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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
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
Molecular Weight | 602.5 g/mol |
---|---|
Molecular Formula | C10H18O21S4 |
XLogP3 | -5.6 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 21 |
Rotatable Bond Count | 10 |
Exact Mass | 601.92234227 g/mol |
Monoisotopic Mass | 601.92234227 g/mol |
Topological Polar Surface Area | 356 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 1140 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 8 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Elmiron |
PubMed Health | Pentosan Polysulfate Sodium (By mouth) |
Drug Classes | Cystitis Agent, Urinary Stone Agent |
Drug Label | Pentosan 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 Ingredient | Pentosan polysulfate sodium |
Dosage Form | Capsule |
Route | Oral |
Strength | 100mg |
Market Status | Prescription |
Company | Janssen Pharms |
2 of 2 | |
---|---|
Drug Name | Elmiron |
PubMed Health | Pentosan Polysulfate Sodium (By mouth) |
Drug Classes | Cystitis Agent, Urinary Stone Agent |
Drug Label | Pentosan 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 Ingredient | Pentosan polysulfate sodium |
Dosage Form | Capsule |
Route | Oral |
Strength | 100mg |
Market Status | Prescription |
Company | Janssen Pharms |
For the relief of bladder pain or discomfort associated with interstitial cystitis.
FDA Label
Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects.
Anticoagulants
Agents that prevent BLOOD CLOTTING. (See all compounds classified as Anticoagulants.)
Absorption
Slow
4.8 hours
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.
Pentosan Polysulfate Sodium IH
Date of Issue : 2022-07-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0124
Address of the Firm : 28A, IDA Nacharam, Hyderabad, India, Nacharam Village, Uppal Mandal, Medchal - M...
Pentosan Polysulphate Sodium IH
Date of Issue : 2022-06-15
Valid Till : 2025-07-07
Written Confirmation Number : WC-0165
Address of the Firm : Plot No. A-1/2102 & 2103, Phase-III, G.I.D.C Vapi-396195, Valsad, Gujarat, India
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2022-06-15
Registration Number : 20220615-209-J-1314
Manufacturer Name : Aragen Life Sciences Limited
Manufacturer Address : Manufacturing Unit-I, Plot No. 28A, IDA, Nacharam Village, Uppal Mandal, Medchal - Ma...
NDC Package Code : 42973-367
Start Marketing Date : 2024-01-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42973-118
Start Marketing Date : 2009-11-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-051
Start Marketing Date : 2017-07-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17359-3805
Start Marketing Date : 2023-12-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17359-3800
Start Marketing Date : 2021-05-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 60592-240
Start Marketing Date : 2019-12-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62991-3120
Start Marketing Date : 2017-03-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-2706
Start Marketing Date : 2013-03-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 42571-476
Start Marketing Date : 2024-07-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-0052
Start Marketing Date : 2018-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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ABOUT THIS PAGE
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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.
A SP 54, Tavan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SP 54, Tavan, including repackagers and relabelers. The FDA regulates SP 54, Tavan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SP 54, Tavan 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 SP 54, Tavan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SP 54, Tavan supplier is an individual or a company that provides SP 54, Tavan active pharmaceutical ingredient (API) or SP 54, Tavan finished formulations upon request. The SP 54, Tavan suppliers may include SP 54, Tavan API manufacturers, exporters, distributors and traders.
click here to find a list of SP 54, Tavan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SP 54, Tavan DMF (Drug Master File) is a document detailing the whole manufacturing process of SP 54, Tavan active pharmaceutical ingredient (API) in detail. Different forms of SP 54, Tavan DMFs exist exist since differing nations have different regulations, such as SP 54, Tavan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SP 54, Tavan DMF submitted to regulatory agencies in the US is known as a USDMF. SP 54, Tavan USDMF includes data on SP 54, Tavan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SP 54, Tavan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SP 54, Tavan suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a SP 54, Tavan Drug Master File in Korea (SP 54, Tavan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SP 54, Tavan. The MFDS reviews the SP 54, Tavan KDMF as part of the drug registration process and uses the information provided in the SP 54, Tavan KDMF to evaluate the safety and efficacy of the drug.
After submitting a SP 54, Tavan 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 SP 54, Tavan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SP 54, Tavan suppliers with KDMF on PharmaCompass.
A SP 54, Tavan written confirmation (SP 54, Tavan WC) is an official document issued by a regulatory agency to a SP 54, Tavan manufacturer, verifying that the manufacturing facility of a SP 54, Tavan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SP 54, Tavan APIs or SP 54, Tavan finished pharmaceutical products to another nation, regulatory agencies frequently require a SP 54, Tavan WC (written confirmation) as part of the regulatory process.
click here to find a list of SP 54, Tavan suppliers with Written Confirmation (WC) on PharmaCompass.
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 SP 54, Tavan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SP 54, Tavan 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 SP 54, Tavan 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 SP 54, Tavan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SP 54, Tavan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SP 54, Tavan suppliers with NDC on PharmaCompass.
SP 54, Tavan 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 SP 54, Tavan 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 SP 54, Tavan GMP manufacturer or SP 54, Tavan GMP API supplier for your needs.
A SP 54, Tavan CoA (Certificate of Analysis) is a formal document that attests to SP 54, Tavan's compliance with SP 54, Tavan specifications and serves as a tool for batch-level quality control.
SP 54, Tavan CoA mostly includes findings from lab analyses of a specific batch. For each SP 54, Tavan 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.
SP 54, Tavan may be tested according to a variety of international standards, such as European Pharmacopoeia (SP 54, Tavan EP), SP 54, Tavan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SP 54, Tavan USP).