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 |
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Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Cystitis, Interstitial.
Lead Product(s): Ferumoxytol,Gadobutrol
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Lipella Pharmaceuticals | National Institutes of Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 13, 2023
Lead Product(s) : Ferumoxytol,Gadobutrol
Therapeutic Area : Urology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Lipella Pharmaceuticals | National Institutes of Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Cystitis, Interstitial.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
April 13, 2023
Details:
The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Hematology Brand Name: Feraheme
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition November 16, 2020
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Covis Pharma
Deal Size : $647.0 million
Deal Type : Acquisition
Covis Group Completes Acquisition of AMAG Pharmaceuticals
Details : The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.
Product Name : Feraheme
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : $647.0 million
November 16, 2020
Details:
With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not suitable or ineffective.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Hematology Brand Name: Feraheme
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition October 01, 2020
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Covis Pharma
Deal Size : $647.0 million
Deal Type : Acquisition
Covis Group Announces Agreement to Acquire AMAG Pharmaceuticals
Details : With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not su...
Product Name : Feraheme
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : $647.0 million
October 01, 2020
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia, Iron-Deficiency.
Lead Product(s): Ferumoxytol,Sodium Chloride,Ferrous Sulfate,Ascorbic Acid
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: AMAG Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2020
Lead Product(s) : Ferumoxytol,Sodium Chloride,Ferrous Sulfate,Ascorbic Acid
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AMAG Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia, Iron-Deficiency.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
February 13, 2020
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Anemia, Iron-Deficiency.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: AMAG Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 19, 2019
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : AMAG Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Anemia, Iron-Deficiency.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
December 19, 2019
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Anemia.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 06, 2019
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Anemia.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
September 06, 2019
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia, Iron-Deficiency.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2019
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia, Iron-Deficiency.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
March 28, 2019
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Post-Bariatric, Anemia, Iron-Deficiency.
Lead Product(s): Ferumoxytol,Ascorbic Acid,Ferrous Sulfate,Sodium Chloride
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: AMAG Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 17, 2018
Lead Product(s) : Ferumoxytol,Ascorbic Acid,Ferrous Sulfate,Sodium Chloride
Therapeutic Area : Hematology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : AMAG Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in clinical studies for the treatment of Post-Bariatric, Anemia, Iron-Deficiency.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
December 17, 2018
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia, Iron-Deficiency-associated with Pregnancy.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: AMAG Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2018
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AMAG Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia, Iron-Deficiency-associated with Pregnancy.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
September 05, 2018
Details:
Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia-associated with Renal Insufficiency, Chronic.
Lead Product(s): Ferumoxytol,Inapplicable
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 08, 2018
Lead Product(s) : Ferumoxytol,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ferumoxytol is a Vitamins/Minerals/Inorganic Salts drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Anemia-associated with Renal Insufficiency, Chronic.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
August 08, 2018
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
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferumoxytol manufacturer or Ferumoxytol supplier.
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 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).