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