In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Theochron Drug Master File in Korea (Theochron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Theochron. The MFDS reviews the Theochron KDMF as part of the drug registration process and uses the information provided in the Theochron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Theochron 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 Theochron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Theochron suppliers with KDMF on PharmaCompass.