Find Cholestyramine manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

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USP

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API REF. PRICE (USD/KG)

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Chemistry

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Also known as: Q418006
Molecular Formula
C21H30ClN
Molecular Weight
331.9  g/mol
InChI Key
KNDHRUPPBXRELB-UHFFFAOYSA-M

Cholestyramine
1 2D Structure

Cholestyramine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[4-[3-(4-ethylphenyl)butyl]phenyl]-trimethylazanium;chloride
2.1.2 InChI
InChI=1S/C21H30N.ClH/c1-6-18-9-13-20(14-10-18)17(2)7-8-19-11-15-21(16-12-19)22(3,4)5;/h9-17H,6-8H2,1-5H3;1H/q+1;/p-1
2.1.3 InChI Key
KNDHRUPPBXRELB-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CCC1=CC=C(C=C1)C(C)CCC2=CC=C(C=C2)[N+](C)(C)C.[Cl-]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Q418006

2.3 Create Date
2013-02-04
3 Chemical and Physical Properties
Molecular Weight 331.9 g/mol
Molecular Formula C21H30ClN
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count1
Rotatable Bond Count6
Exact Mass331.2066777 g/mol
Monoisotopic Mass331.2066777 g/mol
Topological Polar Surface Area0 Ų
Heavy Atom Count23
Formal Charge0
Complexity300
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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01

Jai Radhe Sales

India

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

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

02

Jiangsu Kingshan New Material

China

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

Cophex
Not Confirmed
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Jiangsu Kingshan New Material

China

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

arrow
Cophex
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

Purolite

United Kingdom

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

Cophex
Not Confirmed
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Purolite

United Kingdom

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

arrow
Cophex
Not Confirmed
USDMF arrow-down CEP/COS JDMF arrow-down EU-WC NDC arrow-down KDMF VMF Others AUDIT
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04

ION EXCHANGE INDIA LIMITED

India

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

Cophex
Not Confirmed
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ION EXCHANGE INDIA LIMITED

India

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

arrow
Cophex
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCInactive-api NDC arrow-down KDMF VMF Others AUDIT
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05

PHAEX POLYMERS PRIVATE LTD

India

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

Cophex
Not Confirmed
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PHAEX POLYMERS PRIVATE LTD

India

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

arrow
Cophex
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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06

The Dow Chemical Company

U.S.A

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

Cophex
Not Confirmed
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The Dow Chemical Company

U.S.A

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

arrow
Cophex
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

THERMAX LTD CHEMICAL DIV

India

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

Cophex
Not Confirmed
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THERMAX LTD CHEMICAL DIV

India

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

arrow
Cophex
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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08

The Dow Chemical Company

U.S.A

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

Cophex
Not Confirmed
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The Dow Chemical Company

U.S.A

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

arrow
Cophex
Not Confirmed
USDMF Inactive-api CEP/COS JDMF arrow-down EU-WC NDC KDMF VMF Others AUDIT
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09

The Dow Chemical Company

U.S.A

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

Cophex
Not Confirmed
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The Dow Chemical Company

U.S.A

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

arrow
Cophex
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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10

The Dow Chemical Company

U.S.A

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

Cophex
Not Confirmed
arrow

The Dow Chemical Company

U.S.A

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

arrow
Cophex
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

AACR Annual meeting
Not Confirmed

01

AACR Annual meeting
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-06

Pay. Date : 2013-09-27

DMF Number : 23171

Submission : 2009-10-05

Status : Active

Type : II

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02

AACR Annual meeting
Not Confirmed

03

AACR Annual meeting
Not Confirmed

03

AACR Annual meeting
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27607

Submission : 2013-08-02

Status : Active

Type : II

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04

Purolite Llc

United Kingdom

USDMF

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AACR Annual meeting
Not Confirmed

04

Purolite Llc

United Kingdom
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AACR Annual meeting
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-04-02

Pay. Date : 2014-01-22

DMF Number : 7324

Submission : 1988-02-05

Status : Active

Type : II

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05

Rohm And Haas Co

U.S.A

USDMF

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AACR Annual meeting
Not Confirmed

