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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 |
---|---|
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 | |
---|---|
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 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17746
Submission : 2004-10-07
Status : Active
Type : II
NDC Package Code : 44498-001
Start Marketing Date : 2005-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18541
Submission : 2005-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34228
Submission : 2019-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21983
Submission : 2008-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17645
Submission : 2004-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17602
Submission : 2004-08-13
Status : Inactive
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm :
NDC Package Code : 68022-7505
Start Marketing Date : 2016-02-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18541
Submission : 2005-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17746
Submission : 2004-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17602
Submission : 2004-08-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21983
Submission : 2008-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17645
Submission : 2004-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34228
Submission : 2019-12-03
Status : Active
Type : II
Sodium Ferric Gluconate Complex (IH
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm : Plot No.262, 263, IDA, Pashamylaram, Medak District, A.P
SODIUM FERRIC GLUCONATE COMPLEX
NDC Package Code : 44498-001
Start Marketing Date : 2005-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
SODIUM FERRIC GLUCONATE COMPLEX
NDC Package Code : 68022-7505
Start Marketing Date : 2016-02-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Ferlixit
Dosage Form : Sodium Ferrigluconato 62.5Mg 5Ml 5 Units Use The Parenteral Or Oral Routes
Dosage Strength : 5 VIALS OS EV 62.5 mg 5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferritin Oti
Dosage Form : Sodium 781,2Ferrigluconato Mg/100Ml 240Ml Oral Use
Dosage Strength : 1 Bottle 240 ml 62.5 mg/8 ml syrup
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferritin Oti
Dosage Form :
Dosage Strength : To Os Soluz 10 Vials 62.5 Mg 8 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferritin Oti
Dosage Form :
Dosage Strength : 20 Cps 62.5 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Hemocromo 40
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferriemina
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Extrafer
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Rossepar
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 62.5 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Ferrosprint
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 62.5 Mg 14 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Ferlixit
Dosage Form : Sodium Ferrigluconato 62.5Mg 5Ml 5 Units Use The Parenteral Or Oral Routes
Dosage Strength : 5 VIALS OS EV 62.5 mg 5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferritin Oti
Dosage Form : Sodium 781,2Ferrigluconato Mg/100Ml 240Ml Oral Use
Dosage Strength : 1 Bottle 240 ml 62.5 mg/8 ml syrup
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferritin Oti
Dosage Form :
Dosage Strength : To Os Soluz 10 Vials 62.5 Mg 8 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferritin Oti
Dosage Form :
Dosage Strength : 20 Cps 62.5 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Hemocromo 40
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ferriemina
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Extrafer
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Rossepar
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 62.5 Mg 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Ferrosprint
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 62.5 Mg 14 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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Excipients by Applications
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Grade : Parenteral, Oral, Topical
Category : Parenteral, Solubilizers, Topical
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Application : Topical
Excipient Details : A&C’s Benzyl Alcohol multi-compendial is a preservative which meets USP-NF, EP, BP and JP monographs.
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Global Sales Information
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class H
Dosage Form : Sodium Ferrigluconato 62.5Mg 5Ml...
Dosage Strength : 5 VIALS OS EV 62.5 mg 5 ml
Price Per Pack (Euro) : 6.5
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form :
Dosage Strength : To Os Soluz 10 Vials 62.5 Mg 8 Ml
Price Per Pack (Euro) : 9.39
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 20 Cps 62.5 Mg
Price Per Pack (Euro) : 11.48
Published in :
Country : Italy
RX/OTC/DISCN : Class C
FRANCIA FARMAC.IND.FAR.BIO.Srl
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Price Per Pack (Euro) : 10.85
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form : Sodium 781,2Ferrigluconato Mg/10...
