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