01 1Bayer AG
01 1Bayer Korea Co., Ltd.
01 1Iopromide
01 1Germany
Registrant Name : Bayer Korea Co., 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
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PharmaCompass offers a list of Iopromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Iopromide manufacturer or Iopromide supplier for your needs.
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A Ultravist manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultravist, including repackagers and relabelers. The FDA regulates Ultravist manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultravist 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 Ultravist manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ultravist supplier is an individual or a company that provides Ultravist active pharmaceutical ingredient (API) or Ultravist finished formulations upon request. The Ultravist suppliers may include Ultravist API manufacturers, exporters, distributors and traders.
click here to find a list of Ultravist 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 Ultravist Drug Master File in Korea (Ultravist KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ultravist. The MFDS reviews the Ultravist KDMF as part of the drug registration process and uses the information provided in the Ultravist KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ultravist 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 Ultravist API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ultravist suppliers with KDMF on PharmaCompass.
