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