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    Chemistry

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    Also known as: Choline ion, Bilineurine, 62-49-7, Choline cation, 2-hydroxy-n,n,n-trimethylethanaminium, Cholinum
    Molecular Formula
    C5H14NO+
    Molecular Weight
    104.17  g/mol
    InChI Key
    OEYIOHPDSNJKLS-UHFFFAOYSA-N
    FDA UNII
    N91BDP6H0X
    Choline
    A basic constituent of lecithin that is found in many plants and animal organs. It is important as a precursor of acetylcholine, as a methyl donor in various metabolic processes, and in lipid metabolism.
    1 2D Structure

    Choline

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-hydroxyethyl(trimethyl)azanium
    2.1.2 InChI
    InChI=1S/C5H14NO/c1-6(2,3)4-5-7/h7H,4-5H2,1-3H3/q+1
    2.1.3 InChI Key
    OEYIOHPDSNJKLS-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C[N+](C)(C)CCO
    2.2 Other Identifiers
    2.2.1 UNII
    N91BDP6H0X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-hydroxy-n,n,n-trimethylethanaminium

    2. Bitartrate, Choline

    3. Bursine

    4. Chloride, Choline

    5. Choline Bitartrate

    6. Choline Chloride

    7. Choline Citrate

    8. Choline Hydroxide

    9. Choline O Sulfate

    10. Choline O-sulfate

    11. Citrate, Choline

    12. Fagine

    13. Hydroxide, Choline

    14. O-sulfate, Choline

    15. Vidine

    2.3.2 Depositor-Supplied Synonyms

    1. Choline Ion

    2. Bilineurine

    3. 62-49-7

    4. Choline Cation

    5. 2-hydroxy-n,n,n-trimethylethanaminium

    6. Cholinum

    7. Ethanaminium, 2-hydroxy-n,n,n-trimethyl-

    8. (2-hydroxyethyl)trimethylammonium

    9. Trimethylethanolamine

    10. N-trimethylethanolamine

    11. Vitamin J

    12. 2-hydroxyethyl(trimethyl)azanium

    13. Ccris 5847

    14. Ai3-24208

    15. Brn 1736748

    16. N,n,n-trimethylethanol-ammonium

    17. Chebi:15354

    18. (beta-hydroxyethyl)trimethylammonium

    19. Chembl920

    20. N91bdp6h0x

    21. (2-hydroxyethyl)trimethylazanium

    22. 2-hydroxy-n,n,n-trimethyl-ethanaminium

    23. Bilineurine; Choline Cation; Choline Ion; Nanoveson C; Vitamin J

    24. Cht

    25. Nsc402838

    26. Ncgc00015219-03

    27. Einecs 200-535-1

    28. Unii-n91bdp6h0x

    29. 2-hydroxyethyl(trimethyl)ammonium

    30. 1oba

    31. 2reg

    32. 3ppq

    33. Choline (dcf)

    34. Choline (8ci)

    35. Nanoveson C

    36. Spectrum_000258

    37. 2ha3

    38. 3r6u

    39. Choline [vandf]

    40. Choline [mi]

    41. Spectrum2_001938

    42. Spectrum4_000867

    43. Spectrum5_001579

    44. Lopac-c-1754

    45. Choline [who-dd]

    46. Bmse000285

    47. Bmse000953

    48. Bmse001003

    49. Epitope Id:116046

    50. Schembl3142

    51. Lopac0_000180

    52. Kbiogr_001533

    53. Kbioss_000738

    54. 3-04-00-00651 (beilstein Handbook Reference)

