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    Chemistry

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    Also known as: 73-78-9, Lidocaine hcl, Lidothesin, Xyloneural, Lignocaine hydrochloride, Lidocaine (hydrochloride)
    Molecular Formula
    C14H23ClN2O
    Molecular Weight
    270.80  g/mol
    InChI Key
    IYBQHJMYDGVZRY-UHFFFAOYSA-N
    FDA UNII
    EC2CNF7XFP
    Lidocaine Hydrochloride
    A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.
    1 2D Structure

    Lidocaine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C14H22N2O.ClH/c1-5-16(6-2)10-13(17)15-14-11(3)8-7-9-12(14)4;/h7-9H,5-6,10H2,1-4H3,(H,15,17);1H
    2.1.3 InChI Key
    IYBQHJMYDGVZRY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCN(CC)CC(=O)NC1=C(C=CC=C1C)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    EC2CNF7XFP
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide

    2. 2-2etn-2mephacn

    3. Dalcaine

    4. Lidocaine

    5. Lidocaine Carbonate

    6. Lidocaine Carbonate (2:1)

    7. Lidocaine Hydrocarbonate

    8. Lidocaine Monoacetate

    9. Lidocaine Monohydrochloride

    10. Lidocaine Monohydrochloride, Monohydrate

    11. Lidocaine Sulfate (1:1)

    12. Octocaine

    13. Xylesthesin

    14. Xylocaine

    15. Xylocitin

    16. Xyloneural

    2.3.2 Depositor-Supplied Synonyms

    1. 73-78-9

    2. Lidocaine Hcl

    3. Lidothesin

    4. Xyloneural

    5. Lignocaine Hydrochloride

    6. Lidocaine (hydrochloride)

    7. Lidocaton

    8. Xylocard

    9. Lidocaine Hydrochloride Anhydrous

    10. Lidopen

    11. Acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl)-, Monohydrochloride

    12. Lta Ii Kit

    13. Laryng-o-jet Kit

    14. Ec2cnf7xfp

    15. Linocaine Hydrochloride

    16. Mls000069665

    17. Laryngotracheal Anesthesia Kit

    18. 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide Hydrochloride

    19. 2-diethylamino-2',6'-acetoxylidide Hydrochloride

    20. Alphacaine Hydrochloride

    21. Nsc-757420

    22. Smr000058468

    23. Xylocaine (tn)

    24. Alpha-diethylamino-2,6-acetoxylidine Hydrochloride

    25. Laryng-o-jet

    26. Omega-diethylamino-2,6-dimethylacetanilide Hydrochloride

    27. Xilina Hydrochloride

    28. 73-78-9 (hcl); 6108-05-0 (monohydrate)

