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Chemistry

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Also known as: 114870-03-0, Arixtra, Quixidar, Fondaparin sodium, Sr-90107a, Org 31540
Molecular Formula
C31H43N3Na10O49S8
Molecular Weight
1728.1  g/mol
InChI Key
XEKSTYNIJLDDAZ-JASSWCPGSA-D
FDA UNII
X0Q6N9USOZ

Fondaparinux Sodium
Synthetic pentasaccharide that mediates the interaction of HEPARIN with ANTITHROMBINS and inhibits FACTOR Xa; it is used for prevention of VENOUS THROMBOEMBOLISM after surgery.
1 2D Structure

Fondaparinux Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
decasodium;(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5R,6R)-6-[(2R,3S,4S,5R,6R)-2-carboxylato-4-hydroxy-6-[(2R,3S,4R,5R,6S)-4-hydroxy-6-methoxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl)oxan-3-yl]oxy-5-sulfonatooxyoxan-3-yl]oxy-5-(sulfonatoamino)-4-sulfonatooxy-2-(sulfonatooxymethyl)oxan-3-yl]oxy-3-[(2R,3R,4R,5S,6R)-4,5-dihydroxy-3-(sulfonatoamino)-6-(sulfonatooxymethyl)oxan-2-yl]oxy-4,5-dihydroxyoxane-2-carboxylate
2.1.2 InChI
InChI=1S/C31H53N3O49S8.10Na/c1-69-27-9(33-85(48,49)50)13(37)17(6(74-27)3-71-88(57,58)59)76-31-22(83-91(66,67)68)16(40)21(24(81-31)26(43)44)79-29-10(34-86(51,52)53)19(82-90(63,64)65)18(7(75-29)4-72-89(60,61)62)77-30-15(39)14(38)20(23(80-30)25(41)42)78-28-8(32-84(45,46)47)12(36)11(35)5(73-28)2-70-87(54,55)56;;;;;;;;;;/h5-24,27-40H,2-4H2,1H3,(H,41,42)(H,43,44)(H,45,46,47)(H,48,49,50)(H,51,52,53)(H,54,55,56)(H,57,58,59)(H,60,61,62)(H,63,64,65)(H,66,67,68);;;;;;;;;;/q;10*+1/p-10/t5-,6-,7-,8-,9-,10-,11-,12-,13-,14-,15-,16+,17-,18-,19-,20+,21+,22-,23+,24-,27+,28-,29-,30-,31-;;;;;;;;;;/m1........../s1
2.1.3 InChI Key
XEKSTYNIJLDDAZ-JASSWCPGSA-D
2.1.4 Canonical SMILES
COC1C(C(C(C(O1)COS(=O)(=O)[O-])OC2C(C(C(C(O2)C(=O)[O-])OC3C(C(C(C(O3)COS(=O)(=O)[O-])OC4C(C(C(C(O4)C(=O)[O-])OC5C(C(C(C(O5)COS(=O)(=O)[O-])O)O)NS(=O)(=O)[O-])O)O)OS(=O)(=O)[O-])NS(=O)(=O)[O-])O)OS(=O)(=O)[O-])O)NS(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
2.1.5 Isomeric SMILES
CO[C@@H]1[C@@H]([C@H]([C@@H]([C@H](O1)COS(=O)(=O)[O-])O[C@H]2[C@@H]([C@H]([C@@H]([C@@H](O2)C(=O)[O-])O[C@@H]3[C@@H]([C@H]([C@@H]([C@H](O3)COS(=O)(=O)[O-])O[C@H]4[C@@H]([C@H]([C@@H]([C@H](O4)C(=O)[O-])O[C@@H]5[C@@H]([C@H]([C@@H]([C@H](O5)COS(=O)(=O)[O-])O)O)NS(=O)(=O)[O-])O)O)OS(=O)(=O)[O-])NS(=O)(=O)[O-])O)OS(=O)(=O)[O-])O)NS(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
2.2 Other Identifiers
2.2.1 UNII
X0Q6N9USOZ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Arixtra

