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    Chemistry

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    Also known as: 37300-21-3, Pentosan sulfuric polyester, Polypentose sulfate, [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] hydrogen sulfate, Xylan, hydrogen sulfate, Unii-f59p8b75r4
    Molecular Formula
    C10H18O21S4
    Molecular Weight
    602.5  g/mol
    InChI Key
    FCCNSUIJIOOXEZ-SJYYZXOBSA-N
    Pentosan Polysulfate Sodium
    A sulfated pentosyl polysaccharide with heparin-like properties.
    1 2D Structure

    Pentosan Polysulfate Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(2R,3R,4S,5R)-2-hydroxy-5-[(2S,3R,4S,5R)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] hydrogen sulfate
    2.1.2 InChI
    InChI=1S/C10H18O21S4/c11-3-1-26-10(8(31-35(22,23)24)5(3)28-32(13,14)15)27-4-2-25-9(12)7(30-34(19,20)21)6(4)29-33(16,17)18/h3-12H,1-2H2,(H,13,14,15)(H,16,17,18)(H,19,20,21)(H,22,23,24)/t3-,4-,5+,6+,7-,8-,9-,10+/m1/s1
    2.1.3 InChI Key
    FCCNSUIJIOOXEZ-SJYYZXOBSA-N
    2.1.4 Canonical SMILES
    C1C(C(C(C(O1)OC2COC(C(C2OS(=O)(=O)O)OS(=O)(=O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)O
    2.1.5 Isomeric SMILES
    C1[C@H]([C@@H]([C@H]([C@@H](O1)O[C@@H]2CO[C@H]([C@@H]([C@H]2OS(=O)(=O)O)OS(=O)(=O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bay 946

    2. Bay-946

    3. Elmiron

    4. Fibrocid

    5. Hemoclar

    6. Hoe 946

    7. Hoe Bay 946

    8. Hoe-946

    9. Hoe-bay 946

    10. Hoe-bay-946

    11. Pentosan Polysulfate Sodium

    12. Pentosan Polysulphate Sodium

    13. Pentosan Sulfuric Polyester

    14. Pentosane Sulfuric Polyester

    15. Polyester, Pentosan Sulfuric

    16. Polyester, Pentosane Sulfuric

    17. Polypentose Sulfate

    18. Polysulfate Sodium, Pentosan

    19. Polysulfate, Pentosan

    20. Polysulfated Xylan

    21. Polysulphate Sodium, Pentosan

    22. Pz 68

    23. Pz-68

    24. Pz68

    25. Sodium, Pentosan Polysulfate

    26. Sodium, Pentosan Polysulphate

    27. Sp 54

    28. Sp 54, Tavan

    29. Sp-54

    30. Sp54

    31. Sp54, Xylan

    32. Sulfate, Polypentose

    33. Sulfate, Xylan

    34. Sulfuric Polyester, Pentosan

    35. Sulfuric Polyester, Pentosane

    36. Tavan Sp 54

    37. Xylan Sp54

    38. Xylan Sulfate

    39. Xylan, Polysulfated

    2.2.2 Depositor-Supplied Synonyms

    1. 37300-21-3

    2. Pentosan Sulfuric Polyester

    3. Polypentose Sulfate

    4. [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] Hydrogen Sulfate

    5. Xylan, Hydrogen Sulfate

    6. Unii-f59p8b75r4

    7. Schembl157354

    8. Chembl4073796

    9. Chebi:184555

    10. F59p8b75r4

    11. Db00686

    12. Q7165276

    13. [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulooxyoxan-2-yl]oxy-3-sulooxyoxan-4-yl] Hydrogen Sulate

    14. [(2r,3r,4s,5r)-2-hydroxy-5-{[(2s,3r,4s,5r)-5-hydroxy-3,4-bis(sulfooxy)oxan-2-yl]oxy}-4-(sulfooxy)oxan-3-yl]oxidanesulfonic Acid

    15. [(2s,3r,4s,5r)-5-hydroxy-2-{[(3r,4s,5r,6r)-6-hydroxy-4,5-bis(sulfooxy)oxan-3-yl]oxy}-4-(sulfooxy)oxan-3-yl]oxidanesulfonic Acid

