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1. Arixtra
2. Fondaparinux
3. Quixidar
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
Molecular Weight | 1728.1 g/mol |
---|---|
Molecular Formula | C31H43N3Na10O49S8 |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 52 |
Rotatable Bond Count | 20 |
Exact Mass | 1726.7707769 g/mol |
Monoisotopic Mass | 1726.7707769 g/mol |
Topological Polar Surface Area | 901 Ų |
Heavy Atom Count | 101 |
Formal Charge | 0 |
Complexity | 3330 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 25 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 11 |
1 of 4 | |
---|---|
Drug Name | Arixtra |
Drug Label | ARIXTRA (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 Ingredient | Fondaparinux sodium |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | 5mg/0.4ml; 2.5mg/0.5ml; 7.5mg/0.6ml; 10mg/0.8ml |
Market Status | Prescription |
Company | Agi |
2 of 4 | |
---|---|
Drug Name | Fondaparinux sodium |
PubMed Health | Fondaparinux (Injection) |
Drug Classes | Anticoagulant |
Drug Label | ARIXTRA (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 Ingredient | Fondaparinux sodium |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | 2.5mg/0.5ml; 7.5mg/0.6ml; 5mg/0.4ml; 10mg/0.8ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
3 of 4 | |
---|---|
Drug Name | Arixtra |
Drug Label | ARIXTRA (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 Ingredient | Fondaparinux sodium |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | 5mg/0.4ml; 2.5mg/0.5ml; 7.5mg/0.6ml; 10mg/0.8ml |
Market Status | Prescription |
Company | Agi |
4 of 4 | |
---|---|
Drug Name | Fondaparinux sodium |
PubMed Health | Fondaparinux (Injection) |
Drug Classes | Anticoagulant |
Drug Label | ARIXTRA (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 Ingredient | Fondaparinux sodium |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | 2.5mg/0.5ml; 7.5mg/0.6ml; 5mg/0.4ml; 10mg/0.8ml |
Market Status | Prescription |
Company | Dr Reddys Labs |
* 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.
Factor Xa Inhibitors
Endogenous factors and drugs that inhibit or block the activity of FACTOR XA. (See all compounds classified as Factor Xa Inhibitors.)
B01AX05
B01AX05
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15259
Submission : 2001-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28762
Submission : 2014-11-30
Status : Active
Type : II
Registrant Name : Handok Co., Ltd.
Registration Date : 2013-03-29
Registration Number : 20130329-193-I-126-01
Manufacturer Name : Aspen notre dame de bondeville@Ajinomoto Omnichem@Aspen Oss BV@ORIL Industrie
Manufacturer Address : 1, rue de l'Abbaye, 76960 Notre Dame De Bondeville@Cooppallaan 91, Wetteren, Oost-Vlaanderen, B-9230, Belgium_x000D_ (Manufacturer 1)@Kloosterstraat6 5349 AB OSS, The Netherlands_x000D_ (Manufacturer 2)@13, rue Auguste Desgenétais, BOLBEC, 76210, France
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-04
Pay. Date : 2022-03-29
DMF Number : 22579
Submission : 2009-02-26
Status : Active
Type : II
Date of Issue : 2025-07-25
Valid Till : 2028-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
NDC Package Code : 55111-839
Start Marketing Date : 2009-02-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37499
Submission : 2022-10-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-07
Pay. Date : 2013-09-26
DMF Number : 27563
Submission : 2013-12-30
Status : Active
Type : II
NDC Package Code : 65129-1258
Start Marketing Date : 2013-06-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-05
Pay. Date : 2013-08-30
DMF Number : 27336
Submission : 2013-09-27
Status : Active
Type : II
NDC Package Code : 57884-0026
Start Marketing Date : 2013-09-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (180g/180g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-06
Pay. Date : 2016-09-06
DMF Number : 30767
Submission : 2016-07-15
Status : Active
Type : II
NDC Package Code : 62227-006
Start Marketing Date : 2019-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15259
Submission : 2001-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28762
Submission : 2014-11-30
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-04
Pay. Date : 2022-03-29
DMF Number : 22579
Submission : 2009-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-14
Pay. Date : 2014-01-22
DMF Number : 27873
Submission : 2014-01-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27475
Submission : 2013-09-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15257
Submission : 2001-01-19
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-05
Pay. Date : 2013-08-30
DMF Number : 27336
Submission : 2013-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25093
Submission : 2011-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-07
Pay. Date : 2013-09-26
DMF Number : 27563
Submission : 2013-12-30
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2025-07-25
Valid Till : 2028-06-16
Written Confirmation Number : WC-0034
Address of the Firm : Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 112, Sri Venkateswara Co-operati...
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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
Lead Product(s) : Fondaparinux Sodium,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Viatris
Deal Size : $757.2 million
Deal Type : Acquisition
Divestment of Aspen’s European Thrombosis Business to Mylan and Withdrawal of Cautionary
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
Details:
Undisclosed
Lead Product(s): Fondaparinux Sodium,Aspirin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: HAEMONETICS
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 12, 2013
Lead Product(s) : Fondaparinux Sodium,Aspirin
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : HAEMONETICS
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 12, 2013
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
Lead Product(s) : Fondaparinux Sodium,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : GSK
Deal Size : Inapplicable
Deal Type : Inapplicable
Fondaparinux in Critically Ill Patients With Renal Failure
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 08, 2011
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
Lead Product(s) : Fondaparinux Sodium,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : GSK
Deal Size : Inapplicable
Deal Type : Inapplicable
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 12, 2010
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...
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...
Regulatory Info :
Registration Country : Sweden
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
Regulatory Info :
Registration Country : Sweden
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
Regulatory Info :
Registration Country : Sweden
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Hydrochloric Acid NF
Application : Parenteral
Excipient Details : A&C's Hydrochloric Acid NF is used as a low pH neutralizing agent for pharmaceutical applications.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : NaCl Multi-compendial Low...
Application : Parenteral
Excipient Details : A & C's Sodium Chloride multi-compendial low endotoxin is an excipient meeting USP-NF, EP, BP and JP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Low Endotoxin
Ingredient(s) : Sodium Chloride Excipient
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Sodium Chloride USP
Application : Parenteral
Excipient Details : A & C's Sodium Chloride is an excipient meeting the USP monograph.
Global Sales Information
RX/OTC/DISCN : Class A
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
RX/OTC/DISCN : Class A
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
RX/OTC/DISCN : Class A
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
RX/OTC/DISCN : Class A
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
RX/OTC/DISCN : Class A
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
RX/OTC/DISCN :
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 :
RX/OTC/DISCN :
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 :
RX/OTC/DISCN :
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 :
RX/OTC/DISCN :
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 :
RX/OTC/DISCN :
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 :
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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.
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.
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.
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.
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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).
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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.
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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).
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.
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.
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.
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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.
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).