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Chemistry

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Also known as: 9007-72-1, Ex-a3450, (2s,3s,4s,5r)-4-[(2r,3r,4r,5s,6r)-5-[(2r,3r,4r,5s,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate
Molecular Formula
C24H44FeO25-
Molecular Weight
788.4  g/mol
InChI Key
MFBBZTDYOYZJGB-HAONTEFVSA-L

Ferric Carboxymaltose
Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.
1 2D Structure

Ferric Carboxymaltose

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3S,4S,5R)-4-[(2R,3R,4R,5S,6R)-5-[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate
2.1.2 InChI
InChI=1S/C24H42O22.Fe.2H2O.O/c25-1-5(29)18(11(32)14(35)21(39)40)44-23-16(37)12(33)20(7(3-27)42-23)46-24-17(38)13(34)19(8(4-28)43-24)45-22-15(36)10(31)9(30)6(2-26)41-22;;;;/h5-20,22-38H,1-4H2,(H,39,40);;2*1H2;/q;+3;;;-2/p-2/t5-,6-,7-,8-,9-,10+,11+,12-,13-,14+,15-,16-,17-,18+,19-,20-,22-,23-,24-;;;;/m1..../s1
2.1.3 InChI Key
MFBBZTDYOYZJGB-HAONTEFVSA-L
2.1.4 Canonical SMILES
C(C1C(C(C(C(O1)OC2C(OC(C(C2O)O)OC3C(OC(C(C3O)O)OC(C(CO)O)C(C(C(=O)[O-])O)O)CO)CO)O)O)O)O.O.[OH-].[O-2].[Fe+3]
2.1.5 Isomeric SMILES
C([C@@H]1[C@H]([C@@H]([C@H]([C@H](O1)O[C@@H]2[C@H](O[C@@H]([C@@H]([C@H]2O)O)O[C@@H]3[C@H](O[C@@H]([C@@H]([C@H]3O)O)O[C@@H]([C@@H](CO)O)[C@H]([C@@H](C(=O)[O-])O)O)CO)CO)O)O)O)O.O.[OH-].[O-2].[Fe+3]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Ferinject

2. Injectafer

3. Iron Carboxymaltose

4. Iron Dextri-maltose

5. Polynuclear Iron (iii)-hydroxide 4(r)-(poly-(1->4)-o-alpha-d-glucopyranosyl)-oxy-2(r),3(s),5(r), 6-tetrahydroxy-hexanoate

6. Vit 45

7. Vit-45

2.2.2 Depositor-Supplied Synonyms

1. 9007-72-1

2. Ex-a3450

3. (2s,3s,4s,5r)-4-[(2r,3r,4r,5s,6r)-5-[(2r,3r,4r,5s,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate

2.3 Create Date
2014-11-22
3 Chemical and Physical Properties
Molecular Weight 788.4 g/mol
Molecular Formula C24H44FeO25-
Hydrogen Bond Donor Count16
Hydrogen Bond Acceptor Count25
Rotatable Bond Count13
Exact Mass788.152102 g/mol
Monoisotopic Mass788.152102 g/mol
Topological Polar Surface Area382 Ų
Heavy Atom Count50
Formal Charge-1
Complexity940
Isotope Atom Count0
Defined Atom Stereocenter Count19
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count5
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameInjectafer
PubMed Healthferric carboxymaltose
Drug ClassesIron Supplement
Drug LabelFerric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(14)-O--D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative mo...
Active IngredientFerric carboxymaltose
Dosage FormInjectable
RouteIntravenous
Strength750mg iron/15ml (50mg iron/ml)
Market StatusPrescription
CompanyLuitpold
Patent7612109; 7754702

2 of 2  
Drug NameInjectafer
PubMed Healthferric carboxymaltose
Drug ClassesIron Supplement
Drug LabelFerric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(14)-O--D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative mo...
Active IngredientFerric carboxymaltose
Dosage FormInjectable
RouteIntravenous
Strength750mg iron/15ml (50mg iron/ml)
Market StatusPrescription
CompanyLuitpold
Patent7612109; 7754702

4.2 Drug Indication

Ferric carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

When measured using positron emission tomography (PET), the red cell uptake of 59-Fe and 52-Fe from INJECTAFER ranged from 61% to 99%. In patients with iron deficiency, the red cell uptake ranged from 91% to 99%. In patients with renal anemia, the red cell uptake ranged from 61% to 84%.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Parenteral Iron Replacement [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Iron [CS]
5.3 Absorption, Distribution and Excretion

Absorption

When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 g/mL to 333 g/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).


Route of Elimination

Renal elimination of iron was negligible.


Volume of Distribution

3 L


5.4 Biological Half-Life

7 to 12 hours.


