Synopsis
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1. Azd1722
2. Rdx5791
1. 1234423-95-0
2. Azd1722
3. Azd-1722
4. Tenapanor Free Base
5. Rdx-5791
6. Azd 1722
7. Rdx 5791
8. Ibsrela
9. Rdx5791
10. Wyd79216a6
11. 1234423-95-0 (free Base)
12. 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
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)
14. Tenapanor [inn]
15. 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
16. Tenapanor [usan:inn]
17. Unii-wyd79216a6
18. Khk-7791
19. Tenapanor [mi]
20. Tenapanor (usan/inn)
21. Tenapanor [usan]
22. Tenapanor [who-dd]
23. Gtpl8449
24. Chembl3304485
25. Schembl15267600
26. Dtxsid40154016
27. Khk7791
28. Bdbm381823
29. Rdx013 Component Tenapanor
30. Bcp24892
31. Bcp28554
32. Ex-a2506
33. Rdx-013 Component Tenapanor
34. Mfcd28386333
35. Tenapanor; Azd1722; Rdx5791
36. Us10272079, Compound 002
37. Us10272079, Compound 180
38. Akos037648586
39. Tenapanor Component Of Rdx013
40. Cs-6273
41. Db11761
42. Tenapanor Component Of Rdx-013
43. Ac-36104
44. Bs-14732
45. Bt178667
46. Hy-15991
47. J3.655.031g
48. D11652
49. A929505
50. Q17122912
51. Azd 1722;azd1722;azd-1722;rdx5791;rdx 5791;rdx-5791
52. Azd-1722; Azd 1722; Azd1722; Rdx 5791; Rdx-5791; Rdx5791
53. 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-
54. 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
Molecular Weight | 1145.0 g/mol |
---|---|
Molecular Formula | C50H66Cl4N8O10S2 |
XLogP3 | 5.1 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 14 |
Rotatable Bond Count | 29 |
Exact Mass | 1144.306793 g/mol |
Monoisotopic Mass | 1142.309743 g/mol |
Topological Polar Surface Area | 235 Ų |
Heavy Atom Count | 74 |
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 | 1 |
Tenapanor is indicated for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in adults. It is also currently being investigated as a treatment for hyperphosphatemia in chronic kidney disease patients undergoing dialysis (NCT02081534 and NCT02675998).
Through the inhibition of dietary sodium absorption tenapanor causes an increase in water secretion into the intestines, thereby decreasing transit time and softening stool consistency.
A - Alimentary tract and metabolism
A06 - Drugs for constipation
A06A - Drugs for constipation
A06AX - Other drugs for constipation
A06AX08 - Tenapanor
Absorption
Tenapanor undergoes very minimal systemic absorption following oral administration. During clinical trials, plasma concentrations were below the limit of quantitation (i.e. less than 0.5 ng/mL) in the majority of samples from healthy subjects - for this reason, typical pharmacokinetic values related to absorption such as AUC and Cmax were unable to be ascertained. The effects of tenapanor are greatest when administered 5 to 10 minutes before meals.
Route of Elimination
Following administration of a radio labeled dose of tenapanor, 70% of the radioactivity was excreted in the feces within 120 hours of administration and 79% within 240 hours. Approximately 65% of the total dose is excreted as unchanged parent drug within 144 hours of administration. Only 9% of the administered dose was found in the urine, existing primarily as metabolites. Tenapanor's M1 metabolite is excreted unchanged in the urine and accounts for approximately 1.5% of the total dose within 144 hours of administration.
The majority of tenapanor's metabolism to its primary metabolite, M1, is catalyzed via CYP3A4/5. Exposure of tenapanor to hepatic CYP enzymes is likely limited due to its minimal systemic absorption, so its metabolism may be due to intestinal CYP enzyme activity. The M1 metabolite of tenapanor is a P-glycoprotein substrate and, in contrast to its parent drug, can be detected in plasma, reaching a Cmax of approximately 15 ng/mL at steady state. It is not considered active against NHE3.
Tenapanor's FDA label states that its half-life could not be determined during clinical trials due to its minimal systemic absorption resulting in plasma concentrations below the limit of quantitation (i.e. less than 0.5 ng/mL).
Tenapanor is a locally-acting small molecule inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3), an antiporter expressed on the apical surface of enterocytes in the small intestine and colon which is involved in sodium-fluid homeostasis. By inhibiting this antiporter tenapanor causes retention of sodium within the lumen of the intestine - this results in an osmotic gradient that draws water into the lumen and softens stool consistency. There is some evidence that tenapanor can inhibit the uptake of dietary phosphorus in the gastrointestinal tract, though the exact mechanism of this activity has yet to be elucidated.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC Package Code : 24823-914
Start Marketing Date : 2022-06-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
About the Company : Wuhan Sun-shine chemical Corporation Limited (Shanghai Sun-shine Chemical Technology Corporation Limited) is a high-tech enterprise engaged inR&D and sales of related compounds of ...
