Synopsis
Synopsis
0
CEP/COS
0
VMF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.
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.
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 : 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 :
Date of Issue : 2024-09-20
Valid Till : 2027-09-20
Written Confirmation Number : WC-592
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 : 2022-12-30
Valid Till : 2025-12-30
Written Confirmation Number : WC-0545
Address of the Firm :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
About the Company : Atomgrid is a global company that specializes in the manufacturing and sourcing of specialty chemicals. The company manages end-to-end manufacturing and sourcing needs, covering R&...
About the Company : Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulousness. Bajaj Healt...
About the Company : Cerata Pharmaceuticals LLP was established by Mr. Pratik Kansara and Mr. Darshan with a grand vision of being the “most preferred supply partner to pharmaceutical customers world...
About the Company : Kimia Biosciences, established in 1993, is focused on manufacturing bulk drugs for various therapeutic segments. With a strong emphasis on excellence and advanced technologies, Kim...
About the Company : Rakshit is an integrated API manufacturing company. Established in 2000. Today Rakshit has emerged a dependable and strong manufacturer of key APIs & intermediates for global marke...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
APIs
Reply
18 Mar 2025
Reply
27 Mar 2024
Reply
05 Mar 2024
Reply
09 Nov 2023
Reply
31 Oct 2023
Reply
19 Oct 2023
Reply
09 Oct 2023
Reply
18 Sep 2023
Reply
10 Jun 2023
Reply
08 May 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FDF DOSSIERS
Reply
18 Apr 2024
Reply
21 Oct 2023
Reply
28 Apr 2023
Reply
11 Mar 2023
Reply
29 Sep 2021
Reply
23 Sep 2021
Reply
28 Jun 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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.
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).
Comment (1)
