Synopsis
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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 |
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39032
Submission : 2023-10-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-25
Pay. Date : 2022-12-15
DMF Number : 37265
Submission : 2022-07-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-12
Pay. Date : 2013-11-21
DMF Number : 27718
Submission : 2013-11-26
Status : Active
Type : II
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
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ferumoxytol 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 Ferumoxytol manufacturer or Ferumoxytol supplier for your needs.
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PharmaCompass also assists you with knowing the Ferumoxytol API Price utilized in the formulation of products. Ferumoxytol API Price is not always fixed or binding as the Ferumoxytol Price is obtained through a variety of data sources. The Ferumoxytol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AMAG Pharmaceuticals Brand of Ferumoxytol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMAG Pharmaceuticals Brand of Ferumoxytol, including repackagers and relabelers. The FDA regulates AMAG Pharmaceuticals Brand of Ferumoxytol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMAG Pharmaceuticals Brand of Ferumoxytol 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 AMAG Pharmaceuticals Brand of Ferumoxytol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AMAG Pharmaceuticals Brand of Ferumoxytol supplier is an individual or a company that provides AMAG Pharmaceuticals Brand of Ferumoxytol active pharmaceutical ingredient (API) or AMAG Pharmaceuticals Brand of Ferumoxytol finished formulations upon request. The AMAG Pharmaceuticals Brand of Ferumoxytol suppliers may include AMAG Pharmaceuticals Brand of Ferumoxytol API manufacturers, exporters, distributors and traders.
click here to find a list of AMAG Pharmaceuticals Brand of Ferumoxytol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMAG Pharmaceuticals Brand of Ferumoxytol DMF (Drug Master File) is a document detailing the whole manufacturing process of AMAG Pharmaceuticals Brand of Ferumoxytol active pharmaceutical ingredient (API) in detail. Different forms of AMAG Pharmaceuticals Brand of Ferumoxytol DMFs exist exist since differing nations have different regulations, such as AMAG Pharmaceuticals Brand of Ferumoxytol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMAG Pharmaceuticals Brand of Ferumoxytol DMF submitted to regulatory agencies in the US is known as a USDMF. AMAG Pharmaceuticals Brand of Ferumoxytol USDMF includes data on AMAG Pharmaceuticals Brand of Ferumoxytol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMAG Pharmaceuticals Brand of Ferumoxytol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AMAG Pharmaceuticals Brand of Ferumoxytol suppliers with USDMF on PharmaCompass.
AMAG Pharmaceuticals Brand of Ferumoxytol 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 AMAG Pharmaceuticals Brand of Ferumoxytol 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 AMAG Pharmaceuticals Brand of Ferumoxytol GMP manufacturer or AMAG Pharmaceuticals Brand of Ferumoxytol GMP API supplier for your needs.
A AMAG Pharmaceuticals Brand of Ferumoxytol CoA (Certificate of Analysis) is a formal document that attests to AMAG Pharmaceuticals Brand of Ferumoxytol's compliance with AMAG Pharmaceuticals Brand of Ferumoxytol specifications and serves as a tool for batch-level quality control.
AMAG Pharmaceuticals Brand of Ferumoxytol CoA mostly includes findings from lab analyses of a specific batch. For each AMAG Pharmaceuticals Brand of Ferumoxytol 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.
AMAG Pharmaceuticals Brand of Ferumoxytol may be tested according to a variety of international standards, such as European Pharmacopoeia (AMAG Pharmaceuticals Brand of Ferumoxytol EP), AMAG Pharmaceuticals Brand of Ferumoxytol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AMAG Pharmaceuticals Brand of Ferumoxytol USP).