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    Chemistry

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    Also known as: Ferrous salt, Iron(ii) sulfate, 7720-78-7, Iron sulfate, Iron(2+) sulfate, Iron sulphate
    Molecular Formula
    FeO4S
    Molecular Weight
    151.91  g/mol
    InChI Key
    BAUYGSIQEAFULO-UHFFFAOYSA-L
    FDA UNII
    2IDP3X9OUD
    Ferrous Sulfate
    Iron deficiency anemia is a large public health concern worldwide, especially in young children, infants, and women of childbearing age. This type of anemia occurs when iron intake, iron stores, and iron loss do not adequately support the formation of erythrocytes, also known as red blood cells. Ferrous sulfate is a synthetic agent used in the treatment of iron deficiency. It is the gold standard of oral iron therapy in the UK and many other countries.
    1 2D Structure

    Ferrous Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    iron(2+);sulfate
    2.1.2 InChI
    InChI=1S/Fe.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
    2.1.3 InChI Key
    BAUYGSIQEAFULO-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    [O-]S(=O)(=O)[O-].[Fe+2]
    2.2 Other Identifiers
    2.2.1 UNII
    2IDP3X9OUD
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Aktiferrin

    2. Apo-ferrous Sulfate

    3. Biofer

    4. Ceferro

    5. Conferon

    6. Eisendragees-ratiopharm

    7. Eisensulfat Stada

    8. Feospan

    9. Fer-gen-sol

    10. Fer-in-sol

    11. Feratab

    12. Fero-gradumet

    13. Ferodan

    14. Ferogradumet

    15. Ferro-gradumet

    16. Ferrogamma

    17. Ferrograd

    18. Ferroinfant

    19. Ferrous Sulfate, Heptahydrate

    20. Ferrous Sulphate

    21. Hmatopan

    22. Haemoprotect

    23. Hemobion

    24. Hemofer

    25. Iron(ii) Sulfate Heptahydrate

    26. Kendural

    27. Mol-iron

    28. Plastufer

    29. Slow-fe

    30. Vitaferro Kapseln

    2.3.2 Depositor-Supplied Synonyms

    1. Ferrous Salt

    2. Iron(ii) Sulfate

    3. 7720-78-7

    4. Iron Sulfate

    5. Iron(2+) Sulfate

    6. Iron Sulphate

    7. Ferrous Sulfate Anhydrous

    8. Iron Sulfate (1:1)

    9. Iron(2+) Sulphate

    10. Feso4

    11. Iron(ii) Sulfate (1:1)

    12. Iron Sulfate (feso4)

    13. Ferrous Sulfate (1:1)

    14. Sulfuric Acid, Iron(2+) Salt (1:1)

    15. Sulfuric Acid, Iron(2+) Salt

    16. 2idp3x9oud

    17. 16547-58-3

    18. Iron(2+) Sulfate (anhydrous)

    19. Iron Vitriol; Iron(2+) Sulfate

    20. Combiron

    21. Odophos

    22. Kesuka

    23. Sal Chalybis

    24. Green Salts

    25. Quickfloc (salt)

    26. Slow Fe

    27. Ferrosulfat [german]

    28. Ferrosulfat

    29. Ccris 6796

    30. Hsdb 465

    31. Sfe 171

    32. Ferrous Sulfate Solution

    33. Einecs 231-753-5

    34. Unii-2idp3x9oud

    35. Nsc 57631

    36. Iron(ii) Sulfate Solution

    37. Nsc 146177

    38. Ai3-51903

    39. Ferrous Sulphate Anhydrous

    40. Iron(ii)sulphate

    41. Fe(ii) Sulphate

    42. Iron(ii) Sulphate

    43. Einecs 240-616-9

    44. Iron(2+);sulfate

    45. Iron (as Sulphate)

    46. Iron (ii) Sulphate

    47. Ferrous Sulfate,dried

    48. Errous Hydrogen Sulfide

    49. Sulfuric Acid, Iron(2+) Salt (1:?)

    50. Iron Sulphate (feso4)

    51. Ferrous Sulfate, 98%

    52. Ferrous Sulfate (anh.)

    53. Fe(ii)so4

    54. Dsstox_cid_9688

    55. Ferrous Sulfate, Anhydrous

    56. Ferrous Sulphate (1:1)

    57. Ec 231-753-5

    58. Ferrous Sulphate, Anhydrous

    59. Ferrous Sulfate (anhydrous)

    60. Dsstox_rid_78808

    61. Iron(2+) Sulfate (anh.)

    62. Dsstox_gsid_29688

    63. Ferrous Sulfate [mi]

    64. Iron(ii) Sulfate (feso4)

    65. Ferrous Sulfate [iso]

    66. Ferrous Sulfate [hsdb]

    67. Dtxsid0029688

    68. Chebi:75832

    69. Ferrous Sulfate [who-dd]

    70. Ferrous Sulphate Exsiccated (dried)

    71. Iron(ii) Sulphate (1:1)

    72. Tox21_202580

    73. Ferrous Sulfate,dried [vandf]

