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    Chemistry

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    Also known as: 7487-88-9, Magnesium sulphate, Magnesium sulfate anhydrous, Mgso4, Sulfuric acid magnesium salt (1:1), Magnesium sulfate (1:1)
    Molecular Formula
    MgO4S
    Molecular Weight
    120.37  g/mol
    InChI Key
    CSNNHWWHGAXBCP-UHFFFAOYSA-L
    FDA UNII
    ML30MJ2U7I
    Magnesium Sulfate
    A small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. (From AMA Drug Evaluations Annual, 1992, p1083)
    1 2D Structure

    Magnesium Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    magnesium;sulfate
    2.1.2 InChI
    InChI=1S/Mg.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
    2.1.3 InChI Key
    CSNNHWWHGAXBCP-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    [O-]S(=O)(=O)[O-].[Mg+2]
    2.2 Other Identifiers
    2.2.1 UNII
    ML30MJ2U7I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Heptahydrate Magnesium Sulfate

    2. Magnesium Sulfate, Heptahydrate

    3. Sulfate, Magnesium

    2.3.2 Depositor-Supplied Synonyms

    1. 7487-88-9

    2. Magnesium Sulphate

    3. Magnesium Sulfate Anhydrous

    4. Mgso4

    5. Sulfuric Acid Magnesium Salt (1:1)

    6. Magnesium Sulfate (1:1)

    7. Magnesiumsulfat

    8. Magnesiumsulfate

    9. Magnesium Sulfate, Anhydrous

    10. Sulfuric Acid Magnesium Salt

    11. Magnesium(ii) Sulfate

    12. Magnesium;sulfate

    13. Magnesium Sulphate Anhydrous

    14. Sulfato De Magnesio

    15. Chebi:32599

    16. Mfcd00011110

    17. Magnesium Sulfate,anhydrous

    18. Ml30mj2u7i

    19. Magnesium Sulphate, Anhydrous

    20. Magnesium Sulfate Anhydrous

    21. Sulfuric Acid, Mono-c10-16-alkyl Esters, Magnesium Salts

    22. Sal Angalis

    23. Sal De Sedlitz

    24. Tomix Ot

    25. 139939-75-6

    26. Ot-s (drying Agent)

    27. Ot-s

    28. 68081-97-0

    29. Sulfuric Acid Magnesiumsalt (1:1), Hydrate (8ci,9ci)

    30. Caswell No. 534

    31. Magnesii Sulfas

    32. Magnesii Sulfas; Magnesium Sulfate; Magnesium Sulphate; Mg-ok; Ot-s

    33. Anhydrous Magnesium Sulfate

    34. Sulfuric Acid Magnesium Salt (van)

    35. Arrosalt 2327

    36. Hsdb 664

    37. Einecs 231-298-2

    38. Unii-ml30mj2u7i

    39. Epa Pesticide Chemical Code 050503

    40. Magnesium Sulfate In Plastic Container

    41. Nsc 146179

    42. Magnesium Sulfate, Unspecified

    43. Sda 15-062-07

    44. Ccris 8411

    45. Sn 00

    46. Einecs 242-691-3

    47. Einecs 268-365-0

    48. Sulfuric Acid, C10-16 Alkyl Ester, Magnesium Salt

    49. Sulphate Of Magnesia

    50. (c10-c16) Alkylalcohol Sulfuric Acid, Magnesium Salt

    51. Magnesium Sulfate In Dextrose 5% In Plastic Container

    52. Ai3-02029

    53. Epitope Id:158536

    54. Ec 231-298-2

    55. C10-c16 Alkyl Alcohol Sulfuric Acid Magnesium Salt

    56. Magnesium Sulfate [mi]

    57. Chembl2021423

    58. Dtxsid6042105

    59. Magnesium Sulfate [hsdb]

    60. Magnesium Sulfate, Anhydrous Powder

    61. Magnesium Sulfate, Anhydrous Granular

    62. Akos015902894

    63. Db00653

    64. Magnesium Sulfate, 1m Aqueous Solution

    65. Magnesium Sulfate Anhydrous [ii]

    66. 18939-43-0

    67. Magnesium Sulfate,anhydrous [vandf]

    68. Ft-0628097

    69. M1890

    70. Magnesium Sulfate Anhydrous [orange Book]

    71. Magnesium Sulfate Heptahydrate Solution, 2.25%

