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1. Feostat
2. Ferrocap
3. Fersaday
4. Fersamal
5. Ferval
6. Fumar
7. Galfer
8. Ircon
9. Nephro-fer
10. Palafer
11. Rulofer N
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
| Molecular Weight | 169.90 g/mol |
|---|---|
| Molecular Formula | C4H2FeO4 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 0 |
| Exact Mass | 169.930244 g/mol |
| Monoisotopic Mass | 169.930244 g/mol |
| Topological Polar Surface Area | 80.3 Ų |
| Heavy Atom Count | 9 |
| Formal Charge | 0 |
| Complexity | 108 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Ferrous fumarate |
| Active Ingredient | Ferrous fumarate |
| Dosage Form | Tablet |
| Route | oral |
| Strength | 75mg |
| Market Status | Tentative Approval |
| Company | Barr Labs |
| 2 of 2 | |
|---|---|
| Drug Name | Ferrous fumarate |
| Active Ingredient | Ferrous fumarate |
| Dosage Form | Tablet |
| Route | oral |
| Strength | 75mg |
| Market Status | Tentative Approval |
| Company | Barr Labs |
Used in preventing and treating iron-deficiency anemia.
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.
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.)
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
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.
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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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29276
Submission : 2015-03-25
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 33135
Submission : 2018-11-23
Status : Active
Type : IV
GDUFA
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DMF Number : 34498
Submission : 2021-02-12
Status : Active
Type : II
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DMF Number : 17321
Submission : 2004-04-16
Status : Inactive
Type : II
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DMF Number : 211
Submission : 1940-01-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24184
Submission : 2010-09-13
Status : Inactive
Type : IV
Certificate Number : R0-CEP 2010-147 - Rev 00
Issue Date : 2012-02-22
Type : Chemical
Substance Number : 902
Status : Withdrawn by EDQM F...
Certificate Number : R1-CEP 2012-400 - Rev 00
Issue Date : 2020-02-19
Type : Chemical
Substance Number : 902
Status : Valid
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Dosage Form : Capsule
Grade : Oral
Application : Solubilizers
Excipient Details : L-Lysine acetate is used as a solubilizer in capsules along with other oral solid dosage forms.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 206.24 g/mol
Ingredient(s) : L-Lysine Acetate
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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.
A Palafer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palafer, including repackagers and relabelers. The FDA regulates Palafer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palafer 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 Palafer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Palafer supplier is an individual or a company that provides Palafer active pharmaceutical ingredient (API) or Palafer finished formulations upon request. The Palafer suppliers may include Palafer API manufacturers, exporters, distributors and traders.
click here to find a list of Palafer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Palafer DMF (Drug Master File) is a document detailing the whole manufacturing process of Palafer active pharmaceutical ingredient (API) in detail. Different forms of Palafer DMFs exist exist since differing nations have different regulations, such as Palafer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Palafer DMF submitted to regulatory agencies in the US is known as a USDMF. Palafer USDMF includes data on Palafer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Palafer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Palafer suppliers with USDMF on PharmaCompass.
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 Palafer Drug Master File in Japan (Palafer JDMF) empowers Palafer 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 Palafer JDMF during the approval evaluation for pharmaceutical products. At the time of Palafer 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 Palafer suppliers with JDMF on PharmaCompass.
A Palafer CEP of the European Pharmacopoeia monograph is often referred to as a Palafer Certificate of Suitability (COS). The purpose of a Palafer CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Palafer EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Palafer to their clients by showing that a Palafer CEP has been issued for it. The manufacturer submits a Palafer CEP (COS) as part of the market authorization procedure, and it takes on the role of a Palafer CEP holder for the record. Additionally, the data presented in the Palafer CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Palafer DMF.
A Palafer CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Palafer 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 Palafer suppliers with CEP (COS) on PharmaCompass.
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 Palafer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Palafer API and other APIs are published in this directory by the FDA.
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 Palafer 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.
The NDC directory also contains data on finished compounded human drug products that contain Palafer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Palafer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Palafer suppliers with NDC on PharmaCompass.
Palafer 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 Palafer 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 Palafer GMP manufacturer or Palafer GMP API supplier for your needs.
A Palafer CoA (Certificate of Analysis) is a formal document that attests to Palafer's compliance with Palafer specifications and serves as a tool for batch-level quality control.
Palafer CoA mostly includes findings from lab analyses of a specific batch. For each Palafer 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.
Palafer may be tested according to a variety of international standards, such as European Pharmacopoeia (Palafer EP), Palafer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Palafer USP).