    74. Db13257

    75. Ncgc00260129-01

    76. Cas-7720-78-7

    77. Ft-0626420

    78. Q214863

    79. 8063-79-4

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 151.91 g/mol
    Molecular Formula FeO4S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count0
    Exact Mass151.886665 g/mol
    Monoisotopic Mass151.886665 g/mol
    Topological Polar Surface Area88.6 Ų
    Heavy Atom Count6
    Formal Charge0
    Complexity62.2
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Initial response to iron therapy ...will confirm or negate diagnosis of iron-deficiency anemia. Ferrous sulfate, 150-300 mg thrice daily, is given for 3 wk. Beginning about a wk after starting therapy, circulating hemoglobin should rise about 0.1-0.3 g % daily; less severe anemia, less daily rise.

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1290

    Supplementation with 30-60 mg of iron daily (ie, 150-300 mg of ferrous sulfate) has been advocated for pregnant women ...and 0.3-0.6 mL of ferrous sulfate pediatric "drops" daily for low-birth-weight infants from 1 month until 1 yr of age. Physician must use his judgement in this regard... .

    Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1290

    Hematinic.

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 717

    MEDICATION (VET): In iron deficiency. Astringent.

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 717

    For more Therapeutic Uses (Complete) data for FERROUS SULFATE (11 total), please visit the HSDB record page.

    4.2 Drug Warning

    ... A double-lumen perfusion tube was positioned orogastrically into a 40-cm segment of the proximal small intestine in six healthy volunteers (25 +/- 5 yr). The segment was perfused with saline and subsequently with saline containing 80 mg iron as ferrous sulfate at a rate of 10 mL/min. Intestinal fluid samples were collected at 15-min intervals. Thiobarbituric acid reactive substances concentrations as an indicator of lipid peroxidation increased significantly from 0.07 uM (range, 0-0.33 uM) during saline perfusion to 3.35 uM (range, 1.19-7.27 uM) during iron perfusion (P<0.05). Nonprotein antioxidant capacity increased significantly from 474 uM (range, 162-748 uM) to 1,314 uM (range, 674-1,542 uM) (P<0.05). These data show that a single dosage of ferrous sulfate induces oxidative damage and the subsequent release of an antioxidant in the small intestine in vivo in healthy volunteers.

    Troost FJ et al; Am J Physiol Gastrointest Liver Physiol 285 (2): G354-9 (2003)

    Adverse effects of ferrous sulfate are those of iron compounds in general, but they are rarely severe when drug is taken in therapeutic doses; however, relatively small overdoses can cause serious intoxication in infants and children.

    Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 780

    VET: Administer with or after feeding to help avoid gastritis.

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 221

    Adverse effects are generally dose dependent; in 10% of patients they are severe enough to be intolerable. Gastrointestinal disturbances ... are most common. Ferrous sulfate is absorbed best when taken between meals, but gastrointestinal symptoms may be minimized by reducing the dose and/or giving it in divided amounts with meals or shortly thereafter. In some patients, admin of one-half the total daily dose at bedtime improves tolerance. ... Large doses of ferrous sulfate may aggravate existing gastrointestinal diseases ... . Acute severe iron poisoning is uncommon in adults but does occur in children who ingest formulations intended for adults. In young children, as little as 400 mg of elemental iron is potentially fatal.

    American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 5th ed. Chicago: American Medical Association, 1983., p. 797

    For more Drug Warnings (Complete) data for FERROUS SULFATE (9 total), please visit the HSDB record page.