2. Fondaparinux

3. Quixidar

2.3.2 Depositor-Supplied Synonyms

1. 114870-03-0

2. Arixtra

3. Quixidar

4. Fondaparin Sodium

5. Sr-90107a

6. Org 31540

7. Sr 90107a

8. Fondaparinux Sodium For Assay

9. Org-31540

10. Fondaparinux Sodium Identification

11. X0q6n9usoz

12. Ic-851589

13. Xantidar

14. Arixtra (tn)

15. Unii-x0q6n9usoz

16. Fondaparinux Sodium [usan]

17. Fondaparinux Sodium [usan:inn:ban]

18. Gsk-576428

19. Ic 85158

20. Sr-90107

21. Chembl1200644

22. Fondaparinux Sodium [mi]

23. Fondaparinux Sodium [inn]

24. Fondaparinux Sodium [jan]

25. Dtxsid501027612

26. Fondaparinux Sodium [mart.]

27. Fondaparinux Sodium (jan/usp/inn)

28. Fondaparinux Sodium [usp-rs]

29. Fondaparinux Sodium [who-dd]

30. Natural Heparin Pentasaccharide Sodium

31. Akos005146286

32. Fondaparinux Sodium [ema Epar]

33. Ccg-270693

34. Fondaparinux Sodium [orange Book]

35. As-80003

36. Fondaparinux Sodium [usp Monograph]

37. C71476

38. D01844

39. A803253

40. Q421218

41. Alpha-d-glucopyranoside, Methyl O-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-beta-d-glucopyranuronosyl(1-4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-2-o-sulfo-alpha-l-idopyranuronosyl-(1-4)-2-deoxy-2-(sulfoamino)-, 6-(hydrogen Sulfate), Decasodium Salt

42. Decasodium 6-[6-[2-carboxylato-4-hydroxy-6-[4-hydroxy-6-methoxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl)tetrahydropyran-3-yl]oxy-5-sulfonatooxy-tetrahydropyran-3-yl]oxy-5-(sulfonatoamino)-4-sulfonatooxy-2-(sulfonatooxymethyl)tetrahydropyran-3-yl]oxy-3-[4;fondaparinux Sodium

43. Methly O-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-beta-d-glucopyranuronosyl-(1-4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-2-o-sulfo-alpha-l-idopyranuronosyl-(1-4)-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranoside, Decasodium Salt

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 1728.1 g/mol
Molecular Formula C31H43N3Na10O49S8
Hydrogen Bond Donor Count9
Hydrogen Bond Acceptor Count52
Rotatable Bond Count20
Exact Mass1726.7707769 g/mol
Monoisotopic Mass1726.7707769 g/mol
Topological Polar Surface Area901 Ų
Heavy Atom Count101
Formal Charge0
Complexity3330
Isotope Atom Count0
Defined Atom Stereocenter Count25
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count11
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameArixtra
Drug LabelARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)--D-glucopyranosyl-(1...
Active IngredientFondaparinux sodium
Dosage FormInjectable
RouteSubcutaneous
Strength5mg/0.4ml; 2.5mg/0.5ml; 7.5mg/0.6ml; 10mg/0.8ml
Market StatusPrescription
CompanyAgi

2 of 4  
Drug NameFondaparinux sodium
PubMed HealthFondaparinux (Injection)
Drug ClassesAnticoagulant
Drug LabelARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)--D-glucopyranosyl-(1...
Active IngredientFondaparinux sodium
Dosage FormInjectable
RouteSubcutaneous
Strength2.5mg/0.5ml; 7.5mg/0.6ml; 5mg/0.4ml; 10mg/0.8ml
Market StatusPrescription
CompanyDr Reddys Labs

3 of 4  
Drug NameArixtra
Drug LabelARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)--D-glucopyranosyl-(1...
Active IngredientFondaparinux sodium
Dosage FormInjectable
RouteSubcutaneous
Strength5mg/0.4ml; 2.5mg/0.5ml; 7.5mg/0.6ml; 10mg/0.8ml
Market StatusPrescription
CompanyAgi

4 of 4  
Drug NameFondaparinux sodium
PubMed HealthFondaparinux (Injection)
Drug ClassesAnticoagulant
Drug LabelARIXTRA (fondaparinux sodium) Injection is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)--D-glucopyranosyl-(1...
Active IngredientFondaparinux sodium
Dosage FormInjectable
RouteSubcutaneous
Strength2.5mg/0.5ml; 7.5mg/0.6ml; 5mg/0.4ml; 10mg/0.8ml
Market StatusPrescription
CompanyDr Reddys Labs

4.2 Drug Indication

* 1. 5-mg/0. 3-ml and 2. 5-mg/0. 5-ml solution for injection:

Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery.

Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.

Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease.

Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.

* 2. 5-mg/0. 5-ml solution for injection:

Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated.

infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.

* 5-mg/0. 4-ml, 7. 5-mg/0. 6-ml and 10-mg/0. 8-ml solution for injection:

Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.