    72. Magnesium Sulfate, 1m Aqueous Solution, Sterile

    73. Magnesium Sulfate Anhydrous [usp Monograph]

    74. Q288266

    75. Sr-01000944338

    76. J-014575

    77. J-519590

    78. Sr-01000944338-1

    79. Magnesium Sulfate, Anhydrous Powder Trace Metals Grade, 99.95%

    80. Magnesium Sulfate, Anhydrous Granular Trace Metals Grade, 99.95%

    81. Suprep Bowel Prep Kit Component Magnesium Sulfate Anhydrous

    82. Magnesium Sulfate Anhydrous Component Of Suprep Bowel Prep Kit

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 120.37 g/mol
    Molecular Formula MgO4S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count0
    Exact Mass119.9367713 g/mol
    Monoisotopic Mass119.9367713 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 Drug Information
    1 of 4  
    Drug NameMagnesium sulfate
    PubMed HealthMagnesium Sulfate
    Drug ClassesAnti-Inflammatory, Anticonvulsant, Laxative, Laxative, Hyperosmotic, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
    Drug LabelMagnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in...
    Active IngredientMagnesium sulfate
    Dosage FormInjectable
    RouteInjection
    Strength500mg/ml
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Usa

    2 of 4  
    Drug NameMagnesium sulfate in plastic container
    Active IngredientMagnesium sulfate
    Dosage FormInjectable
    RouteInjection
    Strength4gm/100ml (40mg/ml); 4gm/50ml (80mg/ml); 2gm/50ml (40mg/ml); 20gm/500ml (40mg/ml); 40gm/1000ml(40mg/ml)
    Market StatusPrescription
    CompanyHospira

    3 of 4  
    Drug NameMagnesium sulfate
    PubMed HealthMagnesium Sulfate
    Drug ClassesAnti-Inflammatory, Anticonvulsant, Laxative, Laxative, Hyperosmotic, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
    Drug LabelMagnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in...
    Active IngredientMagnesium sulfate
    Dosage FormInjectable
    RouteInjection
    Strength500mg/ml
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Usa

    4 of 4  
    Drug NameMagnesium sulfate in plastic container
    Active IngredientMagnesium sulfate
    Dosage FormInjectable
    RouteInjection
    Strength4gm/100ml (40mg/ml); 4gm/50ml (80mg/ml); 2gm/50ml (40mg/ml); 20gm/500ml (40mg/ml); 40gm/1000ml(40mg/ml)
    Market StatusPrescription
    CompanyHospira

    4.2 Therapeutic Uses

    Analgesics; Anesthetics; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Cathartics; Tocolytic Agents

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    AN EFFECTIVE & WIDELY EMPLOYED SALINE CATHARTIC. /HEPTAHYDRATE, USP/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 743

    FULL DOSES OF SALINE CATHARTICS (15 G MAGNESIUM SULFATE OR ITS EQUIVALENT) PRODUCE A SEMIFLUID OR WATERY EVACUATION IN 3 HR OR LESS. LOW DOSES PRODUCE A LAXATIVE EFFECT WITH GREATER LATENCY.

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1005

    A COLD, WET COMPRESS OF MAGNESIUM SULFATE SOLN IN WATER HAS BEEN EMPLOYED IN TREATMENT OF SUCH SKIN DISORDERS AS ERYSIPELAS. HOT CONCN AQ SOLN...(ABOUT 1 LB/PINT OF WATER) ARE SOMETIMES USED IN TREATMENT OF DEEP-SEATED INFECTIONS, CLOTHS BEING SATURATED & APPLIED WHILE HOT. ACTION MUCH LIKE THAT OF POULTICE. /HEPTAHYDRATE/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 743

    For more Therapeutic Uses (Complete) data for MAGNESIUM SULFATE (32 total), please visit the HSDB record page.