    4.3 Drug Indication

    Ferrous sulfate is used for the prevention and treatment of iron deficiency anemia in adults and children.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Ferrous sulfate replenishes iron, an essential component in hemoglobin, myoglobin, and various enzymes. It replaces the iron that is usually found in hemoglobin and myoglobin. Iron participates in oxygen transport and storage, electron transport and energy metabolism, antioxidant and beneficial pro-oxidant functions, oxygen sensing, tissue proliferation and growth, as well as DNA replication and repair.

    5.2 ATC Code

    B - Blood and blood forming organs

    B03 - Antianemic preparations

    B03A - Iron preparations

    B03AA - Iron bivalent, oral preparations

    B03AA07 - Ferrous sulfate

    B - Blood and blood forming organs

    B03 - Antianemic preparations

    B03A - Iron preparations

    B03AD - Iron in combination with folic acid

    B03AD03 - Ferrous sulfate

    5.3 Absorption, Distribution and Excretion

    Absorption

    Approximately 5 10% of dietary iron is absorbed, and this absorption rate increases to up to 30% in iron deficiency states. Oral iron supplements are absorbed up to 60% via active and passive transport processes. Gastrointestinal absorption of iron occurs via strict regulation by the enterocyte and duodenal cytochrome and ferric reductase enzymes. The hormone hepcidin heavily regulates iron absorption and distribution throughout the body. The median time to maximum serum concentration (Tmax) is generally 4 hours after administration. Between 2-8 hours post administration, average serum iron concentrations fluctuate by 20%, according to one study. Bioavailability of iron depends on whether it is administered in a film coated tablet or enteric coated tablet. One pharmacokinetic study in healthy volunteers revealed a 30% bioavailability for enteric coated tablets. The AUC of enteric coated tablets varied between a lower limit of -46.93 to 5.25 molxh/l. Cmax is higher for film coated tablets, ranging from 3.4 to 22.1 mol/h/l. It is advisable to take ferrous sulfate with ascorbic acid, as this practice may increase absorption. Avoid antacids, tea, coffee,tea, dairy products, eggs, and whole-grain bread for at least an hour after taking ferrous sulfate. Calcium can decrease iron absorption by 33% if taken concomitantly.

    Route of Elimination

    Oral iron is recycled, with some loss in the urine, sweat, and desquamation. Some iron can be lost during menstrual bleeding This loss is balanced by changes in intestinal absorption. The enzyme hepcidin promotes the excretion of iron via the sloughing of enterocytes with ferritin stores into the feces.

    Volume of Distribution

    About 60% of iron is distributed the erythrocytes. The remainder of the iron is found in muscle tissues (as a part of myoglobin), and in a variety of different enzymes, as well as in storage form. Most stored iron is in the form of ferritin, which can be found in the liver, bone marrow, spleen and, and muscle. Iron crosses the placenta and is also found in breast milk.

    ... The bioavailability studies were carried out using four groups of 30 female mice each. In two groups, we studied the absorption of ferrous ascorbate and ferrous sulfate, both in water as reference standards, which show absorptions of 13.1+/-4.9% and 13.2+/-4.3%, respectively. With the third group, we studied the absorption of ferrous sulfate in milk; its value, 7.9+/-3.2%, is significantly lower than that of the remaining groups, with a p < 0.01. The studies with SFE-171 in milk, were performed on the fourth group, with a result of 11.6+/-4.5%, demonstrating that its absorption does not differ significantly from that of the reference standards. The absorption mechanism was determined by means of in vivo self-displacement studies of the ferrous ion and the SFE-171, taking ferrous sulfate as the reference compound. For this study, 210 female mice were used, and no significant difference between the absorption mechanism of both products could be observed.

    PMID:9630425 Boccio JR et al; Biol Trace Elem Res 62 (1-2): 65-73 (1998)

    We investigated the iron bioavailability of microencapsulated ferrous sulfate (SFE-171) in a diet based on powdered milk by using the prophylactic method in rats.The SFE-171 was added into fluid milk and industrially processed into powdered milk, which was then mixed in our laboratory with a normalized diet (17.2 +/- 2.1 mg Fe/kg). A reference standard diet using ferrous sulfate as iron-fortifying source (19.8 p+/- 2.9 mg Fe/kg) and a control diet without added iron (4.6 +/- 0.8 mg Fe/kg) were prepared in the laboratory in a similar way. These diets were administered to different groups of weaning rats for 28 d as the only solid nourishment. The iron bioavailability of the different sources was calculated as the relation between the mass of iron incorporated into hemoglobin during the treatment and the total iron intake per animal. The iron bioavailability values of SFE-171 and ferrous sulfate in the fortified diets were 41.6 +/- 6.6% and 42.6 +/- 4.2%, respectively; these results were significantly higher (P < 0.01) than the iron bioavailability of the control diet (28.8 +/- 8.1%).

