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Chemistry

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Also known as: Citicoline sodium, 33818-15-4, Citicoline sodium salt, Cytidine 5'-diphosphocholine sodium, Cdp-choline sodium, Citicoline, sodium
Molecular Formula
C14H25N4NaO11P2
Molecular Weight
510.31  g/mol
InChI Key
YWAFNFGRBBBSPD-KDVMHAGBSA-M

Citicoline Sodium
1 2D Structure

Citicoline Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;[[(2S,3R,4S,5S)-5-(4-amino-2-oxopyrimidin-1-yl)-3,4-dihydroxyoxolan-2-yl]methoxy-oxidophosphoryl] 2-(trimethylazaniumyl)ethyl phosphate
2.1.2 InChI
InChI=1S/C14H26N4O11P2.Na/c1-18(2,3)6-7-26-30(22,23)29-31(24,25)27-8-9-11(19)12(20)13(28-9)17-5-4-10(15)16-14(17)21;/h4-5,9,11-13,19-20H,6-8H2,1-3H3,(H3-,15,16,21,22,23,24,25);/q;+1/p-1/t9-,11-,12-,13-;/m0./s1
2.1.3 InChI Key
YWAFNFGRBBBSPD-KDVMHAGBSA-M
2.1.4 Canonical SMILES
C[N+](C)(C)CCOP(=O)([O-])OP(=O)([O-])OCC1C(C(C(O1)N2C=CC(=NC2=O)N)O)O.[Na+]
2.1.5 Isomeric SMILES
C[N+](C)(C)CCOP(=O)([O-])OP(=O)([O-])OC[C@H]1[C@@H]([C@@H]([C@H](O1)N2C=CC(=NC2=O)N)O)O.[Na+]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Citicoline Sodium

2. 33818-15-4

3. Citicoline Sodium Salt

4. Cytidine 5'-diphosphocholine Sodium

5. Cdp-choline Sodium

6. Citicoline, Sodium

7. Cdp-choline, Sodium

8. Cytidine 5'-diphosphocholine Sodium Salt

9. Cytidine 5'-diphosphocholine Sodium Salt Dihydrate

10. Cytidine-5'-diphosphocholine Monosodium Salt

11. A821952

12. Sodium [[(2s,3r,4s,5s)-5-(4-amino-2-oxo-pyrimidin-1-yl)-3,4-dihydroxy-tetrahydrofuran-2-yl]methoxy-oxido-phosphoryl] 2-(trimethylammonio)ethyl Phosphate;citicoline Sodium Salt

2.3 Create Date
2010-07-26
3 Chemical and Physical Properties
Molecular Weight 510.31 g/mol
Molecular Formula C14H25N4NaO11P2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count11
Rotatable Bond Count10
Exact Mass510.08927590 g/mol
Monoisotopic Mass510.08927590 g/mol
Topological Polar Surface Area216 Ų
Heavy Atom Count32
Formal Charge0
Complexity813
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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Interquim SA

Spain

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

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Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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LGM Pharma

U.S.A

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

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

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DKSH

Switzerland

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

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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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Jai Radhe Sales

India

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

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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Tenatra Chemie

India

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

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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Zeal MediPharma

India

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

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Virtual BoothDelivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.

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SNJ Labs

India

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

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Virtual BoothSNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.

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08

SNJ Lifecare

India

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

China Battery Fair
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SNJ Lifecare

India

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

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Global Calcium

India

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

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Global Calcium

India

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USDMF

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PEGS Boston Summit
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PEGS Boston Summit
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12724

Submission : 1997-10-20

Status : Inactive

Type : II

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PEGS Boston Summit
Not Confirmed

02

PEGS Boston Summit
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27708

Submission : 2013-11-11

Status : Inactive

Type : II

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Snj Lifecare Pvt Ltd

India

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39545

Submission : 2024-02-16

Status : Active

Type : II

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EU WC

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BPI Europe
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Citicoline Sodium IP/USP

Date of Issue : 2024-09-20

Valid Till : 2027-09-20

Written Confirmation Number : WC-592

Address of the Firm : Plot No. 411/1 & 412/2, L.I.C. Sector, Silvassa Road, G.I.D.C. Vapi,396 195. Dis...

