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    Also known as: 25416-65-3, Levothyroxine sodium, L-thyroxine sodium xhydrate, Levothyroxine sodium hydrate, L-thyroxine sodium hydrate, Monosodium l-thyroxine hydrate
    Molecular Formula
    C15H12I4NNaO5
    Molecular Weight
    816.87  g/mol
    InChI Key
    ANMYAHDLKVNJJO-LTCKWSDVSA-M
    FDA UNII
    B82379R9W0
    Levothyroxine Sodium
    The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.
    1 2D Structure

    Levothyroxine Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;hydrate
    2.1.2 InChI
    InChI=1S/C15H11I4NO4.Na.H2O/c16-8-4-7(5-9(17)13(8)21)24-14-10(18)1-6(2-11(14)19)3-12(20)15(22)23;;/h1-2,4-5,12,21H,3,20H2,(H,22,23);;1H2/q;+1;/p-1/t12-;;/m0../s1
    2.1.3 InChI Key
    ANMYAHDLKVNJJO-LTCKWSDVSA-M
    2.1.4 Canonical SMILES
    C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)CC(C(=O)[O-])N.O.[Na+]
    2.1.5 Isomeric SMILES
    C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)C[C@@H](C(=O)[O-])N.O.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    B82379R9W0
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3,5,3',5'-tetraiodothyronine

