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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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,UNIVERSAL MAJESTIC, P L LOKHANDE MARG CHEMBUR,MAHARASHTPIN-400071"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691433000,"product":"FERROUS FUMARATE BP PHARMACEUTICAL BULK DRUG HARMLESS MEDICAL POWDER ACTIVE PHARMA INGREDIENTSALLO PATHIC RE-IMPORTS","address":"1209,1210,1211,CABIN A,12TH FLOOR, ,UNIVERSAL MAJESTIC, P L LOKHANDE MARG CHEMBUR,MAHARASHTPIN-400071","city":"CHEMBUR","supplier":"REYOUNG PHARMACEUTICAL CO LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"AQUATIC REMEDIES LTD","customerCountry":"INDIA","quantity":"8000.00","actualQuantity":"8000","unit":"KGS","unitRateFc":"3.9","totalValueFC":"31856.4","currency":"USD","unitRateINR":"326.6","date":"08-Aug-2023","totalValueINR":"2638869.948","totalValueInUsd":"31856.4","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29171940","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1209,1210,1211,CABIN A,12TH FLOOR, ,UNIVERSAL MAJESTIC, P L LOKHANDE MARG CHEMBUR,MAHARASHTPIN-400071"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700591400,"product":"FERROUS FUMARATE POWDER, PH.EUR.ED.USP-NF-2023 (BATCH NO.3133548)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"DRPAUL LOHMANN GMBH CO KGAA","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"20.7","totalValueFC":"10467.3","currency":"USD","unitRateINR":"1743.3","date":"22-Nov-2023","totalValueINR":"871625","totalValueInUsd":"10467.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29171940","bill_no":"1004710","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"N\/A","customerAddress":"564\/A\/22, ROAD NO.92"},{"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":1712514600,"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":"399.04","actualQuantity":"399.04","unit":"KGS","unitRateFc":"1640.4","totalValueFC":"8160.6","currency":"INR","unitRateINR":"1707.8","date":"08-Apr-2024","totalValueINR":"681472.4","totalValueInUsd":"8160.6","indian_port":"JNPT","hs_no":"29171940","bill_no":"2933549","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":"Q2","strtotime":1714069800,"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":"399.04","actualQuantity":"399.04","unit":"KGS","unitRateFc":"1640.4","totalValueFC":"8160.6","currency":"INR","unitRateINR":"1707.8","date":"26-Apr-2024","totalValueINR":"681472.4","totalValueInUsd":"8160.6","indian_port":"JNPT","hs_no":"29171940","bill_no":"3216295","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":"Q2","strtotime":1718735400,"product":"FERROUS FUMARATE POWDER, PH EUR 11 EDBATCH NO:3144130 (FOR LAB R & D USES ONLY)","address":"NO.22, 7TH CROSS, MUDDAPPA","city":"BANGALORE","supplier":"DRPAUL LOHMANN GMBH COKGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"LYRUS LIFE SCIENCES PRIVATE LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"144.5","totalValueFC":"4045.7","currency":"EURO","unitRateINR":"13509.3","date":"19-Jun-2024","totalValueINR":"337732.85","totalValueInUsd":"4045.7","indian_port":"Bangalore Air","hs_no":"29171990","bill_no":"4078773","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"HAUPTSTRASSE 2EMMERTHAL-KIRCHOH NI31860 DE GERMANY","customerAddress":"NO.22, 7TH CROSS, MUDDAPPA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733682600,"product":"FERROUS FUMARATE POWDER, PH.EUR.11ED., USP-NF 2024 (POWDER G RADE)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"UNDISCLOSED","supplierCountry":"GERMANY","foreign_port":"HANNOVER, NI","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"1200.00","actualQuantity":"1200","unit":"KGS","unitRateFc":"15.8","totalValueFC":"19053.4","currency":"USD","unitRateINR":"1349.1","date":"09-Dec-2024","totalValueINR":"1618947","totalValueInUsd":"19053.4","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29171990","bill_no":"7126294","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER, NI","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"FERROUS 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Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739471400,"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":"224.46","actualQuantity":"224.46","unit":"KGS","unitRateFc":"19.2","totalValueFC":"4382.4","currency":"USD","unitRateINR":"1697.9","date":"14-Feb-2025","totalValueINR":"381107.99","totalValueInUsd":"4382.4","indian_port":"JNPT","hs_no":"29171940","bill_no":"8344657","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":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,"}]
    03-Jan-2022
    26-Jun-2025
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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.

    Palafer Manufacturers

    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.

    Palafer Suppliers

    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.

    Palafer USDMF

    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.

    Palafer 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 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.

    Palafer CEP

    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.

    Palafer 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 Palafer as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Palafer 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 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.

    Compounded drug products

    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 GMP

    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.

    Palafer CoA

    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).

    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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