    16. 11096-31-4

    2.3 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 602.5 g/mol
    Molecular Formula C10H18O21S4
    XLogP3-5.6
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count21
    Rotatable Bond Count10
    Exact Mass601.92234227 g/mol
    Monoisotopic Mass601.92234227 g/mol
    Topological Polar Surface Area356 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity1140
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameElmiron
    PubMed HealthPentosan Polysulfate Sodium (By mouth)
    Drug ClassesCystitis Agent, Urinary Stone Agent
    Drug LabelPentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water...
    Active IngredientPentosan polysulfate sodium
    Dosage FormCapsule
    RouteOral
    Strength100mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 2  
    Drug NameElmiron
    PubMed HealthPentosan Polysulfate Sodium (By mouth)
    Drug ClassesCystitis Agent, Urinary Stone Agent
    Drug LabelPentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water...
    Active IngredientPentosan polysulfate sodium
    Dosage FormCapsule
    RouteOral
    Strength100mg
    Market StatusPrescription
    CompanyJanssen Pharms

    4.2 Drug Indication

    For the relief of bladder pain or discomfort associated with interstitial cystitis.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects.

    5.2 MeSH Pharmacological Classification

    Anticoagulants

    Agents that prevent BLOOD CLOTTING. (See all compounds classified as Anticoagulants.)

    5.3 Absorption, Distribution and Excretion

    Absorption

    Slow

    5.4 Biological Half-Life

    4.8 hours

    5.5 Mechanism of Action

    Pentosan polysulfate is a polymer of xylose hydrogen sulfate and contains two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It has been shown to interact also with the heparin-binding site of FGFR-1. It inhibits the growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.

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NO.37","city":"BOMBAY ,MAHARASHTRA","supplier":"TRICON ENTERPRISES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"JIANGXI CHIBANG PHARMACEUTICAL CO.,LTD","customerCountry":"SPAIN","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"2725","totalValueFC":"32453.9","currency":"USD","unitRateINR":235193.75,"date":"11-Feb-2025","totalValueINR":"2822325","totalValueInUsd":"32453.9","indian_port":"Madras Air","hs_no":"29339990","bill_no":"8081487","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"KAMALA BHUVAN NO.2, 1ST FLR. 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FV0973 ( TL. MO. TL\/AZ\/22\/001419 DATE 25.05.2022 ) LOT NO. 22P0532","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"ITALFARMACO S.P.A","supplierCountry":"ITALY","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3900","totalValueFC":"4029","currency":"EUR","unitRateINR":"320580","date":"11-Aug-2022","totalValueINR":"320580","totalValueInUsd":"4029","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"9961571","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"}]
    06-Jan-2021
    19-Feb-2025
    KGS
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    Drugs in Development

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    Australia's Paradigm Biopharmaceuticals Says Phase 2 Trial in Osteoarthritis Shows Signs of Disease Modification at 6-Month Follow-Up

    Details:

    Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. Clinical study has demonstrated that iPPS may slow the progression of osteoarthritis of the knee.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 11, 2023

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    01

    Paradigm Biopharmaceuticals

    Australia
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    Paradigm Biopharmaceuticals

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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Australia's Paradigm Biopharmaceuticals Says Phase 2 Trial in Osteoarthritis Shows Signs of Diseas...

    Details : Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. Clinical study has demonstrated that iPPS may slow the progression of osteoarthritis of the knee.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    April 11, 2023

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    Paradigm Achieves Primary Endpoint in PARA_OA_008 Synovial Fluid Biomarker Phase 2 Clinical Trial

    Details:

    Pentosan Polysulfate Sodium (under the name Zilosul®) is used to treat osteoarthritis. iPPS impacted multiple biomarkers measured in the synovial fluid. Reductions in nerve growth factor (NGF) indicate iPPS mechanisms related to pain reduction.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Zilosul

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 04, 2022

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    02

    Paradigm Biopharmaceuticals

    Australia
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    BePharma
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Paradigm Achieves Primary Endpoint in PARA_OA_008 Synovial Fluid Biomarker Phase 2 Clinical Trial

    Details : Pentosan Polysulfate Sodium (under the name Zilosul®) is used to treat osteoarthritis. iPPS impacted multiple biomarkers measured in the synovial fluid. Reductions in nerve growth factor (NGF) indicate iPPS mechanisms related to pain reduction.

