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Chemistry

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Also known as: Iron(ii) fumarate, 141-01-5, Feostat, Palafer, Galfer, Ircon
Molecular Formula
C4H2FeO4
Molecular Weight
169.90  g/mol
InChI Key
PMVSDNDAUGGCCE-TYYBGVCCSA-L
FDA UNII
R5L488RY0Q

Ferrous Fumarate
Ferrous Fumarate is the fumarate salt form of the mineral iron. Administration of ferrous fumarate results in elevation of serum iron concentration, which is then assimilated into hemoglobin, required for the transport of oxygen, or trapped in the reticuloendothelial cells for storage. This agent is used as a dietary supplement, and to prevent or treat iron deficiency related syndromes.
1 2D Structure

Ferrous Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioate;iron(2+)
2.1.2 InChI
InChI=1S/C4H4O4.Fe/c5-3(6)1-2-4(7)8;/h1-2H,(H,5,6)(H,7,8);/q;+2/p-2/b2-1+;
2.1.3 InChI Key
PMVSDNDAUGGCCE-TYYBGVCCSA-L
2.1.4 Canonical SMILES
C(=CC(=O)[O-])C(=O)[O-].[Fe+2]
2.1.5 Isomeric SMILES
C(=C/C(=O)[O-])\C(=O)[O-].[Fe+2]
2.2 Other Identifiers
2.2.1 UNII
R5L488RY0Q
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Feostat

2. Ferrocap

3. Fersaday

4. Fersamal

5. Ferval

6. Fumar

7. Galfer

8. Ircon

9. Nephro-fer

10. Palafer

11. Rulofer N

2.3.2 Depositor-Supplied Synonyms

1. Iron(ii) Fumarate

2. 141-01-5

3. Feostat

4. Palafer

5. Galfer

6. Ircon

7. Ercoferro

8. Ferrofume

9. Tolferain

10. Cpiron

11. Hemoton

12. Toleron

13. Tolifer

14. Erco-fer

15. Ferrousfumarate

16. Iron(2+) Fumarate

17. Iron Fumarate

18. 2-butenedioic Acid (2e)-, Iron(2+) Salt (1:1)

19. Fumaric Acid, Iron(2+) Salt (1:1)

20. 2-butenedioic Acid (e)-, Iron(2+) Salt (1:1)

21. R5l488ry0q

22. 2-butenedioic Acid, (e)-, Iron(2+) Salt

23. Fersamal

24. Fumar

25. (e)-but-2-enedioate;iron(2+)

26. Feroton

27. Ferronat

28. Ferrone

29. Ferrotemp

30. Fumafer

31. Fumiron

32. Firon

33. One-iron

34. Fumar-f

35. Ferrocite

36. Fumaric Acid, Iron(2+) Salt

37. Ccris 6896

38. Einecs 205-447-7

39. Unii-r5l488ry0q

40. Ferrofumarate

41. Heferol

42. Orgasal

43. Ferrous Fumarate [usp:jan]

44. Feostat (tn)

45. Ferrum (tn)

46. Iron (as Fumarate)

47. Meterfer

48. Iron (as Ferrous Fumarate)

49. Schembl24284

50. Schembl24286

51. Ferrous Fumarate (jan/usp)

52. Ferrous Fumarate [ii]

53. Ferrous Fumarate [mi]

54. Ferrous Fumarate [fcc]

55. Ferrous Fumarate [jan]

56. Ferrous Fumarate [inci]

57. Dtxsid7047148

58. Ferrous Fumarate [vandf]

59. Chebi:31607

60. Amy8976

61. Ferrous Fumarate [mart.]

62. Ferrous Fumarate [who-dd]

63. Ferrous Fumarate [who-ip]

64. Hy-b1651

65. Einecs 231-731-5

66. Mfcd00058315

67. Akos015918237

68. Ferrous Fumarate [orange Book]

69. Db14491

70. Ferrosi Fumaras [who-ip Latin]

71. Ferrous Fumarate [ep Monograph]

72. Ferrous Fumarate [usp Monograph]

73. Iron (as Ferrous Fumarate) [vandf]

74. 2-butenedioic Acid (2e)-, Iron(2+) Salt

75. Cs-0013603

76. Norquest Fe Component Ferrous Fumarate

77. D01194

78. Ferrous Fumarate Component Of Norquest Fe

79. Lo Minastrin Fe Component Ferrous Fumarate

80. Minastrin 24 Fe Component Ferrous Fumarate

81. Q416370

82. 2-butenedioic Acid (2e)-, Iron(2+) Salt (1:?)

