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