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    Also known as: Compound sodium lactate solution, 72-17-3, Sodium dl-lactate, Lactic acid sodium salt, Monosodium lactate, Sodium 2-hydroxypropanoate
    Molecular Formula
    C3H5NaO3
    Molecular Weight
    112.06  g/mol
    InChI Key
    NGSFWBMYFKHRBD-UHFFFAOYSA-M
    FDA UNII
    TU7HW0W0QT
    Sodium Lactate
    The sodium salt of racemic or inactive lactic acid. It is a hygroscopic agent used intravenously as a systemic and urinary alkalizer.
    1 2D Structure

    Sodium Lactate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;2-hydroxypropanoate
    2.1.2 InChI
    InChI=1S/C3H6O3.Na/c1-2(4)3(5)6;/h2,4H,1H3,(H,5,6);/q;+1/p-1
    2.1.3 InChI Key
    NGSFWBMYFKHRBD-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    CC(C(=O)[O-])O.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    TU7HW0W0QT
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Lactate, Sodium

    2.3.2 Depositor-Supplied Synonyms

    1. Compound Sodium Lactate Solution

    2. 72-17-3

    3. Sodium Dl-lactate

    4. Lactic Acid Sodium Salt

    5. Monosodium Lactate

    6. Sodium 2-hydroxypropanoate

    7. Lacolin

    8. Per-glycerin

    9. Lactic Acid, Monosodium Salt

    10. Sodium Alpha-hydroxypropionate

    11. Monosodium 2-hydroxypropanoate

    12. Propanoic Acid, 2-hydroxy-, Monosodium Salt

    13. 312-85-6

    14. Sodium (dl)-lactate

    15. Ccris 7316

    16. Natrum Lacticum

    17. 2-hydroxypropanoic Acid, Monosodium Salt

    18. Compound Solution Of Sodium Lactate

    19. Dl-lactic Acid Sodium Salt

    20. Lactate (sodium)

    21. E325

    22. Ai3-03131

    23. Sodium Lactate Solution

    24. Tu7hw0w0qt

    25. Sodium (lactate) Anhydrous

    26. Ins No.325

    27. (+/-)-2-hydroxypropionic Acid Sodium Salt

    28. Chebi:75228

    29. Ins-325

    30. (2r)-2-hydroxypropanoate (sodium)

