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