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