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