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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 15 USDMF, 10 CEP/COS, 2 JDMF, 5 EU WC, 5 KDMF, 20 NDC API, 13 Listed Suppliers, $ API Reference Price

27 API Suppliers
15 USDMF
10 CEP/COS
2 JDMF
5 EU WC
5 KDMF
20 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

591 FDF Dossiers, 264 FDA Orange Book, 187 Europe, 29 Canada, 37 Australia, 19 South Africa, 55 Listed Dossiers

591 FDF Dossiers
264 FDA Orange Book
187 Europe
29 Canada
37 Australia
19 South Africa
55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG, TABLET;ORAL - 0.025MG;0.0063MG, TABLET;ORAL - 0.05MG;0.0125MG, TABLET;ORAL - 0.15MG;0.0375MG, TABLET;ORAL - 0.1MG;0.025MG, POWDER;INTRAVENOUS - 100MCG/VIAL, POWDER;INTRAVENOUS - 200MCG/VIAL, POWDER;INTRAVENOUS - 500MCG/VIAL, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium, CAPSULE;ORAL - 0.013MG, CAPSULE;ORAL - 0.025MG, CAPSULE;ORAL - 0.0375MG, CAPSULE;ORAL - 0.044MG, CAPSULE;ORAL - 0.05MG, CAPSULE;ORAL - 0.0625MG, CAPSULE;ORAL - 0.075MG, CAPSULE;ORAL - 0.088MG, CAPSULE;ORAL - 0.112MG, CAPSULE;ORAL - 0.125MG, CAPSULE;ORAL - 0.137MG, CAPSULE;ORAL - 0.15MG, CAPSULE;ORAL - 0.175MG, CAPSULE;ORAL - 0.1MG, CAPSULE;ORAL - 0.2MG

drugProductComposition
TABLET;ORAL - 0.0125MG;0.0031MG
TABLET;ORAL - 0.025MG;0.0063MG
TABLET;ORAL - 0.05MG;0.0125MG
TABLET;ORAL - 0.15MG;0.0375MG
TABLET;ORAL - 0.1MG;0.025MG
POWDER;INTRAVENOUS - 100MCG/VIAL
POWDER;INTRAVENOUS - 200MCG/VIAL
POWDER;INTRAVENOUS - 500MCG/VIAL
TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
CAPSULE;ORAL - 0.013MG
CAPSULE;ORAL - 0.025MG
CAPSULE;ORAL - 0.0375MG
CAPSULE;ORAL - 0.044MG
CAPSULE;ORAL - 0.05MG
CAPSULE;ORAL - 0.0625MG
CAPSULE;ORAL - 0.075MG
CAPSULE;ORAL - 0.088MG
CAPSULE;ORAL - 0.112MG
CAPSULE;ORAL - 0.125MG
CAPSULE;ORAL - 0.137MG
CAPSULE;ORAL - 0.15MG
CAPSULE;ORAL - 0.175MG
CAPSULE;ORAL - 0.1MG
CAPSULE;ORAL - 0.2MG

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 20 SPI Pharma, 7 DKSH, 9 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 2 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 31 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 42 Direct Compression, 29 Disintegrants & Superdisintegrants, 28 Thickeners and Stabilizers, 26 Granulation, 26 Controlled & Modified Release, 24 Taste Masking, 20 Parenteral, 20 Lubricants & Glidants, 18 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 14 Solubilizers, 9 Film Formers & Plasticizers, 9 Empty Capsules, 7 API Stability Enhancers, 6 Emulsifying Agents, 6 Topical, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

8 DATA COMPILATION #PharmaFlow, 89 NEWS #PharmaBuzz

media
8 DATA COMPILATION #PharmaFlow
89 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 177 Finished Drug Prices, 8 Annual Reports

globalSalesInformation
8 US Medicaid Prescriptions
177 Finished Drug Prices
8 Annual Reports

MARKET PLACE

30 APIs, 14 FDF Dossiers

marketPlace
30 APIs
14 FDF Dossiers

PATENTS & EXCLUSIVITIES

125 US Patents

patents
125 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 3 Others

otherSolutions
3 EDQM
3 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 6,623

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

591

FDF Dossiers

264

FDA Orange Book

187

Europe

Canada

Australia

South Africa

Listed Dossiers

9DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

125

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

396,370,051

Annual Reports (USD Million)

5,367

Finished Drug Prices

271 RELATED EXCIPIENT COMPANIES

446EXCIPIENTS BY APPLICATIONS

Chemistry

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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

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 Formula	C₁₅H₁₂I₄NNaO₅
Molecular Weight	816.87 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	816.6792 g/mol
Monoisotopic Mass	816.6792 g/mol
Topological Polar Surface Area	96.6 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	426
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Levo-t
Drug Label	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) sodium has an empir
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg 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 Status	Prescription
Company	Alara Pharm

2 of 8
Drug Name	Levothroid
PubMed Health	Thyroid Supplement (By mouth)
Drug Classes	Diagnostic Agent, Thyroid Function, Thyroid Supplement
Drug Label	LEVOTHROID (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 Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg 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 Status	Prescription
Company	Lloyd

3 of 8
Drug Name	Levothyroxine sodium
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet; Powder; Injectable
Route	injection; Oral; Intravenous
Strength	0.05mg 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 Status	Prescription
Company	Fresenius Kabi Usa; Mylan

4 of 8
Drug Name	Levoxyl
Drug Label	LEVOXYL (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 Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg 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 Status	Prescription
Company	King Pharms R And D

5 of 8
Drug Name	Levo-t
Drug Label	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) sodium has an empir
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg 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 Status	Prescription
Company	Alara Pharm

