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    Chemistry

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    Also known as: Naloxone hcl, 357-08-4, Narcan, Narcanti, Naloxone (hydrochloride), Evzio
    Molecular Formula
    C19H22ClNO4
    Molecular Weight
    363.8  g/mol
    InChI Key
    RGPDIGOSVORSAK-STHHAXOLSA-N
    FDA UNII
    F850569PQR
    Naloxone Hydrochloride
    A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.
    1 2D Structure

    Naloxone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H21NO4.ClH/c1-2-8-20-9-7-18-15-11-3-4-12(21)16(15)24-17(18)13(22)5-6-19(18,23)14(20)10-11;/h2-4,14,17,21,23H,1,5-10H2;1H/t14-,17+,18+,19-;/m1./s1
    2.1.3 InChI Key
    RGPDIGOSVORSAK-STHHAXOLSA-N
    2.1.4 Canonical SMILES
    C=CCN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)O)O4)O.Cl
    2.1.5 Isomeric SMILES
    C=CCN1CC[C@]23[C@@H]4C(=O)CC[C@]2([C@H]1CC5=C3C(=C(C=C5)O)O4)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    F850569PQR
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Abello, Naloxone

    2. Curamed, Naloxon

    3. Dihydride, Naloxone Hydrochloride

    4. Hydrobromide, Naloxone

    5. Hydrochloride Dihydride, Naloxone

    6. Hydrochloride, Naloxone

    7. Mrz 2593

    8. Mrz 2593 Br

    9. Mrz 2593-br

    10. Mrz 2593br

    11. Mrz-2593

    12. Mrz2593

    13. Nalone

    14. Naloxon Curamed

    15. Naloxon Ratiopharm

    16. Naloxon-ratiopharm

    17. Naloxone

    18. Naloxone Abello

    19. Naloxone Hydrobromide

    20. Naloxone Hydrochloride Dihydride

    21. Naloxone Hydrochloride, (5 Beta,9 Alpha,13 Alpha,14 Alpha)-isomer

    22. Naloxone, (5 Beta,9 Alpha,13 Alpha,14 Alpha)-isomer

    23. Narcan

    24. Narcanti

    2.3.2 Depositor-Supplied Synonyms

    1. Naloxone Hcl

    2. 357-08-4

    3. Narcan

    4. Narcanti

    5. Naloxone (hydrochloride)

    6. Evzio

    7. Nih 7890

    8. En-15304

    9. Anhydrous Naloxone Hydrochloride

    10. Chebi:31892

    11. F850569pqr

    12. Nsc-757109

    13. (-)-n-allyl-14-hydroxynordihydromorphinone Hydrochloride

    14. 357-08-4 (hcl)

    15. 17-allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    16. (5alpha)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    17. (4r,4as,7ar,12bs)-3-allyl-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7ah)-one Hydrochloride

    18. Nalonee

    19. Mls000069540

    20. Naloxonehydrochloride

    21. Smr000058766

    22. Unii-f850569pqr

    23. Prestwick_879

    24. Einecs 206-611-0

    25. Mfcd00069322

    26. Narcan (tn)

    27. Kloxxado

    28. Evzio (tn)

    29. Nafoxone Hydrochloride

    30. Nal-oxon Hydrochloride

    31. Naloxone Hydrochloride [usan:usp:jan]

    32. En 15304

    33. Chembl1718

    34. C19h21no4.hcl

    35. Schembl41390

    36. L-n-allyl-14-hydroxynordihydromorphinone Hydrochloride

    37. Naloxone Hydrochloride Anhydrous

    38. Dtxsid70957097

    39. Hms1568g04

    40. Naloxone Hydrochloride [mi]

    41. Act02626

    42. Naloxone Hydrochloride (jp17/usp)

    43. Naloxone Hydrochloride [jan]

    44. (5a)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    45. 17-allyl-4,5-alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    46. Naloxone Hydrochloride [usan]

