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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

Levothyroxine Sodium
The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.
1 2D Structure

Levothyroxine Sodium

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

1. 3,5,3',5'-tetraiodothyronine

2. Berlthyrox

3. Dexnon

4. Eferox

5. Eltroxin

6. Eltroxine

7. Euthyrox

8. Eutirox

9. L Thyrox

10. L Thyroxin Beta

11. L Thyroxin Henning

12. L Thyroxine

13. L Thyroxine Roche

14. L-3,5,3',5'-tetraiodothyronine

15. L-thyrox

16. L-thyroxin Beta

17. L-thyroxin Henning

18. L-thyroxine

19. L-thyroxine Roche

20. Lvothyrox

21. Levo T

22. Levo-t

23. Levothroid

24. Levothyroid

25. Levothyroxin Deladande

26. Levothyroxin Delalande

27. Levothyroxine

28. Levothyroxine Sodium

29. Levoxine

30. Levoxyl

31. Novothyral

32. Novothyrox

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

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

35. Oroxine

36. Sodium Levothyroxine

37. Synthroid

38. Synthrox

39. T4 Thyroid Hormone

40. Thevier

41. Thyrax

42. Thyroid Hormone, T4

43. Thyroxin

44. Thyroxine

45. Tiroidine

46. Tiroxina Leo

47. Unithroid

2.3.2 Depositor-Supplied Synonyms

1. 25416-65-3

2. Levothyroxine Sodium

3. L-thyroxine Sodium Xhydrate

4. Levothyroxine Sodium Hydrate

5. L-thyroxine Sodium Hydrate

6. Monosodium L-thyroxine Hydrate

7. 31178-59-3

8. Chebi:6447

9. Levothroid

10. Synthroid

11. Levothyrox

12. Levaxin

13. Levoxyl

14. Oroxine

15. Soloxine

16. Eferox

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

18. B82379r9w0

19. Thyroxine Sodium

20. Levo-t

21. Liotrix (t4)

22. Thyroxine Sodium Salt

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

24. Latequatro

25. Letequatro

26. Levoroxin

27. Levotiron

28. Tiroxina

29. Tivoral

30. Levo-tiroxina Glaxo

31. Nsc-259940

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

33. Unii-b82379r9w0

34. Levothroid (tn)

35. Synthroid (tn)

36. Levoxyl (tn)

37. Levothyroxine Sodium [usp:inn:jan]

38. Starbld0009614

39. L-thyroxin Monosodium Salt

40. T4 (liotrix)

41. Levothyroxine Sodium (usp)

42. Schembl2327406

43. Chembl2103741

44. L-thyroxine Sodium Salt Monohydrate

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

46. Levothyroxine Sodium Hydrate (jp17)

47. Mfcd06408007

48. Akos015895962

49. Ks-1237

50. D01010

51. E78443

52. Levothyroxine Sodium Monohydrate [who-ip]

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

54. A817851

55. Q27107209

56. Levothyroxinum Natricum Monohydrate [who-ip Latin]

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

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

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

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

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

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

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

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

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

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

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

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

H03 - Thyroid therapy

H03A - Thyroid preparations

H03AA - Thyroid hormones

H03AA01 - Levothyroxine sodium


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Levothyroxine Sodium Hydrate

Registration Number : 221MF10168

Registrant's Address : Am Kraftwerk 6, D-66450 Bexbach, Germany

Initial Date of Registration : 2009-07-30

Latest Date of Registration : 2009-07-30

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Levothyroxine Sodium

Registration Number : 217MF10456

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

Initial Date of Registration : 2005-08-24

Latest Date of Registration : 2017-12-06

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Levothyroxine sodium USP/Ph.Eur

Date of Issue : 2022-09-19

Valid Till : 2025-07-02

Written Confirmation Number : WC-0119

Address of the Firm : Plot No. 35, 36, 38, 39, 40, 49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal-Mal...

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Levothyroxine Sodium USP/Ph.Eur

Date of Issue : 2023-11-15

Valid Till : 2026-11-14

Written Confirmation Number : WC-0404

Address of the Firm : Plot No. 40/A, Sy Nos. 13,15,16,51,52 & 182, J.N. Pharma city, Thanam Village, P...

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Levothyroxine Sodium USP

Date of Issue : 2022-04-08

Valid Till : 2025-04-03

Written Confirmation Number : WC-0427

Address of the Firm : Plot No.49 & 50, J.N. Pharma City, Parawada (M), Visakhapatanam

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Levothyroxine Sodium BP/Ph.Eur

Date of Issue : 2023-11-03

Valid Till : 2026-11-02

Written Confirmation Number : WC-0572

Address of the Firm : SurveyNo.338(P-38), NexttoMIDCindustrialarea, KHNo.:25/3,kanhan-Mansar Highway N...

