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Chemistry

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Also known as: Tenapanor hcl, 1234365-97-9, Azd-1722 hydrochloride, Tenapanor dihydrochloride, Tenapanor hydrochloride [usan], Rdx-5791
Molecular Formula
C50H68Cl6N8O10S2
Molecular Weight
1218.0  g/mol
InChI Key
VFRAXTZDILCRKY-OWRGXFNZSA-N
FDA UNII
50605O2ZNS

Tenapanor Hydrochloride
1 2D Structure

Tenapanor Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C50H66Cl4N8O10S2.2ClH/c1-61-31-43(41-27-37(51)29-47(53)45(41)33-61)35-7-5-9-39(25-35)73(65,66)59-15-19-71-23-21-69-17-13-57-49(63)55-11-3-4-12-56-50(64)58-14-18-70-22-24-72-20-16-60-74(67,68)40-10-6-8-36(26-40)44-32-62(2)34-46-42(44)28-38(52)30-48(46)54;;/h5-10,25-30,43-44,59-60H,3-4,11-24,31-34H2,1-2H3,(H2,55,57,63)(H2,56,58,64);2*1H/t43-,44-;;/m0../s1
2.1.3 InChI Key
VFRAXTZDILCRKY-OWRGXFNZSA-N
2.1.4 Canonical SMILES
CN1CC(C2=C(C1)C(=CC(=C2)Cl)Cl)C3=CC(=CC=C3)S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)C4=CC=CC(=C4)C5CN(CC6=C5C=C(C=C6Cl)Cl)C.Cl.Cl
2.1.5 Isomeric SMILES
CN1C[C@H](C2=C(C1)C(=CC(=C2)Cl)Cl)C3=CC(=CC=C3)S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)C4=CC=CC(=C4)[C@@H]5CN(CC6=C5C=C(C=C6Cl)Cl)C.Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
50605O2ZNS
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Azd1722

2. Rdx5791

3. Tenapanor

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2014-09-27
3 Chemical and Physical Properties
Molecular Weight 1218.0 g/mol
Molecular Formula C50H68Cl6N8O10S2
Hydrogen Bond Donor Count8
Hydrogen Bond Acceptor Count14
Rotatable Bond Count29
Exact Mass1216.260149 g/mol
Monoisotopic Mass1214.263099 g/mol
Topological Polar Surface Area235 Ų
Heavy Atom Count76
Formal Charge0
Complexity1770
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

API SUPPLIERS

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01

Hebi Xinhe Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Hebi Xinhe Pharmaceutical

China

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Hovione

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Tenapanor Hydrochloride

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...

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 Park in Heshan District, Hebi City, the company spans 146,200 square meters, with a planned construction area of 80,300 square meters and a total investment of CNY 750 million. Our facilities include production plants, warehouses, office buildings, fire safety infrastructure, and waste treatment systems.
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Drugs in Development

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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

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01

Pharma MES 2025
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Pharma MES 2025
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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

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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

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02

Ardelyx

U.S.A
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Pharma MES 2025
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Ardelyx

U.S.A
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Pharma MES 2025
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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

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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

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Ardelyx

U.S.A
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Pharma MES 2025
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Ardelyx

U.S.A
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Pharma MES 2025
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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

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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

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Ardelyx

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Pharma MES 2025
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Ardelyx

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Pharma MES 2025
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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

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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

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Ardelyx

U.S.A
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Pharma MES 2025
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Ardelyx

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Pharma MES 2025
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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

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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

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Ardelyx

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Ardelyx

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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

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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

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Ardelyx

U.S.A
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Pharma MES 2025
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Ardelyx

U.S.A
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Pharma MES 2025
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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

blank

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

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Ardelyx

U.S.A
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Pharma MES 2025
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Ardelyx

U.S.A
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Pharma MES 2025
Not Confirmed

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

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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

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Ardelyx

U.S.A
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Ardelyx

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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

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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

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Ardelyx

U.S.A
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Ardelyx

U.S.A
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Pharma MES 2025
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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

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TENAPANOR HYDROCHLORIDE

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

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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

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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

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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

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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 :

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TENAPANOR HYDROCHLORIDE

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 :

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TENAPANOR HYDROCHLORIDE

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 :

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TENAPANOR HYDROCHLORIDE

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 :

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US Patents

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TENAPANOR HYDROCHLORIDE

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

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TENAPANOR HYDROCHLORIDE

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

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TENAPANOR HYDROCHLORIDE

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

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TENAPANOR HYDROCHLORIDE

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

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TENAPANOR HYDROCHLORIDE

US Patent Number : 8969377

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 211801

Patent Use Code :

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Patent Expiration Date : 2029-12-30

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TENAPANOR HYDROCHLORIDE

US Patent Number : 10940146

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Application Number : 213931

Patent Use Code : U-381

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Patent Use Description : TREATMENT OF HYPERPHOS...

Patent Expiration Date : 2034-04-10

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US Patent Number : 12016856

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Application Number : 213931

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Patent Expiration Date : 2029-12-30

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Application Number : 213931

Patent Use Code : U-3736

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Patent Expiration Date : 2034-04-10

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US Patent Number : 12016856

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Application Number : 211801

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Patent Expiration Date : 2029-12-30

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Application Number : 213931

Patent Use Code : U-381

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Patent Use Description : TREATMENT OF HYPERPHOS...

Patent Expiration Date : 2034-04-10

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ABOUT THIS PAGE

Looking for 1234365-97-9 / Tenapanor Hydrochloride API manufacturers, exporters & distributors?

Tenapanor Hydrochloride manufacturers, exporters & distributors 1

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.

API | Excipient name

Tenapanor Hydrochloride

Synonyms

Tenapanor hcl, 1234365-97-9, Azd-1722 hydrochloride, Tenapanor dihydrochloride, Tenapanor hydrochloride [usan], Rdx-5791

Cas Number

1234365-97-9

Unique Ingredient Identifier (UNII)

50605O2ZNS

Tenapanor Hydrochloride Manufacturers

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.

Tenapanor Hydrochloride Suppliers

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.

Tenapanor Hydrochloride 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 Tenapanor Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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.

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 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.

Compounded drug products

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 GMP

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.

Tenapanor Hydrochloride CoA

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).

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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