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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
    Thyroxine
    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

    Thyroxine

    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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    SANDOZ GMBH Kundl AT

    Switzerland
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    Levothyroxine Sodium, Code 460 187 - Code 460 13...

    Certificate Number : CEP 1998-141 - Rev 11

    Status : Valid

    Issue Date : 2023-09-26

    Type : Chemical

    Substance Number : 401

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    Listed Suppliers

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    01

    Suanfarma

    Spain
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    CPhI North America
    Exhibiting
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    Virtual BoothSuanfarma, at the Core of a Better Life.

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    Levothyroxine Sodium

    About the Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an innovative and sustai...

    Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an innovative and sustainable way. With 10 global offices, it serves over 400 customers in 70+ countries. Suanfarma collaborates closely with clients on final formulations, delivering customized solutions and adding value throughout the drug development process. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    02

    Biophore India Pharmaceuticals Pvt ...

    India
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    CPhI North America
    Booth #1015
    • fda
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Levothyroxine Sodium

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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    03

    LGM Pharma

    U.S.A
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    CPhI North America
    Booth #730
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Levothyroxine Sodium

    About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

    LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    04

    Willow Birch Pharma

    U.S.A
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    Compounding Pharmacy Compliance
    Attending
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    Levothyroxine Sodium

    About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

    Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    05

    Symbiotica Speciality Ingredients S...

    Malaysia
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    FCE Pharma
    Attending
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    Virtual BoothSymbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.

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    Levothyroxine Sodium

    About the Company : Symbiotica is a Malaysia-based manufacturer of high-quality Active Pharmaceutical Ingredients (APIs), specialising in steroidal, hormonal, and niche non-steroidal compounds for glo...

    Symbiotica is a Malaysia-based manufacturer of high-quality Active Pharmaceutical Ingredients (APIs), specialising in steroidal, hormonal, and niche non-steroidal compounds for global pharmaceutical markets. With over 25 years of industry expertise, we serve 250+ clients across 80+ countries through PIC/S GMP, USFDA, PMDA certified facilities. Our tailored API solutions are driven by strong R&D, stringent quality systems, and regulatory compliance, delivering reliable and innovative pharmaceutical solutions worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    06

    Anhui Biochem Pharmaceutical

    China
    PEGS Boston Summit
    Not Confirmed
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    Anhui Biochem Pharmaceutical

    China
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    PEGS Boston Summit
    Not Confirmed
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    Levothyroxine Sodium

    About the Company : Anhui Biochem Pharmaceutical Co., Ltd. is a high tech enterprise which has integrated R&D, production and marketing specializing in synthetic technology of chiral compounds. We has...

    Anhui Biochem Pharmaceutical Co., Ltd. is a high tech enterprise which has integrated R&D, production and marketing specializing in synthetic technology of chiral compounds. We has complete industry chain from API to FPPs products. We also have the largest, most complete line of anti-AIDS&HBV API Production facilities. The API products include Lamivudine USP, Zidovudine USP, Ritonavir USP, lopinavir, Nevirapine USP, Tenofovir Disoproxil Fumarate, Entecavir, NGF(Mouse Nerve Growth Factor), Capecitabine and other intermediates. The FPPs products include Lamivudine Tablet(100mg/150mg/300mg)
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    07

    Aurore Life Sciences

    India
    PEGS Boston Summit
    Not Confirmed
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    Aurore Life Sciences

    India
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    Not Confirmed
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    Levothyroxine Sodium

    About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...

    Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with vast experience across the pharmaceutical value chain, the company is on a mission to become the most preferred partner for pharmaceuticals. At Aurore, we aim to push the boundaries to manufacture and deliver high quality products that can be relied upon by both customers and regulators. Our thrust on rapidly adding capabilities have led us to acquire, integrate and expand our reach across the geographies.
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    08

    Biotechnica DWC

    Algeria
    PEGS Boston Summit
    Not Confirmed
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    Biotechnica DWC

    Algeria
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    PEGS Boston Summit
    Not Confirmed
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    Levothyroxine Sodium

    About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...

    BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies all over the world. Biotechnica is an integrated global solution provider from design to implementation of industrial projects in the areas of Pharmaceuticals,Agri-food ,Cosmetics and Nutrition. With more than 25 years of experience in the assembly of plants, particularly in the pharmaceutical sector, we accompany our customers in the various stages of their projects – E-CTD Dossieers – Raw Materiels – Equipements – Accessories – Packaging – Distribution.
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    09

    GLAND PHARMA LIMITED

    India
    PEGS Boston Summit
    Not Confirmed
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    GLAND PHARMA LIMITED

    India
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    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Levothyroxine Sodium

    About the Company : A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his...

    A globally renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his time. Since inception, Gland Pharma stands testimony to the founder’s exemplary commitment to Quality, having emerged as a global player with presence in about 90 countries in five continents. We have a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions and ophthalmic solutions.
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    10

    Guangzhou Tosun Pharmaceutical

    China
    PEGS Boston Summit
    Not Confirmed
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    Guangzhou Tosun Pharmaceutical

    China
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    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Levothyroxine Sodium

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    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

    read-more

    DOSAGE - CAPSULE;ORAL - 0.088MG

    USFDA APPLICATION NUMBER - 21924

    read-more

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

    Thyroxine manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Thyroxine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Thyroxine manufacturer or Thyroxine supplier for your needs.

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

    API | Excipient name

    Thyroxine

    Synonyms

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

    Cas Number

    31178-59-3

    Unique Ingredient Identifier (UNII)

    B82379R9W0

    About Thyroxine

    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.

    TIROSINT-SOL Manufacturers

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

    TIROSINT-SOL Suppliers

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

    click here to find a list of TIROSINT-SOL suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    TIROSINT-SOL USDMF

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

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

    click here to find a list of TIROSINT-SOL suppliers with USDMF on PharmaCompass.

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

    TIROSINT-SOL KDMF

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

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

    After submitting a TIROSINT-SOL 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 TIROSINT-SOL API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of TIROSINT-SOL suppliers with KDMF on PharmaCompass.

    TIROSINT-SOL CEP

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

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

    TIROSINT-SOL WC

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

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

    TIROSINT-SOL 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 TIROSINT-SOL as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of TIROSINT-SOL suppliers with NDC on PharmaCompass.

    TIROSINT-SOL GMP

    TIROSINT-SOL 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 TIROSINT-SOL GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right TIROSINT-SOL GMP manufacturer or TIROSINT-SOL GMP API supplier for your needs.

    TIROSINT-SOL CoA

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

    TIROSINT-SOL CoA mostly includes findings from lab analyses of a specific batch. For each TIROSINT-SOL 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.

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