    Product Name : Zilosul

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    October 04, 2022

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    MPS Clinical Program Update and Paradigm to Present at the International Conference on Lysosomal Diseases

    Details:

    Three of the four subjects included in Paradigm's open-label phase 2 trial of pentosan polysulfate sodium (PPS) in MPS-I have completed the 48-week study, with a 6-month treatment extension available.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 12, 2022

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    03

    Paradigm Biopharmaceuticals

    Australia
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    MPS Clinical Program Update and Paradigm to Present at the International Conference on Lysosomal D...

    Details : Three of the four subjects included in Paradigm's open-label phase 2 trial of pentosan polysulfate sodium (PPS) in MPS-I have completed the 48-week study, with a 6-month treatment extension available.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    August 12, 2022

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    FDA Grants Fast Track Designation for Paradigm Biopharmaceuticals Phase III Osteoarthritis Program

    Details:

    Zilosul (pentosan polysulfate sodium (PPS) is a semi-synthetic drug manufactured from European beech xylans that are sulfated to produce a negatively charged product that mimics glycosaminoglycans (GAGs).


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Zilosul

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 12, 2022

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    04

    Paradigm Biopharmaceuticals

    Australia
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    BePharma
    Not Confirmed

    Paradigm Biopharmaceuticals

    Australia
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    BePharma
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Grants Fast Track Designation for Paradigm Biopharmaceuticals Phase III Osteoarthritis Program

    Details : Zilosul (pentosan polysulfate sodium (PPS) is a semi-synthetic drug manufactured from European beech xylans that are sulfated to produce a negatively charged product that mimics glycosaminoglycans (GAGs).

    Product Name : Zilosul

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    April 12, 2022

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    Paradigm Biopharmaceuticals Initiates a Phase 3 Clinical Trial in Knee Osteoarthritis Across the U.S

    Details:

    The purpose of the study is to measure the change in pain and function with subcutaneous injections of Zilosul (Pentosan Polysulfate Sodium) compared with subcutaneous injections of placebo in participants with kOA pain.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Rheumatology Brand Name: Zilosul

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 17, 2022

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    05

    Paradigm Biopharmaceuticals

    Australia
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Rheumatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Paradigm Biopharmaceuticals Initiates a Phase 3 Clinical Trial in Knee Osteoarthritis Across the U...

    Details : The purpose of the study is to measure the change in pain and function with subcutaneous injections of Zilosul (Pentosan Polysulfate Sodium) compared with subcutaneous injections of placebo in participants with kOA pain.

    Product Name : Zilosul

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    March 17, 2022

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    Paradigm Biopharmaceuticals Receives US FDA Feedback on IND Application for PPS in Knee OA

    Details:

    In parallel, Paradigm is continuing Phase 3 study start-up preparation at sites in the US and Australia. Additional sites may be added in order to ensure completion of this pivotal study, within the planned commercialisation timelines.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Zilosul

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 25, 2021

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    06

    Paradigm Biopharmaceuticals

    Australia
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Paradigm Biopharmaceuticals Receives US FDA Feedback on IND Application for PPS in Knee OA

    Details : In parallel, Paradigm is continuing Phase 3 study start-up preparation at sites in the US and Australia. Additional sites may be added in order to ensure completion of this pivotal study, within the planned commercialisation timelines.

    Product Name : Zilosul

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    May 25, 2021

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    Paradigm Biopharmaceuticals has Clear Path Towards Zilosul® OA Phase 3 Clinical Trial and Product Registration in Europe

    Details:

    Positive feedback has been received from European Medicines Agency after Paradigm’s recent Scientific Advice meeting, a key regulatory milestone which supports and validates the company’s clinical development and commercialisation plans for Zilosul® in Europe.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Zilosul

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 28, 2020

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    07

    Paradigm Biopharmaceuticals

    Australia
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    BePharma
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    Paradigm Biopharmaceuticals

    Australia
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    BePharma
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Paradigm Biopharmaceuticals has Clear Path Towards Zilosul® OA Phase 3 Clinical Trial and Product...

