In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Theoplus Drug Master File in Korea (Theoplus KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Theoplus. The MFDS reviews the Theoplus KDMF as part of the drug registration process and uses the information provided in the Theoplus KDMF to evaluate the safety and efficacy of the drug.
After submitting a Theoplus KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Theoplus API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Theoplus suppliers with KDMF on PharmaCompass.