83. J-007445

84. J-521364

85. 7705-12-6

2.4 Create Date
2006-04-28
3 Chemical and Physical Properties
Molecular Weight 169.90 g/mol
Molecular Formula C4H2FeO4
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass169.930244 g/mol
Monoisotopic Mass169.930244 g/mol
Topological Polar Surface Area80.3 Ų
Heavy Atom Count9
Formal Charge0
Complexity108
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameFerrous fumarate
Active IngredientFerrous fumarate
Dosage FormTablet
Routeoral
Strength75mg
Market StatusTentative Approval
CompanyBarr Labs

2 of 2  
Drug NameFerrous fumarate
Active IngredientFerrous fumarate
Dosage FormTablet
Routeoral
Strength75mg
Market StatusTentative Approval
CompanyBarr Labs

4.2 Drug Indication

Used in preventing and treating iron-deficiency anemia.


5 Pharmacology and Biochemistry
5.1 Pharmacology

The major activity of supplemental iron is in the prevention and treatment of iron deficiency anemia. Iron has putative immune-enhancing, anticarcinogenic and cognition-enhancing activities.


5.2 MeSH Pharmacological Classification

Trace Elements

A group of chemical elements that are needed in minute quantities for the proper growth, development, and physiology of an organism. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) (See all compounds classified as Trace Elements.)


5.3 ATC Code

B - Blood and blood forming organs

B03 - Antianemic preparations

B03A - Iron preparations

B03AA - Iron bivalent, oral preparations

B03AA02 - Ferrous fumarate


B - Blood and blood forming organs

B03 - Antianemic preparations

B03A - Iron preparations

B03AD - Iron in combination with folic acid

B03AD02 - Ferrous fumarate


5.4 Absorption, Distribution and Excretion

Absorption

The efficiency of absorption depends on the salt form, the amount administered, the dosing regimen and the size of iron stores. Subjects with normal iron stores absorb 10% to 35% of an iron dose. Those who are iron deficient may absorb up to 95% of an iron dose.


5.5 Mechanism of Action

Iron is necessary for the production of hemoglobin. Iron-deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia.


