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