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