01 1Juzen Chemical Corporation
02 1Korea Biochem Pharmaceutical Co., Ltd.
01 1Astellas Pharma Korea Co., Ltd.
02 1Korea Biochem Pharmaceutical Co., Ltd.
01 2Ipragliflozin L-proline
01 1Japan
02 1South Korea
Registrant Name : Astellas Pharma Korea Co., Ltd.
Registration Date : 2014-09-05
Registration Number : Su3778-5-ND
Manufacturer Name : Juzen Chemical Corporation
Manufacturer Address : 1-10, Kiba-machi, Toyama City, Toyama 930-0806
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2022-12-14
Registration Number : 2152-19-ND
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
33
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A suglat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of suglat, including repackagers and relabelers. The FDA regulates suglat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. suglat 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 suglat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A suglat supplier is an individual or a company that provides suglat active pharmaceutical ingredient (API) or suglat finished formulations upon request. The suglat suppliers may include suglat API manufacturers, exporters, distributors and traders.
click here to find a list of suglat 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 suglat Drug Master File in Korea (suglat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of suglat. The MFDS reviews the suglat KDMF as part of the drug registration process and uses the information provided in the suglat KDMF to evaluate the safety and efficacy of the drug.
After submitting a suglat 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 suglat API can apply through the Korea Drug Master File (KDMF).
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