    Details : Positive feedback has been received from European Medicines Agency after Paradigm’s recent Scientific Advice meeting, a key regulatory milestone which supports and validates the company’s clinical development and commercialisation plans for Zilosul®...

    Product Name : Zilosul

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 28, 2020

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    Paradigm Biopharmaceuticals has Significant Clarity on Development Pathway for Zilusol

    Details:

    Proceeds will be applied to costs of the second phase 3 osteoarthritis (OA) clinical trial and leaves Paradigm fully-funded through to completion of this trial.


    Lead Product(s): Pentosan Polysulfate Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Bell Potter Securities

    Deal Size: $35.0 million Upfront Cash: Undisclosed

    Deal Type: Financing April 20, 2020

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    Paradigm Biopharmaceuticals

    Australia
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    Paradigm Biopharmaceuticals

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    BePharma
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    Lead Product(s) : Pentosan Polysulfate Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Bell Potter Securities

    Deal Size : $35.0 million

    Deal Type : Financing

    DEALS_DEV arrow-down

    Paradigm Biopharmaceuticals has Significant Clarity on Development Pathway for Zilusol

    Details : Proceeds will be applied to costs of the second phase 3 osteoarthritis (OA) clinical trial and leaves Paradigm fully-funded through to completion of this trial.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    April 20, 2020

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    Regulatory Info : Originator

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    Pentosan Polysulfate Sodium

    Brand Name : Tavan-SP 54 Injection

    Dosage Form : INJ

    Dosage Strength : 100mg/ml

    Packaging : 1X1mg/ml

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    PENTOSAN POLYSULFATE SODIUM

    Brand Name : CARTROPHEN VET INJ.SC 100MG/ML

    Dosage Form : SOLUTION

    Dosage Strength : 100MG/ML

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    Application Number : 2082101

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    PENTOSAN POLYSULFATE SODIUM

    Brand Name : ELMIRON

    Dosage Form : CAPSULE

    Dosage Strength : 100MG

    Packaging : 100

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    Application Number : 2029448

    Regulatory Info : Prescription

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    Pentosan Sulfuric Polyester

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    Dosage Form : Cream

    Dosage Strength : 1MG/G

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    Dosage Strength : 5MG/G

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    Sodium pentosan polysulfase

    Brand Name : Elmiron

    Dosage Form : Caps

    Dosage Strength : 100mg

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    PENTOSAN POLYSULFATE SODIUM

    Brand Name : ELMIRON

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 100MG

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    Approval Date : 1996-09-26

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    Dosage Strength : Pom Derm 40 G 1,5%  

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    ABOUT THIS PAGE

    Looking for 37300-21-3 / Pentosan Polysulfate Sodium API manufacturers, exporters & distributors?

    Pentosan Polysulfate Sodium manufacturers, exporters & distributors 1

    60

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

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

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

    API | Excipient name

    Pentosan Polysulfate Sodium

    Synonyms

    37300-21-3, Pentosan sulfuric polyester, Polypentose sulfate, [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] hydrogen sulfate, Xylan, hydrogen sulfate, Unii-f59p8b75r4

    Cas Number

    37300-21-3

    About Pentosan Polysulfate Sodium

    A sulfated pentosyl polysaccharide with heparin-like properties.

    Pentosan polysulfate Manufacturers

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

    Pentosan polysulfate Suppliers

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

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

    Pentosan polysulfate USDMF

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

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

    click here to find a list of Pentosan polysulfate suppliers with USDMF on PharmaCompass.

    Pentosan polysulfate KDMF

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

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

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

    click here to find a list of Pentosan polysulfate suppliers with KDMF on PharmaCompass.

    Pentosan polysulfate WC

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

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

    Pentosan polysulfate 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 Pentosan polysulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Pentosan polysulfate suppliers with NDC on PharmaCompass.

    Pentosan polysulfate GMP

    Pentosan polysulfate 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 Pentosan polysulfate 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 Pentosan polysulfate GMP manufacturer or Pentosan polysulfate GMP API supplier for your needs.

    Pentosan polysulfate CoA

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

    Pentosan polysulfate CoA mostly includes findings from lab analyses of a specific batch. For each Pentosan polysulfate 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.

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