05

06

Rohm And Haas Co

U.S.A

USDMF

arrow
AACR Annual meeting
Not Confirmed

06

AACR Annual meeting
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6506

Submission : 1986-07-11

Status : Inactive

Type : II

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Dow Chemical Co

U.S.A

USDMF

arrow
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Not Confirmed

07

AACR Annual meeting
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5759

Submission : 1985-02-18

Status : Inactive

Type : II

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Dsp

U.S.A

USDMF

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Not Confirmed

08

Dsp

U.S.A
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GDUFA

DMF Review : Complete

Rev. Date : 2013-04-23

Pay. Date : 2012-12-03

DMF Number : 5673

Submission : 1984-12-10

Status : Active

Type : II

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09

AACR Annual meeting
Not Confirmed
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JDMF

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01

S. C. PUROLITE S. R. L.

United Kingdom
AACR Annual meeting
Not Confirmed
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S. C. PUROLITE S. R. L.

United Kingdom
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Not Confirmed

Cholestyramine

Registration Number : 223MF10027

Registrant's Address : Str. Aleeea Uzinei Nr. 11, 505700 Victoria, Judetul Brasov, Romania

Initial Date of Registration : 2011-02-25

Latest Date of Registration : 2011-02-25

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02

DSP

U.S.A
AACR Annual meeting
Not Confirmed
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DSP

U.S.A
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DUOLITET.M. AP143/1083, Cholestyramine

Registration Number : 228MF10132

Registrant's Address : 22 Rue Brunel 75017 Paris France

Initial Date of Registration : 2016-07-25

Latest Date of Registration : 2023-03-07

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EU WC

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01

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Cholestyramine Resin USP

Date of Issue : 2016-03-04

Valid Till : 2019-03-03

Written Confirmation Number : WC-0352

Address of the Firm : Plot No.25 26, Phase-II G.I.D.C, Vatva, Ahmedabad-382445

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02

AACR Annual meeting
Not Confirmed
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CHOLESTYRAMINE RESIN USP/EP/USP

Date of Issue : 2020-01-31

Valid Till : 2022-07-02

Written Confirmation Number : WC-0132A1

Address of the Firm : Plot No.5811-12-13, GIDC Industrial Estate, Ankleshwar-393 002 Bharuch, Gujarat

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03

AACR Annual meeting
Not Confirmed
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Cholestyramine Resin (USP/EP/BP)/Colestyramine EP/BP

Date of Issue : 2020-01-31

Valid Till : 2022-07-02

Written Confirmation Number : WC-0132

Address of the Firm : Plot No.5811-12-13, GIDC Industrial Estate, Ankleshwar-393 002 Bharuch, Gujarat

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04

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Not Confirmed
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CHOLESTYRAMINE USP/EP/BP

Date of Issue : 2023-04-06

Valid Till : 2025-12-27

Written Confirmation Number : WC-0393

Address of the Firm : Plot F 10, MIDC, Murbad 421 401,Taluka - Murbad, District Thane, Maharashtra Sta...

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NDC API

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01

Arvo
Not Confirmed
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CHOLESTYRAMINE

NDC Package Code : 71052-151

Start Marketing Date : 2019-06-19

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (5000g/5000g)

Marketing Category : BULK INGREDIENT

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02

Fagron Inc

Netherlands
Arvo
Not Confirmed
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Fagron Inc

Netherlands
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Arvo
Not Confirmed

CHOLESTYRAMINE

NDC Package Code : 51552-0684

Start Marketing Date : 1998-04-01

End Marketing Date : 2027-10-15

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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03

Arvo
Not Confirmed
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Arvo
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CHOLESTYRAMINE

NDC Package Code : 55363-454

Start Marketing Date : 2012-09-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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04

Arvo
Not Confirmed
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Arvo
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CHOLESTYRAMINE

NDC Package Code : 55363-454

Start Marketing Date : 2012-09-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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05

Arvo
Not Confirmed
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Arvo
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CHOLESTYRAMINE

NDC Package Code : 62991-2650

Start Marketing Date : 2011-02-05

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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06

Medisca Inc.

U.S.A
Arvo
Not Confirmed
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Medisca Inc.