    55. Divk1c_000107

    56. N,n,n-trimethylethanolammonium

    57. Spbio_001975

    58. Gtpl4551

    59. Dtxsid8043789

    60. Kbio1_000107

    61. Kbio2_000738

    62. Kbio2_003306

    63. Kbio2_005874

    64. Nsc6393

    65. Ninds_000107

    66. (2-hydroxyethyl)trimethyl Ammonium

    67. Mono-2-hydroxyethyltrimethylammonium

    68. Nsc-6393

    69. Zinc3079337

    70. Bbl005532

    71. Bdbm50026220

    72. Stl137772

    73. Akos005721137

    74. 2-hydroxyethyl)trimethylammonium

    75. Ccg-204275

    76. Db00122

    77. Idi1_000107

    78. Ncgc00015219-01

    79. Ncgc00015219-02

    80. Ncgc00015219-04

    81. Ncgc00015219-07

    82. Ncgc00015219-10

    83. Ncgc00162082-01

    84. Carbachol Impurity A [ep Impurity]

    85. Sbi-0050168.p003

    86. 2-hydroxy-n,n,n-trimethylammonium Chloride

    87. (.beta.-hydroxyethyl)trimethylammonium

    88. C00114

    89. D07690

    90. Ab00053822_02

    91. Ethanaminium, 2-hydroxy-n,n,n-trimethyl- (9ci)

    92. Q193166

    93. Acetylcholine Chloride Impurity A [ep Impurity]

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 104.17 g/mol
    Molecular Formula C5H14NO+
    XLogP3-0.4
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count2
    Exact Mass104.107539070 g/mol
    Monoisotopic Mass104.107539070 g/mol
    Topological Polar Surface Area20.2 Ų
    Heavy Atom Count7
    Formal Charge1
    Complexity46.5
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    For nutritional supplementation, also for treating dietary shortage or imbalance

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    This compound is needed for good nerve conduction throughout the CNS (central nervous system) as it is a precursor to acetylcholine (ACh). Choline is also needed for gallbladder regulation, liver function and lecithin (a key lipid) formation. Choline also aids in fat and cholesterol metabolism and prevents excessive fat build up in the liver. Choline has been used to mitigate the effects of Parkinsonism and tardive dyskinesia. Choline deficiencies may result in excessive build-up of fat in the liver, high blood pressure, gastric ulcers, kidney and liver dysfunction and stunted growth.

    5.2 MeSH Pharmacological Classification

    Lipotropic Agents

    Endogenous factors or drugs that increase the transport and metabolism of LIPIDS including the synthesis of LIPOPROTEINS by the LIVER and their uptake by extrahepatic tissues. (See all compounds classified as Lipotropic Agents.)

    Nootropic Agents

    Drugs used to specifically facilitate learning or memory, particularly to prevent the cognitive deficits associated with dementias. These drugs act by a variety of mechanisms. (See all compounds classified as Nootropic Agents.)

    5.3 Metabolism/Metabolites

    Choline has known human metabolites that include Trimethylazanium and acetaldehyde.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.4 Mechanism of Action

    Choline is a major part of the polar head group of phosphatidylcholine. Phosphatidylcholine's role in the maintenance of cell membrane integrity is vital to all of the basic biological processes: information flow, intracellular communication and bioenergetics. Inadequate choline intake would negatively affect all these processes. Choline is also a major part of another membrane phospholipid, sphingomyelin, also important for the maintenance of cell structure and function. It is noteworthy and not surprising that choline deficiency in cell culture causes apoptosis or programmed cell death. This appears to be due to abnormalities in cell membrane phosphatidylcholine content and an increase in ceramide, a precursor, as well as a metabolite, of sphingomyelin. Ceramide accumulation, which is caused by choline deficiency, appears to activate Caspase, a type of enzyme that mediates apoptosis. Betaine or trimethylglycine is derived from choline via an oxidation reaction. Betaine is one of the factors that maintains low levels of homocysteine by resynthesizing L-methionine from homocysteine. Elevated homocysteine levels are a significant risk factor for atherosclerosis, as well as other cardiovascular and neurological disorders. Acetylcholine is one of the major neurotransmitters and requires choline for its synthesis. Adequate acetylcholine levels in the brain are believed to be protective against certain types of dementia, including Alzheimer's disease.

