01 1Macco Organiques, SRO
02 2Macco Organiques, sro
01 1Daeshin Pharmaceutical Co., Ltd.
02 1Masung LS Co., Ltd.
03 1Space Industry Co., Ltd.
01 3Potassium chloride
01 3Canada
Registrant Name : Space Industry Co., Ltd.
Registration Date : 2024-07-25
Registration Number : 20220520-209-J-1266(2)
Manufacturer Name : Macco Organiques, sro
Manufacturer Address : Zahradní 1938/46c, 792 01 Bruntál, Czech Republic
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-05-20
Registration Number : 20220520-209-J-1266
Manufacturer Name : Macco Organiques, sro
Manufacturer Address : Zahradní 1938/ 46c, 792 01 Bruntál
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2024-04-05
Registration Number : 20220520-209-J-1266(1)
Manufacturer Name : Macco Organiques, SRO
Manufacturer Address : Zahradní 1938/ 46c, 792 01 Bruntál
A K-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of K-Dur, including repackagers and relabelers. The FDA regulates K-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. K-Dur 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 K-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A K-Dur supplier is an individual or a company that provides K-Dur active pharmaceutical ingredient (API) or K-Dur finished formulations upon request. The K-Dur suppliers may include K-Dur API manufacturers, exporters, distributors and traders.
click here to find a list of K-Dur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 K-Dur Drug Master File in Korea (K-Dur KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of K-Dur. The MFDS reviews the K-Dur KDMF as part of the drug registration process and uses the information provided in the K-Dur KDMF to evaluate the safety and efficacy of the drug.
After submitting a K-Dur 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 K-Dur API can apply through the Korea Drug Master File (KDMF).
click here to find a list of K-Dur suppliers with KDMF on PharmaCompass.
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