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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.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Pentosan Polysulfate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentosan Polysulfate Sodium, including repackagers and relabelers. The FDA regulates Pentosan Polysulfate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentosan Polysulfate 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 Pentosan Polysulfate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentosan Polysulfate Sodium supplier is an individual or a company that provides Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) or Pentosan Polysulfate Sodium finished formulations upon request. The Pentosan Polysulfate Sodium suppliers may include Pentosan Polysulfate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pentosan Polysulfate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentosan Polysulfate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Pentosan Polysulfate Sodium DMFs exist exist since differing nations have different regulations, such as Pentosan Polysulfate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentosan Polysulfate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Pentosan Polysulfate Sodium USDMF includes data on Pentosan Polysulfate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentosan Polysulfate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium Drug Master File in Korea (Pentosan Polysulfate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pentosan Polysulfate Sodium. The MFDS reviews the Pentosan Polysulfate Sodium KDMF as part of the drug registration process and uses the information provided in the Pentosan Polysulfate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pentosan Polysulfate 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 Pentosan Polysulfate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pentosan Polysulfate Sodium suppliers with KDMF on PharmaCompass.
A Pentosan Polysulfate Sodium written confirmation (Pentosan Polysulfate Sodium WC) is an official document issued by a regulatory agency to a Pentosan Polysulfate Sodium manufacturer, verifying that the manufacturing facility of a Pentosan Polysulfate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pentosan Polysulfate Sodium APIs or Pentosan Polysulfate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Pentosan Polysulfate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Pentosan Polysulfate Sodium 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 Pentosan Polysulfate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pentosan Polysulfate 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 Pentosan Polysulfate 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 Pentosan Polysulfate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentosan Polysulfate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pentosan Polysulfate Sodium suppliers with NDC on PharmaCompass.
Pentosan Polysulfate 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 Pentosan Polysulfate 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 Pentosan Polysulfate Sodium GMP manufacturer or Pentosan Polysulfate Sodium GMP API supplier for your needs.
A Pentosan Polysulfate Sodium CoA (Certificate of Analysis) is a formal document that attests to Pentosan Polysulfate Sodium's compliance with Pentosan Polysulfate Sodium specifications and serves as a tool for batch-level quality control.
Pentosan Polysulfate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Pentosan Polysulfate 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.
Pentosan Polysulfate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentosan Polysulfate Sodium EP), Pentosan Polysulfate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentosan Polysulfate Sodium USP).
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