    29. Rucaina Hydrochloride

    30. Xycaine Hydrochloride

    31. Xylotox Hydrochloride

    32. Duncaine Hydrochloride

    33. Isicaine Hydrochloride

    34. Lidocain Hydrochloride

    35. Anestacon Hydrochloride

    36. Gravocain Hydrochloride

    37. Leostesin Hydrochloride

    38. Xylocitin Hydrochloride

    39. Lidothesin Hydrochloride

    40. Xylestesin Hydrochloride

    41. Glydo

    42. Lidocaine Viscous

    43. Pediatric Lta Kit

    44. Chebi:50512

    45. Xylocaine Preservative Free

    46. Sr-01000000189

    47. Unii-ec2cnf7xfp

    48. Einecs 200-803-8

    49. Xylocaine 4% Preservative Free

    50. Xylocaine 5% W/ Glucose 7.5%

    51. Lidocaine Hydrochloride Viscous

    52. S 202

    53. V 262

    54. Xylocaine 1.5% W/ Dextrose 7.5%

    55. Dalcaine (tn)

    56. Prestwick_296

    57. N-(diethylaminoacetyl)-2,6-dimethylaniline Hydrochloride

    58. Lidoca Ne Hydrochloride

    59. Lidocaine Hydrochloride Preservative Free

    60. Opera_id_351

    61. Lidocaine Hydrochloride In Plastic Container

    62. Lidocaine Hydrochloride 0.2% In Dextrose 5%

    63. Lidocaine Hydrochloride 0.4% In Dextrose 5%

    64. Lidocaine Hydrochloride 5% And Dextrose 7.5%

    65. Spectrum1500689

    66. Chembl541521

    67. Dtxsid4058782

    68. Hy-b0185a

    69. 2',6'-acetoxylidide, 2-(diethylamino)-, Monohydrochloride

    70. Hms1568i21

    71. Hms1921c22

    72. Lidocaine Hydrochloride Preservative Free In Plastic Container

    73. Pharmakon1600-01500689

    74. Lidocaine Hydrochloride (jan/usp)

    75. 2',6'-acetoxylidide, 2-(diethylamino)-, Hydrochloride

    76. Bcp30473

    77. Lidocaine Hydrochloride 0.2% In Dextrose 5% In Plastic Container

    78. Lidocaine Hydrochloride 0.4% In Dextrose 5% In Plastic Container

    79. Lidocaine Hydrochloride 0.8% In Dextrose 5% In Plastic Container

    80. Tox21_500669

    81. Ccg-39281

    82. Lidocaine Hydrochloride [jan]

    83. Lidocaine Hydrochloride 0.1% And Dextrose 5% In Plastic Container

    84. Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container

    85. Lidocaine Hydrochloride 0.4% And Dextrose 5% In Plastic Container

    86. Lidocaine Hydrochloride 0.8% And Dextrose 5% In Plastic Container

    87. Nsc757420

    88. S4667

    89. (unlabeled)lidocaine-d6 Hydrochloride

    90. Akos015889456

    91. Cs-3888

    92. Lp00669

    93. Nsc 757420

    94. Sb19119

    95. Anhydrous Lidocaine Hydrochloride

    96. Lidocaine Hydrochloride [who-dd]

    97. Ncgc00094030-01

    98. Ncgc00094030-02

    99. Ncgc00094030-03

    100. Ncgc00094030-04

    101. Ncgc00094030-05

    102. Ncgc00261354-01

    103. Ac-11712

    104. As-35171

    105. Eu-0100669

    106. Lignocaine Hydrochloride Pound>>lidocaine Hcl

    107. A16132

    108. D02086

    109. L 5647

    110. Lidocaine Hydrochloride Anhydrous [mart.]

    111. A837924

    112. Q-201304

    113. Sr-01000000189-3

    114. Sr-01000000189-9

    115. Q27122094

    116. 2-(diethylamino)-2',6'-acetoxylidide Monohydrochloride

    117. 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide;hydrochloride

    118. 2-(diethylamino)-n-(2,6-dimethylphenyl)ethanamide Hydrochloride

    119. Acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl)-, Hydrochloride (1:1)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 270.80 g/mol
    Molecular Formula C14H23ClN2O
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count5
    Exact Mass270.1498911 g/mol
    Monoisotopic Mass270.1498911 g/mol
    Topological Polar Surface Area32.3 Ų
    Heavy Atom Count18
    Formal Charge0
    Complexity228
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 18  
    Drug NameLaryng-o-jet kit
    Drug LabelDESCRIPTIONLidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is che...
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteTopical
    Strength4%
    Market StatusPrescription
    CompanyIntl Medication

    2 of 18  
    Drug NameLidocaine hydrochloride
    Active IngredientLidocaine hydrochloride
    Dosage FormJelly; Injectable; Solution
    RouteInjection; Oral; Topical
    Strength0.5%; 1%; 20%; 2%; 4%
    Market StatusPrescription
    CompanyWockhardt; Igi Labs; Hospira; Roxane; Watson Labs; Intl Medication; Hi Tech Pharma; Vintage; Luitpold; Agila Speclts; Akorn

