In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- Drug Master File in Korea (4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)-. The MFDS reviews the 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- KDMF as part of the drug registration process and uses the information provided in the 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- KDMF to evaluate the safety and efficacy of the drug.
After submitting a 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- 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 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-, 4,4-dioxide, (2S,5R)- suppliers with KDMF on PharmaCompass.