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1. Accrufer
2. Iron (iii) Maltol
3. Iron(3+) Tris(2-methyl-4-oxo-4h-pyran-3-olate)
1. 33725-54-1
2. Iron (iii) Maltol
3. Ferric Maltol [inn]
4. Ferric Maltol [usan]
5. St10
6. Ma10qyf1z0
7. Iron(3+);2-methyl-4-oxopyran-3-olate
8. Iron(iii) 2-methyl-4-oxo-4h-pyran-3-olate
9. St10-021
10. Iron Maltol
11. Feraccru (tn)
12. Unii-ma10qyf1z0
13. Ferric Maltol [mi]
14. Ferric Maltol (usan/inn)
15. Ferric Maltol [usan:inn]
16. Ferric Maltol [who-dd]
17. St-10
18. Ferric Maltol [orange Book]
19. Who 9974
20. Db15598
21. Iron(iii)2-methyl-4-oxo-4h-pyran-3-olate
22. D10833
23. E83926
24. Q27283748
25. Iron, Tris(3-hydroxy-2-methyl-4h-pyran-4-onato-o3,o4)-
26. Iron, Tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)-
27. Tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)iron(iii)
| Molecular Weight | 431.2 g/mol |
|---|---|
| Molecular Formula | C18H15FeO9 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 0 |
| Exact Mass | 431.006543 g/mol |
| Monoisotopic Mass | 431.006543 g/mol |
| Topological Polar Surface Area | 148 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 200 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 4 |
Ferric maltol is indicated to treat iron deficiency in adults.
Feraccru is indicated in adults for the treatment of iron deficiency.
Treatment of iron deficiency
Ferric maltol is used to provide supplemental iron to patients with an iron deficiency. It has a wide therapeutic index as patients generally take 30mg twice daily, while concentrations of 20mg/kg may produce toxicity. Patients should be counselled regarding the risk of inflammatory bowel disease flares, iron overload, and accidental ingestion in children.
Hematinics
Agents which improve the quality of the blood, increasing the hemoglobin level and the number of erythrocytes. They are used in the treatment of anemias. (See all compounds classified as Hematinics.)
B03AB
B - Blood and blood forming organs
B03 - Antianemic preparations
B03A - Iron preparations
B03AB - Iron trivalent, oral preparations
B03AB10 - Ferric maltol
Absorption
Ferric maltol dissociates in the gastrointestinal tract, leading to a Tmax of 1.5-3.0 hours for iron concentrations. Mean serum iron increases by 146mol/L in iron deficient patients following a single dose. a 60mg dose is approximately 14% bioavailable. 60 minutes after injection of radiolabelled ferric maltol, 11+2% of the dose is present in the bone marrow, 181% is present in the liver, and 2.61% is in the urine. Maltol has an AUC of 0.022-0.205h\*g/mL and maltol glucuronide has an AUC of 9.83-30.9h\*g/mL.
Route of Elimination
39.8-60% of an oral dose of ferric maltol is excreted in the urine as a glucuronide conjugate. Iron and ferric maltol are not excreted in the urine and unabsorbed ferric maltol is eliminated in the feces.
Volume of Distribution
Data regarding the volume of distribution of ferric maltol is not readily available.
Clearance
Data regarding the clearance of ferric maltol is not readily available.
_In vitro_, ferric maltol metabolism is predominantly glucuronidation of maltol by UGT1A6 and sulfation.
Maltol has a half life of 0.7h.
Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin.
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A Ferric Maltol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Maltol, including repackagers and relabelers. The FDA regulates Ferric Maltol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Maltol 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 Ferric Maltol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferric Maltol supplier is an individual or a company that provides Ferric Maltol active pharmaceutical ingredient (API) or Ferric Maltol finished formulations upon request. The Ferric Maltol suppliers may include Ferric Maltol API manufacturers, exporters, distributors and traders.
click here to find a list of Ferric Maltol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Ferric Maltol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ferric Maltol 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 Ferric Maltol 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 Ferric Maltol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric Maltol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ferric Maltol suppliers with NDC on PharmaCompass.
Ferric Maltol 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 Ferric Maltol 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 Ferric Maltol GMP manufacturer or Ferric Maltol GMP API supplier for your needs.
A Ferric Maltol CoA (Certificate of Analysis) is a formal document that attests to Ferric Maltol's compliance with Ferric Maltol specifications and serves as a tool for batch-level quality control.
Ferric Maltol CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Maltol 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.
Ferric Maltol may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Maltol EP), Ferric Maltol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Maltol USP).
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