Synopsis
Synopsis
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EU WC
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VMF
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EDQM
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1. Azd1722
2. Rdx5791
3. Tenapanor
1. Tenapanor Hcl
2. 1234365-97-9
3. Azd-1722 Hydrochloride
4. Tenapanor Dihydrochloride
5. Tenapanor Hydrochloride [usan]
6. Rdx-5791
7. Azd1722 Hydrochloride
8. Tenapanor (hydrochloride)
9. 50605o2zns
10. Ibsrela
11. Rdx5791
12. 1-[2-[2-[2-[[3-[(4s)-6,8-dichloro-2-methyl-3,4-dihydro-1h-isoquinolin-4-yl]phenyl]sulfonylamino]ethoxy]ethoxy]ethyl]-3-[4-[2-[2-[2-[[3-[(4s)-6,8-dichloro-2-methyl-3,4-dihydro-1h-isoquinolin-4-yl]phenyl]sulfonylamino]ethoxy]ethoxy]ethylcarbamoylamino]butyl]urea;dihydrochloride
13. N,n'-(10,17,-dioxo-3,6,21,24-tetraoxa-9,11,16,18-tetraazahexacosane-1,26-diyl)bis(((4s)-6,8-dichloro-2-methyl-1,2,3,4-tetrahydroisoquinolin-4-yl)benzenesulfonamide) Dihydrochloride
14. Tenapanor Hydrochloride (usan)
15. 17-[[[3-[(4s)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl]phenyl]sulfonyl]amino]-n-[2-[2-[2-[[[3-[(4s)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl]phenyl]sulfonyl]amino]ethoxy]ethoxy]ethyl]-8-oxo-12,15-dioxa-2,7,9-triazaheptadecanamide Dihydrochloride
16. Unii-50605o2zns
17. Tenapanor 2hcl
18. Ibsrela (tn)
19. Tenapanordihydrochloride
20. Chembl3301627
21. Dtxsid701027856
22. Tenapanor Hydrochloride [mi]
23. Hy-15991a
24. Tenapanor Hydrochloride [jan]
25. Tenapanor Hydrochloride [who-dd]
26. Cs-0066545
27. Tenapanor Hydrochloride [orange Book]
28. D11653
29. D87161
30. Q27260760
31. 12,15-dioxa-2,7,9-triazaheptadecanamide, 17-(((3-((4s)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl)phenyl)sulfonyl)amino)-n-(2-(2-(2-(((3-((4s)-6,8-dichloro-1,2,3,4-tetrahydro-2-methyl-4-isoquinolinyl)phenyl)sulfonyl)amino)ethoxy)ethoxy)ethyl)-8-oxo-, Hydrochloride (1:2)
32. 3-((s)-6,8-dichloro-2-methyl-1,2,3,4-tetrahydroisoquinolin-4-yl)-n-(26-((3-((s)-6,8-dichloro-2-methyl-1,2,3,4-tetrahydroisoquinolin-4-yl)phenyl)sulfonamido)-10,17-dioxo-3,6,21,24-tetraoxa-9,11,16,18-tetraazahexacosyl)benzenesulfonamide Dihydrochloride
Molecular Weight | 1218.0 g/mol |
---|---|
Molecular Formula | C50H68Cl6N8O10S2 |
Hydrogen Bond Donor Count | 8 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 29 |
Exact Mass | 1216.260149 g/mol |
Monoisotopic Mass | 1214.263099 g/mol |
Topological Polar Surface Area | 235 Ų |
Heavy Atom Count | 76 |
Formal Charge | 0 |
Complexity | 1770 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
NDC Package Code : 50909-1706
Start Marketing Date : 2019-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Hebi Xinhe Pharmaceutical Co., Ltd. is a subsidiary of Tianjin Zhennuo Pharmaceutical Group Co., Ltd., with a registered capital of CNY 100 million. Located in Jijiashan Industrial...
