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EMBO CAPS® by Suheung receives China DMF Number for Gelatin


EmboCaps® by Suheung announces today that the China DMF filing for Empty Hard Gelatin Capsule(F20190000400) successfully completed on December 30, 2019

According to the new CFDA regulations, “Announcement of the CFDA on Adjusting the Review and Approval Matters of the Drug Substance, Excipients and Packaging Materials No. 146, 2017” released on November 30, 2017; the Drug Substance, Excipients and Packaging Materials (hereinafter referred to as Excipient) are required to be reviewed and approved at the same time as approving the registration application of the drug product. As of November, 23 2017, Excipient manufacturers need to submit filing dossiers to CFDA to be approved by CFDA in order to receive a "The DMF filing acceptance notice”, also known as “Pre-assignment DMF Number”.

After receipt of "The DMF filing acceptance notice", Finished Dosage Form Pharmaceutical manufacturers can go ahead with a research or CFDA drug registration with the Excipient that only have Pre-assignment DMF Numbers. Then CFDA will conduct a Technical Review / Assessment of Excipient DMF dossier along with the drug application.

Once the Technical Review is finally approved by CFDA, the Excipient can be imported to China for all purposes without any limit. The subsequent pharmaceutical manufacturer who is intended to apply for CFDA drug registration with Excipient, will only need to receive a Letter of Authorization (LOA) issued by the Excipient manufacturers, and CFDA utilize existing Excipient DMF data without further technical review again.

China is potentially the largest healthcare market in the world and became the world's secondlargest by sales in 2018 at the value of around $137 billion which is expected to surge up to almost $570 billion in 2022.

Due to its recent regulatory changes and market potential value, it is very good opportunity and attractive to foreign pharma companies to enter the Chinese market. Under these favorable circumstances, Finished Dosage Form pharmaceutical manufacturers intending to export Chinese market can proceed with the final registration stage, Technical Review, with our Gelatin DMF Number F20190000400.

Further inquiries may be directed to our Global Business Group at