1. 5 mg/0. 3 ml and 2. 5 mg/0. 5 ml, solution for injection:

Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.

Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5. 1).

Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.

2. 5 mg/0. 5 ml, solution for injection:

Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4. 4 and 5. 1).

Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.

5 mg/0. 4 ml, 7. 5 mg/0. 6 ml and 10 mg/0. 8 ml solution for injection:

Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Factor Xa Inhibitors

Endogenous factors and drugs that inhibit or block the activity of FACTOR XA. (See all compounds classified as Factor Xa Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Factor Xa Inhibitors [MoA]; Factor Xa Inhibitor [EPC]
5.3 ATC Code

B01AX05


B01AX05


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Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737397800,"product":"FONDAPARINUX SODIUM","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"JAKARTA SOEKARNO-HA","customer":"PTWOLONG SOKO INDONESIA","customerCountry":"INDONESIA","quantity":"0.16","actualQuantity":"0.16","unit":"KGS","unitRateFc":"357000","totalValueFC":"56439.5","currency":"USD","unitRateINR":30417075.9375,"date":"21-Jan-2025","totalValueINR":"4866732.15","totalValueInUsd":"56439.5","indian_port":"Hyderabad Air","hs_no":"29389090","bill_no":"7449022","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742322600,"product":"FONDAPARINUX SODIUM","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR REDDY'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"JAKARTA SOEKARNO-HA","customer":"PT FERRON PAR PHARMACEUTICALS","customerCountry":"INDONESIA","quantity":"0.28","actualQuantity":"280","unit":"GMS","unitRateFc":"500","totalValueFC":"139065.4","currency":"USD","unitRateINR":43019.67435714286,"date":"19-Mar-2025","totalValueINR":"12045508.82","totalValueInUsd":"139065.4","indian_port":"Hyderabad Air","hs_no":"29400000","bill_no":"9137303","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750876200,"product":"FONDAPARINUX SODIUM","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR REDDY'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"NANJING","customer":"NANJING KING FRIEND BIOCHEMICAL","customerCountry":"CHINA","quantity":"0.28","actualQuantity":"0.279","unit":"KGS","unitRateFc":"360000","totalValueFC":"100398.3","currency":"USD","unitRateINR":30920309.175627235,"date":"26-Jun-2025","totalValueINR":"8626766.26","totalValueInUsd":"100398.3","indian_port":"Hyderabad Air","hs_no":"29400000","bill_no":"3041950","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750876200,"product":"FONDAPARINUX SODIUM","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR REDDY'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"NANJING","customer":"NANJING KING FRIEND BIOCHEMICAL","customerCountry":"CHINA","quantity":"0.31","actualQuantity":"0.311","unit":"KGS","unitRateFc":"360000","totalValueFC":"111918.9","currency":"USD","unitRateINR":30921800.353697751,"date":"26-Jun-2025","totalValueINR":"9616679.91","totalValueInUsd":"111918.9","indian_port":"Hyderabad Air","hs_no":"29400000","bill_no":"3041789","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669401000,"product":"FONDAPARINUX SODIUM FOR ASSAY (QTY: 3 X 0.2 GMS, VALUE: USD61.15\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"FRANCE","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0006","unit":"KGS","unitRateFc":"305750","totalValueFC":"209.6","currency":"USD","unitRateINR":"28513366.7","date":"26-Nov-2022","totalValueINR":"17108.02","totalValueInUsd":"209.6","indian_port":"HYDERABAD AIR","hs_no":"29329990","bill_no":"3489256","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669401000,"product":"FONDAPARINUX SODIUM FOR ASSAY (QTY: 9 X 0.6 ML, VALUE: USD 364\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"FRANCE","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.0054","unit":"KGS","unitRateFc":"606666.7","totalValueFC":"3743.4","currency":"USD","unitRateINR":"56575983.3","date":"26-Nov-2022","totalValueINR":"305510.31","totalValueInUsd":"3743.4","indian_port":"HYDERABAD AIR","hs_no":"29329990","bill_no":"3489256","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710873000,"product":"FONDAPARINUX SODIUM (QTY:0.021KG)(CAS NO:114870-03-0) ASPERINV","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"BRIGHTGENE BIO MEDICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.021","unit":"KGS","unitRateFc":"600000","totalValueFC":"12708.4","currency":"USD","unitRateINR":"50250000","date":"20-Mar-2024","totalValueINR":"1055250","totalValueInUsd":"12708.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2663270","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TECHNOLOGY CO., LTD BUILDING C25-C28 NO.218 XINGHU ROAD SUZHOU INDUSTRIAL PARK SUZHOU JIANGSU 215123 China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
24-Jun-2022
26-Jun-2025
KGS
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Average Price (USD/KGS)

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Drugs in Development

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Details:

Under the terms of the agreement, Mylan Ireland Limited will acquire the commercialisation rights and related intellectual property relating to Aspen’s Thrombosis Business in Europe which includes Arixtra, Fraxiparine, Mono-Embolex and Orgaran.


