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