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INDIA.","supplier":"LIPOID AG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ACULIFE HEALTHCARE PRIVATE LTD","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"193","totalValueFC":"86212.8","currency":"EURO","unitRateINR":"18313.5","date":"21-Dec-2024","totalValueINR":"7325413.35","totalValueInUsd":"86212.8","indian_port":"Ahmedabad Air","hs_no":"29232090","bill_no":"7372076","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"SENNWEIDSTRASSE 44 CH-6312 STEINHAUSEN SWITZERLAND","customerAddress":"COMMERCE HOUSE V,BESIDES VODAFONE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736101800,"product":"CHOLINE CHLORIDE CHOLINE CHLORIDE","address":"11TH FLOOR, BILDING 8-C,","city":"GURGAON, HARYANA","supplier":"KIRSCH PHARMA GMBH","supplierCountry":"CHINA","foreign_port":"BREMERHAVEN","customer":"NUTRICIA INTERNATIONAL PRIVATE LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"17.9","totalValueFC":"8967.3","currency":"EURO","unitRateINR":"1546.5","date":"06-Jan-2025","totalValueINR":"773244.5","totalValueInUsd":"8967.3","indian_port":"JNPT","hs_no":"29231000","bill_no":"7636169","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BREMERHAVEN","supplierAddress":"ERZWAESCHE 2 D-38229 SALZGITTER SDNF SDNF Germany","customerAddress":"11TH FLOOR, BILDING 8-C,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736879400,"product":"CYTIDINE DIPHOSPHATE CHOLINE HYDROCHLORIDE HYDROCHLORIIDE","address":"1568\/8","city":"DELHI","supplier":"APELOA HONGKONG LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PHARMCHEM","customerCountry":"INDIA","quantity":"700.00","actualQuantity":"700","unit":"KGS","unitRateFc":"74","totalValueFC":"52022.8","currency":"USD","unitRateINR":"6408.4","date":"15-Jan-2025","totalValueINR":"4485880","totalValueInUsd":"52022.8","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"7802645","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"FLAT\/RM 2914, 29F HO KING COMMERCIA L CENTRE, 2-16 FA YUEN STREET, MONGKOK KL SDNF","customerAddress":"1568\/8"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738780200,"product":"ALCOLEC H PC 85 - LIPOID H 85 (PHOSPHATIDYLCHOLINE) (SUNFLOWER LECITHIN CONCENTRATE)ALCOLEC H PC 90 - LIPOID H 90 (PHOSPHATIDYLCHOLINE) (SUNFLOW","address":"RANCHOD KRUPA DHARMAJ","city":"","supplier":"VERDURE SCIENCESINC","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"PHARMANZA HERBAL PRIVATE LTD","customerCountry":"INDIA","quantity":"90.00","actualQuantity":"90","unit":"KGS","unitRateFc":"308.9","totalValueFC":"27844.5","currency":"USD","unitRateINR":"26905.2","date":"06-Feb-2025","totalValueINR":"2421467.1","totalValueInUsd":"27844.5","indian_port":"Bombay Air","hs_no":"29232090","bill_no":"8198326","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"17150 METRO PARK CT NOBLESVILLE, IN 46060 SDNF UNITED STATES","customerAddress":"RANCHOD KRUPA DHARMAJ"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741199400,"product":"CHOLINE BITARTRATE CONDITIONED","address":"EI-362-363-364 SITAPURA INDL. AREA,","city":"JAIPUR","supplier":"JUBILANT INGREVIA LTD SEZUNIT 1","supplierCountry":"INDIA","foreign_port":"JUBILANT\/SEZ\/VILAYAT","customer":"AMOL PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"5.3","totalValueFC":"5391.3","currency":"USD","unitRateINR":"467","date":"06-Mar-2025","totalValueINR":"466980","totalValueInUsd":"5391.3","indian_port":"JUBILANT-CHEMICAL-SEZ\/VILAYAT","hs_no":"29231000","bill_no":"8724640","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JUBILANT\/SEZ\/VILAYAT","supplierAddress":"Plot No. P1-L1,, Within Jubilant SE AT PLOT NO. 5, VILAYAT GIDC SDNF India","customerAddress":"EI-362-363-364 SITAPURA INDL. AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745173800,"product":"4-AMINO-2-CARBONYL PYRIMIDINE-1-?-D-RIBOFURANOSIDE-5\\'-DIPHOSPHATE CHOLINE4-AMINO-2-CARBONYL PYRIMIDINE-1-?