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