Details:
Wan Ti Le (tenapanor HCl) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of chronic kidney disease.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Wan Ti Le
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Ardelyx
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2025
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Ardelyx
Deal Size : Inapplicable
Deal Type : Inapplicable
Fosun Pharma Received NMPA Approval for Wan Ti Le (Tenapanor Hydrochloride Tablets)
Details : Wan Ti Le (tenapanor HCl) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of chronic kidney disease.
Product Name : Wan Ti Le
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 26, 2025
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment of pediatric Hyperphosphatemia.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 15, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric H...
Details : Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment of pediatric Hyperphosphatemia.
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 15, 2023
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 17, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor
Details : Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease o...
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 17, 2023
Details:
The financing will support the commercialization of company's two FDA approved products, Ibsrela (tenapanor), for irritable bowel syndrome with constipation, and Xphozah (tenapanor), indicated to reduce serum phosphorus in adults with chronic kidney disease.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: SLR Capital Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 17, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : SLR Capital Partners
Deal Size : Undisclosed
Deal Type : Financing
Details : The financing will support the commercialization of company's two FDA approved products, Ibsrela (tenapanor), for irritable bowel syndrome with constipation, and Xphozah (tenapanor), indicated to reduce serum phosphorus in adults with chronic kidney dise...
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 17, 2023
Details:
Phozevel (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the NHE3, indicated for the treatment improvement of hyperphosphatemia in adult patients with CKD on dialysis.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Phozevel
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 25, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tenapanor for Hyperphosphatemia Approved in Japan
Details : Phozevel (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the NHE3, indicated for the treatment improvement of hyperphosphatemia in adult patients with CKD on dial...
Product Name : Phozevel
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 25, 2023
Details:
The agreement provides Fosun Pharma the rights to develop and commercialize Ardelyx's lead product, tenapanor, in China for the treatment of patients with irritable bowel syndrome with constipation and for the treatment of hyperphosphatemia related to chronic kidney disease.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Fosun Pharmaceutical
Deal Size: $125.0 million Upfront Cash: $12.0 million
Deal Type: Licensing Agreement July 13, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Fosun Pharmaceutical
Deal Size : $125.0 million
Deal Type : Licensing Agreement
Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China
Details : The agreement provides Fosun Pharma the rights to develop and commercialize Ardelyx's lead product, tenapanor, in China for the treatment of patients with irritable bowel syndrome with constipation and for the treatment of hyperphosphatemia related to ch...
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : $12.0 million
July 13, 2023
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 17, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease o...
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 17, 2023
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 18, 2023
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for XPHOZAH® (tenapan...
Details : Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease o...
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 18, 2023
Details:
Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 16, 2022
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Ardelyx Provides Update on FDA Appeal for XPHOZAH® (tenapanor) for the Control of Serum Phosphoru...
Details : Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 16, 2022
Details:
XPHOZAH (tenapanor),is an investigational first-in-class phosphate absorption inhibitor, With its unique blocking MOA, XPHOZAH acts locally in gut, reducing phosphate absorption through paracellular pathway, primary pathway of phosphate absorption.
Lead Product(s): Tenapanor Hydrochloride,Inapplicable
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 03, 2022
Lead Product(s) : Tenapanor Hydrochloride,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : XPHOZAH (tenapanor),is an investigational first-in-class phosphate absorption inhibitor, With its unique blocking MOA, XPHOZAH acts locally in gut, reducing phosphate absorption through paracellular pathway, primary pathway of phosphate absorption.
Product Name : Xphozah
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 03, 2022
Regulatory Info : RX
Registration Country : USA
Brand Name : IBSRELA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 2019-09-12
Application Number : 211801
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : XPHOZAH
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2023-10-17
Application Number : 213931
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XPHOZAH
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Packaging :
Approval Date : 2023-10-17
Application Number : 213931
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : XPHOZAH
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 30MG BASE
Packaging :
Approval Date : 2023-10-17
Application Number : 213931
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : IBSRELA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 50MG BASE
Approval Date : 2019-09-12
Application Number : 211801
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : XPHOZAH
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2023-10-17
Application Number : 213931
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : XPHOZAH
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2023-10-17
Application Number : 213931
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : XPHOZAH
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 30MG BASE
Approval Date : 2023-10-17
Application Number : 213931
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Global Sales Information
Market Place
Reply
09 May 2025
Reply
30 Nov 2023
Patents & EXCLUSIVITIES
Patent Expiration Date : 2033-08-01
US Patent Number : 8541448
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 211801
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-08-01
Patent Expiration Date : 2029-12-30
US Patent Number : 8969377
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 213931
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-30
Patent Expiration Date : 2034-04-10
US Patent Number : 10940146
Drug Substance Claim :
Drug Product Claim :
Application Number : 213931
Patent Use Code : U-381
Delist Requested :
Patent Use Description : TREATMENT OF HYPERPHOS...
