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 excipient.

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.

Further inquiries may be directed to our Global Business Group at inquiries@embocaps.com North American group at nasales@embocaps.com or our European group at europe@embocaps.com.