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