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