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    Chemistry

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    Also known as: Algolysin, Butalgin, Fenadone, Mecodin, Depridol, Dolophine
    Molecular Formula
    C21H28ClNO
    Molecular Weight
    345.9  g/mol
    InChI Key
    FJQXCDYVZAHXNS-UHFFFAOYSA-N
    FDA UNII
    229809935B
    Methadone Hydrochloride
    A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
    1 2D Structure

    Methadone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    6-(dimethylamino)-4,4-diphenylheptan-3-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C21H27NO.ClH/c1-5-20(23)21(16-17(2)22(3)4,18-12-8-6-9-13-18)19-14-10-7-11-15-19;/h6-15,17H,5,16H2,1-4H3;1H
    2.1.3 InChI Key
    FJQXCDYVZAHXNS-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCC(=O)C(CC(C)N(C)C)(C1=CC=CC=C1)C2=CC=CC=C2.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    229809935B
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Amidone

    2. Biodone

    3. Dolophine

    4. Hydrochloride, Methadone

    5. Metadol

    6. Metasedin

    7. Methaddict

    8. Methadone

    9. Methadose

    10. Methex

    11. Phenadone

    12. Phymet

    13. Physeptone

    14. Pinadone

    15. Symoron

    2.3.2 Depositor-Supplied Synonyms

    1. Algolysin

    2. Butalgin

    3. Fenadone

    4. Mecodin

    5. Depridol

    6. Dolophine

    7. Methadose

    8. Moheptan

    9. Miadone

    10. Phenadone Hydrochloride

    11. Dolofin Hydrochloride

    12. 1095-90-5

    13. Methadone Hcl

    14. Ketalgin Hydrochloride

    15. Algidon

    16. Fenadon

    17. Heptadon

    18. Polamidon

    19. Adolan

    20. Adanon Hydrochloride

    21. Physeptone

    22. Diaminon Hydrochloride

    23. Dl-methadone Hydrochloride

    24. Dolophine Hydrochloride

    25. Dolohepton

    26. Westadone

    27. Althose Hydrochloride

    28. Mephenon

    29. Racemic Methadone Hydrochloride

    30. (+-)-methadone Hydrochloride

    31. Ccris 3320

    32. An-148

    33. Methadonium Chloride

    34. Dolophin Hydrochloride

    35. 4,4-diphenyl-6-dimethylamino-3-heptanone Hydrochloride

    36. Hoechst 10820

    37. 6-(dimethylamino)-4,4-diphenyl-3-heptanone Hydrochloride

    38. Dl-6-dimethylamino-4,4-diphenyl-3-heptanone Hydrochloride

    39. An 148

    40. Nsc-19600

    41. Methadone Hydrochloride Cii

    42. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride

    43. 6-(dimethylamino)-4,4-diphenylheptan-3-one Hydrochloride

    44. 125-56-4

    45. Chebi:50140

    46. 6-dimethylamino-4,4-diphenyl-3-heptanone.hcl

    47. Althose

    48. 6-(dimethylamino)-4,4-diphenylheptan-3-one;hydrochloride

    49. Tussal

    50. Dsstox_cid_501

    51. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride, (+-)-

    52. Diskets Dispersible

    53. Dsstox_rid_75626

    54. Dsstox_gsid_20501

    55. 229809935b

    56. (+-)-tussal

    57. (+/-)-methadone Hydrochloride

    58. Cas-1095-90-5

    59. Einecs 214-140-7

    60. Nsc 19600

    61. Methadose Oral Concentrate

    62. Methadose Sugar-free Oral

    63. Biscuits

    64. Dollies

    65. Macodin

    66. Medicine

    67. Dolly

    68. Methadone Hydrochloride [usp]

    69. Methadone Hydrochloride Intensol

    70. Tussol:

    71. Drg-0023

    72. Amidone Hydrochloride