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Levothyroxine sodium hydrate

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-11-25

Registration Number : 20201125-209-J-789

Manufacturer Name : Azico Biophore India Private...

Manufacturer Address : Plot Number 40/A, Sy. No. 13,15,16,51,52 & 182, JN.Pharma city, Thanam(V), Anakapalli...

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02

Peptido GmbH

Germany
Chemicals America
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Peptido GmbH

Germany
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Levothyroxine sodium hydrate

Registrant Name : Bukwang Pharmaceutical Co., Ltd.

Registration Date : 2019-02-18

Registration Number : 20181023-209-J-104(1)

Manufacturer Name : Peptido GmbH

Manufacturer Address : Am Kraftwerk 6, 66450 Bexbach, Germany

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03

Peptido GmbH

Germany
Chemicals America
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Peptido GmbH

Germany
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Chemicals America
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Levothyroxine sodium hydrate

Registrant Name : Samnam Pharmaceutical Co., Ltd.

Registration Date : 2020-01-10

Registration Number : 20181023-209-J-104(3)

Manufacturer Name : Peptido GmbH

Manufacturer Address : Am Kraftwerk 6, 66450 Bexbach, Germany

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04

Peptido GmbH

Germany
Chemicals America
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Peptido GmbH

Germany
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Levothyroxine sodium hydrate

Registrant Name : Wooshin Labotech Co., Ltd.

Registration Date : 2019-12-03

Registration Number : 20181023-209-J-104(2)

Manufacturer Name : Peptido GmbH

Manufacturer Address : Am Kraftwerk 6, 66450 Bexbach, Germany

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05

Peptido GmbH

Germany
Chemicals America
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Peptido GmbH

Germany
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Levothyroxine sodium hydrate

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2018-10-23

Registration Number : 20181023-209-J-104

Manufacturer Name : Peptido GmbH

Manufacturer Address : Am Kraftwerk 6, 66450 Bexbach, Germany

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

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, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
Biophore

02

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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 hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

03

Bioiberica

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.

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Levothyroxine Sodium

About the Company : Bioiberica is a global Life Science company with more than 45 years' experience in the production and development of molecules of high biological and therapeutic value for the phar...

Bioiberica is a global Life Science company with more than 45 years' experience in the production and development of molecules of high biological and therapeutic value for the pharmaceutical and nutraceutical industries. This specialisation positions Bioiberica among the leading Heparin API manufacturers and as a world reference of other biologically-derived APIs and scientifically backed nutraceutical ingredients for mobility, digestive health and skin & beauty. Through its vertically integrated supply chain, Bioiberica ensures the highest quality, safety and full traceability of its products, which are produced in Europe.
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04

Chemicals America
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Chemicals America
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Levothyroxine Sodium

About the Company : Aasraw Biochemical Technology Co.,ltd was reorganized by a Shanghai based Biochemical Engineering Laboratory in 2008, which was built by 5 Chinese Ph. Doctors, who are majored at C...

Aasraw Biochemical Technology Co.,ltd was reorganized by a Shanghai based Biochemical Engineering Laboratory in 2008, which was built by 5 Chinese Ph. Doctors, who are majored at Chemical Engineering in University of Tulsa, Oklahoma, USA. The new born AASraw gained more investment and attracted more top genius guys in the biochemical industry. There are more advantaged equipment and instruments to be being adopted for analyzing, testing, Synthesis, etc., for example, DSC, GV, HPLC, UV, RV, etc. Till now, there are more than 20 key technology engineers. The fixed assets is more than USD30 million.
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05

Chemicals America
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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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06

Chemicals America
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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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07

Biotechnica DWC

Algeria
Chemicals America
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Biotechnica DWC

Algeria
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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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08

Fareva

Luxembourg
Chemicals America
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Fareva

Luxembourg
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Chemicals America
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Levothyroxine Sodium

About the Company : Fareva’s API division has special technologies for high potent APIs (HPAPIs) down to the OEB-6 level, aseptic crystallization (sterile APIs), Spray Drying etc, with volumes rangi...