    2. Berlthyrox

    3. Dexnon

    4. Eferox

    5. Eltroxin

    6. Eltroxine

    7. Euthyrox

    8. Eutirox

    9. L Thyrox

    10. L Thyroxin Beta

    11. L Thyroxin Henning

    12. L Thyroxine

    13. L Thyroxine Roche

    14. L-3,5,3',5'-tetraiodothyronine

    15. L-thyrox

    16. L-thyroxin Beta

    17. L-thyroxin Henning

    18. L-thyroxine

    19. L-thyroxine Roche

    20. Lvothyrox

    21. Levo T

    22. Levo-t

    23. Levothroid

    24. Levothyroid

    25. Levothyroxin Deladande

    26. Levothyroxin Delalande

    27. Levothyroxine

    28. Levothyroxine Sodium

    29. Levoxine

    30. Levoxyl

    31. Novothyral

    32. Novothyrox

    33. O-(4-hydroxy-3,5-diiodophenyl) 3,5-diiodo-l-tyrosine

    34. O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodotyrosine

    35. Oroxine

    36. Sodium Levothyroxine

    37. Synthroid

    38. Synthrox

    39. T4 Thyroid Hormone

    40. Thevier

    41. Thyrax

    42. Thyroid Hormone, T4

    43. Thyroxin

    44. Thyroxine

    45. Tiroidine

    46. Tiroxina Leo

    47. Unithroid

    2.3.2 Depositor-Supplied Synonyms

    1. 25416-65-3

    2. Levothyroxine Sodium

    3. L-thyroxine Sodium Xhydrate

    4. Levothyroxine Sodium Hydrate

    5. L-thyroxine Sodium Hydrate

    6. Monosodium L-thyroxine Hydrate

    7. 31178-59-3

    8. Chebi:6447

    9. Levothroid

    10. Synthroid

    11. Levothyrox

    12. Levaxin

    13. Levoxyl

    14. Oroxine

    15. Soloxine

    16. Eferox

    17. Sodium;(2s)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;hydrate

    18. B82379r9w0

    19. Thyroxine Sodium

    20. Levo-t

    21. Liotrix (t4)

    22. Thyroxine Sodium Salt

    23. L-tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, Monosodium Salt, Monohydrate

    24. Latequatro

    25. Letequatro

    26. Levoroxin

    27. Levotiron

    28. Tiroxina

    29. Tivoral

    30. Levo-tiroxina Glaxo

    31. Nsc-259940

    32. L-tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, Monosodium Salt, Hydrate

    33. Unii-b82379r9w0

    34. Levothroid (tn)

    35. Synthroid (tn)

    36. Levoxyl (tn)

    37. Levothyroxine Sodium [usp:inn:jan]

    38. Starbld0009614

    39. L-thyroxin Monosodium Salt

    40. T4 (liotrix)

    41. Levothyroxine Sodium (usp)

    42. Schembl2327406

    43. Chembl2103741

    44. L-thyroxine Sodium Salt Monohydrate

    45. 3,3',5,5'-tetraiodo-l-thyronine Monosodium Salt Hydrate

    46. Levothyroxine Sodium Hydrate (jp17)

    47. Mfcd06408007

    48. Akos015895962

    49. Ks-1237

    50. D01010

    51. E78443

    52. Levothyroxine Sodium Monohydrate [who-ip]

    53. 3,3',5,5'-tetraiodo-l-thyronine Monosodium Salt

    54. A817851

    55. Q27107209

    56. Levothyroxinum Natricum Monohydrate [who-ip Latin]

    57. Sodium 2-amino-3-[4-(4-hydroxy-3,5-diiodo-phenoxy)-3,5-diiodo-phenyl]propanoate Hydrate

    58. Sodium (s)-2-amino-3-(4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl)propanoate Xhydrate

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 816.87 g/mol
    Molecular Formula C15H12I4NNaO5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass816.6792 g/mol
    Monoisotopic Mass816.6792 g/mol
    Topological Polar Surface Area96.6 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity426
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameLevo-t
    Drug LabelLevothyroxine sodium tablets, USP contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.Levothyroxine (T4) sodium has an empir
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyAlara Pharm

    2 of 8  
    Drug NameLevothroid
    PubMed HealthThyroid Supplement (By mouth)
    Drug ClassesDiagnostic Agent, Thyroid Function, Thyroid Supplement
    Drug LabelLEVOTHROID (levothyroxine sodium tablets, USP) contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyLloyd

    3 of 8  
    Drug NameLevothyroxine sodium
    Active IngredientLevothyroxine sodium
    Dosage FormTablet; Powder; Injectable
    Routeinjection; Oral; Intravenous
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 200mcg/vial; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 descr
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Mylan

    4 of 8  
    Drug NameLevoxyl
    Drug LabelLEVOXYL (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3,5,5-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu...
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyKing Pharms R And D

    5 of 8  
    Drug NameLevo-t
    Drug LabelLevothyroxine sodium tablets, USP contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.Levothyroxine (T4) sodium has an empir
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyAlara Pharm

    6 of 8  
    Drug NameLevothroid
    PubMed HealthThyroid Supplement (By mouth)
    Drug ClassesDiagnostic Agent, Thyroid Function, Thyroid Supplement
    Drug LabelLEVOTHROID (levothyroxine sodium tablets, USP) contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyLloyd

    7 of 8  
    Drug NameLevothyroxine sodium
    Active IngredientLevothyroxine sodium
    Dosage FormTablet; Powder; Injectable
    Routeinjection; Oral; Intravenous
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 200mcg/vial; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 descr
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Mylan

    8 of 8  
    Drug NameLevoxyl
    Drug LabelLEVOXYL (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3,5,5-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu...
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyKing Pharms R And D

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    l-Thyroxine [EPC]; Thyroxine [CS]
    5.2 ATC Code

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H03 - Thyroid therapy

    H03A - Thyroid preparations

    H03AA - Thyroid hormones

    H03AA01 - Levothyroxine sodium

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    Registration Number : 217MF10456

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2005-08-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 43858-410

    Start Marketing Date : 2010-02-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    09

    MSN Laboratories

    India

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

    SupplySide West
    Not Confirmed
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    MSN Laboratories

    India

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

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    SupplySide West
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38710

    Submission : 2023-09-29

    Status : Active

    Type : II

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

    NDC Package Code : 54893-0125

    Start Marketing Date : 2023-09-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Macleods Pharmaceuticals Limited

    India

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

    SupplySide West
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    Macleods Pharmaceuticals Limited

    India

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

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    SupplySide West
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-23

    Pay. Date : 2017-03-06

    DMF Number : 31203

    Submission : 2017-01-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2017-040 - Rev 00

