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