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