    Issue Date : 2023-04-03

    Type : Chemical

    Substance Number : 401

    Status : Valid

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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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SODIUM USP&PH.EUR.(NEW SITE))LEVOTHYROXINE SODIUM MILLED (119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"1.68","actualQuantity":"1678","unit":"GMS","unitRateFc":"7.6","totalValueFC":"12892.4","currency":"USD","unitRateINR":"665.5","date":"08-Mar-2025","totalValueINR":"1116704.52","totalValueInUsd":"12892.4","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"8779492","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741372200,"product":"LEVOTHYROXINE SODIUM MILLED (119320)(LEVOTHYRO. SODIUM USP&PH.EUR.(NEW SITE))LEVOTHYROXINE SODIUM MILLED (119320)","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"3.57","actualQuantity":"3570","unit":"GMS","unitRateFc":"7.6","totalValueFC":"27428.9","currency":"USD","unitRateINR":"665.5","date":"08-Mar-2025","totalValueINR":"2375825.47","totalValueInUsd":"27428.9","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"8779492","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 UNITED STATES","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"LEVOTHYROXINE SODIUM USP","address":"D-68, AMBABARI","city":"JAIPUR, RAJASTHAN","supplier":"LUPIN LTD","supplierCountry":"INDIA","foreign_port":"INDORE(EPZ\/SEZ)","customer":"ELCON DRUGS AND FORMULATIONS LTD","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"10","totalValueFC":"502.2","currency":"USD","unitRateINR":"870","date":"27-Mar-2025","totalValueINR":"43500","totalValueInUsd":"502.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29379090","bill_no":"9131358","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"INDORE(EPZ\/SEZ)","supplierAddress":"PLOT NO. M2 & M2 A ISEZ PHASE II MISC ZONE PITHAMPUR SDNF India","customerAddress":"D-68, AMBABARI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746815400,"product":"LEVOTHYROXINE SODIUM I.P LEVOTHYROXINE SODIUM I.P","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"WELDING GMBH COKG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10000","unit":"GMS","unitRateFc":"5.6","totalValueFC":"55730.2","currency":"EURO","unitRateINR":"474.8","date":"10-May-2025","totalValueINR":"4748250","totalValueInUsd":"55730.2","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"9976865","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"POSTFACH 30 58 40-20318 ,HAMBURG ES PLANDE 39-20354 HAMBURG GERMANY SDNF Germany","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749234600,"product":"LEVOTHYROXINE SODIUM I.P LEVOTHYROXINE SODIUM I.P","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"WELDING GMBH COKG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15000","unit":"GMS","unitRateFc":"5.6","totalValueFC":"84888.1","currency":"EURO","unitRateINR":"486.3","date":"07-Jun-2025","totalValueINR":"7294042.5","totalValueInUsd":"84888.1","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"2517913","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"POSTFACH 30 58 40-20318 ,HAMBURG ES PLANDE 39-20354 HAMBURG GERMANY SDNF Germany","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750012200,"product":"LEVOTHYROXINE SODIUM PH EUR","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"UNDISCLOSED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT AM MAIN, HE","customer":"WOCKHARDT LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"13581.9","totalValueFC":"27424.5","currency":"EURO","unitRateINR":"1178230","date":"16-Jun-2025","totalValueINR":"2356460","totalValueInUsd":"27424.5","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"2685480","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT AM MAIN, HE","supplierAddress":"N\/A","customerAddress":"WOCKHARDT TOWERS, BANDRA KURLA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750185000,"product":"460187,LEVOTHYROXINE SODIUM I.P.,BATCH N0-B750282,CAS NUMBER-55-03-8,IUPAC: SODIUM (2S)-2-AMINO-3-[4-(4- HYDROXY-3,5-DII460187,LEVOTHYROXINE SODIUM I.P.,BATCH N0-B750282","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"SANDOZ GMBH","supplierCountry":"AUSTRIA","foreign_port":"LINZ","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5000","unit":"GMS","unitRateFc":"15","totalValueFC":"75533.5","currency":"EURO","unitRateINR":"1298.1","date":"18-Jun-2025","totalValueINR":"6490250","totalValueInUsd":"75533.5","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"2720451","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINZ","supplierAddress":"BIOCHEMIESTRASSE 10 6250 KUNDL SDNF SDNF AUSTRIA","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753986600,"product":"LEVOTHYROXINE SODIUM I.P LEVOTHYROXINE SODIUM I.P","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"WELDING GMBH COKG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15000","unit":"GMS","unitRateFc":"5.7","totalValueFC":"84844.1","currency":"EURO","unitRateINR":"495","date":"01-Aug-2025","totalValueINR":"7425532.5","totalValueInUsd":"84844.1","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"3624514","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"POSTFACH 30 58 40-20318 ,HAMBURG ES PLANDE 39-20354 HAMBURG GERMANY SDNF Germany","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756924200,"product":"LEVOTHYROXINE SODIUM USP LEVOTHYROXINE SODIUM USP","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"MAIA PHARMACEUTICALS INC","supplierCountry":"SWITZERLAND","foreign_port":"NEWARK, NJ","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"14.5","unit":"GMS","unitRateFc":"1850","totalValueFC":"26712.8","currency":"USD","unitRateINR":"162615","date":"04-Sep-2025","totalValueINR":"2357917.5","totalValueInUsd":"26712.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4287624","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK, NJ","supplierAddress":"707 STATE ROAD, SUITE 104; PRINCETON, NJ 08540 USA US","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1757010600,"product":"POLYPEPTIDE HORMONES, PROTEIN HORMONES AND GLYCOPROTEIN HORMONES, LEVOTHYROXINE SODIUM I.P.,LIC NO IL\/BD-015115 RC\/BD-00POLYPEPTIDE HORMONES, PROTEIN HORMONES AND GLYCOPROTEIN HORM","address":"3-4, CORPORATE PARK,","city":"MUMBAI. MAHARASHTRA","supplier":"WELDING GMBH COKG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ABBOTT INDIA LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"5157","totalValueFC":"207988.9","currency":"EURO","unitRateINR":"458974.5","date":"05-Sep-2025","totalValueINR":"18358980","totalValueInUsd":"207988.9","indian_port":"Bombay Air","hs_no":"29379020","bill_no":"4316489","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"20318 HAMBURGESPLANADE 39. 20354 HA MBURGPOSTBOX 305840 SDNF GERMANY","customerAddress":"3-4, CORPORATE PARK,"}]
    01-Jan-2022
    30-Sep-2025
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    API Imports and Exports

