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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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 |
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
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...
About the Company : Lupin Limited is a global pharmaceutical leader, based in Mumbai, India, with a strong presence in over 100 markets. It specializes in branded and generic formulations, complex gen...
About the Company : We introduce ourselves as manufacturer of Active Pharmaceutical Ingredients (API) and intermediates with a professional approach that is aimed at finest results. We have etched a r...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
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
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Intraven...
Dosage Strength : 30MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Injection For Intraven...
Dosage Strength : 30MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Global Sales Information
Market Place
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23 Sep 2021
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30 May 2019
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29 Mar 2019
ABOUT THIS PAGE
A Ferumoxytol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferumoxytol, including repackagers and relabelers. The FDA regulates Ferumoxytol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Ferumoxytol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferumoxytol supplier is an individual or a company that provides Ferumoxytol active pharmaceutical ingredient (API) or Ferumoxytol finished formulations upon request. The Ferumoxytol suppliers may include Ferumoxytol API manufacturers, exporters, distributors and traders.
click here to find a list of Ferumoxytol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ferumoxytol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ferumoxytol active pharmaceutical ingredient (API) in detail. Different forms of Ferumoxytol DMFs exist exist since differing nations have different regulations, such as Ferumoxytol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ferumoxytol DMF submitted to regulatory agencies in the US is known as a USDMF. Ferumoxytol USDMF includes data on Ferumoxytol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ferumoxytol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ferumoxytol suppliers with USDMF on PharmaCompass.
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 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 Ferumoxytol GMP manufacturer or Ferumoxytol GMP API supplier for your needs.
A Ferumoxytol CoA (Certificate of Analysis) is a formal document that attests to Ferumoxytol's compliance with Ferumoxytol specifications and serves as a tool for batch-level quality control.
Ferumoxytol CoA mostly includes findings from lab analyses of a specific batch. For each 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.
Ferumoxytol may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferumoxytol EP), Ferumoxytol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferumoxytol USP).
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