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Sevelamer Hydrochloride

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 16 USDMF, 1 JDMF, 5 EU WC, 5 NDC API, 15 Listed Suppliers, $ API Reference Price

24 API Suppliers
16 USDMF
1 JDMF
5 EU WC
5 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

84 FDF Dossiers, 13 FDA Orange Book, 45 Europe, 1 Canada, 16 Australia, 1 South Africa, 8 Listed Dossiers

84 FDF Dossiers
13 FDA Orange Book
45 Europe
1 Canada
16 Australia
1 South Africa
8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG, TABLET;ORAL - 800MG

drugProductComposition
TABLET;ORAL - 400MG
TABLET;ORAL - 800MG

RELATED EXCIPIENT COMPANIES

2 DKSH, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 BASF, 1 Finar, 2 Gangwal Chemicals, 2 Microlex e.U, 4 Roquette, 1 Sigachi Industries, 1 Valens Pharmachem

relatedExcipients
2 DKSH
1 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
3 BASF
1 Finar
2 Gangwal Chemicals
2 Microlex e.U
4 Roquette
1 Sigachi Industries
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

7 Film Formers & Plasticizers, 5 Lubricants & Glidants, 5 Coating Systems & Additives, 4 Topical, 3 Direct Compression, 3 Emulsifying Agents, 3 Fillers, Diluents & Binders, 3 Thickeners and Stabilizers, 2 Solubilizers, 1 Coloring Agents, 1 Co-Processed Excipients, 1 API Stability Enhancers, 1 Parenteral, 1 Controlled & Modified Release, 1 Granulation

excipientsByApplications
7 Film Formers & Plasticizers
5 Lubricants & Glidants
5 Coating Systems & Additives
4 Topical
3 Direct Compression
3 Emulsifying Agents
3 Fillers, Diluents & Binders
3 Thickeners and Stabilizers
2 Solubilizers
1 Coloring Agents
1 Co-Processed Excipients
1 API Stability Enhancers
1 Parenteral
1 Controlled & Modified Release
1 Granulation

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 16 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
16 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 40 Finished Drug Prices, 8 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
40 Finished Drug Prices
8 Annual Reports

MARKET PLACE

6 APIs, 9 FDF Dossiers

marketPlace
6 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

patents
6 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 115

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

7DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

25,801,839

Annual Reports (USD Million)

3,811

Finished Drug Prices

19 RELATED EXCIPIENT COMPANIES

41EXCIPIENTS BY APPLICATIONS

Chemistry

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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

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 Formula	C₆H₁₃Cl₂NO
Molecular Weight	186.08 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	2
Exact Mass	185.0374194 g/mol
Monoisotopic Mass	185.0374194 g/mol
Topological Polar Surface Area	38.6 Å²
Heavy Atom Count	10
Formal Charge	0
Complexity	55.1
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

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

API SUPPLIERS

01

Century Pharmaceuticals

India

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

CPhI India 2024

Booth #2.F34

Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.

Contact Supplier

India

Virtual Booth

Digital Content

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

02

EUROAPI

France

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

TIDES Europe 2024

Exhibiting

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

Contact Supplier

France

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF

EU-WC NDC KDMF VMF Others AUDIT

03

LGM Pharma

U.S.A

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

BioFlorida Conference

Attending

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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

04

Ami Lifesciences Private Limited

India

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

CPhI India 2024

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC

NDC KDMF VMF Others AUDIT

05

Octavius Pharma Pvt. Ltd

India

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

CPhI India 2024

Attending

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

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

06

USV Private Limited

India

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

CPhI India 2024

Attending

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC

NDC KDMF VMF Others AUDIT

Portfolio PDF

07

Sun Pharmaceutical Industries Limi...