6 of 8
Drug Name	Levothroid
PubMed Health	Thyroid Supplement (By mouth)
Drug Classes	Diagnostic Agent, Thyroid Function, Thyroid Supplement
Drug Label	LEVOTHROID (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 Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg 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 Status	Prescription
Company	Lloyd

7 of 8
Drug Name	Levothyroxine sodium
Active Ingredient	Levothyroxine sodium
Dosage Form	Tablet; Powder; Injectable
Route	injection; Oral; Intravenous
Strength	0.05mg 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 Status	Prescription
Company	Fresenius Kabi Usa; Mylan

8 of 8
Drug Name	Levoxyl
Drug Label	LEVOXYL (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 Ingredient	Levothyroxine sodium
Dosage Form	Tablet
Route	Oral
Strength	0.05mg 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 Status	Prescription
Company	King 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

API SUPPLIERS

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USDMF

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"LEVOTHYROXINE SODIUM","address":"PLOT NO 75 INDUSTRIAL AREA PHASE -","city":"CHANDIGARH,CHANDIGARH","supplier":"WELDING GMBH & CO.KG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ACME GENERICS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"4470","totalValueFC":"97728.7","currency":"EUR","unitRateINR":"412357.5","date":"12-Nov-2024","totalValueINR":"8247150","totalValueInUsd":"97728.7","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6632827","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"POST BOX 30 58 40, 20318, HAMBURG E SPLANADE 39, 20354 HAMBURG Hamburg, , GERMANY GERMANY","customerAddress":"PLOT NO 75 INDUSTRIAL AREA PHASE -"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"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":"0.02","actualQuantity":"15.4","unit":"GMS","unitRateFc":"1207.5","totalValueFC":"18807.4","currency":"USD","unitRateINR":"103060.1","date":"26-Nov-2024","totalValueINR":"1587125.93","totalValueInUsd":"18807.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6892585","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":"2024","qtr":"Q4","strtotime":1732559400,"product":"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":"0.04","actualQuantity":"39.6","unit":"GMS","unitRateFc":"1207.5","totalValueFC":"48362","currency":"USD","unitRateINR":"103060.1","date":"26-Nov-2024","totalValueINR":"4081180.95","totalValueInUsd":"48362","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6892585","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":"2024","qtr":"Q4","strtotime":1734460200,"product":"LEVOTHYROXINE SODIUM PH EUR LEVOTHYROXINE SODIUM PH EUR","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"WELDING GMBH& CO KG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"WOCKHARDT","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"12516.4","totalValueFC":"12616.7","currency":"USD","unitRateINR":"1072030","date":"18-Dec-2024","totalValueINR":"1072030","totalValueInUsd":"12616.7","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"7316656","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ESPLANADE 39 - 20354 HAMBURG SDNF SDNF Germany","customerAddress":"WOCKHARDT TOWERS, BANDRA KURLA"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

01

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Digital Content

Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

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Corporate PDF

02

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

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Corporate PDF

03

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

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Corporate PDF

04

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

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05

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

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Corporate PDF

06

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

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Corporate PDF

07

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

Product Web Link

Corporate PDF

08

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

Product Web Link

Corporate PDF

09

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

Product Web Link

Corporate PDF

10

AbbVie Inc

U.S.A

PharmaVenue

Not Confirmed

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U.S.A

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Digital Content

Regulatory Info : RX

Registration Country : USA

LEVOTHYROXINE SODIUM

Brand Name : SYNTHROID

Dosage Form : TABLET;ORAL

Dosage Strength : 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Packaging :

Approval Date : 2002-07-24

Application Number : 21402

Regulatory Info : RX

Registration Country : USA

Product Web Link

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.0125MG;0.0031MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.025MG;0.0063MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.05MG;0.0125MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.15MG;0.0375MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - TABLET;ORAL - 0.1MG;0.025MG

USFDA APPLICATION NUMBER - 16807

DOSAGE - POWDER;INTRAVENOUS - 100MCG/VIAL

USFDA APPLICATION NUMBER - 202231

DOSAGE - POWDER;INTRAVENOUS - 200MCG/VIAL

USFDA APPLICATION NUMBER - 202231

DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL

USFDA APPLICATION NUMBER - 202231

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DOSAGE - CAPSULE;ORAL - 0.013MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.025MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.0375MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.044MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.05MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.0625MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.075MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.088MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.112MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.125MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.137MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.15MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.175MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.1MG

USFDA APPLICATION NUMBER - 21924

DOSAGE - CAPSULE;ORAL - 0.2MG

USFDA APPLICATION NUMBER - 21924

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ABOUT THIS PAGE

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.

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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.

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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).

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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.

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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.

Find Levothyroxine Sodium manufacturers, exporters & distributors on PharmaCompass

Levothyroxine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers

15 USDMF

10 CEP/COS

2 JDMF

5 EU WC

5 KDMF

20 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

591 FDF Dossiers

264 FDA Orange Book

187 Europe

29 Canada

37 Australia

19 South Africa

55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.0125MG;0.0031MG

TABLET;ORAL - 0.025MG;0.0063MG

TABLET;ORAL - 0.05MG;0.0125MG

TABLET;ORAL - 0.15MG;0.0375MG

TABLET;ORAL - 0.1MG;0.025MG

POWDER;INTRAVENOUS - 100MCG/VIAL

POWDER;INTRAVENOUS - 200MCG/VIAL

POWDER;INTRAVENOUS - 500MCG/VIAL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CAPSULE;ORAL - 0.013MG

CAPSULE;ORAL - 0.025MG

CAPSULE;ORAL - 0.0375MG

CAPSULE;ORAL - 0.044MG

CAPSULE;ORAL - 0.05MG

CAPSULE;ORAL - 0.0625MG

CAPSULE;ORAL - 0.075MG