In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073 Drug Master File in Korea (Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073. The MFDS reviews the Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073 KDMF as part of the drug registration process and uses the information provided in the Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073 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 Mimpara, Cinacalcet hydrochloride, Sensipar, AMG-073 API can apply through the Korea Drug Master File (KDMF).
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