01 1FORMOSA LABORATORIES, INC.
02 1GE Healthcare AS
01 2Gadodiamide hydrate
01 1Taiwan
02 1United Kingdom
Registration Number : 220MF10205
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2008-09-29
Latest Date of Registration : 2008-11-25
Registration Number : 217MF10960
Registrant's Address : Lindesnesveien 208, 4521 Lindesnes, Norway
Initial Date of Registration : 2005-11-14
Latest Date of Registration : 2010-03-02
A Gadodiamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadodiamide, including repackagers and relabelers. The FDA regulates Gadodiamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadodiamide 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 Gadodiamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadodiamide supplier is an individual or a company that provides Gadodiamide active pharmaceutical ingredient (API) or Gadodiamide finished formulations upon request. The Gadodiamide suppliers may include Gadodiamide API manufacturers, exporters, distributors and traders.
click here to find a list of Gadodiamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Gadodiamide Drug Master File in Japan (Gadodiamide JDMF) empowers Gadodiamide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Gadodiamide JDMF during the approval evaluation for pharmaceutical products. At the time of Gadodiamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Gadodiamide suppliers with JDMF on PharmaCompass.
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