    73. Unii-229809935b

    74. Azt + Methadone Hcl

    75. (+/-)-tussal

    76. (.+-.) Tussal

    77. Methadone Hydrochloride Dl-

    78. Dl-methadone, Hydrochloride

    79. Schembl24293

    80. Dolophine Hydrochloride (tn)

    81. Mls003922099

    82. 6-dimethylamino-4,4-diphenyl-3-heptanone Hydrochloride

    83. Chembl1200825

    84. Dtxsid2020501

    85. (.+-.)-methadone Hydrochloride

    86. Methadone Hydrochloride (jan/usp)

    87. 1,1-diphenyl-1-(2-dimethylaminopropyl)-2-butanone Hydrochloride

    88. Nsc19600

    89. Methadone Hydrochloride [mi]

    90. Tox21_112895

    91. Tox21_202026

    92. Tox21_300633

    93. Methadone Hydrochloride [jan]

    94. Methadone Hydrochloride [vandf]

    95. Methadone Hydrochloride [usp-rs]

    96. Methadone Hydrochloride [who-dd]

    97. Ncgc00254397-01

    98. Ncgc00259575-01

    99. Smr000058978

    100. Ft-0671040

    101. Methadone Hydrochloride [ep Impurity]

    102. Methadone Hydrochloride [orange Book]

    103. Methadone Hydrochloride Cii [usp-rs]

    104. Methadone Hydrochloride [ep Monograph]

    105. D02102

    106. Methadone Hydrochloride [usp Monograph]

    107. Wln: 2vxr & R & Y2 & N1 & 1

    108. 3-heptanone,4-diphenyl-, Hydrochloride,(.+-.)-

    109. 3-heptanone,4-diphenyl-, Hydrochloride, (.+-.)-

    110. Q26840915

    111. (+/-)-methadone Hydrochloride, Powder, >=98% (tlc)

    112. 3-heptanone, Dl-6-dimethylamino-4,4-diphenyl-, Hydrochloride

    113. 4,4-diphenyl-6-dimethylamino-3-heptanone Hydrochloride (+/-)-

    114. Dl-6-(dimethylamino)-4,4-diphenyl-3-heptanone Hydrochloride

    115. 4,4-diphenyl-6-(dimethylamino)-3-heptanone Hydrochloride(.+-.)-

    116. 6-(dimethylamino)-4,4-diphenyl-3-heptanone Hydrochloride (1:1)

    117. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride (1:1)

    118. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride (8ci,9ci)

    119. (+/-)-methadone Hydrochloride Solution, Drug Standard, 1.0 Mg/ml In Methanol

    2.4 Create Date
    2005-06-01
    3 Chemical and Physical Properties
    Molecular Weight 345.9 g/mol
    Molecular Formula C21H28ClNO
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count7
    Exact Mass345.1859422 g/mol
    Monoisotopic Mass345.1859422 g/mol
    Topological Polar Surface Area20.3 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity346
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameDolophine hydrochloride
    Drug LabelDOLOPHINE HYDROCHLORIDE (Methadone Hydrochloride Tablets, USP), for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride i...
    Active IngredientMethadone hydrochloride
    Dosage FormInjectable; Tablet
    RouteInjection; Oral
    Strength5mg; 10mg; 10mg/ml
    Market StatusPrescription
    CompanyMylan Institutional; Roxane

    2 of 8  
    Drug NameMethadone hydrochloride
    Drug LabelDESCRIPTIONMethadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble.Methadone hydrochloride is chemically describ...
    Active IngredientMethadone hydrochloride
    Dosage FormTablet, for suspension; Tablet; Concentrate; Powder; Solution
    RouteOral; For rx compounding
    Strength10mg/5ml; 50gm/bot; 500gm/bot; 10mg/ml; 5mg; 10mg; 100gm/bot; 5mg/5ml; 40mg
    Market StatusPrescription
    CompanyThe Pharmanetwork; Mallinckrodt; Sandoz; Roxane; Vistapharm