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LTD","customerCountry":"INDIA","quantity":"1300.00","actualQuantity":"1300","unit":"KGS","unitRateFc":"15.9","totalValueFC":"20830.3","currency":"USD","unitRateINR":"1334.3","date":"03-Nov-2023","totalValueINR":"1734554","totalValueInUsd":"20830.3","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29171990","bill_no":"1003105","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699295400,"product":"(RE-IMPORT ) FERROUS FUMARATE BP VIDE SB NO. 2564903 DT. 19.07.2023 BATCH NOS. 23070250, 23070251, 23070252, 23070253, M","address":"4, PODAR CHAMBERS, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA","supplier":"BANG TRADING 1992 CO","supplierCountry":"INDIA","foreign_port":"LAEM CHABANG","customer":"INDOSOL EXPORTS","customerCountry":"INDIA","quantity":"8000.00","actualQuantity":"8000","unit":"KGS","unitRateFc":"2","totalValueFC":"16177.5","currency":"USD","unitRateINR":"168.4","date":"07-Nov-2023","totalValueINR":"1347118.08","totalValueInUsd":"16177.5","indian_port":"JNPT","hs_no":"29171940","bill_no":"8660629","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"999\/99 4TH FLOOR,BANG TRADING GROUPBUILDING,RAMA 9 ROAD,SUANLUANG,BANGKOK 10250,THAILAND Thailand","customerAddress":"4, PODAR CHAMBERS, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699295400,"product":"(RE-IMPORT ) FERROUS FUMARATE BP VIDE SB NO. 2850617 DT. 31.07.2023 BATCH NOS. 23070265, 23070266, 23070267, 23070270, M","address":"4, PODAR CHAMBERS, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA","supplier":"BANG TRADING 1992 CO","supplierCountry":"INDIA","foreign_port":"LAEM CHABANG","customer":"INDOSOL EXPORTS","customerCountry":"INDIA","quantity":"7000.00","actualQuantity":"7000","unit":"KGS","unitRateFc":"2","totalValueFC":"14155.3","currency":"USD","unitRateINR":"168.4","date":"07-Nov-2023","totalValueINR":"1178728.32","totalValueInUsd":"14155.3","indian_port":"JNPT","hs_no":"29171940","bill_no":"8660629","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"999\/99 4TH FLOOR,BANG TRADING GROUPBUILDING,RAMA 9 ROAD,SUANLUANG,BANGKOK 10250,THAILAND Thailand","customerAddress":"4, PODAR CHAMBERS, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704997800,"product":"FERROUS FUMARATE","address":"129\/1\/A,GIDC ESTATE, NANDESARI","city":"NANDESARI, DIST.BARODA.","supplier":"REYOUNG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SUDEEP PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"3.8","totalValueFC":"19006.8","currency":"USD","unitRateINR":"315.9","date":"12-Jan-2024","totalValueINR":"1579687.5","totalValueInUsd":"19006.8","indian_port":"JNPT","hs_no":"29171940","bill_no":"9645811","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"NO. 1 RUIYANG ROAD,YIYUAN COUNTY,SHANDONG PROVINCE, CHINA","customerAddress":"129\/1\/A,GIDC ESTATE, NANDESARI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707849000,"product":"FERROUS FUMARATE POWDER PH.EUR 11 ED USP-NF 2023(CAS NO 141-01-5)AS PER INVOICE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"DR PAUL LOHMANN GMBH CO KGAA","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"800.00","actualQuantity":"800","unit":"KGS","unitRateFc":"16.2","totalValueFC":"13093.6","currency":"USD","unitRateINR":"1358","date":"14-Feb-2024","totalValueINR":"1086426","totalValueInUsd":"13093.6","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29171990","bill_no":"1000481","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719599400,"product":"FERROUS FUMARATE","address":"FIRST FLOOR, ELEGANCE TOWER,","city":"COMMERCIAL CENTRE, JASOLA NEW DELHI","supplier":"ACCESS BUSINESS GROUP INTERNATIONAL LLC","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"AMWAY INDIA ENTERPRISES PRIVATE LTD","customerCountry":"INDIA","quantity":"423.98","actualQuantity":"423.98","unit":"KGS","unitRateFc":"1640.4","totalValueFC":"8493.8","currency":"INR","unitRateINR":"1672.4","date":"29-Jun-2024","totalValueINR":"709061.65","totalValueInUsd":"8493.8","indian_port":"JNPT","hs_no":"29171940","bill_no":"4245252","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"7575 FULTON STREET EAST ADA MI 49355 UNITED STATES Fulton, , UNITED STATES UNITED STATES","customerAddress":"FIRST FLOOR, ELEGANCE TOWER,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"FERROUS FUMARATE FERROUS FUMARATE","address":"N\/A","city":"","supplier":"WINCERA AG","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"KHADRI PHARMA LLP","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"10.8","totalValueFC":"2184.9","currency":"USD","unitRateINR":"928.3","date":"27-Dec-2024","totalValueINR":"185652","totalValueInUsd":"2184.9","indian_port":"Hyderabad Air","hs_no":"29171940","bill_no":"7490116","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"QUADERSTRASSE 11 7000 CHUR SDNF CH","customerAddress":"N\/A"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736965800,"product":"FERROUS FUMARATE POWDER, PH.EUR.11 ED. USP NFBATCH NO.3150785","address":"Plot No.564\/A\/22 ,\u00a0 Road No.92,Jubilee Hills ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096","city":"","supplier":"DRPAUL LOHMANN GMBH COKGAA","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"SENADOR LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"19.2","totalValueFC":"9645.4","currency":"USD","unitRateINR":"1663.4","date":"16-Jan-2025","totalValueINR":"831713.75","totalValueInUsd":"9645.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29171940","bill_no":"7808875","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"Haupstrabe 2 Emmerthal SDNF Germany","customerAddress":"Plot No.564\/A\/22 ,\u00a0 Road No.92,Jubilee Hills ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"FERROUS FUMARATE FERROUS FUMARATE","address":"FIRST FLOOR, ELEGANCE TOWER,","city":"COMMERCIAL CENTRE, JASOLA NEW DELHI","supplier":"ACCESS BUSINESS GROUP INTERNATIONAL LLC","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"AMWAY INDIA ENTERPRISES PRIVATE LTD","customerCountry":"INDIA","quantity":"124.70","actualQuantity":"124.7","unit":"KGS","unitRateFc":"22.1","totalValueFC":"2758.5","currency":"INR","unitRateINR":"1923.7","date":"03-Feb-2025","totalValueINR":"239887.83","totalValueInUsd":"2758.5","indian_port":"Bombay Air","hs_no":"29171940","bill_no":"8154076","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"7575 FULTON STREET EAST ADA MI 4935 5 UNITED STATES Fulton, , UNITED ST ATES UNITED STATES","customerAddress":"FIRST FLOOR, ELEGANCE TOWER,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"( FOR R & D PURPOSE ) FERROUS FUMARATE POWDER (TL # TL\/WZ\/23\/001567)( FOR R & D PURPOSE ) FERROUS FUMARATE POWDER (TL # TL\/WZ\/23","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"DR PAUL LOHMANN GMBH CO KGAA","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"WOCKHARDT LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"46.8","totalValueFC":"1180.8","currency":"EURO","unitRateINR":"4107.4","date":"24-Feb-2025","totalValueINR":"102683.75","totalValueInUsd":"1180.8","indian_port":"Bombay Air","hs_no":"29171990","bill_no":"8537542","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HAUPTSTRASSE 2 D-31860 EMMERTHAL G ERMANY SDNF Germany","customerAddress":"WOCKHARDT TOWERS, BANDRA KURLA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745260200,"product":"FERROUS FUMARATE FERROUS FUMARATE","address":"FIRST FLOOR, ELEGANCE TOWER,","city":"COMMERCIAL CENTRE, JASOLA NEW DELHI","supplier":"ACCESS BUSINESS GROUP INTERNATIONAL LLC","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"AMWAY INDIA ENTERPRISES PRIVATE LTD","customerCountry":"INDIA","quantity":"124.70","actualQuantity":"124.7","unit":"KGS","unitRateFc":"20","totalValueFC":"2514.7","currency":"INR","unitRateINR":"1726.2","date":"22-Apr-2025","totalValueINR":"215263.09","totalValueInUsd":"2514.7","indian_port":"JNPT","hs_no":"29171940","bill_no":"9634781","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"7575 FULTON STREET EAST ADA MI 4935 5 UNITED STATES Fulton, , UNITED ST ATES UNITED STATES","customerAddress":"FIRST FLOOR, ELEGANCE TOWER,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745951400,"product":"FERROUS FUMARATE POWDER PH.EUR.11 ED. 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ABOUT THIS PAGE