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 0.0125MG;0.0031MG

    USFDA APPLICATION NUMBER - 16807

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    DOSAGE - TABLET;ORAL - 0.025MG;0.0063MG

    USFDA APPLICATION NUMBER - 16807

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    DOSAGE - TABLET;ORAL - 0.05MG;0.0125MG

    USFDA APPLICATION NUMBER - 16807

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    DOSAGE - TABLET;ORAL - 0.15MG;0.0375MG

    USFDA APPLICATION NUMBER - 16807

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    DOSAGE - TABLET;ORAL - 0.1MG;0.025MG

    USFDA APPLICATION NUMBER - 16807

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    DOSAGE - POWDER;INTRAVENOUS - 100MCG/VIAL

    USFDA APPLICATION NUMBER - 202231

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    DOSAGE - POWDER;INTRAVENOUS - 200MCG/VIAL

    USFDA APPLICATION NUMBER - 202231

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    DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL

    USFDA APPLICATION NUMBER - 202231

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    DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21116

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    DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21210

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    DOSAGE - TABLET;ORAL - 0.025MG **See current ...DOSAGE - TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.075MG **See current ...DOSAGE - TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.088MG **See current ...DOSAGE - TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.112MG **See current ...DOSAGE - TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.125MG **See current ...DOSAGE - TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.137MG **See current ...DOSAGE - TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.15MG **See current A...DOSAGE - TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.175MG **See current ...DOSAGE - TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.1MG **See current An...DOSAGE - TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.2MG **See current An...DOSAGE - TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - TABLET;ORAL - 0.3MG **See current An...DOSAGE - TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

    USFDA APPLICATION NUMBER - 21402

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    DOSAGE - CAPSULE;ORAL - 0.013MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.025MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.0375MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.044MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.05MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.0625MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.075MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.088MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.112MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.125MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.137MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.15MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.175MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.1MG

    USFDA APPLICATION NUMBER - 21924

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    DOSAGE - CAPSULE;ORAL - 0.2MG