Lead Product(s): Fondaparinux Sodium,Inapplicable

Therapeutic Area: Hematology Brand Name: Arixtra

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Viatris

Deal Size: $757.2 million Upfront Cash: $310.4 million

Deal Type: Acquisition August 09, 2020

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Details : Under the terms of the agreement, Mylan Ireland Limited will acquire the commercialisation rights and related intellectual property relating to Aspen’s Thrombosis Business in Europe which includes Arixtra, Fraxiparine, Mono-Embolex and Orgaran.

Product Name : Arixtra

Product Type : Other Small Molecule

Upfront Cash : $310.4 million

August 09, 2020

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LifeBridge Health

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ChemOutsourcing
Not Confirmed

LifeBridge Health

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Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 12, 2013

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  • Development Update

Details:

Undisclosed


Lead Product(s): Fondaparinux Sodium,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: GSK

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 08, 2011

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03

Wayne State University

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Not Confirmed

Wayne State University

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Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 08, 2011

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  • Development Update

Details:

Undisclosed


Lead Product(s): Fondaparinux Sodium,Inapplicable

Therapeutic Area: Nephrology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: GSK

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 12, 2010

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Duke University

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Duke University

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Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 12, 2010

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INTERMEDIATE SUPPLIERS

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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 114903-05-8

End Use API : Fondaparinux Sodium

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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ChemOutsourcing
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CAS Number : 2466-76-4

End Use API : Fondaparinux 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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FDF Dossiers

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Aspen API

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Regulatory Info :

Registration Country : Sweden

fondaparinux sodium

Brand Name : Arixtra

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 5 MG / 0.4 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Aspen API

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Regulatory Info :

Registration Country : Sweden

fondaparinux sodium

Brand Name : Arixtra

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 2.5 MG / 0.5 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Aspen API

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Regulatory Info :

Registration Country : Sweden

fondaparinux sodium

Brand Name : Arixtra

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 10 MG / 0.8 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Aspen API

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Regulatory Info :

Registration Country : Italy

Fondaparinux

Brand Name : Arixtra

Dosage Form : Fondaparinux 1,5Mg 0,3Ml 10 Units Parenteral Use

Dosage Strength : 10 SYRINGES SC 1.5 mg 0.3 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Aspen API

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Regulatory Info :

Registration Country : Italy

Fondaparinux

Brand Name : Arixtra

Dosage Form : Fondaparinux 2,5Mg 0,5Ml 10 Inita' Parenteral Use

Dosage Strength : 10 SYRINGES SC 2.5 mg 0.5 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Aspen API

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Regulatory Info :

Registration Country : Italy

Fondaparinux

Brand Name : Arixtra

Dosage Form : Fondaparinux 5Mg 0.4 Ml 10 Units Parenteral Use

Dosage Strength : 10 SYRINGES SC 5 mg 0.4 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Aspen API

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Regulatory Info :

Registration Country : Norway

Fondaparinux

Brand Name : Arixtra

Dosage Form : Injection fluid, resolution

Dosage Strength : 10 mg/0.8 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Aspen API

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Regulatory Info :

Registration Country : Norway

Fondaparinux

Brand Name : Arixtra

Dosage Form : Injection fluid, resolution

Dosage Strength : 2.5 mg/0.5 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Aspen API

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Regulatory Info :

Registration Country : Norway

Fondaparinux

Brand Name : Arixtra

Dosage Form : Injection fluid, resolution

Dosage Strength : 2.5 mg/0.5 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Aspen API

Netherlands
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Regulatory Info :

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Fondaparinux

Brand Name : Arixtra

Dosage Form : Injection fluid, resolution

Dosage Strength : 5 mg/0.4 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 10MG/0.8ML

USFDA APPLICATION NUMBER - 21345

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 2.5MG/0.5M...DOSAGE - INJECTABLE;SUBCUTANEOUS - 2.5MG/0.5ML

USFDA APPLICATION NUMBER - 21345

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 5MG/0.4ML

USFDA APPLICATION NUMBER - 21345

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DOSAGE - INJECTABLE;SUBCUTANEOUS - 7.5MG/0.6M...DOSAGE - INJECTABLE;SUBCUTANEOUS - 7.5MG/0.6ML

USFDA APPLICATION NUMBER - 21345

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NEWS #PharmaBuzz

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Global Sales Information

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Regulatory FDF Prices

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Brand Name : Arixtra

Netherlands
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  • EDQM
  • WHO-GMP

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Fondaparinux Sodium

Dosage Form : Fondaparinux 1,5Mg 0,3Ml 10 Unit...

