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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
| Molecular Weight | 510.31 g/mol |
|---|---|
| Molecular Formula | C14H25N4NaO11P2 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 10 |
| Exact Mass | 510.08927590 g/mol |
| Monoisotopic Mass | 510.08927590 g/mol |
| Topological Polar Surface Area | 216 Ų |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 813 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
API SUPPLIERS
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2021-07-11
Registration Number : 20210711-209-J-1062
Manufacturer Name : Interquim, SA
Manufacturer Address : Joan Buscallà 10 E-08173 Sant Cugat del Vallès (Barcelona), Spain
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39545
Submission : 2024-02-16
Status : Active
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12724
Submission : 1997-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27708
Submission : 2013-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39545
Submission : 2024-02-16
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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...
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...
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...
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 Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Citicoline Sodium
Dosage Form : Granules for Oral Solution
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Cambodia
Brand Name : BRALIN
Dosage Form : Injection
Dosage Strength : 500MG/4ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Cambodia
Regulatory Info : Generic
Registration Country : India
Brand Name : QUANIL
Dosage Form : TABLET
Dosage Strength : 1.5MG
Packaging : Sachet
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 250MG/ML
Packaging : 4ml Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : N-CITI 500
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name : CITXL
Dosage Form : TABLET
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info :
Registration Country : Spain
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Citicoline Sodium
Dosage Form : Granules for Oral Solu...
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Granules for Oral Solu...
Dosage Strength : 500MG
Brand Name : Citicoline Sodium
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
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
Packaging :
Regulatory Info : Generic
Cytidine Diphosphate Choline; Piracetam
Dosage : FILM COATED TABLET
Dosage Strength : 500MG; 800MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : ORAL SUSPENSION
Dosage Strength : 250
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : ORAL SUSPENSION
Dosage Strength : 250
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : TABLET
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : TABLET
Dosage Strength : 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 500MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name : QUANIL
Dosage Form : SOLUTION
Dosage Strength : 100MG/ML
Packaging : PET Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging : PET Bottle
Regulatory Info : Generic
Dosage : SOLUTION
Dosage Strength : 100MG/ML
Brand Name : QUANIL
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
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
Packaging : 2 ML, 4 ML
Regulatory Info :
Dosage : Liquid Injection
Dosage Strength : 250MG/ML
Brand Name : Citicoline
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : N-CITI PLUS
Dosage Form : Tablet
Dosage Strength : 500MG; 800MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 500MG; 800MG
Brand Name : N-CITI PLUS
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 1000MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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ABOUT THIS PAGE
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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.
A Citicoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citicoline, including repackagers and relabelers. The FDA regulates Citicoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citicoline 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Citicoline supplier is an individual or a company that provides Citicoline active pharmaceutical ingredient (API) or Citicoline finished formulations upon request. The Citicoline suppliers may include Citicoline API manufacturers, exporters, distributors and traders.
click here to find a list of Citicoline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Citicoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Citicoline active pharmaceutical ingredient (API) in detail. Different forms of Citicoline DMFs exist exist since differing nations have different regulations, such as Citicoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Citicoline DMF submitted to regulatory agencies in the US is known as a USDMF. Citicoline USDMF includes data on Citicoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Citicoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Citicoline suppliers with USDMF on PharmaCompass.
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 Drug Master File in Japan (Citicoline JDMF) empowers Citicoline 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Citicoline 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 suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Citicoline Drug Master File in Korea (Citicoline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Citicoline. The MFDS reviews the Citicoline KDMF as part of the drug registration process and uses the information provided in the Citicoline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Citicoline 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Citicoline suppliers with KDMF on PharmaCompass.
A Citicoline written confirmation (Citicoline WC) is an official document issued by a regulatory agency to a Citicoline manufacturer, verifying that the manufacturing facility of a Citicoline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Citicoline APIs or Citicoline finished pharmaceutical products to another nation, regulatory agencies frequently require a Citicoline WC (written confirmation) as part of the regulatory process.
click here to find a list of Citicoline suppliers with Written Confirmation (WC) on PharmaCompass.
Citicoline 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 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 GMP manufacturer or Citicoline GMP API supplier for your needs.
A Citicoline CoA (Certificate of Analysis) is a formal document that attests to Citicoline's compliance with Citicoline specifications and serves as a tool for batch-level quality control.
Citicoline CoA mostly includes findings from lab analyses of a specific batch. For each Citicoline 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Citicoline EP), Citicoline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Citicoline USP).
