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