Dosage Strength : 1 Bottle 240 ml 62.5 mg/8 ml syrup
Price Per Pack (Euro) : 4.8
Published in :
Country : Italy
RX/OTC/DISCN : Class A
BIO HEALTH CARE PHARMACEUTICAL
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 62.5 Mg 10 Ml
Price Per Pack (Euro) : 11
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
LA.FA.RE. Srl
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Price Per Pack (Euro) : 7.75
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MARVECSPHARMA SERVICES Srl
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 62.5 Mg 14 Ml
Price Per Pack (Euro) : 11.22
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
SO.SE.PHARM Srl
Dosage Form :
Dosage Strength : Os Soluz 10 Vials 40 Mg 10 Ml
Price Per Pack (Euro) : 7.85
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
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ABOUT THIS PAGE
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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 SODIUM FERRIC GLUCONATE COMPLEX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SODIUM FERRIC GLUCONATE COMPLEX, including repackagers and relabelers. The FDA regulates SODIUM FERRIC GLUCONATE COMPLEX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SODIUM FERRIC GLUCONATE COMPLEX 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 SODIUM FERRIC GLUCONATE COMPLEX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SODIUM FERRIC GLUCONATE COMPLEX supplier is an individual or a company that provides SODIUM FERRIC GLUCONATE COMPLEX active pharmaceutical ingredient (API) or SODIUM FERRIC GLUCONATE COMPLEX finished formulations upon request. The SODIUM FERRIC GLUCONATE COMPLEX suppliers may include SODIUM FERRIC GLUCONATE COMPLEX API manufacturers, exporters, distributors and traders.
click here to find a list of SODIUM FERRIC GLUCONATE COMPLEX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SODIUM FERRIC GLUCONATE COMPLEX DMF (Drug Master File) is a document detailing the whole manufacturing process of SODIUM FERRIC GLUCONATE COMPLEX active pharmaceutical ingredient (API) in detail. Different forms of SODIUM FERRIC GLUCONATE COMPLEX DMFs exist exist since differing nations have different regulations, such as SODIUM FERRIC GLUCONATE COMPLEX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SODIUM FERRIC GLUCONATE COMPLEX DMF submitted to regulatory agencies in the US is known as a USDMF. SODIUM FERRIC GLUCONATE COMPLEX USDMF includes data on SODIUM FERRIC GLUCONATE COMPLEX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SODIUM FERRIC GLUCONATE COMPLEX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SODIUM FERRIC GLUCONATE COMPLEX suppliers with USDMF on PharmaCompass.
A SODIUM FERRIC GLUCONATE COMPLEX written confirmation (SODIUM FERRIC GLUCONATE COMPLEX WC) is an official document issued by a regulatory agency to a SODIUM FERRIC GLUCONATE COMPLEX manufacturer, verifying that the manufacturing facility of a SODIUM FERRIC GLUCONATE COMPLEX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SODIUM FERRIC GLUCONATE COMPLEX APIs or SODIUM FERRIC GLUCONATE COMPLEX finished pharmaceutical products to another nation, regulatory agencies frequently require a SODIUM FERRIC GLUCONATE COMPLEX WC (written confirmation) as part of the regulatory process.
click here to find a list of SODIUM FERRIC GLUCONATE COMPLEX 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 SODIUM FERRIC GLUCONATE COMPLEX as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SODIUM FERRIC GLUCONATE COMPLEX 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 SODIUM FERRIC GLUCONATE COMPLEX 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 SODIUM FERRIC GLUCONATE COMPLEX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SODIUM FERRIC GLUCONATE COMPLEX NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SODIUM FERRIC GLUCONATE COMPLEX suppliers with NDC on PharmaCompass.
SODIUM FERRIC GLUCONATE COMPLEX 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 SODIUM FERRIC GLUCONATE COMPLEX 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 SODIUM FERRIC GLUCONATE COMPLEX GMP manufacturer or SODIUM FERRIC GLUCONATE COMPLEX GMP API supplier for your needs.
A SODIUM FERRIC GLUCONATE COMPLEX CoA (Certificate of Analysis) is a formal document that attests to SODIUM FERRIC GLUCONATE COMPLEX's compliance with SODIUM FERRIC GLUCONATE COMPLEX specifications and serves as a tool for batch-level quality control.
SODIUM FERRIC GLUCONATE COMPLEX CoA mostly includes findings from lab analyses of a specific batch. For each SODIUM FERRIC GLUCONATE COMPLEX 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.
SODIUM FERRIC GLUCONATE COMPLEX may be tested according to a variety of international standards, such as European Pharmacopoeia (SODIUM FERRIC GLUCONATE COMPLEX EP), SODIUM FERRIC GLUCONATE COMPLEX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SODIUM FERRIC GLUCONATE COMPLEX USP).