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Also known as: Sevelamer hcl, 152751-57-0, 2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride, 182683-00-7, Chebi:32127, Bcp21176
Molecular Formula
C6H13Cl2NO
Molecular Weight
186.08  g/mol
InChI Key
KHNXRSIBRKBJDI-UHFFFAOYSA-N

Sevelamer Hydrochloride
A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.
1 2D Structure

Sevelamer Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C3H5ClO.C3H7N.ClH/c4-1-3-2-5-3;1-2-3-4;/h3H,1-2H2;2H,1,3-4H2;1H
2.1.3 InChI Key
KHNXRSIBRKBJDI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C=CCN.C1C(O1)CCl.Cl
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Carbonate, Sevelamer

2. Gt335 012

3. Gt335-012

4. Gt335012

5. Hydrochloride, Sevelamer

6. Renagel

7. Sevelamer

8. Sevelamer Carbonate

2.2.2 Depositor-Supplied Synonyms

1. Sevelamer Hcl

2. 152751-57-0

3. 2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride

4. 182683-00-7

5. Chebi:32127

6. Bcp21176

7. Cga75157

8. Sevelamer Hydrochloride (jan/usan)

9. S4129

10. Akos025149504

11. Ac-2089

12. Hs-0082

13. Db-063954

14. Ft-0653684

15. D01983

16. Ab01568265_01

17. 2-propen-1-amine Hydrochloride Polymer With (chloromethyl)oxirane

2.3 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 186.08 g/mol
Molecular Formula C6H13Cl2NO
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count2
Exact Mass185.0374194 g/mol
Monoisotopic Mass185.0374194 g/mol
Topological Polar Surface Area38.6 Ų
Heavy Atom Count10
Formal Charge0
Complexity55.1
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Chelating Agents

Chemicals that bind to and remove ions from solutions. Many chelating agents function through the formation of COORDINATION COMPLEXES with METALS. (See all compounds classified as Chelating Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Phosphate Chelating Activity [MoA]; Phosphate Binder [EPC]
5.3 ATC Code

V03AE02


USDMF

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Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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GDUFA

DMF Review : Complete

Rev. Date : 2023-12-20

Pay. Date : 2023-09-18

DMF Number : 38198

Submission : 2023-06-27

Status : Active

Type : II

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38016

Submission : 2023-03-01

Status : Active

Type : II

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Chemo Iberica Sa

Spain

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CPHI Middle east
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CPHI Middle east
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GDUFA

DMF Review : N/A

Rev. Date :

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DMF Number : 22349

Submission : 2008-12-23

Status : Inactive

Type : II

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CPHI Middle east
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CPHI Middle east
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GDUFA

DMF Review : Complete

Rev. Date : 2019-02-15

Pay. Date : 2019-02-07

DMF Number : 21488

Submission : 2008-03-31

Status : Active

Type : II

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Rev. Date :

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DMF Number : 14695

Submission : 2000-02-24

Status : Inactive

Type : II

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Sevelamer Hydrochloride IH

Date of Issue : 2022-08-11

Valid Till : 2025-06-26

Written Confirmation Number : WC-0054

Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...

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Sevelamer Hydrochloride IH

Date of Issue : 2022-06-27

Valid Till : 2025-06-02

Written Confirmation Number : WC-0012

Address of the Firm : MIs USV Private Limited ,B-1/8,MIDC, Lote Parshuram, Tal., Dist. Ratnagiri, Khed...

USV Private Limited

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Sevelamer Hydrochloride IH

Date of Issue : 2022-06-24

Valid Till : 2025-07-02

Written Confirmation Number : WC-0097

Address of the Firm : Block No. 251/P, 252/P, 253 to 255, 256/P,258/P, 276/P, 277/P, 278/P, 279 To 282...

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Sevelamer Hydrochloride (IH)

Date of Issue : 2019-10-07

Valid Till : 2022-07-02

Written Confirmation Number : WC-0226

Address of the Firm : D-24 and D24/1 MIDC Kurkumbh Tal. Daund, Dist Pune 413 802, Maharashtra State

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Sevelamer Hydrochloride IH

Date of Issue : 2022-09-30

Valid Till : 2025-08-04

Written Confirmation Number : WC-0127

Address of the Firm : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore-607 005

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20-Jan-2021
16-Oct-2024
KGS
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DOSAGE - TABLET;ORAL - 400MG

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DOSAGE - TABLET;ORAL - 800MG

USFDA APPLICATION NUMBER - 21179

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