    4.3 Drug Warning

    SOME ABSORPTION OF COMPONENT IONS OF SALINE CATHARTICS DOES OCCUR, & IN CERTAIN INSTANCES THEY MAY PRODUCE SYSTEMIC TOXICITY. IN AN INDIVIDUAL WITH IMPAIRED RENAL FUNCTION, ACCUM OF MAGNESIUM IONS IN BODY FLUIDS MAY BE SUFFICIENT TO CAUSE INTOXICATION. MAGNESIUM CATHARTICS SHOULD BE ADMIN ONLY IF RENAL FUNCTION IS ADEQUATE.

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1005

    THE DRUG IS GENERALLY SAFE BUT CAN CAUSE TEMPORARY LOSS OF DEEP TENDON REFLEXES IN MOTHER & MAY SUPPRESS SKELETAL MUSCLE ACTIVITY IN NEONATE. IT SHOULD NOT BE USED IN PT WITH HEART DISEASE...

    American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 4th ed. Chicago: American Medical Association, 1980., p. 798

    NEONATE MAY BE DROWSY & EXHIBIT RESP DIFFICULTIES & DIMINISHED MUSCLE TONE. HOWEVER...NO RELATIONSHIP BETWEEN PLASMA MAGNESIUM CONCN OF BLOOD COLLECTED FROM UMBILICAL CORD & THE APGAR SCORE /HAS BEEN FOUND/.

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 882

    Patients receiving parenteral magnesium sulfate shold be observed carefully, and serum magnesium concn should be monitored to avoid overdosage. ... An IV preparation of a calcium salt (e.g., calcium gluconate) should be readily available for use when magnesium sulfate is given IV. /Magnesium sulfate injection/

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 2163

    For more Drug Warnings (Complete) data for MAGNESIUM SULFATE (14 total), please visit the HSDB record page.

    4.4 Drug Indication

    Used for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children. Also indicated for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia. Also used in uterine tetany as a myometriat relaxant.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Magnesium sulfate is a small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. Magnesium sulfate is gaining popularity as an initial treatment in the management of various dysrhythmias, particularly torsades de pointes, and dyrhythmias secondary to TCA overdose or digitalis toxicity.

    5.2 MeSH Pharmacological Classification

    Calcium Channel Blockers

    A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    Analgesics

    Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)

    Anticonvulsants

    Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

    Tocolytic Agents

    Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)

    Anesthetics

    Agents capable of inducing a total or partial loss of sensation, especially tactile sensation and pain. They may act to induce general ANESTHESIA, in which an unconscious state is achieved, or may act locally to induce numbness or lack of sensation at a targeted site. (See all compounds classified as Anesthetics.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Calculi Dissolution Agent [EPC]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A06 - Drugs for constipation

    A06A - Drugs for constipation

    A06AD - Osmotically acting laxatives

    A06AD04 - Magnesium sulfate

    A - Alimentary tract and metabolism

    A12 - Mineral supplements

    A12C - Other mineral supplements

    A12CC - Magnesium

    A12CC02 - Magnesium sulfate

    B - Blood and blood forming organs

    B05 - Blood substitutes and perfusion solutions

    B05X - I.v. solution additives

    B05XA - Electrolyte solutions

    B05XA05 - Magnesium sulfate

    D - Dermatologicals

    D11 - Other dermatological preparations

    D11A - Other dermatological preparations

    D11AX - Other dermatologicals

    D11AX05 - Magnesium sulfate

    V - Various

    V04 - Diagnostic agents

    V04C - Other diagnostic agents

    V04CC - Tests for bile duct patency

    V04CC02 - Magnesium sulfate

    5.5 Absorption, Distribution and Excretion

    Route of Elimination

    Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

    Magnesium sulfate is excreted by the kidneys at a rate that varies from one patient to another but that is directly proportional to the serum concn and glomerular filtration.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 2164

    PLASMA CONCN OF MAGNESIUM INCR IN FETUS & APPROACH MATERNAL BLOOD VALUES AFTER MAGNESIUM SULFATE ADMIN IN ECLAMPSIA & PREECLAMPSIA.

    Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 882

    5.6 Metabolism/Metabolites

    None

    5.7 Biological Half-Life

    43.2 hours (for newborns)

    5.8 Mechanism of Action

    Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Magnesium sulfate reduces striated muscle contractions and blocks peripheral neuromuscular transmission by reducing acetylcholine release at the myoneural junction. Additionally, Magnesium inhibits Ca2+ influx through dihydropyridine-sensitive, voltage-dependent channels. This accounts for much of its relaxant action on vascular smooth muscle.

    CATHARTIC ACTION RESULTS FROM FACT THAT MGSO4 IS NOT ABSORBED FROM INTESTINAL TRACT, & THUS RETAINS SUFFICIENT WATER WITHIN LUMEN OF BOWEL TO MAKE AN ISOTONIC SOLN. IN EVENT...SALT IS GIVEN IN HYPERTONIC SOLN, SOURCE OF WATER WOULD BE BODY FLUIDS, &...DEHYDRATING ACTION IS EXERTED. /HEPTAHYDRATE, USP/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 743

    EXACT MECHANISM OF.../CNS/ DEPRESSANT ACTIVITY IS NOT FULLY KNOWN; HOWEVER, EXCESS MAGNESIUM APPEARS TO DECR AMT OF ACETYLCHOLINE LIBERATED BY MOTOR NERVE IMPULSE. /HEPTAHYDRATE INJECTION USP/

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 2163

    Isolated myometrial strips were obtained from humans undergoing elective cesarean section at term pregnancy and Wistar albino rats on gestational days 19-21. These strips were mounted in organ baths for recording of isometric tensions. The effect of magnesium sulfate, isradipine, and ritodrine on the amplitude and frequency of spontaneous contractions was compared. ... Ritodrine (10-8-10-5 M) concentration-dependently inhibited the frequency and amplitude of spontaneous contractions of myometrial strips. At 10-4 M, tachyphylaxis of ritodrine occurred and contractions started again. Magnesium sulfate (10-7-10-4 M) inhibited the frequency but did not change the amplitude of the spontaneous contractions. Isradipine (10-7-10-4 M) had a concentration-related inhibitor effect on both the frequency and amplitude of the spontaneous contractions. The effects of magnesium sulfate, isradipine, and ritodrine were considerably similar in myometrium strips obtained from pregnant rats and humans. ...

    PMID:12225296 Kantas E, et al; Acta Obstet Gynecol Scand 81(9): 825-830 (2002)

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31874

    Submission : 2017-09-12

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Global Calcium

    India

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

    PharmaVenue
    Not Confirmed
    arrow

    Global Calcium

    India

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

    arrow
    PharmaVenue
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-04-30

    Pay. Date : 2023-12-28

    DMF Number : 36873

    Submission : 2022-11-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Avantor Performance Materials

    U.S.A

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

    PharmaVenue
    Not Confirmed
    arrow

    Avantor Performance Materials

    U.S.A

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

    arrow
    PharmaVenue
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33571

    Submission : 2019-03-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 10106-5054

    Start Marketing Date : 2019-01-14

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    blank

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    08

    S D Fine Chem Limited

    India

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

    PharmaVenue
    Not Confirmed
    arrow

    S D Fine Chem Limited

    India

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

    arrow
    PharmaVenue
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28690

    Submission : 2014-09-29

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Tomita Pharmaceutical

    Japan

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

    PharmaVenue
    Not Confirmed
    arrow

    Tomita Pharmaceutical

    Japan

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

    arrow
    PharmaVenue
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25268

    Submission : 2011-04-27

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10106

    Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1

    Initial Date of Registration : 2016-06-06

    Latest Date of Registration : --

     EU-WC NDC KDMF VMF Others AUDIT
    blank

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    Website

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    10

    Tomita Pharmaceutical

    Japan

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

    PharmaVenue
    Not Confirmed
    arrow

    Tomita Pharmaceutical

    Japan

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

    arrow
    PharmaVenue
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32931

    Submission : 2018-10-29

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10096

    Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1

    Initial Date of Registration : 2015-03-20

    Latest Date of Registration : --

     EU-WC NDC KDMF VMF Others AUDIT
    blank

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    Only 10 entries up to this point, click to access all click full view read-more
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    API Reference Price