Fareva’s API division has special technologies for high potent APIs (HPAPIs) down to the OEB-6 level, aseptic crystallization (sterile APIs), Spray Drying etc, with volumes ranging from a few kgs to multi tons production. Fareva’s Drug Product division offers different technologies: injectables (lyophilized, solution, suspension, vial, ampoules, pre-filled syringes), unidoses and multidoses BFS, solids (tablets, hard capsules, powders), semi-solids (cream, gel suppositories) and liquids (oral and external, sprays, aerosols).
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09

Chemicals America
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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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Laurus Labs

India
Chemicals America
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Laurus Labs

India
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Levothyroxine Sodium

About the Company : Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Ph...

Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus Labs also manufactures APIs in oncology and other therapeutic areas. Its strategic and early investments in R&D and manufacturing infrastructure have enabled it to become one of the leading suppliers of APIs in the ARV therapeutic area. Out of Ten largest generic pharmaceutical companies in the world, by revenues, are our customers.
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API Reference Price

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SDNF Germany","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750012200,"product":"LEVOTHYROXINE SODIUM PH EUR","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"UNDISCLOSED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT AM MAIN, HE","customer":"WOCKHARDT LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"13581.9","totalValueFC":"27424.5","currency":"EURO","unitRateINR":"1178230","date":"16-Jun-2025","totalValueINR":"2356460","totalValueInUsd":"27424.5","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"2685480","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT AM MAIN, HE","supplierAddress":"N\/A","customerAddress":"WOCKHARDT TOWERS, BANDRA KURLA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750185000,"product":"460187,LEVOTHYROXINE SODIUM I.P.,BATCH N0-B750282,CAS NUMBER-55-03-8,IUPAC: SODIUM (2S)-2-AMINO-3-[4-(4- HYDROXY-3,5-DII460187,LEVOTHYROXINE SODIUM I.P.,BATCH N0-B750282","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"SANDOZ GMBH","supplierCountry":"AUSTRIA","foreign_port":"LINZ","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5000","unit":"GMS","unitRateFc":"15","totalValueFC":"75533.5","currency":"EURO","unitRateINR":"1298.1","date":"18-Jun-2025","totalValueINR":"6490250","totalValueInUsd":"75533.5","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"2720451","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINZ","supplierAddress":"BIOCHEMIESTRASSE 10 6250 KUNDL SDNF SDNF AUSTRIA","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750185000,"product":"460187,LEVOTHYROXINE SODIUM ORAL,BATCH N0-B750282,CAS NUMBER55-03-8,IUPAC:SODIUM (2S)-2-AMINO-3-[4-(4- HYDROXY-3,5-DIIO460187,LEVOTHYROXINE SODIUM ORAL,BATCH N0-B750282,CAS NUMBER","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"SANDOZ GMBH","supplierCountry":"AUSTRIA","foreign_port":"LINZ","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"21","unit":"GMS","unitRateFc":"15","totalValueFC":"317.2","currency":"EURO","unitRateINR":"1298.1","date":"18-Jun-2025","totalValueINR":"27259.05","totalValueInUsd":"317.2","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"2720451","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINZ","supplierAddress":"BIOCHEMIESTRASSE 10 6250 KUNDL SDNF SDNF AUSTRIA","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1751049000,"product":"LEVOTHYROXINE SODIUM I.P LEVOTHYROXINE SODIUM I.P","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"WELDING GMBH COKG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10000","unit":"GMS","unitRateFc":"5.6","totalValueFC":"57413.9","currency":"EURO","unitRateINR":"493.3","date":"28-Jun-2025","totalValueINR":"4933310","totalValueInUsd":"57413.9","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"2937725","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"POSTFACH 30 58 40-20318 ,HAMBURG ES PLANDE 39-20354 HAMBURG GERMANY SDNF Germany","customerAddress":"DR ANNIE BESANT ROAD"}]
01-Jan-2022
28-Jun-2025
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INTERMEDIATE SUPPLIERS

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01

Chemicals America
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Chemicals America
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CAS Number : 18835-59-1

End Use API : Levothyroxine Sodium

About The Company : Louis Pharmaceuticals Private Limited is an Advanced Intermediates Manufacturing firm. The Company is established in 2009 and has an integrated focus from vario...

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02

Chemicals America
Not Confirmed
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Chemicals America
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CAS Number : 19231-06-2

End Use API : Levothyroxine Sodium

About The Company : Louis Pharmaceuticals Private Limited is an Advanced Intermediates Manufacturing firm. The Company is established in 2009 and has an integrated focus from vario...

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03

Chemicals America
Not Confirmed
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Chemicals America
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CAS Number : 19231-06-2

End Use API : Levothyroxine Sodium

About The Company : Novick Bio-Sciences is a rapidly-growing Contract Research and Development Organization (CRDO) providing chemistry and formulation development services to Globa...

