01 1Orgapharm
01 1Dong-A ST Co., Ltd.
01 1Imiquimod
01 1France
Registrant Name : Dong-A ST Co., Ltd.
Registration Date : 2023-02-15
Registration Number : 20230215-209-J-1446
Manufacturer Name : Orgapharm
Manufacturer Address : Zone Industrielle, Rue du Moulin De La Canne, Pithiviers, 45300, France
95
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A TMX 101 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TMX 101, including repackagers and relabelers. The FDA regulates TMX 101 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TMX 101 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of TMX 101 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A TMX 101 supplier is an individual or a company that provides TMX 101 active pharmaceutical ingredient (API) or TMX 101 finished formulations upon request. The TMX 101 suppliers may include TMX 101 API manufacturers, exporters, distributors and traders.
click here to find a list of TMX 101 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a TMX 101 Drug Master File in Korea (TMX 101 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TMX 101. The MFDS reviews the TMX 101 KDMF as part of the drug registration process and uses the information provided in the TMX 101 KDMF to evaluate the safety and efficacy of the drug.
After submitting a TMX 101 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 TMX 101 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TMX 101 suppliers with KDMF on PharmaCompass.