    3 of 18  
    Drug NameLidocaine hydrochloride in plastic container
    Drug LabelEach mL contains:Lidocaine Hydrochloride . . . . . . . . . . 20 mg (2%)Inactive ingredients: flavoring, methylparaben, propylparaben, sodium carboxymethylcellulose, and sodium saccharin in an aqueous solution.Lidocaine Viscous (Lidocaine Hydrochlorid...
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength0.5%; 1%; 2%
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Usa

    4 of 18  
    Drug NameLidocaine hydrochloride preservative free
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1%; 20%; 1.5%; 2%; 4%
    Market StatusPrescription
    CompanyHospira; Aurobindo Pharma; Intl Medication; Fresenius Kabi Usa; Agila Speclts

    5 of 18  
    Drug NameLidocaine hydrochloride preservative free in plastic container
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1%; 2%
    Market StatusPrescription
    CompanyHospira

    6 of 18  
    Drug NameLidocaine hydrochloride viscous
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteOral
    Strength2%
    Market StatusPrescription
    CompanyVintage

    7 of 18  
    Drug NameLidocaine viscous
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteOral
    Strength2%
    Market StatusPrescription
    CompanyRoxane

    8 of 18  
    Drug NameLta ii kit
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteTopical
    Strength4%
    Market StatusPrescription
    CompanyHospira

    9 of 18  
    Drug NameXylocaine preservative free
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1%; 20%; 2%; 4%
    Market StatusPrescription
    CompanyFresenius Kabi Usa

    10 of 18  
    Drug NameLaryng-o-jet kit
    Drug LabelDESCRIPTIONLidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is che...
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteTopical
    Strength4%
    Market StatusPrescription
    CompanyIntl Medication

    11 of 18  
    Drug NameLidocaine hydrochloride
    Active IngredientLidocaine hydrochloride
    Dosage FormJelly; Injectable; Solution
    RouteInjection; Oral; Topical
    Strength0.5%; 1%; 20%; 2%; 4%
    Market StatusPrescription
    CompanyWockhardt; Igi Labs; Hospira; Roxane; Watson Labs; Intl Medication; Hi Tech Pharma; Vintage; Luitpold; Agila Speclts; Akorn

    12 of 18  
    Drug NameLidocaine hydrochloride in plastic container
    Drug LabelEach mL contains:Lidocaine Hydrochloride . . . . . . . . . . 20 mg (2%)Inactive ingredients: flavoring, methylparaben, propylparaben, sodium carboxymethylcellulose, and sodium saccharin in an aqueous solution.Lidocaine Viscous (Lidocaine Hydrochlorid...
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength0.5%; 1%; 2%
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Usa

    13 of 18  
    Drug NameLidocaine hydrochloride preservative free
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1%; 20%; 1.5%; 2%; 4%
    Market StatusPrescription
    CompanyHospira; Aurobindo Pharma; Intl Medication; Fresenius Kabi Usa; Agila Speclts

    14 of 18  
    Drug NameLidocaine hydrochloride preservative free in plastic container
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1%; 2%
    Market StatusPrescription
    CompanyHospira

    15 of 18  
    Drug NameLidocaine hydrochloride viscous
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteOral
    Strength2%
    Market StatusPrescription
    CompanyVintage

    16 of 18  
    Drug NameLidocaine viscous
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteOral
    Strength2%
    Market StatusPrescription
    CompanyRoxane

    17 of 18  
    Drug NameLta ii kit
    Active IngredientLidocaine hydrochloride
    Dosage FormSolution
    RouteTopical
    Strength4%
    Market StatusPrescription
    CompanyHospira

    18 of 18  
    Drug NameXylocaine preservative free
    Active IngredientLidocaine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1%; 20%; 2%; 4%
    Market StatusPrescription
    CompanyFresenius Kabi Usa

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Voltage-Gated Sodium Channel Blockers

    A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)

    Anesthetics, Local

    Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Amides [CS]; Antiarrhythmic [EPC]; Local Anesthesia [PE]; Amide Local Anesthetic [EPC]