U.S.A
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Arvo
Not Confirmed

CHOLESTYRAMINE

NDC Package Code : 38779-0822

Start Marketing Date : 2009-01-22

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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07

Arvo
Not Confirmed
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Arvo
Not Confirmed

CHOLESTYRAMINE

NDC Package Code : 51927-4962

Start Marketing Date : 2016-09-19

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (90kg/90kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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08

Purolite LLC

United Kingdom
Arvo
Not Confirmed
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Purolite LLC

United Kingdom
arrow
Arvo
Not Confirmed

CHOLESTYRAMINE

NDC Package Code : 68444-0001

Start Marketing Date : 2010-10-12

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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09

Arvo
Not Confirmed
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Arvo
Not Confirmed

CHOLESTYRAMINE

NDC Package Code : 49452-2011

Start Marketing Date : 1999-09-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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DSP

Country
Arvo
Not Confirmed
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DSP

Country
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Arvo
Not Confirmed

CHOLESTYRAMINE

NDC Package Code : 53933-2175

Start Marketing Date : 1998-10-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1620844200,"product":"BULK DRUGS: CHOLESTYRAMINE RESIN USP (IO NEX SB 45)","address":"KAMALA BHUVAN NO.2, 1ST FLR. NO.37SAHAR RD., ANDHERI (E)","city":"BOMBAY ,MAHARASHTRA","supplier":"TRICON ENTERPRISES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"PNP. LAB.","customerCountry":"INDONESIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"26.9","totalValueFC":"5291","currency":"USD","unitRateINR":1937.8,"date":"13-May-2021","totalValueINR":"387560","totalValueInUsd":"5291","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"1756384","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"KAMALA BHUVAN NO.2, 1ST FLR. NO.37SAHAR RD., ANDHERI (E), BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1629916200,"product":"BULK DRUGS : COLESTYRAMINE EP (IONEX SB4 8)","address":"KAMALA BHUVAN NO.2, 1ST FLR. NO.37SAHAR RD., ANDHERI (E)","city":"BOMBAY ,MAHARASHTRA","supplier":"TRICON ENTERPRISES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DUESSELDORF","customer":"FA.PH.GMB.","customerCountry":"GERMANY","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"26.9","totalValueFC":"3925","currency":"USD","unitRateINR":1940.74,"date":"26-Aug-2021","totalValueINR":"291111","totalValueInUsd":"3925","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4125591","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"KAMALA BHUVAN NO.2, 1ST FLR. NO.37SAHAR RD., ANDHERI (E), BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"RAW MATERIAL FOR USE IN PHARMACEUTICAL INDUSTRY : CHOLESTYRAMINE RESIN USP","address":"A 401 NEELKANTH AVENUE,OPP SEEMA H","city":"AHMEDABAD,GUJARAT","supplier":"GONANE PHARMA","supplierCountry":"INDIA","foreign_port":"SANTIAGO DE CHILE -","customer":"HSBC BANK","customerCountry":"CHILE","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"40","totalValueFC":"2959.8","currency":"USD","unitRateINR":2487,"date":"01-Oct-2024","totalValueINR":"248700","totalValueInUsd":"2959.8","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"4494730","productDescription":"API","marketType":"REGULATED MARKET","country":"CHILE","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"A 401 NEELKANTH AVENUE,OPP SEEMA H, AHMEDABAD,GUJARAT","customerAddress":""}]
13-May-2021
01-Oct-2024
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Europe

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cholestyramine (anhydrous)

Brand Name : Questran

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Colestyramine

Brand Name : Questran

Dosage Form : Cholestyramine 4G 12 Combined Oral Use

Dosage Strength : os groun 12 bust 4 g

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Not Confirmed
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Colestyramine

Brand Name : Questran

Dosage Form : Powder for potion, suspension

Dosage Strength : 4 g

Packaging : Dose Bag

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Colestyramine

Brand Name : Questran Loc

Dosage Form : Powder for potion, suspension

Dosage Strength : 4 g

Packaging : Dose Bag

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

Orifarm AB

Denmark
AACR Annual meeting
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Orifarm AB

Denmark
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cholestyramine (anhydrous)

Brand Name : Questran

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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cholestyramine (anhydrous)

Brand Name : Questran Loc

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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cholestyramine (anhydrous)