    47. Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, Hydrochloride, (-)-

    48. S3066

    49. Naloxone Hydrochloride [vandf]

    50. Akos024418753

    51. Morphinan-6-one, 17-allyl-4,5-alpha-epoxy-3,14-dihydroxy-, Hydrochloride

    52. Naloxone Hydrochloride [mart.]

    53. Ccg-220111

    54. Cs-1335

    55. Ks-5379

    56. Naloxone Hydrochloride [who-dd]

    57. Nc00587

    58. Nsc 757109

    59. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, Hydrochloride, (5.alpha.)-

    60. Hy-17417

    61. Naloxone Hydrochloride [green Book]

    62. Naloxone Hydrochloride [orange Book]

    63. Sw197001-3

    64. Naloxone Hydrochloride [usp Monograph]

    65. D01340

    66. Suboxone Component Naloxone Hydrochloride

    67. Targiniq Component Naloxone Hydrochloride

    68. Naloxone Hydrochloride Anhydrous [who-ip]

    69. Talwin Nx Component Naloxone Hydrochloride

    70. 357n084

    71. Naloxone Hydrochloride Component Of Suboxone

    72. Naloxone Hydrochloride Component Of Targiniq

    73. Sr-01000597918

    74. Sr-01000737374

    75. Naloxone Hydrochloride Component Of Talwin Nx

    76. Sr-01000597918-1

    77. Sr-01000737374-3

    78. W-106655

    79. Q27114711

    80. Naloxoni Hydrochloridum Anhydrous [who-ip Latin]

    81. (5alpha)-17-allyl-3,14-dihydroxy-4,5-epoxymorphinan-6-one Hydrochloride

    82. 17-allyl-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one Hydrochloride

    83. (17r)-17-allyl-3,14-dihydroxy-6-oxo-4,5alpha-epoxymorphinan-17-ium Chloride

    84. (5?)-4,5-epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one Hydrochloride

    85. (5a)-4,5-epoxy-3,14-dihydroxy-17-(2-propen-1-yl)-morphinan-6-one Hydrochloride

    86. (5alpha)-4,5-epoxy-3,14-dihydroxy-17-(2-propen-1-yl)morphinan-6-one Hydrochloride (1:1)

    87. (5alpha,17r)-17-allyl-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium Chloride

    88. 17-allyl-4,5.alpha.-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    89. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, Hydrochloride, (5alpha)-

    90. (4r,4as,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

    91. (4r,4as,7ar,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

    92. (5alpha)-4,5-epoxy-3,14-dihydro-17-(2-pr Openyl)morphinan-6-one Hydrochloride

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 363.8 g/mol
    Molecular Formula C19H22ClNO4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass363.1237359 g/mol
    Monoisotopic Mass363.1237359 g/mol
    Topological Polar Surface Area70 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity594
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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 4  
    Drug NameEvzio
    PubMed HealthNaloxone (Injection)
    Drug ClassesToxicology-Antidote Agent
    Drug LabelEVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one h...
    Active IngredientNaloxone hydrochloride
    Dosage FormSolution
    RouteIntramuscular, subcutaneous
    Strength0.4mg/0.4ml
    Market StatusPrescription
    CompanyKaleo

    2 of 4  
    Drug NameNaloxone hydrochloride
    Drug LabelAmpul, Fliptop Vial, Opioid AntagonistProtect from light.RxNaloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sod...
    Active IngredientNaloxone hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1mg/ml; 0.4mg/ml
    Market StatusPrescription
    CompanyHospira; Intl Medication; Mylan Institutional

    3 of 4  
    Drug NameEvzio
    PubMed HealthNaloxone (Injection)
    Drug ClassesToxicology-Antidote Agent
    Drug LabelEVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one h...
    Active IngredientNaloxone hydrochloride
    Dosage FormSolution
    RouteIntramuscular, subcutaneous
    Strength0.4mg/0.4ml
    Market StatusPrescription
    CompanyKaleo

    4 of 4  
    Drug NameNaloxone hydrochloride
    Drug LabelAmpul, Fliptop Vial, Opioid AntagonistProtect from light.RxNaloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sod...
    Active IngredientNaloxone hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength1mg/ml; 0.4mg/ml
    Market StatusPrescription
    CompanyHospira; Intl Medication; Mylan Institutional

