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DOSAGE - SOLUTION;INTRAVENOUS - 100MG/ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/ML (100MG/ML)
USFDA APPLICATION NUMBER - 208171
DOSAGE - SOLUTION;INTRAVENOUS - 1GM/10ML (100...DOSAGE - SOLUTION;INTRAVENOUS - 1GM/10ML (100MG/ML)
USFDA APPLICATION NUMBER - 208171
DOSAGE - SOLUTION;INTRAVENOUS - 500MG/5ML (10...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/5ML (100MG/ML)
USFDA APPLICATION NUMBER - 208171
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ABOUT THIS PAGE
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.
Ferric Derisomaltose Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ferric Derisomaltose GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ferric Derisomaltose GMP manufacturer or Ferric Derisomaltose GMP API supplier for your needs.
A Ferric Derisomaltose CoA (Certificate of Analysis) is a formal document that attests to Ferric Derisomaltose's compliance with Ferric Derisomaltose specifications and serves as a tool for batch-level quality control.
Ferric Derisomaltose CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Derisomaltose CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ferric Derisomaltose may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Derisomaltose EP), Ferric Derisomaltose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Derisomaltose USP).
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