01 1Vifor (International) Inc.
01 1Carboxymethyl maltose ferric
01 1Switzerland
Registration Number : 229MF10211
Registrant's Address : Rechenstrasse 37, CH-9001 St. Gallen
Initial Date of Registration : 2017-12-01
Latest Date of Registration : 2023-10-04
A Ferric Carboxymaltose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Carboxymaltose, including repackagers and relabelers. The FDA regulates Ferric Carboxymaltose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Carboxymaltose 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 Ferric Carboxymaltose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferric Carboxymaltose supplier is an individual or a company that provides Ferric Carboxymaltose active pharmaceutical ingredient (API) or Ferric Carboxymaltose finished formulations upon request. The Ferric Carboxymaltose suppliers may include Ferric Carboxymaltose API manufacturers, exporters, distributors and traders.
click here to find a list of Ferric Carboxymaltose 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 Ferric Carboxymaltose Drug Master File in Japan (Ferric Carboxymaltose JDMF) empowers Ferric Carboxymaltose 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 Ferric Carboxymaltose JDMF during the approval evaluation for pharmaceutical products. At the time of Ferric Carboxymaltose 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 Ferric Carboxymaltose suppliers with JDMF on PharmaCompass.
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