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    [{"dataSource":"API Import","activeIngredients":"MAGNESIUM SULFATE HEPTAHYDRATE","year":"2021","qtr":"Q1","strtotime":1612463400,"product":"MAGNESIUM SULFATE HEPTAHYDRATE, USP","address":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"TOMITA PHARMACEUTICAL","supplierCountry":"JAPAN","foreign_port":"OSAKA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"1800.00","actualQuantity":"1800","unit":"KGS","unitRateFc":"33","totalValueFC":"60210.4","currency":"USD","unitRateINR":"2435.4","date":"05-Feb-2021","totalValueINR":"4383720","totalValueInUsd":"60210.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"2629880","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"OSAKA","supplierAddress":"","customerAddress":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"MAGNESIUM SULFATE HEPTAHYDRATE","year":"2021","qtr":"Q2","strtotime":1620930600,"product":"MAGNESIUM SULFATE HEPTAHYDRATE,USP (PARENTERAL DOSAGE FORM)","address":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"TOMITA PHARMACEUTICAL","supplierCountry":"JAPAN","foreign_port":"OSAKA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"33","totalValueFC":"67352.1","currency":"USD","unitRateINR":"2466.8","date":"14-May-2021","totalValueINR":"4933500","totalValueInUsd":"67352.1","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"3950022","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"OSAKA","supplierAddress":"","customerAddress":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1626373800,"product":"MAGNESIUM SULFATE HEPTAHYDRATE, USP (PARENTERAL DOSAGE FORM)","address":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"TOMITA PHARMACEUTICAL","supplierCountry":"JAPAN","foreign_port":"OSAKA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"33","totalValueFC":"66773.3","currency":"USD","unitRateINR":"2488.2","date":"16-Jul-2021","totalValueINR":"4976400","totalValueInUsd":"66773.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"4699872","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"OSAKA","supplierAddress":"","customerAddress":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693679400,"product":"RONACARE MAGNESIUM SULFATE (RAW MATERIAL FOR MANUFACTURING OF COSMETIC) (NOT FOR FOOD GRADE)","address":"A-802, Crescenzo, C\/38-39, G-Block","city":"Mumbai","supplier":"INTERCOS EUROPE S.P.A","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"INTERCOS INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"8.2","totalValueFC":"11.6","currency":"EUR","unitRateINR":"959","date":"03-Sep-2023","totalValueINR":"959.01","totalValueInUsd":"11.6","indian_port":"Delhi Air","hs_no":"29319090","bill_no":"7657970","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"20123 MILANO, PIAZZA DIAZ, 1 Milano, , ItalySDNF Italy","customerAddress":"A-802, Crescenzo, C\/38-39, G-Block"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"3014181 311378-RONACARE MAGNESIUM SULFATE 132219 (CODE. B065A) (RAW MATERIAL FOR MANUFACTURING OF COSMETIC) (NOT FOR FOO","address":"A-802, Crescenzo, C\/38-39, G-Block","city":"Mumbai","supplier":"INTERCOS EUROPE S.P.A","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"INTERCOS INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"8.5","totalValueFC":"33.9","currency":"EUR","unitRateINR":"944.1","date":"06-Jun-2024","totalValueINR":"2832.3","totalValueInUsd":"33.9","indian_port":"Delhi Air","hs_no":"29319090","bill_no":"3864409","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"20123 MILANO, PIAZZA DIAZ, 1 Milano, , ItalySDNF Italy","customerAddress":"A-802, Crescenzo, C\/38-39, G-Block"}]
    05-Feb-2021
    06-Jun-2024
    KGS
    overview
    Loading...

