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ACTIVE PHARMA INGREDIENTS

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JDMF

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EU WC

EU WC

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NDC API

NDC API

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Chemistry

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Also known as: Bcp30643
Molecular Formula
Fe3H2O4
Molecular Weight
233.55  g/mol
InChI Key
UCNNJGDEJXIUCC-UHFFFAOYSA-L

Ferumoxytol
1 2D Structure

Ferumoxytol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
hydroxy(oxo)iron;iron
2.1.2 InChI
InChI=1S/3Fe.2H2O.2O/h;;;2*1H2;;/q;2*+1;;;;/p-2
2.1.3 InChI Key
UCNNJGDEJXIUCC-UHFFFAOYSA-L
2.1.4 Canonical SMILES
O[Fe]=O.O[Fe]=O.[Fe]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Bcp30643

2.3 Create Date
2011-02-18
3 Chemical and Physical Properties
Molecular Weight 233.55 g/mol
Molecular Formula Fe3H2O4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass233.800115 g/mol
Monoisotopic Mass233.800115 g/mol
Topological Polar Surface Area74.6 Ų
Heavy Atom Count7
Formal Charge0
Complexity10.3
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameFeraheme
PubMed HealthParenteral Mineral/Trace Mineral Combination (Injection)
Drug ClassesAnticonvulsant, Laxative, Hyperosmotic, Nutritive Agent, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
Drug LabelFeraheme, 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 IngredientFerumoxytol
Dosage FormSolution
RouteIntravenous
Strengtheq 510mg iron/17ml (eq 30mg iron/ml)
Market StatusPrescription
CompanyAmag Pharms

2 of 2  
Drug NameFeraheme
PubMed HealthParenteral Mineral/Trace Mineral Combination (Injection)
Drug ClassesAnticonvulsant, Laxative, Hyperosmotic, Nutritive Agent, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
Drug LabelFeraheme, 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 IngredientFerumoxytol
Dosage FormSolution
RouteIntravenous
Strengtheq 510mg iron/17ml (eq 30mg iron/ml)
Market StatusPrescription
CompanyAmag Pharms

API SUPPLIERS

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01

Rochem International Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Flag U.S.A
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Rochem

02

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024
Not Confirmed
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MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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AES 2024
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

Apicore LLC

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024
Not Confirmed
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Apicore LLC

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AES 2024
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024
Not Confirmed
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Lek Pharmaceuticals

Slovenia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AES 2024
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024
Not Confirmed
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Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
AES 2024
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Vijayasri Organics Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024
Not Confirmed
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USDMF

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01

Apicore Llc

India

USDMF

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AES 2024
Not Confirmed

01

Apicore Llc

India
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AES 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39032

Submission : 2023-10-24

Status : Active

Type : II

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02

Lek Pharmaceuticals Dd

Slovenia

USDMF

arrow
AES 2024
Not Confirmed

02

AES 2024
Not Confirmed

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

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03

AES 2024
Not Confirmed

03

AES 2024
Not Confirmed

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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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Flag U.S.A
Digital Content Digital Content

Ferumoxytol

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...

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-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
Rochem

02

Hetero Drugs

India
AES 2024
Not Confirmed
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Hetero Drugs

India
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AES 2024
Not Confirmed

Ferumoxytol

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...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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03

AES 2024
Not Confirmed
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AES 2024
Not Confirmed

Feraheme

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...

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 respectable place in the industry with proven expertise in manufacturing a wide spectrum of products. Vijayasri today is one of the prominent manufacturers of Active Pharmaceutical Ingredients (API) and intermediates. Our excellent Performance in Contract manufacturing over the years has also earned us the status of a trustable name in the pharmaceutical industry.
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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1644777000,"product":"BULK DRUG FERUMOXYTOL","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.75","actualQuantity":"750","unit":"GMS","unitRateFc":"30","totalValueFC":"22226.1","currency":"USD","unitRateINR":2221.3333333333335,"date":"14-Feb-2022","totalValueINR":"1666000","totalValueInUsd":"22226.1","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"8204675","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682533800,"product":"FERUMOXYTOL","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.31","actualQuantity":"0.31","unit":"KGS","unitRateFc":"30000","totalValueFC":"9236.9","currency":"USD","unitRateINR":2441935.4838709678,"date":"27-Apr-2023","totalValueINR":"757000","totalValueInUsd":"9236.9","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"9592757","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696876200,"product":"PHARMACEUTICAL RAW MATERIAL: FERUMOXYTOL","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"MERCANTILE BANK LIMITED","customerCountry":"BANGLADESH","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"30000","totalValueFC":"43566.4","currency":"USD","unitRateINR":2417333.3333333335,"date":"10-Oct-2023","totalValueINR":"3626000","totalValueInUsd":"43566.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4520862","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708367400,"product":"BULK DRUG FERUMOXYTOL BATCH NO. FRMX\/22\/11\/03","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"ODIN PHARMACEUTICALS LLC","customerCountry":"UNITED STATES","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"28000","totalValueFC":"6934.7","currency":"USD","unitRateINR":2301600,"date":"20-Feb-2024","totalValueINR":"575400","totalValueInUsd":"6934.7","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"7683523","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"PHARMACEUTICAL RAW MATERIAL: FERUMOXYTOL","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATE","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M\/S. RK PHARMA INC","customerCountry":"UNITED STATES","quantity":"23.53","actualQuantity":"23.53","unit":"KGS","unitRateFc":"12376.8","totalValueFC":"279582.5","currency":"USD","unitRateINR":998400,"date":"25-Oct-2024","totalValueINR":"23492352","totalValueInUsd":"279582.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5135854","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATE, VADODARA","customerAddress":""}]
14-Feb-2022
25-Oct-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
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Drugs in Development

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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

Therapeutic Area: Hematology Brand Name: Feraheme

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Covis Pharma

Deal Size: $647.0 million Upfront Cash: $647.0 million

Deal Type: Acquisition November 16, 2020

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01

AES 2024
Not Confirmed
AES 2024
Not Confirmed

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.

Brand Name : Feraheme

Molecule Type : Small molecule

Upfront Cash : $647.0 million

November 16, 2020

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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

Therapeutic Area: Hematology Brand Name: Feraheme

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Covis Pharma

Deal Size: $647.0 million Upfront Cash: $647.0 million

Deal Type: Acquisition October 01, 2020

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02

AES 2024
Not Confirmed
AES 2024
Not Confirmed

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...

Brand Name : Feraheme

Molecule Type : Small molecule

Upfront Cash : $647.0 million

October 01, 2020

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Digital Content read-more

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206604

FDA
20 Jan 2021

http://twofourinsight.com/analyzing-data-earliest-market-entry-subsequent-anda-filers/

TWOFOUR INSIGHT
12 Feb 2016

http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&id=2002105

Press Release AMAG PHARMACEUTICALS
29 Dec 2014

Global Sales Information

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Annual Reports

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Brand Name : Feraheme

Ferumoxytol

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Medlab Asia & Asia Health
Not Confirmed

Brand Name : Feraheme

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

Ferumoxytol

Main Therapeutic Indication : Hematology

Currency : USD

2019 Revenue in Millions : 168

2018 Revenue in Millions : 135

Growth (%) : 24

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