    USFDA APPLICATION NUMBER - 21924

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    Drug Cost (USD) : 23,154

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    Prescribers : 38

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    Company : Provell Pharmac

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    Drug Cost (USD) : 1,043,508

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    Prescribers : 51106

    Prescriptions : 108762

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    Company : Neolpharma, Inc

    Levothyroxine Sodium

    Drug Cost (USD) : 240,983

    Year : 2023

    Prescribers : 4433

    Prescriptions : 15014

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    Company : AHP

    Levothyroxine Sodium

    Drug Cost (USD) : 928

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    Prescribers : 59

    Prescriptions : 95

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    Company : Accord Healthca

    Levothyroxine Sodium

    Drug Cost (USD) : 75,301,118

    Year : 2023

    Prescribers : 1448198

    Prescriptions : 5836982

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    Company : Alvogen Inc

    Levothyroxine Sodium

    Drug Cost (USD) : 29,162,881

    Year : 2023

    Prescribers : 773281

    Prescriptions : 2844738

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    Company : Amneal Pharmace

    Levothyroxine Sodium

    Drug Cost (USD) : 189,142,188

    Year : 2023

    Prescribers : 2643415

    Prescriptions : 10484662

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    Company : App-Premierpro

    Levothyroxine Sodium

    Drug Cost (USD) : 16,586

    Year : 2023

    Prescribers :

    Prescriptions : 19

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    Company : App/Fresenius K

    Levothyroxine Sodium

    Drug Cost (USD) : 1,649,196

    Year : 2023

    Prescribers : 81

    Prescriptions : 768

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    Company : Athenex Pharmac

    Levothyroxine Sodium

    Drug Cost (USD) : 951,757

    Year : 2023

    Prescribers : 69

    Prescriptions : 649

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    ABOUT THIS PAGE

    Looking for 31178-59-3 / Levothyroxine Sodium API manufacturers, exporters & distributors?

    Levothyroxine Sodium manufacturers, exporters & distributors 1

    24

    PharmaCompass offers a list of Levothyroxine Sodium 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 Levothyroxine Sodium manufacturer or Levothyroxine Sodium supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levothyroxine Sodium manufacturer or Levothyroxine Sodium supplier.

    PharmaCompass also assists you with knowing the Levothyroxine Sodium API Price utilized in the formulation of products. Levothyroxine Sodium API Price is not always fixed or binding as the Levothyroxine Sodium Price is obtained through a variety of data sources. The Levothyroxine Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Levothyroxine Sodium

    Synonyms

    25416-65-3, L-thyroxine sodium xhydrate, Levothyroxine sodium hydrate, L-thyroxine sodium hydrate, Monosodium l-thyroxine hydrate, 31178-59-3

    Cas Number

    31178-59-3

    Unique Ingredient Identifier (UNII)

    B82379R9W0

    About Levothyroxine Sodium

    The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

    Levothyroxine Manufacturers

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

    Levothyroxine Suppliers

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

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

    Levothyroxine USDMF

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

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

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

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

    Levothyroxine KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Levothyroxine Drug Master File in Korea (Levothyroxine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levothyroxine. The MFDS reviews the Levothyroxine KDMF as part of the drug registration process and uses the information provided in the Levothyroxine KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Levothyroxine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Levothyroxine API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Levothyroxine suppliers with KDMF on PharmaCompass.

    Levothyroxine CEP

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

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

    Levothyroxine WC

    A Levothyroxine written confirmation (Levothyroxine WC) is an official document issued by a regulatory agency to a Levothyroxine manufacturer, verifying that the manufacturing facility of a Levothyroxine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levothyroxine APIs or Levothyroxine finished pharmaceutical products to another nation, regulatory agencies frequently require a Levothyroxine WC (written confirmation) as part of the regulatory process.

    click here to find a list of Levothyroxine suppliers with Written Confirmation (WC) on PharmaCompass.

    Levothyroxine 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 Levothyroxine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Levothyroxine GMP

    Levothyroxine 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 Levothyroxine 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 Levothyroxine GMP manufacturer or Levothyroxine GMP API supplier for your needs.

    Levothyroxine CoA

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

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

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