    Lysionek AE et al; Nutr 18 (3): 279-281 (2002)

    A prospective analytical study was conducted to determine the relationship between nonprotein-bound iron and serum iron concentrations following gastric instillation of ferrous sulfate. Four female pigs (2022 kg) with indwelling central venous lines and gastrostomy tubes were studied. A 5% solution of ferrous sulfate (20 mg elemental iron/kg bwt) was administered through the gastrostomy tube over 1 to 2 min. Six hourly blood samples were collected, and serum samples were subjected to ultrafiltration with the filtrate representing nonprotein-bound iron. Iron concentrations were determined by atomic absorption spectrophotometry. Baseline (mean | SD) iron concentrations were 73 | 25 mug/dL as the serum total and 21 | 4 mug/dL as nonprotein-bound iron. The serum iron and nonprotein-bound iron concentrations achieved a peak of 191 | 66 and 23 | 10, respectively, at 2 h and declined to near baseline values at 6 h. The mean ratio of filtrate to serum iron concentration was 0.

    PMID:8825744 Chyka PA et al; Vet Hum Toxicol 38 (1): 24-26 (1996)

    Gastrointestinal absorption of iron is adequate and essentially equal from...ferrous...sulfate, fumarate, gluconate, succinate, glutamate, and lactate.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1315

    5.4 Metabolism/Metabolites

    The metabolism of iron is complex. Normally, iron exists in the ferrous (Fe2+) or ferric (Fe3+) state, but since Fe2+ is oxidized to Fe3+, which hydrolyzes to insoluble iron(III)hydroxides in neutral aqueous solutions, iron binds to plasma proteins and is either transported or stored throughout the body. There are three proteins that serve to regulate the storage and transport of ingested iron. The first protein , transferrin, transports iron in both the plasma and extracellular fluid. Ceruloplasmin in the plasma and hephaestin on the enterocyte participate in the oxidation and binding of iron to transferrin. The main role of transferrin is the chelation of iron to prevent the production of reactive oxygen species, while facilitating its transport into cells. The transferrin receptor, located on many cells that require iron, binds the transferrin complex and internalizes this complex. Ferritin is a protein that stores iron, making it readily available for body requirements.

    5.5 Biological Half-Life

    The half-life of orally administered iron is not readily available in the literature, with total effects lasting 2-4 months (congruent with the red blood cell life span) with an onset of action of 4 days and peak activity at 7-10 days.

    5.6 Mechanism of Action

    Iron is required to maintain optimal health, particularly for helping to form red blood cells (RBC) that carry oxygen around the body. A deficiency in iron indicates that the body cannot produce enough normal red blood cells. Iron deficiency anemia occurs when body stores of iron decrease to very low levels, and the stored iron is insufficient to support normal red blood cell (RBC) production. Insufficient dietary iron, impaired iron absorption, bleeding, pregnancy, or loss of iron through the urine can lead to iron deficiency. Symptoms of iron deficiency anemia include fatigue, breathlessness, palpitations, dizziness, and headache. Taking iron in supplement form, such as ferrous sulfate, allows for more rapid increases in iron levels when dietary supply and stores are not sufficient. Iron is transported by the divalent metal transporter 1 (DMT1) across the endolysosomal membrane to enter the macrophage. It can then can be incorporated into ferritin and be stored in the macrophage or carried of the macrophage by ferroportin. This exported iron is oxidized by the enzyme to ceruloplasmin to Fe3+, followed by sequestration by transferrin for transport in the serum to various sites, including the bone marrow for hemoglobin synthesis or into the liver. Iron combines with porphyrin and globin chains to form hemoglobin, which is critical for oxygen delivery from the lungs to other tissues.

