investigational New Drug Application), NDA(New Drug Application), or ANDA(Abbreviated New Drug Application) directly rather than establishing a new DMF.
For detailed introduction about DMF please refer to US FDA website

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