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