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    18-Jan-2022
    15-Jun-2025
    KGS
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    Average Price (USD/KGS)

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 4%

    USFDA APPLICATION NUMBER - 10417

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    DOSAGE - INJECTABLE;INJECTION - 1% **Federal ...DOSAGE - INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 16801

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    DOSAGE - INJECTABLE;INJECTION - 2% **Federal ...DOSAGE - INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 16801

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    DOSAGE - INJECTABLE;INJECTION - 20% **Federal...DOSAGE - INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 16801

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    DOSAGE - INJECTABLE;INJECTION - 4% **Federal ...DOSAGE - INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 16801

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    DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;0....DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;0.5%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1....DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1.5%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;2%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.01MG/ML;1%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.01MG/ML;2%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.02MG/ML;2%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 0.5%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 1%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 1.5%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 2%

    USFDA APPLICATION NUMBER - 6488

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    DOSAGE - INJECTABLE;INJECTION - 1%

    USFDA APPLICATION NUMBER - 83158

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    DOSAGE - INJECTABLE;INJECTION - 2%

    USFDA APPLICATION NUMBER - 83158

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    DOSAGE - INJECTABLE;INJECTION - 1%

    USFDA APPLICATION NUMBER - 83173

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    DOSAGE - INJECTABLE;SPINAL - 5%

    USFDA APPLICATION NUMBER - 83914

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    DOSAGE - JELLY;TOPICAL - 2% **Federal Registe...DOSAGE - JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 8816

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    DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%

    USFDA APPLICATION NUMBER - 88389

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    DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

    USFDA APPLICATION NUMBER - 88390

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    ABOUT THIS PAGE

    Looking for 73-78-9 / Lidocaine Hydrochloride API manufacturers, exporters & distributors?

    Lidocaine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Lidocaine Hydrochloride

    Synonyms

    73-78-9, Lidocaine hcl, Lidothesin, Xyloneural, Lignocaine hydrochloride, Lidocaine (hydrochloride)

    Cas Number

    73-78-9

    Unique Ingredient Identifier (UNII)

    EC2CNF7XFP

    About Lidocaine Hydrochloride

    A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.

    Lidocaine Hydrochloride Monohydrate Manufacturers

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

    Lidocaine Hydrochloride Monohydrate Suppliers

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

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

    Lidocaine Hydrochloride Monohydrate USDMF

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

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

    click here to find a list of Lidocaine Hydrochloride Monohydrate suppliers with USDMF on PharmaCompass.

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

    Lidocaine Hydrochloride Monohydrate KDMF

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

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

    After submitting a Lidocaine Hydrochloride Monohydrate 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 Lidocaine Hydrochloride Monohydrate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Lidocaine Hydrochloride Monohydrate suppliers with KDMF on PharmaCompass.

    Lidocaine Hydrochloride Monohydrate CEP

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

    A Lidocaine Hydrochloride Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lidocaine Hydrochloride Monohydrate 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 Lidocaine Hydrochloride Monohydrate suppliers with CEP (COS) on PharmaCompass.

    Lidocaine Hydrochloride Monohydrate WC

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

    click here to find a list of Lidocaine Hydrochloride Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.

    Lidocaine Hydrochloride Monohydrate 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 Lidocaine Hydrochloride Monohydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Lidocaine Hydrochloride Monohydrate suppliers with NDC on PharmaCompass.

    Lidocaine Hydrochloride Monohydrate GMP

    Lidocaine Hydrochloride Monohydrate 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 Lidocaine Hydrochloride Monohydrate 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 Lidocaine Hydrochloride Monohydrate GMP manufacturer or Lidocaine Hydrochloride Monohydrate GMP API supplier for your needs.

    Lidocaine Hydrochloride Monohydrate CoA

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

    Lidocaine Hydrochloride Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Lidocaine Hydrochloride Monohydrate 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.

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