In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pimecrolimus, Elidel, SDZ-ASM-981 Drug Master File in Korea (Pimecrolimus, Elidel, SDZ-ASM-981 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pimecrolimus, Elidel, SDZ-ASM-981. The MFDS reviews the Pimecrolimus, Elidel, SDZ-ASM-981 KDMF as part of the drug registration process and uses the information provided in the Pimecrolimus, Elidel, SDZ-ASM-981 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pimecrolimus, Elidel, SDZ-ASM-981 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 Pimecrolimus, Elidel, SDZ-ASM-981 API can apply through the Korea Drug Master File (KDMF).
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