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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 |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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
Date of Issue : 2025-08-08
Valid Till : 2028-08-07
Written Confirmation Number : WC-0617
Address of the Firm :
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 : 2024-05-29
Valid Till : 2027-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0097
Address of the Firm :
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0097
Address of the Firm :
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, ...
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...
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...
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
About the Company : SNJ Labs Pvt. Ltd., established in 2013, has rapidly emerged as India’s largest manufacturer of Iron Sucrose, achieving a production capacity of 120 MT per year within just five ...
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 : Established in 1995, Cadchem Laboratories Limited (CLL) has progressed into the field of developing and manufacturing niche Active Pharmaceutical Ingredients (API) and intermediate...
About the Company : Chemino Pharma’s goal is to be a top supply partner in the pharmaceutical industry with clear focus on quality, safety and affordability. The company manufactures APIs for both h...
About the Company : We are working in this business since last 14 years, supplying chemicals of all Grades & Quality to our valued customers in major Industries, entirely to their satisfaction and at ...
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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 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.
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 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).