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