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04

Chemicals America
Not Confirmed
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Chemicals America
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CAS Number : 1041-01-6

End Use API : Levothyroxine Sodium

About The Company : Novick Bio-Sciences is a rapidly-growing Contract Research and Development Organization (CRDO) providing chemistry and formulation development services to Globa...

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05

Scinvapharma

India
Chemicals America
Not Confirmed
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Scinvapharma

India
Chemicals America
Not Confirmed
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CAS Number : 1041-01-6

End Use API : Levothyroxine Sodium

About The Company : Scinva is a startup dedicated to offering high-quality products and services, providing a comprehensive range of services from custom synthesis to the trade of ...

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DOSAGE - TABLET;ORAL - 0.0125MG;0.0031MG

USFDA APPLICATION NUMBER - 16807

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DOSAGE - TABLET;ORAL - 0.025MG;0.0063MG

USFDA APPLICATION NUMBER - 16807

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DOSAGE - TABLET;ORAL - 0.05MG;0.0125MG

USFDA APPLICATION NUMBER - 16807

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DOSAGE - TABLET;ORAL - 0.15MG;0.0375MG

USFDA APPLICATION NUMBER - 16807

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DOSAGE - TABLET;ORAL - 0.1MG;0.025MG

USFDA APPLICATION NUMBER - 16807

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DOSAGE - POWDER;INTRAVENOUS - 100MCG/VIAL

USFDA APPLICATION NUMBER - 202231

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DOSAGE - POWDER;INTRAVENOUS - 200MCG/VIAL

USFDA APPLICATION NUMBER - 202231

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DOSAGE - POWDER;INTRAVENOUS - 500MCG/VIAL

USFDA APPLICATION NUMBER - 202231

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21116

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21210

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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

USFDA APPLICATION NUMBER - 21402

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DOSAGE - CAPSULE;ORAL - 0.013MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.025MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.0375MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.044MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.05MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.0625MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.075MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.088MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.112MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.125MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.137MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.15MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.175MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.1MG

USFDA APPLICATION NUMBER - 21924

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DOSAGE - CAPSULE;ORAL - 0.2MG

USFDA APPLICATION NUMBER - 21924

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ABOUT THIS PAGE

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

Levothyroxine Sodium manufacturers, exporters & distributors 1

24

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

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

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

API | Excipient name

Levothyroxine Sodium

Synonyms

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

Cas Number

31178-59-3

Unique Ingredient Identifier (UNII)

B82379R9W0

About Levothyroxine Sodium

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

GlaxoSmithKline Brand of Levothyroxine Sodium Manufacturers

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

GlaxoSmithKline Brand of Levothyroxine Sodium Suppliers

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

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

GlaxoSmithKline Brand of Levothyroxine Sodium USDMF

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

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

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

GlaxoSmithKline Brand of Levothyroxine Sodium 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 GlaxoSmithKline Brand of Levothyroxine Sodium Drug Master File in Japan (GlaxoSmithKline Brand of Levothyroxine Sodium JDMF) empowers GlaxoSmithKline Brand of Levothyroxine Sodium 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 GlaxoSmithKline Brand of Levothyroxine Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of GlaxoSmithKline Brand of Levothyroxine Sodium 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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GlaxoSmithKline Brand of Levothyroxine Sodium KDMF

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

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

After submitting a GlaxoSmithKline Brand of Levothyroxine Sodium 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 GlaxoSmithKline Brand of Levothyroxine Sodium API can apply through the Korea Drug Master File (KDMF).

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GlaxoSmithKline Brand of Levothyroxine Sodium CEP

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

A GlaxoSmithKline Brand of Levothyroxine Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. GlaxoSmithKline Brand of Levothyroxine Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

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GlaxoSmithKline Brand of Levothyroxine Sodium WC

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

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GlaxoSmithKline Brand of Levothyroxine Sodium 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 GlaxoSmithKline Brand of Levothyroxine Sodium as an active pharmaceutical ingredient (API).

Finished drug products

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

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GlaxoSmithKline Brand of Levothyroxine Sodium GMP

GlaxoSmithKline Brand of Levothyroxine Sodium 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 GlaxoSmithKline Brand of Levothyroxine Sodium 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 GlaxoSmithKline Brand of Levothyroxine Sodium GMP manufacturer or GlaxoSmithKline Brand of Levothyroxine Sodium GMP API supplier for your needs.

GlaxoSmithKline Brand of Levothyroxine Sodium CoA

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

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

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