-D-RIBOFURANOSIDE-5\\'-DIPHOS","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"XINXIANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"SOLARA ACTIVE PHARMA SCIENCES LTD","customerCountry":"INDIA","quantity":"1750.00","actualQuantity":"1750","unit":"KGS","unitRateFc":"74.5","totalValueFC":"131590.7","currency":"USD","unitRateINR":"6436.8","date":"21-Apr-2025","totalValueINR":"11264400","totalValueInUsd":"131590.7","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9620364","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.16,JIANWEN ROAD,NORTH DISTRICT,I NDUSTRIAL CLUSTER ZONE,YANJIN COUNT Y,XINXIANG CITY,HENAN China","customerAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748370600,"product":"LIPOID P 20 [FATFREE SOYBEAN LECITHIN WITH 20 % PHOSPHATIDYLCHOLINE (NON-GMO),E 322]LIPOID P 20 [FATFREE SOYBEAN LECITHIN WITH 20 % PHOSPHATIDYL","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"LIPOID AG","supplierCountry":"GERMANY","foreign_port":"MANNHEIM","customer":"EMCURE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"85.7","totalValueFC":"1738","currency":"USD","unitRateINR":"7404","date":"28-May-2025","totalValueINR":"148080.9","totalValueInUsd":"1738","indian_port":"Bombay Air","hs_no":"29232090","bill_no":"2331698","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"MANNHEIM","supplierAddress":"SENWEIDSTR. 44, CH-6312, STEINHAUSE N, SWITZERLAND , , Germany SDNF Switzerland","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748975400,"product":"4-AMINO-2-CARBONYL PYRIMIDINE-1-B-D- RIBOFURANOSIDE -5\\'- DIPHOSPHATE CHOLINE4-AMINO-2-CARBONYL PYRIMIDINE-1-B-D- RIBOFURANOSIDE -5\\'- DIP","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"XINXIANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SOLARA ACTIVE PHARMA SCIENCES LTD","customerCountry":"INDIA","quantity":"5100.00","actualQuantity":"5100","unit":"KGS","unitRateFc":"72.5","totalValueFC":"371792.2","currency":"USD","unitRateINR":"6264","date":"04-Jun-2025","totalValueINR":"31946400","totalValueInUsd":"371792.2","indian_port":"Madras Sea","hs_no":"29339990","bill_no":"2461528","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO. 16, JIANWENROAD, NORTH DISTRICT , INDUSTRIAL CLUSTER ZONE, YANJIN C OUNTY, XINXIANG CITY, HENAN, CHINA","customerAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750617000,"product":"CHOLINE BITARTRATE CONDITIONED","address":"EI-362-363-364 SITAPURA INDL. AREA,","city":"JAIPUR","supplier":"JUBILANT INGREVIA LTD SEZUNIT 1","supplierCountry":"INDIA","foreign_port":"JUBILANT\/SEZ\/VILAYAT","customer":"AMOL PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"5.4","totalValueFC":"8298.7","currency":"USD","unitRateINR":"475.4","date":"23-Jun-2025","totalValueINR":"713070","totalValueInUsd":"8298.7","indian_port":"JUBILANT-CHEMICAL-SEZ\/VILAYAT","hs_no":"29231000","bill_no":"2821309","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JUBILANT\/SEZ\/VILAYAT","supplierAddress":"Plot No. P1-L1,, Within Jubilant SE AT PLOT NO. 5, VILAYAT GIDC SDNF India","customerAddress":"EI-362-363-364 SITAPURA INDL. AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1759084200,"product":"IUPAC EGG PHOSPHOLIPIDS WITH 80% PHOSPHATIDYLCHOLINE(INTERME36 DIATE) 510300 BATCH NO:510300-2254669IUPAC EGG PHOSPHOLIPIDS WITH 80% PHOSPHATIDYLCHOLINE(INTERME","address":"SCO.162-64, SECTOR 34-A,","city":"CHANDIGARH.","supplier":"LIPOID AG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"HEALTH BIOTECH LTD","customerCountry":"INDIA","quantity":"1.30","actualQuantity":"1.3","unit":"KGS","unitRateFc":"252.9","totalValueFC":"330.9","currency":"EURO","unitRateINR":"22469.3","date":"29-Sep-2025","totalValueINR":"29210.14","totalValueInUsd":"330.9","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"4815643","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"SENNWEIDSTRASSE 44 CH-6312 STEINHAU SEN SDNF GERMANY","customerAddress":"SCO.162-64, SECTOR 34-A,"}]
    24-Jan-2022
    29-Sep-2025
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    ABOUT THIS PAGE

