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