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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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12724
Submission : 1997-10-20
Status : Inactive
Type : II
Registration Number : 217MF10245
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27708
Submission : 2013-11-11
Status : Inactive
Type : II
Date of Issue : 2021-08-06
Valid Till : 2024-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0097
Address of the Firm :
Date of Issue : 2024-09-20
Valid Till : 2027-09-20
Written Confirmation Number : WC-592
Address of the Firm :
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
Japanese Pharmacopoeia Citicoline (for manufacturing only)
Registration Number : 217MF10245
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : 2017-04-14
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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INTERMEDIATES SUPPLIERS
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Regulatory Info :
Registration Country : Ukraine
Brand Name : Lira
Dosage Form : Oral Solution
Dosage Strength : 100MG/ML
Packaging : 30ML Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Ukraine
Brand Name : Lira
Dosage Form : Coated Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : TABLET
Dosage Strength : 500MG
Packaging : 20 Or 50 Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Spain
Brand Name : Citicoline Pensa 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
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Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Citicoline Kern Pharma 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 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
Regulatory Info :
Registration Country : Spain
Brand Name : Tecnigen 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
Regulatory Info :
Registration Country : Spain
Brand Name : Citicoline Mylan 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
Regulatory Info :
Registration Country : Spain
Brand Name : Citicoline Tarbis 100 Mg/Ml 30Ml Oral Solution Efg
Dosage Form : Oral Solution
Dosage Strength : 100MG/ML 30 ml/Oral Solution
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 10 Blisters Normon 500Mg 4Ml Solution For Injection Efg
Dosage Form : Solution For Injection
Dosage Strength : 500 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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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 Citicoline Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Citicoline Sodium API and other APIs are published in this directory by the FDA.
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 Citicoline Sodium 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.
The NDC directory also contains data on finished compounded human drug products that contain Citicoline Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Citicoline Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Citicoline Sodium suppliers with NDC on PharmaCompass.
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.
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).
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