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BPI Europe
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Citicoline Sodium 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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Citicoline Sodium IH

Date of Issue : 2022-12-30

Valid Till : 2025-12-30

Written Confirmation Number : WC-0545

Address of the Firm : Plot No.: SP4-4, Industrial Area, Keshwana Rajput, Kotputli, Shahpura, Distt. Ja...

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BPI Europe
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Citicoline Sodium

Date of Issue : 2021-08-06

Valid Till : 2024-03-04

Written Confirmation Number : WC-0294

Address of the Firm : R.S No.33 and 34 Mathur Road Periyakalapet, Punducherry India

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API Reference Price

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G-375 376 PHASE-II"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742841000,"product":"CITICOLINE SODIUM IP CITICOLINE SODIUM IP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"179.6","totalValueFC":"54298.6","currency":"USD","unitRateINR":"15677.4","date":"25-Mar-2025","totalValueINR":"4703215.46","totalValueInUsd":"54298.6","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9090543","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO, 88 YEU NG UK ROAD TSUEN WAN, NT HONG KONG TSUEN, , HONG KONG HONG KONG","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"CITICOLINE MONOSODIUM SALT CITICOLINE MONOSODIUM SALT","address":"D-158-A,OKHLA INDUSTRIAL AREA,","city":"NEW DELHI","supplier":"KYOWA HAKKO BIO","supplierCountry":"JAPAN","foreign_port":"OSAKA - KANSAI INT\\'L","customer":"KUSUM HEALTHCARE PVT LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"160","totalValueFC":"4031.5","currency":"USD","unitRateINR":"13968","date":"26-Mar-2025","totalValueINR":"349200","totalValueInUsd":"4031.5","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"9109318","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"OSAKA - KANSAI INT\\'L","supplierAddress":"101 THOMSON ROAD, #09-03 UNITED SQU ARE, Singapore - 307591, SINGAPORE SDNF SINGAPORE","customerAddress":"D-158-A,OKHLA INDUSTRIAL AREA,"}]
02-Jan-2021
31-Mar-2025
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Quantity (KGS) & Unit rate (USD/KGS) over time

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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Citicoline Sodium

Brand Name : Citicoline Sodium

Dosage Form : Granules for Oral Solution

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Citicoline

Brand Name : BRALIN

Dosage Form : Injection

Dosage Strength : 500MG/4ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Cambodia

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03

PEGS Boston Summit
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PEGS Boston Summit
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Cytidine Diphosphate Choline

Brand Name : QUANIL

Dosage Form : TABLET

Dosage Strength : 1.5MG

Packaging : Sachet

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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04

PEGS Boston Summit
Not Confirmed
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Citicoline

Brand Name :

Dosage Form : Injection

Dosage Strength : 250MG/ML

Packaging : 4ml Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Citicoline

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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06

PEGS Boston Summit
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Citicoline

Brand Name : N-CITI 500

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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PEGS Boston Summit
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Cytidine Diphosphate Choline

Brand Name : CITXL

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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08

Country
PEGS Boston Summit
Not Confirmed
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Country
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PEGS Boston Summit
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Citicoline

Brand Name : Citicoline Tarbis 1000Mg 10 Vials 4Ml Solution For Injection Efg

Dosage Form : Solution For Injection

Dosage Strength : 1000 Mg/SOLUTION FOR INJECTION

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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09

Country
PEGS Boston Summit
Not Confirmed
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Country
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PEGS Boston Summit
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Citicoline

Brand Name : Citicoline Ferrer 1000Mg 10 Vials 4Ml Solution For Injection Efg

Dosage Form : Solution For Injection

Dosage Strength : 1000 Mg/SOLUTION FOR INJECTION

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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10

Country
PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Citicoline

Brand Name : Qualigen Citicoline 1000Mg 10 Sachets 10Ml Oral Solution Efg

Dosage Form : Oral Solution

Dosage Strength : 1000 Mg/Oral Solution

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Citicoline Sodium

Brand Name : Citicoline Sodium

Dosage Form : Granules for Oral Solu...

