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