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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2023
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
November 15, 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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: SLR Capital Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 17, 2023
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Approved
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 : Small molecule
Upfront Cash : Undisclosed
October 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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2023
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Nephrology Brand Name: Phozevel
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Fosun Pharmaceutical
Deal Size: $125.0 million Upfront Cash: $12.0 million
Deal Type: Licensing Agreement July 13, 2023
Lead Product(s) : Tenapanor
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 : Small molecule
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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2023
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IVProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2022
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 : Small molecule
Upfront Cash : Not Applicable
November 03, 2022
Details:
Under the terms of the agreement, Ardelyx will execute a research plan to advance two of Ardelyx’s ongoing research programs focused on the identification and design of Tenapanor (xphozah), a phosphate absorption inhibitor, for the treatment of Hyperphosphatemia.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Brand Name: Xphozah
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Kyowa Kirin
Deal Size: $520.5 million Upfront Cash: $10.5 million
Deal Type: Licensing Agreement October 31, 2022
Lead Product(s) : Tenapanor
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Kyowa Kirin
Deal Size : $520.5 million
Deal Type : Licensing Agreement
Details : Under the terms of the agreement, Ardelyx will execute a research plan to advance two of Ardelyx’s ongoing research programs focused on the identification and design of Tenapanor (xphozah), a phosphate absorption inhibitor, for the treatment of Hyperph...
Product Name : Xphozah
Product Type : Small molecule
Upfront Cash : $10.5 million
October 31, 2022
24 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com//news-release/2024/10/24/2969087/0/en/Ardelyx-Shares-Additional-Data-Supporting-First-In-Class-XPHOZAH-tenapanor-at-the-American-Society-of-Nephrology-s-Kidney-Week.html
15 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/10/15/2963102/0/en/Ardelyx-to-Present-Additional-Data-Supporting-First-In-Class-XPHOZAH-tenapanor-for-Adults-with-Chronic-Kidney-Disease-on-Dialysis-at-the-American-Society-of-Nephrology-s-Kidney-Wee.html
05 Sep 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/09/05/2941309/0/en/Ardelyx-to-Participate-at-the-2024-Cantor-Global-Healthcare-Conference.html
31 Jul 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/07/31/2921836/0/en/Ardelyx-Announces-Publication-of-Two-Plain-Language-Summaries-from-XPHOZAH-tenapanor-Clinical-Trials-in-Current-Medical-Research-and-Opinion.html
18 Jul 2024
// PRESS RELEASE
https://ir.ardelyx.com/news-releases/news-release-details/fda-approves-xphozahr-tenapanor-first-class-phosphate-absorption
21 May 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/05/21/2885550/0/en/Ardelyx-Presents-Additional-Data-at-the-2024-Digestive-Disease-Week-Conference-on-IBSRELA-tenapanor-a-First-In-Class-Treatment-for-IBS-C-in-Adults.html
Global Sales Information
Company :
Tenapanor HCl
Drug Cost (USD) : 5,485,812
Year : 2022
Prescribers : 1294
Prescriptions : 2910
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Main Therapeutic Indication : Hematology
Currency : USD
2023 Revenue in Millions : 0
2022 Revenue in Millions : 0
Growth (%) : New Launch
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ABOUT THIS PAGE
82
PharmaCompass offers a list of Tenapanor 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 manufacturer or Tenapanor supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tenapanor manufacturer or Tenapanor supplier.
PharmaCompass also assists you with knowing the Tenapanor API Price utilized in the formulation of products. Tenapanor API Price is not always fixed or binding as the Tenapanor Price is obtained through a variety of data sources. The Tenapanor Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tenapanor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenapanor, including repackagers and relabelers. The FDA regulates Tenapanor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenapanor 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenapanor supplier is an individual or a company that provides Tenapanor active pharmaceutical ingredient (API) or Tenapanor finished formulations upon request. The Tenapanor suppliers may include Tenapanor API manufacturers, exporters, distributors and traders.
click here to find a list of Tenapanor 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tenapanor 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tenapanor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tenapanor suppliers with NDC on PharmaCompass.
Tenapanor 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 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 GMP manufacturer or Tenapanor GMP API supplier for your needs.
A Tenapanor CoA (Certificate of Analysis) is a formal document that attests to Tenapanor's compliance with Tenapanor specifications and serves as a tool for batch-level quality control.
Tenapanor CoA mostly includes findings from lab analyses of a specific batch. For each Tenapanor 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Tenapanor EP), Tenapanor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tenapanor USP).