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

01

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Citicoline Sodium

Dosage : Granules for Oral Solu...

Dosage Strength : 500MG

Brand Name : Citicoline Sodium

Approval Date :

Application Number :

Registration Country : India

Octavius Pharma

02

Aeon

India
PEGS Boston Summit
Not Confirmed
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Aeon

India
arrow
PEGS Boston Summit
Not Confirmed

Cytidine Diphosphate Choline; Piracetam

Brand Name :

Dosage Form : FILM COATED TABLET

Dosage Strength : 500MG; 800MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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02

Aeon

India
PEGS Boston Summit
Not Confirmed
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Aeon

India
arrow
PEGS Boston Summit
Not Confirmed

Cytidine Diphosphate Choline; Piracetam

Dosage : FILM COATED TABLET

Dosage Strength : 500MG; 800MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Dosage : Tablet

Dosage Strength : 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Brand Name :

Dosage Form : ORAL SUSPENSION

Dosage Strength : 250

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Dosage : ORAL SUSPENSION

Dosage Strength : 250

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Brand Name :

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

blank

05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Dosage : TABLET

Dosage Strength : 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank

06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline

Dosage : Tablet

Dosage Strength : 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank

07

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Cytidine Diphosphate Choline

Brand Name : QUANIL

Dosage Form : SOLUTION

Dosage Strength : 100MG/ML

Packaging : PET Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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07

PEGS Boston Summit
Not Confirmed
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arrow
PEGS Boston Summit
Not Confirmed

Cytidine Diphosphate Choline

Dosage : SOLUTION

Dosage Strength : 100MG/ML

Brand Name : QUANIL

Approval Date :

Application Number :

Registration Country : India

blank

08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Brand Name : Citicoline

Dosage Form : Liquid Injection

Dosage Strength : 250MG/ML

Packaging : 2 ML, 4 ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Dosage : Liquid Injection

Dosage Strength : 250MG/ML

Brand Name : Citicoline

Approval Date :

Application Number :

Registration Country : India

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09

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium; Piracetam

Brand Name : N-CITI PLUS

Dosage Form : Tablet

Dosage Strength : 500MG; 800MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

09

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium; Piracetam

Dosage : Tablet

Dosage Strength : 500MG; 800MG

Brand Name : N-CITI PLUS

Approval Date :

Application Number :

Registration Country : India

blank

10

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

10

PEGS Boston Summit
Not Confirmed
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arrow
PEGS Boston Summit
Not Confirmed

Citicoline Sodium

Dosage : Tablet

Dosage Strength : 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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ABOUT THIS PAGE

Looking for 33818-15-4 / Citicoline Sodium API manufacturers, exporters & distributors?

Citicoline Sodium manufacturers, exporters & distributors 1

33

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

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

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

API | Excipient name

Citicoline Sodium

Synonyms

33818-15-4, Citicoline sodium salt, Cytidine 5'-diphosphocholine sodium, Cdp-choline sodium, Citicoline, sodium, Cdp-choline, sodium

Cas Number

33818-15-4

Citicoline Sodium Manufacturers

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

Citicoline Sodium Suppliers

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

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

Citicoline Sodium USDMF

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

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

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

Citicoline Sodium 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 Citicoline Sodium Drug Master File in Japan (Citicoline Sodium JDMF) empowers Citicoline Sodium 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 Citicoline Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Citicoline Sodium 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 Citicoline Sodium suppliers with JDMF on PharmaCompass.

Citicoline Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Citicoline Sodium Drug Master File in Korea (Citicoline Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Citicoline Sodium. The MFDS reviews the Citicoline Sodium KDMF as part of the drug registration process and uses the information provided in the Citicoline Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Citicoline Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Citicoline Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Citicoline Sodium suppliers with KDMF on PharmaCompass.

Citicoline Sodium WC

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

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

Citicoline Sodium GMP

Citicoline Sodium 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 Citicoline Sodium 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 Citicoline Sodium GMP manufacturer or Citicoline Sodium GMP API supplier for your needs.

Citicoline Sodium CoA

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

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

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