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