01 1Bayer AG
01 1Bayer Korea Ltd.
01 1Iopromide
01 1Germany
Registrant Name : Bayer Korea Ltd.
Registration Date : 2018-07-06
Registration Number : 20180706-210-J-240
Manufacturer Name : Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen Germany
A Iopromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iopromide, including repackagers and relabelers. The FDA regulates Iopromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iopromide 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 Iopromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iopromide supplier is an individual or a company that provides Iopromide active pharmaceutical ingredient (API) or Iopromide finished formulations upon request. The Iopromide suppliers may include Iopromide API manufacturers, exporters, distributors and traders.
click here to find a list of Iopromide 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 Iopromide Drug Master File in Korea (Iopromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iopromide. The MFDS reviews the Iopromide KDMF as part of the drug registration process and uses the information provided in the Iopromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iopromide 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 Iopromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iopromide suppliers with KDMF on PharmaCompass.
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