EMBOCAPS® receives China DMF Number for Two Piece Hard Capsules

Suheung Co., Ltd. is pleased to announce that it has received a new DMF filing acceptance notice and DMF numbers for two-piece hard empty capsules from the National Medical Products Administration (NMPA) in China.

EMBOCAPS® Gelatin Capsule : F20190000400

EMBOCAPS® VG Pro F20190000399

EMBOCAPS® VG Pro LPR (Inhalation) F20200000018 

According to the latest NMPA regulation, the approval of drug substances, excipients, and packaging materials must be obtained simultaneously with the registration application for the drug product. Excipient manufacturers are required to submit filing dossiers to the NMPA for approval in order to receive a DMF filing acceptance notice and pre-assigned DMF number.

After receiving the DMF filing acceptance notice, finished dosage pharmaceutical manufacturers can proceed with research or NMPA drug registration with excipients that have pre-assigned DMF numbers. The NMPA will conduct a technical review/assessment of the excipient's DMF dossier along with the drug application.

Once the NMPA approves the technical review, subsequent pharmaceutical manufacturers intending to apply for NMPA drug registration with the registered excipients will only need to obtain a Letter of Authorization (LOA) issued by the excipient manufacturer. NMPA will utilize the existing DMF data of the excipient without additional technical review.

China is one of the largest healthcare markets in the world and is expected to grow to almost $570 billion in 2022. With this new DMF filing acceptance notice and pre-assigned DMF number, EMBOCAPS is ready to provide pharmaceutical manufacturers intending to export to the Chinese market with the necessary registration and technical review of the hard capsules. 

For further inquiries, please contact our Global Business Group at inquiries@embocaps.com, our North American group at nasales@embocaps.com, or our European group at europe@embocaps.com.