    Looking for 62-49-7 / Choline API manufacturers, exporters & distributors?

    Choline manufacturers, exporters & distributors 1

    22

    PharmaCompass offers a list of Choline 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 Choline manufacturer or Choline supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Choline manufacturer or Choline supplier.

    PharmaCompass also assists you with knowing the Choline API Price utilized in the formulation of products. Choline API Price is not always fixed or binding as the Choline Price is obtained through a variety of data sources. The Choline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Choline

    Synonyms

    Choline ion, Bilineurine, 62-49-7, Choline cation, 2-hydroxy-n,n,n-trimethylethanaminium, Cholinum

    Cas Number

    62-49-7

    Unique Ingredient Identifier (UNII)

    N91BDP6H0X

    About Choline

    A basic constituent of lecithin that is found in many plants and animal organs. It is important as a precursor of acetylcholine, as a methyl donor in various metabolic processes, and in lipid metabolism.

    Choline C-11 Manufacturers

    A Choline C-11 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline C-11, including repackagers and relabelers. The FDA regulates Choline C-11 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline C-11 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 C-11 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Choline C-11 Suppliers

    A Choline C-11 supplier is an individual or a company that provides Choline C-11 active pharmaceutical ingredient (API) or Choline C-11 finished formulations upon request. The Choline C-11 suppliers may include Choline C-11 API manufacturers, exporters, distributors and traders.

    click here to find a list of Choline C-11 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Choline C-11 USDMF

    A Choline C-11 DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline C-11 active pharmaceutical ingredient (API) in detail. Different forms of Choline C-11 DMFs exist exist since differing nations have different regulations, such as Choline C-11 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Choline C-11 DMF submitted to regulatory agencies in the US is known as a USDMF. Choline C-11 USDMF includes data on Choline C-11's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline C-11 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Choline C-11 suppliers with USDMF on PharmaCompass.

    Choline C-11 JDMF

    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 Choline C-11 Drug Master File in Japan (Choline C-11 JDMF) empowers Choline C-11 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 Choline C-11 JDMF during the approval evaluation for pharmaceutical products. At the time of Choline C-11 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 Choline C-11 suppliers with JDMF on PharmaCompass.

    Choline C-11 KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Choline C-11 Drug Master File in Korea (Choline C-11 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Choline C-11. The MFDS reviews the Choline C-11 KDMF as part of the drug registration process and uses the information provided in the Choline C-11 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Choline C-11 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 C-11 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Choline C-11 suppliers with KDMF on PharmaCompass.

    Choline C-11 WC

    A Choline C-11 written confirmation (Choline C-11 WC) is an official document issued by a regulatory agency to a Choline C-11 manufacturer, verifying that the manufacturing facility of a Choline C-11 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Choline C-11 APIs or Choline C-11 finished pharmaceutical products to another nation, regulatory agencies frequently require a Choline C-11 WC (written confirmation) as part of the regulatory process.

    click here to find a list of Choline C-11 suppliers with Written Confirmation (WC) on PharmaCompass.

    Choline C-11 NDC

    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 C-11 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Choline C-11 API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 C-11 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Choline C-11 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Choline C-11 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Choline C-11 suppliers with NDC on PharmaCompass.

    Choline C-11 GMP

    Choline C-11 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 C-11 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 C-11 GMP manufacturer or Choline C-11 GMP API supplier for your needs.

    Choline C-11 CoA

    A Choline C-11 CoA (Certificate of Analysis) is a formal document that attests to Choline C-11's compliance with Choline C-11 specifications and serves as a tool for batch-level quality control.

    Choline C-11 CoA mostly includes findings from lab analyses of a specific batch. For each Choline C-11 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 C-11 may be tested according to a variety of international standards, such as European Pharmacopoeia (Choline C-11 EP), Choline C-11 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Choline C-11 USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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