    31. Nsc-31718

    32. Compound Solution Of Sodium Lactate [inn]

    33. Dl-lactic Acid Sodium Salt, 60% W/w Syrup

    34. E-325

    35. Chembl1357

    36. Lactic Acid, Sodium Salt (van)

    37. Einecs 200-772-0

    38. Einecs 206-231-5

    39. Unii-tu7hw0w0qt

    40. Nsc 31718

    41. Sodium 2-hydroxypropionate

    42. Sodium Lactate [usp:jan]

    43. Mediject L

    44. Sodiumdl-lactate

    45. Sodium Lactate In Plastic Container

    46. Mediject L (tn)

    47. Mfcd00065400

    48. Purasal S/sp 60

    49. Sodium Lactate (7ci)

    50. Sodium2-hydroxypropanoate

    51. Sodium;2-hydroxypropanoate

    52. Sodium Dl-lactate Solution

    53. Ec 200-772-0

    54. Sodium Lactate 1/6 Molar In Plastic Container

    55. Schembl4360

    56. Sodium Lactate (jan/usp)

    57. Sodium Lactate [ii]

    58. Sodium Lactate [mi]

    59. Sodium Lactate 0.167 Molar In Plastic Container

    60. Sodium Lactate [jan]

    61. Sodium Lactate [inci]

    62. Natrum Lacticum [hpus]

    63. Sodium Lactate [vandf]

    64. Dtxsid6052829

    65. Sodium Lactate [usp-rs]

    66. Sodium Lactate [who-dd]

    67. Hy-b2227b

    68. Pharmakon1600-01300036

    69. 2-hydroxypropionic Acid Sodium Salt

    70. Sodium Lactate, (+/-)-

    71. Lactic Acid, Monosodium Salt (8ci)

    72. Nsc760108

    73. Sodium Lactate [orange Book]

    74. Sodium Lactate [usp Impurity]

    75. Sodium Lactate Solution [fcc]

    76. Akos015915154

    77. Lacolin And Dl-lactic Acid Sodium Salt

    78. Nsc-760108

    79. Sb44210

    80. Db-079226

    81. Cs-0030973

    82. E 325

    83. Ft-0656540

    84. Ft-0689056

    85. Ft-0771022

    86. S0928

    87. Sodium Dl-lactate, 60% W/w Aqueous Solution

    88. Sodium Lactate Solution [ep Monograph]

    89. D02183

    90. H11285

    91. Propanoic Acid, 2-hydroxy-, Sodium Salt (1:1)

    92. Q418235

    93. Propanoic Acid, 2-hydroxy-, Monosodium Salt (9ci)

    94. W-104498

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 112.06 g/mol
    Molecular Formula C3H5NaO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count1
    Exact Mass112.01363830 g/mol
    Monoisotopic Mass112.01363830 g/mol
    Topological Polar Surface Area60.4 Ų
    Heavy Atom Count7
    Formal Charge0
    Complexity63.2
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2

    API Reference Price

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AI2024-0050447 DT - 09.09.2024","address":"UNIT NO.514,5TH FLOOR, PALMSPRING","city":"MALAD(W) MUMBAI, MAHARASHTRA.","supplier":"PURAC THAILAND LTD","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"KRAEMER & MARTIN PHARMA HANDELS GMBH DE 47804 KREFELD","customerCountry":"INDIA","quantity":"5500.00","actualQuantity":"5500","unit":"KGS","unitRateFc":"1.7","totalValueFC":"9639.8","currency":"USD","unitRateINR":"146.9","date":"17-Sep-2024","totalValueINR":"807823.5","totalValueInUsd":"9639.8","indian_port":"JNPT","hs_no":"29181110","bill_no":"5649691","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"NO 3 MOO 2 ASIA INDUSTRIAL ESTATE, TAMBON BANCHANG, AMPHOE BANCHANG RA YONG 21130 Thailand","customerAddress":"UNIT NO.514,5TH FLOOR, PALMSPRING"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727721000,"product":"PURASAL S (SODIUM LACTATE) (FOR CAPTIVE CONSUMPTION)","address":"47TH MILESTONE DELHI JAIPUR HIGHWAY","city":"GURGAON , HARYANA","supplier":"PURAC ASIA PACIFIC ","supplierCountry":"THAILAND","foreign_port":"LAEM CHABANG","customer":"PERFETTI VAN MELLE ","customerCountry":"INDIA","quantity":"1100.00","actualQuantity":"1100","unit":"KGS","unitRateFc":"1.7","totalValueFC":"1860.6","currency":"USD","unitRateINR":"142.1","date":"01-Oct-2024","totalValueINR":"156340.8","totalValueInUsd":"1860.6","indian_port":"Delhi TKD ICD","hs_no":"29181110","bill_no":"5896660","productDescription":"API","marketType":"","country":"THAILAND","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"06-19 NORDIC EUROPEAN CENTRE 3 INTERNATIONAL BUSINESS PARK SDNF SDNF","customerAddress":"47TH MILESTONE DELHI JAIPUR HIGHWAY"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"SODIUM LACTATE SODIUM LACTATE","address":"1726\/205, RITCO RICE PALACE","city":"NEW DELHI","supplier":"HENAN JINDAN LACTIC ","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"JEECON FOODS PRIVATE ","customerCountry":"INDIA","quantity":"12000.00","actualQuantity":"12000","unit":"KGS","unitRateFc":"1.1","totalValueFC":"13352.4","currency":"USD","unitRateINR":"94.5","date":"31-Dec-2024","totalValueINR":"1134540","totalValueInUsd":"13352.4","indian_port":"Madras Sea","hs_no":"29181190","bill_no":"7551832","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"NO.8 JINDAN AVENUE, DANCHENG COUNTRY HENAN, CHINA 477150 CHINA","customerAddress":"1726\/205, RITCO RICE PALACE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741026600,"product":"SODIUM LACTATE + 2% SIO2 SODIUM LACTATE + 2% SIO2","address":"PLOT NO.26,2ND CROSS,JIGANI","city":"BANGALORE","supplier":"GIVAUDAN INTERNATIONAL SA","supplierCountry":"SPAIN","foreign_port":"ANTWERPEN","customer":"GIVAUDAN INDIA PRIVATE ","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"13.4","totalValueFC":"271.8","currency":"USD","unitRateINR":"1177","date":"04-Mar-2025","totalValueINR":"23540.2","totalValueInUsd":"271.8","indian_port":"JNPT","hs_no":"29181190","bill_no":"8692967","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"ANTWERPEN","supplierAddress":"CHEMIN DE LA PARFUMERIE 5 CH-1214 VERNIER SDNF SWITZERLAND","customerAddress":"PLOT NO.26,2ND CROSS,JIGANI"}]
    09-Feb-2021
    31-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 16682