    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

    Upgrade, download data, analyse, strategize, subscribe with us contact

    Europe

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    01

    The Fresenius Kabi Norge AS - Halden

    Sweden
    Duphat
    Not Confirmed
    arrow

    The Fresenius Kabi Norge AS - Halden

    Sweden
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Sweden
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Norway

    Magnesium Sulfate

    Brand Name : Addex-Magnesium

    Dosage Form : Concentrate to the infusion fluid

    Dosage Strength : 1 mmol/ml

    Packaging : Hood glass of plastic

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

    blank

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    02

    Grindeks AS

    Latvia
    Duphat
    Not Confirmed
    arrow

    Grindeks AS

    Latvia
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Latvia
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic eCTD

    Registration Country : Latvia

    Magnesium Sulfate

    Brand Name :

    Dosage Form : INJECTION

    Dosage Strength : 250MG/ML

    Packaging : 10 ml amp

    Approval Date :

    Application Number :

    Regulatory Info : Generic eCTD

    Registration Country : Latvia

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    03

    Grindeks AS

    Latvia
    Duphat
    Not Confirmed
    arrow

    Grindeks AS

    Latvia
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Latvia
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : Latvia

    Magnesium Sulfate

    Brand Name :

    Dosage Form : INJECTION

    Dosage Strength : 500MG/ML

    Packaging : 2 ml, 10 ml amp

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Latvia

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    04

    Vefa Ilac

    Turkey
    Duphat
    Not Confirmed
    arrow

    Vefa Ilac

    Turkey
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Turkey
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : Turkey

    Ferrous Fumarate; Zinc Sulfate; Copper Sulfate; Magnesium Sulfate; Ascorbic Acid; Pyridoxine; Vitamin B 12; Folic Acid

    Brand Name : Eurofar

    Dosage Form : CAPSULE

    Dosage Strength :

    Packaging : 30 Tablets

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Turkey

    blank

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    Website

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    05

    Vefa Ilac

    Turkey
    Duphat
    Not Confirmed
    arrow

    Vefa Ilac

    Turkey
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Turkey
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : Turkey

    Glucosamine Sulphate Potassium Chloride; Chondroitin Sulfate A; Boswellia serrata; Hyaluronic Acid; Cucurmin; Magnesium Sulfate; Ascorbic Acid

    Brand Name : Arteasy

    Dosage Form : TABLET

    Dosage Strength :

    Packaging : 30 Tablets

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Turkey

    blank

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    06

    MONICO SpA

    Country
    Duphat
    Not Confirmed
    arrow

    MONICO SpA

    Country
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Country
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Magnesium Sulfate

    Brand Name : Magnesium Sulfate

    Dosage Form :

    Dosage Strength : 5 Ampoules 2 G 10 Ml  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    blank

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    07

    SALF SpA

    Country
    Duphat
    Not Confirmed
    arrow

    SALF SpA

    Country
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Country
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Italy

    Magnesium Sulfate

    Brand Name : Magnesium Sulfate

    Dosage Form :

    Dosage Strength : 5 Ampoules 2 G 10 Ml  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    08

    SALF SpA

    Country
    Duphat
    Not Confirmed
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    SALF SpA

    Country
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Country
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Italy

    Magnesium Sulfate

    Brand Name : Magnesium Sulfate

    Dosage Form :

    Dosage Strength : 1 30 Ml Bottle 2 Meq/Ml  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    09

    SALF SpA

    Country
    Duphat
    Not Confirmed
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    SALF SpA

    Country
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Country
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Magnesium Sulfate

    Brand Name : Magnesium Sulfate

    Dosage Form :

    Dosage Strength : 5 Ampoules 1 G 10 Ml  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    blank

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    Virtual Booth

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    10

    MONICO SpA

    Country
    Duphat
    Not Confirmed
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    MONICO SpA

