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