Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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FDF
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Europe
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Others
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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Finished Drug Prices
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1. Bcp30643
Molecular Weight | 233.55 g/mol |
---|---|
Molecular Formula | Fe3H2O4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 0 |
Exact Mass | 233.800115 g/mol |
Monoisotopic Mass | 233.800115 g/mol |
Topological Polar Surface Area | 74.6 Ų |
Heavy Atom Count | 7 |
Formal Charge | 0 |
Complexity | 10.3 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
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 | Feraheme |
PubMed Health | Parenteral Mineral/Trace Mineral Combination (Injection) |
Drug Classes | Anticonvulsant, Laxative, Hyperosmotic, Nutritive Agent, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent |
Drug Label | Feraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme... |
Active Ingredient | Ferumoxytol |
Dosage Form | Solution |
Route | Intravenous |
Strength | eq 510mg iron/17ml (eq 30mg iron/ml) |
Market Status | Prescription |
Company | Amag Pharms |
2 of 2 | |
---|---|
Drug Name | Feraheme |
PubMed Health | Parenteral Mineral/Trace Mineral Combination (Injection) |
Drug Classes | Anticonvulsant, Laxative, Hyperosmotic, Nutritive Agent, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent |
Drug Label | Feraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme... |
Active Ingredient | Ferumoxytol |
Dosage Form | Solution |
Route | Intravenous |
Strength | eq 510mg iron/17ml (eq 30mg iron/ml) |
Market Status | Prescription |
Company | Amag Pharms |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39032
Submission : 2023-10-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-11-21
DMF Number : 27718
Submission : 2013-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-25
Pay. Date : 2022-12-15
DMF Number : 37265
Submission : 2022-07-18
Status : Active
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intravenous Use
Dosage Strength : 30MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Regulatory Info : RX
Registration Country : USA
Brand Name : FERAHEME
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Packaging :
Approval Date : 2009-06-30
Application Number : 22180
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FERUMOXYTOL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Packaging :
Approval Date : 2021-01-15
Application Number : 206604
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code : AB
Brand Name : FERAHEME
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Approval Date : 2009-06-30
Application Number : 22180
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : FERUMOXYTOL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Approval Date : 2021-01-15
Application Number : 206604
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
20 Jan 2021
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206604
12 Feb 2016
// TWOFOUR INSIGHT
http://twofourinsight.com/analyzing-data-earliest-market-entry-subsequent-anda-filers/
29 Dec 2014
// Press Release AMAG PHARMACEUTICALS
http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&id=2002105
Global Sales Information
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ABOUT THIS PAGE
A Feraheme manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Feraheme, including repackagers and relabelers. The FDA regulates Feraheme manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Feraheme 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 Feraheme manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Feraheme supplier is an individual or a company that provides Feraheme active pharmaceutical ingredient (API) or Feraheme finished formulations upon request. The Feraheme suppliers may include Feraheme API manufacturers, exporters, distributors and traders.
click here to find a list of Feraheme suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Feraheme DMF (Drug Master File) is a document detailing the whole manufacturing process of Feraheme active pharmaceutical ingredient (API) in detail. Different forms of Feraheme DMFs exist exist since differing nations have different regulations, such as Feraheme USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Feraheme DMF submitted to regulatory agencies in the US is known as a USDMF. Feraheme USDMF includes data on Feraheme's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Feraheme USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Feraheme suppliers with USDMF on PharmaCompass.
Feraheme 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 Feraheme 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 Feraheme GMP manufacturer or Feraheme GMP API supplier for your needs.
A Feraheme CoA (Certificate of Analysis) is a formal document that attests to Feraheme's compliance with Feraheme specifications and serves as a tool for batch-level quality control.
Feraheme CoA mostly includes findings from lab analyses of a specific batch. For each Feraheme 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.
Feraheme may be tested according to a variety of international standards, such as European Pharmacopoeia (Feraheme EP), Feraheme JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Feraheme USP).
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