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    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

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    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

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    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

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    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

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    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 17512

    read-more

    DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 17608

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    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML

    USFDA APPLICATION NUMBER - 18883

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 18883

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML

    USFDA APPLICATION NUMBER - 18883

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 18883

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML

    USFDA APPLICATION NUMBER - 18883

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 18883

    read-more

    DOSAGE - INJECTABLE;INJECTION - 5MEQ/ML

    USFDA APPLICATION NUMBER - 18947

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    DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30M...DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 19416

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    DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 19685

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    DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 19685

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    DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 19685

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    DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

    USFDA APPLICATION NUMBER - 19685

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20163

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20163

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20163

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20171

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20171

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20171

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20183

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20183

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20183

    read-more

    DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

    USFDA APPLICATION NUMBER - 20183

    read-more

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    ABOUT THIS PAGE

    Looking for 72-17-3 / Sodium Lactate API manufacturers, exporters & distributors?

    Sodium Lactate manufacturers, exporters & distributors 1

    100

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

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

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

    API | Excipient name

    Sodium Lactate

    Synonyms

    Compound sodium lactate solution, 72-17-3, Sodium dl-lactate, Lactic acid sodium salt, Monosodium lactate, Sodium 2-hydroxypropanoate

    Cas Number

    72-17-3

    Unique Ingredient Identifier (UNII)

    TU7HW0W0QT

    About Sodium Lactate

    The sodium salt of racemic or inactive lactic acid. It is a hygroscopic agent used intravenously as a systemic and urinary alkalizer.

    Lacolin Manufacturers

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

    Lacolin Suppliers

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

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

    Lacolin USDMF

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

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

    click here to find a list of Lacolin suppliers with USDMF on PharmaCompass.

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

    Lacolin CEP

    A Lacolin CEP of the European Pharmacopoeia monograph is often referred to as a Lacolin Certificate of Suitability (COS). The purpose of a Lacolin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lacolin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lacolin to their clients by showing that a Lacolin CEP has been issued for it. The manufacturer submits a Lacolin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lacolin CEP holder for the record. Additionally, the data presented in the Lacolin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lacolin DMF.

    A Lacolin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lacolin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Lacolin suppliers with CEP (COS) on PharmaCompass.

    Lacolin 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 Lacolin as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Lacolin 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 Lacolin 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 Lacolin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lacolin NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Lacolin suppliers with NDC on PharmaCompass.

    Lacolin GMP

    Lacolin 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 Lacolin 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 Lacolin GMP manufacturer or Lacolin GMP API supplier for your needs.

    Lacolin CoA

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

    Lacolin CoA mostly includes findings from lab analyses of a specific batch. For each Lacolin 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.

    Lacolin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lacolin EP), Lacolin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lacolin 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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