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