Looking for 141-01-5 / Ferrous Fumarate API manufacturers, exporters & distributors?

Ferrous Fumarate manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Ferrous Fumarate 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 Ferrous Fumarate manufacturer or Ferrous Fumarate supplier for your needs.

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

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

API | Excipient name

Ferrous Fumarate

Synonyms

Iron(ii) fumarate, 141-01-5, Feostat, Palafer, Galfer, Ircon

Cas Number

141-01-5

Unique Ingredient Identifier (UNII)

R5L488RY0Q

About Ferrous Fumarate

Ferrous Fumarate is the fumarate salt form of the mineral iron. Administration of ferrous fumarate results in elevation of serum iron concentration, which is then assimilated into hemoglobin, required for the transport of oxygen, or trapped in the reticuloendothelial cells for storage. This agent is used as a dietary supplement, and to prevent or treat iron deficiency related syndromes.

Ferrotemp Manufacturers

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

Ferrotemp Suppliers

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

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

Ferrotemp USDMF

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

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

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

Ferrotemp 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 Ferrotemp Drug Master File in Japan (Ferrotemp JDMF) empowers Ferrotemp 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 Ferrotemp JDMF during the approval evaluation for pharmaceutical products. At the time of Ferrotemp 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 Ferrotemp suppliers with JDMF on PharmaCompass.

Ferrotemp CEP

A Ferrotemp CEP of the European Pharmacopoeia monograph is often referred to as a Ferrotemp Certificate of Suitability (COS). The purpose of a Ferrotemp CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ferrotemp EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ferrotemp to their clients by showing that a Ferrotemp CEP has been issued for it. The manufacturer submits a Ferrotemp CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ferrotemp CEP holder for the record. Additionally, the data presented in the Ferrotemp CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ferrotemp DMF.

A Ferrotemp CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ferrotemp CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Ferrotemp suppliers with CEP (COS) on PharmaCompass.

Ferrotemp 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 Ferrotemp as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ferrotemp 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 Ferrotemp 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 Ferrotemp and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferrotemp NDC to their finished compounded human drug products, they may choose to do so.

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

Ferrotemp GMP

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

Ferrotemp CoA

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

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

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