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