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