US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Ferric Carboxymaltose API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ferric Carboxymaltose manufacturer or Ferric Carboxymaltose supplier for your needs.
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PharmaCompass also assists you with knowing the Ferric Carboxymaltose API Price utilized in the formulation of products. Ferric Carboxymaltose API Price is not always fixed or binding as the Ferric Carboxymaltose Price is obtained through a variety of data sources. The Ferric Carboxymaltose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
A Ferric Carboxymaltose DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferric Carboxymaltose active pharmaceutical ingredient (API) in detail. Different forms of Ferric Carboxymaltose DMFs exist exist since differing nations have different regulations, such as Ferric Carboxymaltose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferric Carboxymaltose DMF submitted to regulatory agencies in the US is known as a USDMF. Ferric Carboxymaltose USDMF includes data on Ferric Carboxymaltose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferric Carboxymaltose USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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.
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A Ferric Carboxymaltose written confirmation (Ferric Carboxymaltose WC) is an official document issued by a regulatory agency to a Ferric Carboxymaltose manufacturer, verifying that the manufacturing facility of a Ferric Carboxymaltose active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ferric Carboxymaltose APIs or Ferric Carboxymaltose finished pharmaceutical products to another nation, regulatory agencies frequently require a Ferric Carboxymaltose WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ferric Carboxymaltose as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferric Carboxymaltose API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ferric Carboxymaltose as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ferric Carboxymaltose and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric Carboxymaltose NDC to their finished compounded human drug products, they may choose to do so.
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Ferric Carboxymaltose 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 Carboxymaltose 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 Carboxymaltose GMP manufacturer or Ferric Carboxymaltose GMP API supplier for your needs.
A Ferric Carboxymaltose CoA (Certificate of Analysis) is a formal document that attests to Ferric Carboxymaltose's compliance with Ferric Carboxymaltose specifications and serves as a tool for batch-level quality control.
Ferric Carboxymaltose CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Carboxymaltose 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 Carboxymaltose may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Carboxymaltose EP), Ferric Carboxymaltose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Carboxymaltose USP).