    4.2 Drug Indication

    Treatment of opioid-induced constipation

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Narcotic Antagonists

    Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Opioid Antagonists [MoA]; Opioid Antagonist [EPC]

    API Reference Price

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CHARLES DE G","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"10000","totalValueFC":"9919.7","currency":"EUR","unitRateINR":"917500","date":"05-Dec-2023","totalValueINR":"825750","totalValueInUsd":"9919.7","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"9078089","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"15 RUE TRAVERSIERE 75012 PAIRSSDNFSDNF France","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"NALOXONE HYDROCHLORIDE USP (100% EOU)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"11075","totalValueFC":"1699.7","currency":"USD","unitRateINR":"940205.9","date":"02-Feb-2024","totalValueINR":"141030.88","totalValueInUsd":"1699.7","indian_port":"Madras Air","hs_no":"29391900","bill_no":"9949111","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"PERTH HOUSE MILLENNIUM WAY DUNSTON,CHESTERFIELD DERBYSHIRE,S41 8ND USA UNITED STATES","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717785000,"product":"395474 NALOXONE HCL HP USP (NALOXONE HYDROCHLORIDE USP)","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"12.5","totalValueFC":"6921.6","currency":"EUR","unitRateINR":"1155.6","date":"08-Jun-2024","totalValueINR":"577812.5","totalValueInUsd":"6921.6","indian_port":"Delhi Air","hs_no":"29391900","bill_no":"3895431","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS","supplierAddress":"15, RUE TRAVERSIERE75012 PARISSDNF FRANCE","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"NALOXONE HYDROCHLORIDE- UNMILLED","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"NORAMCO","supplierCountry":"UNITED KINGDOM","foreign_port":"NEWCASTLE","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"49.75","actualQuantity":"49.75","unit":"KGS","unitRateFc":"6500","totalValueFC":"326697.8","currency":"USD","unitRateINR":"548925","date":"06-Jul-2024","totalValueINR":"27309018.75","totalValueInUsd":"326697.8","indian_port":"Madras Air","hs_no":"29391900","bill_no":"4361922","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWCASTLE","supplierAddress":"500 SWEDEN LANDING ROADWILMINGTONDE19801 GB","customerAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"NALOXONE HCL DIHYDRATE API (TEST & ANALYSIS) (FREE OF CHARGESAMPLE) (100%EOU)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"PFIZER INC","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"0.39","actualQuantity":"394.7","unit":"GMS","unitRateFc":"11.3","totalValueFC":"4565.2","currency":"USD","unitRateINR":"970.2","date":"03-Aug-2024","totalValueINR":"382921.08","totalValueInUsd":"4565.2","indian_port":"Madras Air","hs_no":"29391900","bill_no":"4857122","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"275 N. FIELD DR. LAKE FOREST, IL 60045 , UNITED STATESSDNF UNITED STATES","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"}]
    18-Jan-2021
    19-Sep-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

    USFDA APPLICATION NUMBER - 205637

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    DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE

    USFDA APPLICATION NUMBER - 205637

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    DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE

    USFDA APPLICATION NUMBER - 205637

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    DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)

    USFDA APPLICATION NUMBER - 205787

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    DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20733

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    DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20733

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    DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)

    USFDA APPLICATION NUMBER - 209862

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

    USFDA APPLICATION NUMBER - 22410

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE

    USFDA APPLICATION NUMBER - 22410

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

    USFDA APPLICATION NUMBER - 22410

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

    USFDA APPLICATION NUMBER - 22410

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    ABOUT THIS PAGE

    Naloxone Hydrochloride Manufacturers

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

    Naloxone Hydrochloride Suppliers

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

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

    Naloxone Hydrochloride USDMF

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

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

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

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

    Naloxone Hydrochloride KDMF

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

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

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

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

    Naloxone Hydrochloride CEP

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

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

    Naloxone Hydrochloride WC

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

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

    Naloxone Hydrochloride 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 Naloxone Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Naloxone Hydrochloride GMP

    Naloxone Hydrochloride 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 Naloxone Hydrochloride 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 Naloxone Hydrochloride GMP manufacturer or Naloxone Hydrochloride GMP API supplier for your needs.

    Naloxone Hydrochloride CoA

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

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

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