Dosage Strength : 10 SYRINGES SC 1.5 mg 0.3 ml

Price Per Pack (Euro) : 40.47

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Fondaparinux Sodium

Dosage Form : Fondaparinux 10Mg 0,8Ml 10 Units...

Dosage Strength : 10 SYRINGES SC 10 mg 0.8 ml

Price Per Pack (Euro) : 207.01

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Brand Name : Arixtra

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RX/OTC/DISCN : Class A

Fondaparinux Sodium

Dosage Form : Fondaparinux 2,5Mg 0,5Ml 10 Init...

Dosage Strength : 10 SYRINGES SC 2.5 mg 0.5 ml

Price Per Pack (Euro) : 67.45

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Brand Name : Arixtra

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RX/OTC/DISCN : Class A

Fondaparinux Sodium

Dosage Form : Fondaparinux 5Mg 0.4 Ml 10 Units...

Dosage Strength : 10 SYRINGES SC 5 mg 0.4 ml

Price Per Pack (Euro) : 138.04

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Brand Name : Arixtra

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RX/OTC/DISCN : Class A

Fondaparinux Sodium

Dosage Form : Fondaparinux 7,5Mg 0,6Ml 10 Unit...

Dosage Strength : 10 SYRINGES SC 7.5 mg 0.6 ml

Price Per Pack (Euro) : 207.01

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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Fondaparinux Sodium

Dosage Form : Injection fluid, resolution

Dosage Strength : 10 mg/0.8 ml

Price Per Pack (Euro) : 38.61

Published in :

Country : Norway

RX/OTC/DISCN :

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Fondaparinux Sodium

Dosage Form : Injection fluid, resolution

Dosage Strength : 10 mg/0.8 ml

Price Per Pack (Euro) : 123.27

Published in :

Country : Norway

RX/OTC/DISCN :

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Fondaparinux Sodium

Dosage Form : Injection fluid, resolution

Dosage Strength : 10 mg/0.8 ml

Price Per Pack (Euro) : 174.06

Published in :

Country : Norway

RX/OTC/DISCN :

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Fondaparinux Sodium

Dosage Form : Injection fluid, resolution

Dosage Strength : 2.5 mg/0.5 ml

Price Per Pack (Euro) : 14.179

Published in :

Country : Norway

RX/OTC/DISCN :

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RX/OTC/DISCN :

Fondaparinux Sodium

Dosage Form : Injection fluid, resolution

Dosage Strength : 2.5 mg/0.5 ml

Price Per Pack (Euro) : 40.667

Published in :

Country : Norway

RX/OTC/DISCN :

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Looking for 114870-03-0 / Fondaparinux Sodium API manufacturers, exporters & distributors?

Fondaparinux Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fondaparinux Sodium

Synonyms

114870-03-0, Arixtra, Quixidar, Fondaparin sodium, Sr-90107a, Org 31540

Cas Number

114870-03-0

Unique Ingredient Identifier (UNII)

X0Q6N9USOZ

About Fondaparinux Sodium

Synthetic pentasaccharide that mediates the interaction of HEPARIN with ANTITHROMBINS and inhibits FACTOR Xa; it is used for prevention of VENOUS THROMBOEMBOLISM after surgery.

Fondaparinux Sodium Manufacturers

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

Fondaparinux Sodium Suppliers

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

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

Fondaparinux Sodium USDMF

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

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

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

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

After submitting a Fondaparinux 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 Fondaparinux Sodium API can apply through the Korea Drug Master File (KDMF).

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

Fondaparinux Sodium WC

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

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

Fondaparinux 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 Fondaparinux Sodium as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fondaparinux Sodium GMP

Fondaparinux 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 Fondaparinux 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 Fondaparinux Sodium GMP manufacturer or Fondaparinux Sodium GMP API supplier for your needs.

Fondaparinux Sodium CoA

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

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

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