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