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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
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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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PharmaCompass offers a list of Ferric Derisomaltose 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 Derisomaltose manufacturer or Ferric Derisomaltose supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferric Derisomaltose manufacturer or Ferric Derisomaltose supplier.
PharmaCompass also assists you with knowing the Ferric Derisomaltose API Price utilized in the formulation of products. Ferric Derisomaltose API Price is not always fixed or binding as the Ferric Derisomaltose Price is obtained through a variety of data sources. The Ferric Derisomaltose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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 Derisomaltose as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferric Derisomaltose 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 Derisomaltose 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 Derisomaltose and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric Derisomaltose NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ferric Derisomaltose suppliers with NDC 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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