Brand Name : Questran Loc

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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cholestyramine (anhydrous)

Brand Name : Questran Loc

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

2care4 ApS

Country
AACR Annual meeting
Not Confirmed
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2care4 ApS

Country
arrow
AACR Annual meeting
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cholestyramine (anhydrous)

Brand Name : Questran Loc

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Pharmachim AB

Country
AACR Annual meeting
Not Confirmed
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Pharmachim AB

Country
arrow
AACR Annual meeting
Not Confirmed

cholestyramine (anhydrous)

Brand Name : Questran Loc

Dosage Form : POWDER FOR ORAL SUSPENSION, SACHET

Dosage Strength : 4 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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ABOUT THIS PAGE

Looking for / Cholestyramine API manufacturers, exporters & distributors?

Cholestyramine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cholestyramine 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 Cholestyramine manufacturer or Cholestyramine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cholestyramine manufacturer or Cholestyramine supplier.

PharmaCompass also assists you with knowing the Cholestyramine API Price utilized in the formulation of products. Cholestyramine API Price is not always fixed or binding as the Cholestyramine Price is obtained through a variety of data sources. The Cholestyramine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cholestyramine

Synonyms

Q418006

Colestyramine Manufacturers

A Colestyramine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colestyramine, including repackagers and relabelers. The FDA regulates Colestyramine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colestyramine 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 Colestyramine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Colestyramine Suppliers

A Colestyramine supplier is an individual or a company that provides Colestyramine active pharmaceutical ingredient (API) or Colestyramine finished formulations upon request. The Colestyramine suppliers may include Colestyramine API manufacturers, exporters, distributors and traders.

click here to find a list of Colestyramine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Colestyramine USDMF

A Colestyramine DMF (Drug Master File) is a document detailing the whole manufacturing process of Colestyramine active pharmaceutical ingredient (API) in detail. Different forms of Colestyramine DMFs exist exist since differing nations have different regulations, such as Colestyramine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Colestyramine DMF submitted to regulatory agencies in the US is known as a USDMF. Colestyramine USDMF includes data on Colestyramine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colestyramine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Colestyramine suppliers with USDMF on PharmaCompass.

Colestyramine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Colestyramine Drug Master File in Japan (Colestyramine JDMF) empowers Colestyramine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Colestyramine JDMF during the approval evaluation for pharmaceutical products. At the time of Colestyramine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Colestyramine suppliers with JDMF on PharmaCompass.

Colestyramine CEP

A Colestyramine CEP of the European Pharmacopoeia monograph is often referred to as a Colestyramine Certificate of Suitability (COS). The purpose of a Colestyramine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Colestyramine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Colestyramine to their clients by showing that a Colestyramine CEP has been issued for it. The manufacturer submits a Colestyramine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Colestyramine CEP holder for the record. Additionally, the data presented in the Colestyramine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Colestyramine DMF.

A Colestyramine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Colestyramine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Colestyramine suppliers with CEP (COS) on PharmaCompass.

Colestyramine WC

A Colestyramine written confirmation (Colestyramine WC) is an official document issued by a regulatory agency to a Colestyramine manufacturer, verifying that the manufacturing facility of a Colestyramine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Colestyramine APIs or Colestyramine finished pharmaceutical products to another nation, regulatory agencies frequently require a Colestyramine WC (written confirmation) as part of the regulatory process.

click here to find a list of Colestyramine suppliers with Written Confirmation (WC) on PharmaCompass.

Colestyramine 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 Colestyramine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Colestyramine 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 Colestyramine 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 Colestyramine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colestyramine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Colestyramine suppliers with NDC on PharmaCompass.

Colestyramine GMP

Colestyramine 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 Colestyramine 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 Colestyramine GMP manufacturer or Colestyramine GMP API supplier for your needs.

Colestyramine CoA

A Colestyramine CoA (Certificate of Analysis) is a formal document that attests to Colestyramine's compliance with Colestyramine specifications and serves as a tool for batch-level quality control.

Colestyramine CoA mostly includes findings from lab analyses of a specific batch. For each Colestyramine 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.

Colestyramine may be tested according to a variety of international standards, such as European Pharmacopoeia (Colestyramine EP), Colestyramine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Colestyramine 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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