    Country
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Country
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Magnesium Sulfate

    Brand Name : Magnesium Sulfate

    Dosage Form :

    Dosage Strength : 5 Vials 2.5 G 10 Ml  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Listed Dossiers

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    01

    Ethypharm

    France
    arrow
    CPhI WW Frankfurt
    Booth #5.0D100
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

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    Flag France
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    Regulatory Info :

    Registration Country : France

    Magnesium Sulfate

    Brand Name :

    Dosage Form : Ampoule

    Dosage Strength : 150MG/1ML

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : France

    Ethypharm

    Portfolio PDF

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    Virtual Booth

    Digital Content

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    01

    Ethypharm

    France
    arrow
    CPhI WW Frankfurt
    Booth #5.0D100
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Magnesium Sulfate

    Dosage : Ampoule

    Dosage Strength : 150MG/1ML

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country : France

    Ethypharm

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    02

    Demo S.A.

    Greece
    Duphat
    Not Confirmed
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    Demo S.A.

    Greece
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Greece
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country :

    Magnesium Sulfate

    Brand Name :

    Dosage Form : SOLUTION FOR INJECTION

    Dosage Strength : 10% W/V

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country :

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    02

    Demo S.A.

    Greece
    Duphat
    Not Confirmed
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    Demo S.A.

    Greece
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Greece
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info : Generic

    Magnesium Sulfate

    Dosage : SOLUTION FOR INJECTION

    Dosage Strength : 10% W/V

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country :

    blank

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    03

    Demo S.A.

    Greece
    Duphat
    Not Confirmed
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    Demo S.A.

    Greece
    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country :

    Magnesium Sulfate

    Brand Name :

    Dosage Form : SOLUTION FOR INJECTION

    Dosage Strength : 50% W/V

    Packaging : 10 ML

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country :

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    03

    Demo S.A.

    Greece
    Duphat
    Not Confirmed
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    Demo S.A.

    Greece
    arrow
    Duphat
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    Packaging : 10 ML

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    Magnesium Sulfate

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    Registration Country : China

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    L-Carnitine; Betaine; Choline Chloride; Pantothenic Acid; Sorbitol; Magnesium Sulfate

    Brand Name : Intertonic Liquid

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    L-Carnitine; Betaine; Choline Chloride; Pantothenic Acid; Sorbitol; Magnesium Sulfate

    Dosage : Liquid

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    Brand Name : Intertonic Liquid

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    Verve Human Care Laboratories

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    Magnesium Sulfate

    Brand Name : VERMAG

    Dosage Form : Injection

    Dosage Strength : 500MG/ML

    Packaging : 2ml &10ml Ampoule

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    Registration Country : India

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    Packaging : 2ml &10ml Ampoule

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    Magnesium Sulfate

    Dosage : Injection

    Dosage Strength : 500MG/ML

    Brand Name : VERMAG

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    Registration Country : India

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    Zuma Pharma

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 10GM/20ML (500MG/ML)

    USFDA APPLICATION NUMBER - 19316

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    DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 1GM/2ML (500MG/ML)

    USFDA APPLICATION NUMBER - 19316

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    DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 25GM/50ML (500MG/ML)

    USFDA APPLICATION NUMBER - 19316

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    DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 5GM/10ML (500MG/ML)

    USFDA APPLICATION NUMBER - 19316

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    DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

    USFDA APPLICATION NUMBER - 200656

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    DOSAGE - POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;1...DOSAGE - POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

    USFDA APPLICATION NUMBER - 204553

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    DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479G...DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479GM

    USFDA APPLICATION NUMBER - 213135

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    ABOUT THIS PAGE

    Magnesium Sulfate Manufacturers

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

    Magnesium Sulfate Suppliers

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

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

    Magnesium Sulfate USDMF

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

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

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

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

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

    Finished drug products

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

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

    Magnesium Sulfate GMP

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

    Magnesium Sulfate CoA

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

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

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