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1. Sodium Ferric Gluconate Complex
2. 34089-81-1
3. Ferrlecit (tn)
4. Dtxsid80187686
5. Akos015967341
6. D05859
Molecular Weight | 273.98 g/mol |
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Molecular Formula | C6H11FeNaO7+3 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 5 |
Exact Mass | 273.975183 g/mol |
Monoisotopic Mass | 273.975183 g/mol |
Topological Polar Surface Area | 141 Ų |
Heavy Atom Count | 15 |
Formal Charge | 3 |
Complexity | 176 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 2 | |
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Drug Name | Ferrlecit |
PubMed Health | Sodium Ferric Gluconate Complex (Injection) |
Drug Classes | Parenteral Mineral-Trace Mineral |
Drug Label | Ferrlecit (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 440,000 daltons. The macromolecular complex is... |
Active Ingredient | Sodium ferric gluconate complex |
Dosage Form | Injectable |
Route | Injection |
Strength | 62.5mg/5ml |
Market Status | Prescription |
Company | Sanofi Aventis Us |
2 of 2 | |
---|---|
Drug Name | Ferrlecit |
PubMed Health | Sodium Ferric Gluconate Complex (Injection) |
Drug Classes | Parenteral Mineral-Trace Mineral |
Drug Label | Ferrlecit (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 440,000 daltons. The macromolecular complex is... |
Active Ingredient | Sodium ferric gluconate complex |
Dosage Form | Injectable |
Route | Injection |
Strength | 62.5mg/5ml |
Market Status | Prescription |
Company | Sanofi Aventis Us |
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PharmaCompass offers a list of Sodium ferric gluconate 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 Sodium ferric gluconate manufacturer or Sodium ferric gluconate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium ferric gluconate manufacturer or Sodium ferric gluconate supplier.
PharmaCompass also assists you with knowing the Sodium ferric gluconate API Price utilized in the formulation of products. Sodium ferric gluconate API Price is not always fixed or binding as the Sodium ferric gluconate Price is obtained through a variety of data sources. The Sodium ferric gluconate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ferric Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Gluconate, including repackagers and relabelers. The FDA regulates Ferric Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Gluconate 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 Gluconate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferric Gluconate supplier is an individual or a company that provides Ferric Gluconate active pharmaceutical ingredient (API) or Ferric Gluconate finished formulations upon request. The Ferric Gluconate suppliers may include Ferric Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Ferric Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ferric Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferric Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Ferric Gluconate DMFs exist exist since differing nations have different regulations, such as Ferric Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferric Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Ferric Gluconate USDMF includes data on Ferric Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferric Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ferric Gluconate suppliers with USDMF on PharmaCompass.
A Ferric Gluconate written confirmation (Ferric Gluconate WC) is an official document issued by a regulatory agency to a Ferric Gluconate manufacturer, verifying that the manufacturing facility of a Ferric Gluconate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ferric Gluconate APIs or Ferric Gluconate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ferric Gluconate WC (written confirmation) as part of the regulatory process.
click here to find a list of Ferric Gluconate suppliers with Written Confirmation (WC) 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 Gluconate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferric Gluconate 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 Gluconate 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 Gluconate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric Gluconate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ferric Gluconate suppliers with NDC on PharmaCompass.
Ferric Gluconate 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 Gluconate 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 Gluconate GMP manufacturer or Ferric Gluconate GMP API supplier for your needs.
A Ferric Gluconate CoA (Certificate of Analysis) is a formal document that attests to Ferric Gluconate's compliance with Ferric Gluconate specifications and serves as a tool for batch-level quality control.
Ferric Gluconate CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Gluconate 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 Gluconate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Gluconate EP), Ferric Gluconate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Gluconate USP).