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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.

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

02

Apicore LLC

India

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

Duphat
Not Confirmed
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Apicore LLC

India

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

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

MSN Laboratories

India

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

Duphat
Not Confirmed
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MSN Laboratories

India

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

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Duphat
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

Duphat
Not Confirmed
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Lek Pharmaceuticals

Slovenia

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

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

Lupin Ltd

India

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

Duphat
Not Confirmed
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06

Vijayasri Organics Limited

India

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

Duphat
Not Confirmed
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07

Hetero Drugs

India

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

Duphat
Not Confirmed
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Hetero Drugs

India

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

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Duphat
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

Apicore Llc

India

USDMF

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PharmaVenue
Not Confirmed

01

Apicore Llc

India
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PharmaVenue
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

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PharmaVenue
Not Confirmed

02

PharmaVenue
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

PharmaVenue
Not Confirmed

03

PharmaVenue
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
Duphat
Not Confirmed
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Hetero Drugs

India
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Duphat
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

Lupin Ltd

India
Duphat
Not Confirmed
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Lupin Ltd

India
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Duphat
Not Confirmed

Ferumoxytol

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...

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 generics, biotechnology products, and active pharmaceutical ingredients. Known for its innovations, Lupin excels in therapeutic areas such as respiratory, cardiovascular, anti-diabetic, and more. With 15 advanced manufacturing facilities and 7 research centers worldwide, Lupin is driven by a dedicated workforce of over 22,000 professionals.
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04

Duphat
Not Confirmed
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Duphat
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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":"FERUMOXYTOL","year":"2021","qtr":"Q2","strtotime":1618511400,"product":"FERUMOXYTOL BATCH NO RD-503-014-065","address":"PLOT 121 GIDC MAKARPURA INDL.ESTATEMAKARPURA","city":"VADODARA","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"BUCARAMANGA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"ISRAEL","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"27.9","totalValueFC":"540","currency":"USD","unitRateINR":2010.1500000000001,"date":"16-Apr-2021","totalValueINR":"40203","totalValueInUsd":"540","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"1150642","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT 121 GIDC MAKARPURA INDL.ESTATEMAKARPURA, VADODARA","customerAddress":""},{"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":"8201026","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":"2022","qtr":"Q2","strtotime":1652898600,"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":"21931.6","currency":"USD","unitRateINR":2260,"date":"19-May-2022","totalValueINR":"1695000","totalValueInUsd":"21931.6","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"1485601","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":"2022","qtr":"Q4","strtotime":1669919400,"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":"NEW YORK","customer":"RK PHARMA INC","customerCountry":"UNITED STATES","quantity":"7.85","actualQuantity":"7.845","unit":"KGS","unitRateFc":"12000","totalValueFC":"91728.5","currency":"USD","unitRateINR":963543.6583811345,"date":"02-Dec-2022","totalValueINR":"7559000","totalValueInUsd":"91728.5","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"5893895","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","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":"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":""}]
16-Apr-2021
25-Oct-2024
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FDF Dossiers

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01

Pharmathen SA

Greece
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PharmaVenue
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Regulatory Info : USA

Registration Country : Greece

Ferumoxytol

Brand Name :

Dosage Form : Injection For Intravenous Use

Dosage Strength : 30MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

02

Covis Pharma

Luxembourg
PharmaVenue
Not Confirmed
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Covis Pharma

Luxembourg
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PharmaVenue
Not Confirmed

FERUMOXYTOL

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

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03

Sandoz B2B

Switzerland
PharmaVenue
Not Confirmed
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Sandoz B2B

Switzerland
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PharmaVenue
Not Confirmed

FERUMOXYTOL

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

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Pharmathen SA

Greece
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PharmaVenue
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Regulatory Info : USA

Registration Country : Greece

Ferumoxytol

Brand Name :

Dosage Form : Injection For Intraven...

Dosage Strength : 30MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

01

Pharmathen SA

Greece
arrow
PharmaVenue
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Digital Content Digital Content

Packaging :

Regulatory Info : USA

Ferumoxytol

Dosage : Injection For Intraven...

Dosage Strength : 30MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen
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ABOUT THIS PAGE

Ferumoxytol Manufacturers

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.

Ferumoxytol Suppliers

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.

Ferumoxytol USDMF

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 GMP

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.

Ferumoxytol CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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