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1. 2-[[(2r)-2,3-dihydroxypropoxy]-hydroxyphosphoryl]oxyethyl-trimethylazanium
2. [(2r)-2,3-dihydroxypropoxy][2-(trimethylazaniumyl)ethoxy]phosphinic Acid
3. Ch5
4. Glycero-3-phosphocholine
5. Choline-alfoscerate
6. Schembl157824
7. O-(l-glycero-3-phospho)choline
8. Zinc1532714
9. S4972
10. C00670
11. A929212
12. Q27458810
13. 2-{[(s)-{[(2r)-2,3-dihydroxypropyl]oxy}(hydroxy)phosphoryl]oxy}-n,n,n-trimethylethanaminium
| Molecular Weight | 258.23 g/mol |
|---|---|
| Molecular Formula | C8H21NO6P+ |
| XLogP3 | -2.3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 8 |
| Exact Mass | 258.11064939 g/mol |
| Monoisotopic Mass | 258.11064939 g/mol |
| Topological Polar Surface Area | 96.2 Ų |
| Heavy Atom Count | 16 |
| Formal Charge | 1 |
| Complexity | 241 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16614
Submission : 2003-05-22
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32550
Submission : 2018-02-10
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32551
Submission : 2018-02-10
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23645
Submission : 2010-03-15
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29128
Submission : 2015-03-02
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8691
Submission : 1990-08-03
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8817
Submission : 1990-11-06
Status : Inactive
Type : II

Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2018-06-04
Registration Number : 20180604-168-I-551-22
Manufacturer Name : Estek Pharma Co., Ltd. @ [Product Manufacturer] Zhejiang Warrant Pharmaceutical Co., Ltd
Manufacturer Address : 25, Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do (No. 10-11, Block 34, Balan Industrial Complex) @ No. 4290 Xingbin Road, Binhai Industry Zone, Keqiao District, Shaoxing City, Zhejiang Province, China

Date of Issue : 2024-03-21
Valid Till : 2026-02-08
Written Confirmation Number : WC-0479
Address of the Firm :

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LECIVA-GPCH-L-alpha-Glycerylphosphorylcholine USP-NF
Date of Issue : 2024-03-21
Valid Till : 2026-08-02
Written Confirmation Number : WC-479
Address of the Firm : Plot no. C-76 Mirjole Ind. Estate, Ratnagiri MIDC, Ratnagiri - 415639, Maharastr...

LECIVA-GPCH-L-alpha-Glycerylphosphorylcholine USP-NF
Date of Issue : 2024-03-21
Valid Till : 2026-02-08
Written Confirmation Number : WC-0479
Address of the Firm : Plot no. C-76 Mirjole Ind. Estate, Ratnagiri MIDC, Ratnagiri - 415639, Maharastr...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
About the Company : We provide quality products and services, consistently, reliably responsibly and continuously applying some of the world’s most difficult to handle chemical technologies. Synth...

About the Company : Hunan Warrant Pharmaceutical Co., Ltd. is a high-tech joint-stock company founded in 2001. With 3 production bases and 2 R&D center, which is engaged in manufacture & supply of API...

About the Company : Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and op...

About the Company : Samhwa Biopharm Co., Ltd. is a South Korean pharmaceutical company specializing in the development and production of active pharmaceutical ingredients (APIs), excipients, and inter...

About the Company : Benepure is a global research, manufacture and supplier of ingredients and their derivatives for healthcare industry. It owns strong research and development team, cutting-edge equ...

About the Company : Further Pharmaceutical (www.further-pharm.com) is an innovation-driven and service-oriented biopharmaceutical company with global operations that develops and manufactures specialt...

About the Company : Xi'an Tian Guangyuan Biotech is a professional company engaged in natural plant extracts, bio-chemical raw materials research and development, production and sale of high-tech tech...