5.5 Mechanism of Action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.


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TELANGANA,? 500096, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737657000,"product":"FERRIC CARBOXYMALTOSE IH (FCA)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CT0-SEZ -PROCESS UNIT1 DRREDDYS LABORATORIES LT","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"XXP IXXUSTXXA DXXALIXXNTOXXLTDX","customerCountry":"BRAZIL","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7000","totalValueFC":"6932.7","currency":"USD","unitRateINR":597800,"date":"24-Jan-2025","totalValueINR":"597800","totalValueInUsd":"6932.7","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29334100","bill_no":"4000013","productDescription":"API","marketType":"","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Reddy r-SEZ\/Srikakulam","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"FERRIC CARBOXYMALTOSE IH (FCA)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"CT0-SEZ -PROCESS UNIT1 DRREDDYS LABORATORIES LT","supplierCountry":"INDIA","foreign_port":"RIYADH","customer":"AJA PHARMA","customerCountry":"SAUDI ARABIA","quantity":"47.00","actualQuantity":"47","unit":"KGS","unitRateFc":"4506.9","totalValueFC":"209336.8","currency":"USD","unitRateINR":385792.42553191487,"date":"29-Mar-2025","totalValueINR":"18132244","totalValueInUsd":"209336.8","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29334100","bill_no":"4000057","productDescription":"API","marketType":"","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Reddy r-SEZ\/Srikakulam","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670869800,"product":"6904070 FERRIC CARBOXYMALTOSE, (BATCH NO: A22456L)","address":"SPARC TANDALJA","city":"VADODARA","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"25000","totalValueFC":"26135.8","currency":"EURO","unitRateINR":"2153750","date":"13-Dec-2022","totalValueINR":"2153750","totalValueInUsd":"26135.8","indian_port":"DELHI AIR","hs_no":"29400000","bill_no":"3723659","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC TANDALJA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670869800,"product":"6904070 FERRIC CARBOXYMALTOSE, (BATCH NO: A22457L)","address":"SPARC TANDALJA","city":"VADODARA","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"25000","totalValueFC":"3920.4","currency":"EURO","unitRateINR":"2153750","date":"13-Dec-2022","totalValueINR":"323062.5","totalValueInUsd":"3920.4","indian_port":"DELHI AIR","hs_no":"29400000","bill_no":"3723659","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SPARC TANDALJA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698863400,"product":"6904070 FERRIC CARBOXYMALTOSE (BATCH NO: A23349L)","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"18000","totalValueFC":"19314.1","currency":"EURO","unitRateINR":"1608300","date":"02-Nov-2023","totalValueINR":"1608300","totalValueInUsd":"19314.1","indian_port":"Bombay Air","hs_no":"29400000","bill_no":"8594190","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"FERRIC CARBOXYMALTOSE - 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27-Jan-2022
25-Apr-2025
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ABOUT THIS PAGE

Looking for 9007-72-1 / Ferric Carboxymaltose API manufacturers, exporters & distributors?

Ferric Carboxymaltose manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ferric Carboxymaltose 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 Ferric Carboxymaltose manufacturer or Ferric Carboxymaltose supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferric Carboxymaltose manufacturer or Ferric Carboxymaltose supplier.

PharmaCompass also assists you with knowing the Ferric Carboxymaltose API Price utilized in the formulation of products. Ferric Carboxymaltose API Price is not always fixed or binding as the Ferric Carboxymaltose Price is obtained through a variety of data sources. The Ferric Carboxymaltose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ferric Carboxymaltose

Synonyms

9007-72-1, Ex-a3450, (2s,3s,4s,5r)-4-[(2r,3r,4r,5s,6r)-5-[(2r,3r,4r,5s,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate

Cas Number

9007-72-1

About Ferric Carboxymaltose

Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.

Injectafer Manufacturers

A Injectafer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Injectafer, including repackagers and relabelers. The FDA regulates Injectafer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Injectafer 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 Injectafer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Injectafer Suppliers

A Injectafer supplier is an individual or a company that provides Injectafer active pharmaceutical ingredient (API) or Injectafer finished formulations upon request. The Injectafer suppliers may include Injectafer API manufacturers, exporters, distributors and traders.

click here to find a list of Injectafer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Injectafer USDMF

A Injectafer DMF (Drug Master File) is a document detailing the whole manufacturing process of Injectafer active pharmaceutical ingredient (API) in detail. Different forms of Injectafer DMFs exist exist since differing nations have different regulations, such as Injectafer USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Injectafer DMF submitted to regulatory agencies in the US is known as a USDMF. Injectafer USDMF includes data on Injectafer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Injectafer USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Injectafer suppliers with USDMF on PharmaCompass.

Injectafer JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Injectafer Drug Master File in Japan (Injectafer JDMF) empowers Injectafer API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Injectafer JDMF during the approval evaluation for pharmaceutical products. At the time of Injectafer JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Injectafer suppliers with JDMF on PharmaCompass.

Injectafer KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Injectafer Drug Master File in Korea (Injectafer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Injectafer. The MFDS reviews the Injectafer KDMF as part of the drug registration process and uses the information provided in the Injectafer KDMF to evaluate the safety and efficacy of the drug.

After submitting a Injectafer KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Injectafer API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Injectafer suppliers with KDMF on PharmaCompass.

Injectafer WC

A Injectafer written confirmation (Injectafer WC) is an official document issued by a regulatory agency to a Injectafer manufacturer, verifying that the manufacturing facility of a Injectafer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Injectafer APIs or Injectafer finished pharmaceutical products to another nation, regulatory agencies frequently require a Injectafer WC (written confirmation) as part of the regulatory process.

click here to find a list of Injectafer suppliers with Written Confirmation (WC) on PharmaCompass.

Injectafer NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Injectafer as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Injectafer API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Injectafer as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Injectafer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Injectafer NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Injectafer suppliers with NDC on PharmaCompass.

Injectafer GMP

Injectafer 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 Injectafer 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 Injectafer GMP manufacturer or Injectafer GMP API supplier for your needs.

Injectafer CoA

A Injectafer CoA (Certificate of Analysis) is a formal document that attests to Injectafer's compliance with Injectafer specifications and serves as a tool for batch-level quality control.

Injectafer CoA mostly includes findings from lab analyses of a specific batch. For each Injectafer 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.

Injectafer may be tested according to a variety of international standards, such as European Pharmacopoeia (Injectafer EP), Injectafer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Injectafer 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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