    Coagulopathy is a hallmark of severe ferrous sulfate poisoning in humans and lab animals. At iron concn comparable to those of previous animal investigations, the coagulopathy, in other words, the dose-related prolongation of the prothrombin, thrombin, and partial thromboplastin time, was reproduced in human plasma in vitro. Studies of the mechanism by which iron prevents a normal plasma coagulation revealed that the proenzymes of the coagulation cascade and fibrinogen were not damaged by iron. Fibrinogen coagulability and fibrin monomer aggregation were unaffected by very high iron concn. Instead, thrombin was markedly inhibited by iron in its clotting effect on fibrinogen and, specifically, in its fibrinopeptide A-generating capacity, the inhibitory effect being reversible upon iron removal by ethylenediaminetetraacetic acid chelation and gel filtration. Thrombin generation in the presence of iron was reduced as well, indicating an inhibition of one or several other enzymes of the intrinsic coagulation cascade. Because the amidolytic activity of human thrombin as well as factor Xa, kallikrein, and bovine trypsin was also reversibly suppressed by ferrous sulfate, it is considered likely that coagulopathy occurring in iron poisoning is the consequence of a general, physiologically important phenomenon: the susceptibility of serine proteases to nontransferrin-bound iron(3+)

    PMID:6421970 Rosenmund A et al; J Lab Clin Med 103 (4): 524-33 (1984)

    The mechanism of acute iron cardiotoxicity was investigated in isometrically contracting left atrial strips and right ventricular papillary muscles isolated from rabbit hearts. A 90 min exposure to iron (1.8 mM; as ferrous sulfate) reduced the peak-developed tension and the maximal rate of tension development.

    PMID:6695379 Artman M et al; Toxicol Appl Pharmacol 72 (2): 324-32 (1984)

    ... Iron is stored in the liver in the oxidized or ferric state & is tightly bound to protein as ferric ferritin. Xanthine oxidase appears to be involved in the conversion of ferric ferritin to ferrous ferritin. The reduced form of iron is less tightly bound to ferritin and thus is more easily released for utilization. Therefore, a possible inverse relationship between hepatic xanthine oxidase activity & hepatic iron storage exists. Theoretically, the xanthine oxidase inhibitor allopurinol should decrease the activity of xanthine oxidase & increase hepatic iron storage.

    Evaluations of Drug Interactions. 2nd ed. and supplements. Washington, DC: American Pharmaceutical Assn., 1976, 1978., p. 16/7

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31742

    Submission : 2017-05-02

    Status : Active

    Type : II

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    Dr. Paul Lohmann GmbH KG

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
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    Dr. Paul Lohmann GmbH KG

    Germany

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    Certificate Number : R1-CEP 2007-368 - Rev 04

    Issue Date : 2022-01-28

    Type : Chemical

    Substance Number : 2340

    Status : Valid

     JDMF arrow-down
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    Registration Number : 221MF10113

    Registrant's Address : Hauptstrasse 2 D-31860 Emmerthal Germany

    Initial Date of Registration : 2009-06-10

    Latest Date of Registration : --

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    Eagle Chemical

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    09

    Dr. Paul Lohmann GmbH KG

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
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    Dr. Paul Lohmann GmbH KG

    Germany

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
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    Certificate Number : R1-CEP 2007-369 - Rev 03

    Issue Date : 2022-02-01

    Type : Chemical

    Substance Number : 83

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10655

    Registrant's Address : Hauptstrasse 2 D-31860 Emmerthal Germany

    Initial Date of Registration : 2006-07-24

    Latest Date of Registration : --

     EU-WC NDC KDMF VMF Others AUDIT
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    10

    Zim Laboratories

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Acharya Chemicals

    India

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    01

    Acharya Chemicals

    India
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31742

    Submission : 2017-05-02

    Status : Active

    Type : II

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    India Phosphate

    India

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    02

    India Phosphate

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34465

    Submission : 2020-01-31

    Status : Active

    Type : II

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    Salvi Chemical Industries Ltd

    India
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    DMF Review : N/A

    Rev. Date :

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    DMF Number : 29932

    Submission : 2015-03-25

    Status : Active

    Type : II

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    ABOUT THIS PAGE

    Ferrous Sulfate Manufacturers

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

    Ferrous Sulfate Suppliers

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

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

    Ferrous Sulfate USDMF

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

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

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

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

    Ferrous Sulfate CEP

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

    A Ferrous Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ferrous Sulfate 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 Ferrous Sulfate suppliers with CEP (COS) on PharmaCompass.

    Ferrous Sulfate 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 Ferrous Sulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ferrous Sulfate GMP

    Ferrous Sulfate 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 Ferrous Sulfate 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 Ferrous Sulfate GMP manufacturer or Ferrous Sulfate GMP API supplier for your needs.

    Ferrous Sulfate CoA

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

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

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