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