EMBO CAPS® by Suheung receives China DMF Number for HPMC
Suheung Co., Ltd. announces today that the China DMF filing for it’s EMBOCAPS ® Empty
Hard HPMC Capsules has been successfully submitted and received its DMF filing acceptance
notice / Pre-assigned DMF Number F20190000399.
According to the recently promulgated National Medical Products Administration (NMPA –
formerly CFDA - China Food and Drug Administration) regulation, drug substances, excipients
and packaging materials are required to be reviewed and approved at the same time as
approving the registration application of the drug product. Excipient manufacturers need to
submit filing dossiers to NMPA to be approved by NMPA in order to receive a DMF filing
acceptance notice / pre-assigned DMF number
After receipt of the DMF filing acceptance notice, finished dosage Pharmaceutical
manufacturers can go ahead with research or NMPA drug registration with excipients that
already have pre-assigned DMF numbers. Then the NMPA will conduct a technical review /
assessment of excipient’s DMF dossier along with the drug application.
Once a technical review is approved by NMPA, subsequent pharmaceutical manufacturers
that intend to apply for NMPA drug registration with the registered excipients, will only need to
receive a Letter of Authorization (LOA) issued by the excipient manufacturer, and NMPA will
utilize the existing DMF data of the excipient without additional technical review of the said
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.
Under these favorable circumstances, pharmaceutical manufacturers intending to export in to
the Chinese market can proceed with the final registration and technical review, with our empty
hard HPMC capsule DMF Number F20190000399.
Suheung Co. Ltd was founded in 1973 and remains under the same ownership since
inception. Through the Embocaps® by Suheung marketing brand, and fueled by an unrivaled
reputation for quality and consistency, Suheung Co., Ltd. has grown to be the third largest
supplier of empty capsules globally. Embocaps® by Suheung offers a full range of empty
capsules, Size 000 thru 5 in gelatin and non-gelatin variations. Inhalation and liquid compatible
capsules as well as capsules for clinical trials are also available.
- Official announcement_HPMC.pdf (400.5K)