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Details:
Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Alzheimer Disease.
Lead Product(s): Choline Alfoscerate,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 20, 2022

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Lead Product(s) : Choline Alfoscerate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of ChOline ALfoscerate in Patient With Mild to Moderate Alzheimer's Disease
Details : Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Alzheimer Disease.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 20, 2022

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Details:
Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Vascular Cognitive Impairment.
Lead Product(s): Choline Alfoscerate,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Choline Alfoscerate Re-evaluation Consortium
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 20, 2021

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Lead Product(s) : Choline Alfoscerate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Choline Alfoscerate Re-evaluation Consortium
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Vascular Cognitive Impairment.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 20, 2021

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Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Cognitive Dysfunction.
Lead Product(s): Choline Alfoscerate,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Choline Alfoscerate Re-evaluation Consortium
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 13, 2021

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Lead Product(s) : Choline Alfoscerate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Choline Alfoscerate Re-evaluation Consortium
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Cognitive Dysfunction.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 13, 2021

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Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Alzheimer Disease.
Lead Product(s): Choline Alfoscerate,Donepezil
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2018

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Lead Product(s) : Choline Alfoscerate,Donepezil
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
Details : Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Alzheimer Disease.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 22, 2018

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Alzheimer Disease.
Lead Product(s): Choline Alfoscerate,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 07, 2016

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Lead Product(s) : Choline Alfoscerate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Choline Alfoscerate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Alzheimer Disease.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 07, 2016

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
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PharmaCompass offers a list of Glycerylphosphorylcholine 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 Glycerylphosphorylcholine manufacturer or Glycerylphosphorylcholine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glycerylphosphorylcholine manufacturer or Glycerylphosphorylcholine supplier.
PharmaCompass also assists you with knowing the Glycerylphosphorylcholine API Price utilized in the formulation of products. Glycerylphosphorylcholine API Price is not always fixed or binding as the Glycerylphosphorylcholine Price is obtained through a variety of data sources. The Glycerylphosphorylcholine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Choline Alfoscerate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline Alfoscerate, including repackagers and relabelers. The FDA regulates Choline Alfoscerate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline Alfoscerate 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 Choline Alfoscerate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Choline Alfoscerate supplier is an individual or a company that provides Choline Alfoscerate active pharmaceutical ingredient (API) or Choline Alfoscerate finished formulations upon request. The Choline Alfoscerate suppliers may include Choline Alfoscerate API manufacturers, exporters, distributors and traders.
click here to find a list of Choline Alfoscerate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Choline Alfoscerate DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline Alfoscerate active pharmaceutical ingredient (API) in detail. Different forms of Choline Alfoscerate DMFs exist exist since differing nations have different regulations, such as Choline Alfoscerate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Choline Alfoscerate DMF submitted to regulatory agencies in the US is known as a USDMF. Choline Alfoscerate USDMF includes data on Choline Alfoscerate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline Alfoscerate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Choline Alfoscerate suppliers with USDMF 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 Choline Alfoscerate Drug Master File in Korea (Choline Alfoscerate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Choline Alfoscerate. The MFDS reviews the Choline Alfoscerate KDMF as part of the drug registration process and uses the information provided in the Choline Alfoscerate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Choline Alfoscerate 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 Choline Alfoscerate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Choline Alfoscerate suppliers with KDMF on PharmaCompass.
A Choline Alfoscerate written confirmation (Choline Alfoscerate WC) is an official document issued by a regulatory agency to a Choline Alfoscerate manufacturer, verifying that the manufacturing facility of a Choline Alfoscerate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Choline Alfoscerate APIs or Choline Alfoscerate finished pharmaceutical products to another nation, regulatory agencies frequently require a Choline Alfoscerate WC (written confirmation) as part of the regulatory process.
click here to find a list of Choline Alfoscerate 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 Choline Alfoscerate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Choline Alfoscerate 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 Choline Alfoscerate 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 Choline Alfoscerate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Choline Alfoscerate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Choline Alfoscerate suppliers with NDC on PharmaCompass.
Choline Alfoscerate 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 Choline Alfoscerate 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 Choline Alfoscerate GMP manufacturer or Choline Alfoscerate GMP API supplier for your needs.
A Choline Alfoscerate CoA (Certificate of Analysis) is a formal document that attests to Choline Alfoscerate's compliance with Choline Alfoscerate specifications and serves as a tool for batch-level quality control.
Choline Alfoscerate CoA mostly includes findings from lab analyses of a specific batch. For each Choline Alfoscerate 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.
Choline Alfoscerate may be tested according to a variety of international standards, such as European Pharmacopoeia (Choline Alfoscerate EP), Choline Alfoscerate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Choline Alfoscerate USP).