01 1Pharmacosmos A/S
01 1Del Isomaltose Ferric
01 1Denmark
Registration Number : 302MF10143
Registrant's Address : Roervangsvej 30, DK-4300 Holbaek, Denmark
Initial Date of Registration : 2020-12-07
Latest Date of Registration : 2020-12-07
A Ferric Derisomaltose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Derisomaltose, including repackagers and relabelers. The FDA regulates Ferric Derisomaltose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Derisomaltose 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 Derisomaltose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferric Derisomaltose supplier is an individual or a company that provides Ferric Derisomaltose active pharmaceutical ingredient (API) or Ferric Derisomaltose finished formulations upon request. The Ferric Derisomaltose suppliers may include Ferric Derisomaltose API manufacturers, exporters, distributors and traders.
click here to find a list of Ferric Derisomaltose 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 Derisomaltose Drug Master File in Japan (Ferric Derisomaltose JDMF) empowers Ferric Derisomaltose 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 Derisomaltose JDMF during the approval evaluation for pharmaceutical products. At the time of Ferric Derisomaltose 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 Derisomaltose suppliers with JDMF on PharmaCompass.
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