Patent Expiration Date : 2034-04-10
Patent Expiration Date : 2029-12-30
US Patent Number : 8969377
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 213931
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-30
Patent Expiration Date : 2029-12-30
US Patent Number : 8969377
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 211801
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-30
Patent Expiration Date : 2034-04-10
US Patent Number : 10940146
Drug Substance Claim :
Drug Product Claim :
Application Number : 213931
Patent Use Code : U-381
Delist Requested :
Patent Use Description : TREATMENT OF HYPERPHOS...
Patent Expiration Date : 2034-04-10
Patent Expiration Date : 2029-12-30
US Patent Number : 12016856
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 213931
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-30
Patent Expiration Date : 2034-04-10
US Patent Number : 10940146
Drug Substance Claim :
Drug Product Claim :
Application Number : 213931
Patent Use Code : U-3736
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-04-10
Patent Expiration Date : 2029-12-30
US Patent Number : 12016856
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 211801
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-30
Patent Expiration Date : 2034-04-10
US Patent Number : 10272079
Drug Substance Claim :
Drug Product Claim :
Application Number : 213931
Patent Use Code : U-381
Delist Requested :
Patent Use Description : TREATMENT OF HYPERPHOS...
Patent Expiration Date : 2034-04-10
Exclusivity Code : NP
Exclusivity Expiration Date : 2026-10-17
Application Number : 213931
Product Number : 1
Exclusivity Details :
Exclusivity Code : NP
Exclusivity Expiration Date : 2026-10-17
Application Number : 213931
Product Number : 2
Exclusivity Details :
Exclusivity Code : NP
Exclusivity Expiration Date : 2026-10-17
Application Number : 213931
Product Number : 3
Exclusivity Details :
ABOUT THIS PAGE
11
PharmaCompass offers a list of Tenapanor Hydrochloride 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 Tenapanor Hydrochloride manufacturer or Tenapanor Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tenapanor Hydrochloride manufacturer or Tenapanor Hydrochloride supplier.
PharmaCompass also assists you with knowing the Tenapanor Hydrochloride API Price utilized in the formulation of products. Tenapanor Hydrochloride API Price is not always fixed or binding as the Tenapanor Hydrochloride Price is obtained through a variety of data sources. The Tenapanor Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tenapanor Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenapanor Hydrochloride, including repackagers and relabelers. The FDA regulates Tenapanor Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenapanor Hydrochloride 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 Tenapanor Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenapanor Hydrochloride supplier is an individual or a company that provides Tenapanor Hydrochloride active pharmaceutical ingredient (API) or Tenapanor Hydrochloride finished formulations upon request. The Tenapanor Hydrochloride suppliers may include Tenapanor Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Tenapanor Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tenapanor Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tenapanor Hydrochloride 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 Tenapanor Hydrochloride 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 Tenapanor Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tenapanor Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tenapanor Hydrochloride suppliers with NDC on PharmaCompass.
Tenapanor Hydrochloride 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 Tenapanor Hydrochloride 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 Tenapanor Hydrochloride GMP manufacturer or Tenapanor Hydrochloride GMP API supplier for your needs.
A Tenapanor Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Tenapanor Hydrochloride's compliance with Tenapanor Hydrochloride specifications and serves as a tool for batch-level quality control.
Tenapanor Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Tenapanor Hydrochloride 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.
Tenapanor Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Tenapanor Hydrochloride EP), Tenapanor Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tenapanor Hydrochloride USP).