India

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

Compamed

Not Confirmed

08

Solara Active Pharma Sciences

India

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

Compamed

Not Confirmed

09

Lupin Ltd

India

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

Compamed

Not Confirmed

10

The Dow Chemical Company

U.S.A

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

Compamed

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

01

Euroapi Uk Ltd

France

TIDES Europe 2024

Exhibiting

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

Contact Supplier

France

Virtual Booth

Digital Content

Sevelamer Hydrochloride

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

02

Ami Lifesciences Private Ltd

India

CPhI India 2024

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

Contact Supplier

India

Virtual Booth

Digital Content

Sevelamer Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38016

Submission : 2023-03-01

Status : Active

Type : II

03

Chemo Iberica Sa

Spain

Compamed

Not Confirmed

04

Derivados Quimicos Sa Fine Chemicals

Spain

Compamed

Not Confirmed

05

Emcure Pharmaceuticals Ltd

India

Compamed

Not Confirmed

06

Emcure Pharmaceuticals Ltd

India

Compamed

Not Confirmed

07

Formosa Laboratories Inc

Taiwan

Compamed

Not Confirmed

08

Lupin Manufacturing Solutions Ltd

India

Compamed

Not Confirmed

09

Solara Active Pharma Sciences Ltd

India

Compamed

Not Confirmed

10

Dow Chemical Co

U.S.A

Compamed

Not Confirmed

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JDMF

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

EU WC

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

01

Century Pharmaceuticals

India

CPhI India 2024

Booth #2.F34

Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.

Contact Supplier

India

Virtual Booth

Digital Content

Sevelamer Hydrochloride

About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...

Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in India and abroad. Its APIs are manufactured in accordance with cGMP, 21CFR part 10 and ICH guidelines. It also produces intermediates and develops new APIs as per the needs of its clients. Century conducts biotechnological research that focuses on human therapeutic proteins. Currently, research is underway to find treatments for asthma, mastocytosis and basophilic leukemia. Century supplies research-grade biotech products and a wide range of animal health products.

02

EUROAPI

France

TIDES Europe 2024

Exhibiting

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

Contact Supplier

France

Virtual Booth

Digital Content

Sevelamer Hydrochloride

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.

03

LGM Pharma

U.S.A

BioFlorida Conference

Attending

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Sevelamer Hydrochloride

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

04

Ami Lifesciences Private Limited

India

CPhI India 2024

Booth #1.C02

AMI Lifesciences is Driven by Chemistry. Powered by People.

Contact Supplier

India

Virtual Booth

Digital Content

Sevelamer Hydrochloride

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

05

Octavius Pharma Pvt. Ltd

India

CPhI India 2024

Attending

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

Sevelamer Hydrochloride

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...

Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a wide range of products such as tablets, capsules, syrups and ointments. Its portfolio includes finished dosage formulations, herbal/food supplements and APIs. It exports bulk drugs, finished formulations and APIs, while maintaining quality in compliance with WHO GMP norms. With an experienced team, Octavius Pharma provides consulting services for formulation development and marketing. Octavius exports to LATAM, Middle East, African, Asian and CIS countries.

06

USV Private Limited

India

CPhI India 2024

Attending

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

Contact Supplier

India

Virtual Booth

Digital Content

Sevelamer HCl

About the Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Union and Japan), Brande...

USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Union and Japan), Branded Generics and Bio-therapeutics. USV also specializes in Research and Development in Biotechnology, Drug Delivery and Chemistry.31 APIs are currently on offer, 13 are in advanced stages of development and 14 are under development. Segments covered include Diabetes, Cardiology, CNS, Oncology, Dermatology and Ophthalmology.

Portfolio PDF

07

Aspire Lifesciences Pvt Ltd

India

Compamed

Not Confirmed

08

Aurobindo Pharma Limited

India

Compamed

Not Confirmed

09

DEAFARMA

Italy

Compamed

Not Confirmed

10

Hetero Drugs

India

Compamed

Not Confirmed

Only 10 entries up to this point, click to access all

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API Reference Price

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HEATHROW","customer":"SANOFI","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"69.7","totalValueFC":"3151.4","currency":"EUR","unitRateINR":"6602.2","date":"10-Sep-2024","totalValueINR":"264087.2","totalValueInUsd":"3151.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5529387","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"38 BEACH ROAD # 18-11 SOUTH BEACH T OWER SINGAPORE 189767 Singapore, , Singapore Singapore Singapore","customerAddress":"3RD 4TH FLOORS, H.NO. 5-10-173"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - 400MG

USFDA APPLICATION NUMBER - 21179

DOSAGE - TABLET;ORAL - 800MG

USFDA APPLICATION NUMBER - 21179

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01