    3 of 8  
    Drug NameMethadone hydrochloride intensol
    Active IngredientMethadone hydrochloride
    Dosage FormConcentrate
    RouteOral
    Strength10mg/ml
    Market StatusPrescription
    CompanyRoxane

    4 of 8  
    Drug NameMethadose
    Drug LabelMethadose Oral Concentrate (methadone hydrochloride oral concentrate USP) is supplied as a cherry flavored liquid concentrate. Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) is a dye-free, sugar-free, unfla...
    Active IngredientMethadone hydrochloride
    Dosage FormTablet, for suspension; Tablet; Concentrate
    RouteOral
    Strength10mg/ml; 5mg; 10mg; 40mg
    Market StatusPrescription
    CompanyMallinckrodt

    5 of 8  
    Drug NameDolophine hydrochloride
    Drug LabelDOLOPHINE HYDROCHLORIDE (Methadone Hydrochloride Tablets, USP), for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride i...
    Active IngredientMethadone hydrochloride
    Dosage FormInjectable; Tablet
    RouteInjection; Oral
    Strength5mg; 10mg; 10mg/ml
    Market StatusPrescription
    CompanyMylan Institutional; Roxane

    6 of 8  
    Drug NameMethadone hydrochloride
    Drug LabelDESCRIPTIONMethadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble.Methadone hydrochloride is chemically describ...
    Active IngredientMethadone hydrochloride
    Dosage FormTablet, for suspension; Tablet; Concentrate; Powder; Solution
    RouteOral; For rx compounding
    Strength10mg/5ml; 50gm/bot; 500gm/bot; 10mg/ml; 5mg; 10mg; 100gm/bot; 5mg/5ml; 40mg
    Market StatusPrescription
    CompanyThe Pharmanetwork; Mallinckrodt; Sandoz; Roxane; Vistapharm

    7 of 8  
    Drug NameMethadone hydrochloride intensol
    Active IngredientMethadone hydrochloride
    Dosage FormConcentrate
    RouteOral
    Strength10mg/ml
    Market StatusPrescription
    CompanyRoxane

    8 of 8  
    Drug NameMethadose
    Drug LabelMethadose Oral Concentrate (methadone hydrochloride oral concentrate USP) is supplied as a cherry flavored liquid concentrate. Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) is a dye-free, sugar-free, unfla...
    Active IngredientMethadone hydrochloride
    Dosage FormTablet, for suspension; Tablet; Concentrate
    RouteOral
    Strength10mg/ml; 5mg; 10mg; 40mg
    Market StatusPrescription
    CompanyMallinckrodt

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antitussive Agents

    Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)

    Narcotics

    Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

    Analgesics, Opioid

    Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

    API Reference Price

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INDL.ESTATE,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728066600,"product":"PHARMACEUTICAL RAW MATERIAL ACTIVEPHARMACEUTICAL INGREDIENT METHADONE HYDROCHLORIDE EP","address":"206, ERIC HOUSE, 16TH ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVAT","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"HAMBURG EXPRESS","customerCountry":"GERMANY","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"400","totalValueFC":"19420.7","currency":"USD","unitRateINR":32637.088,"date":"05-Oct-2024","totalValueINR":"1631854.4","totalValueInUsd":"19420.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4592371","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"206, ERIC HOUSE, 16TH ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"PHARMACEUTICAL RAW MATERIAL ACTIVEPHARMACEUTICAL INGREDIENT METHADONE HYDROCHLORIDE EP","address":"206, ERIC HOUSE, 16TH ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVAT","supplierCountry":"INDIA","foreign_port":"SOFIA","customer":"S. P. AD","customerCountry":"BULGARIA","quantity":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"410","totalValueFC":"17852.7","currency":"USD","unitRateINR":33479.059999999998,"date":"11-Nov-2024","totalValueINR":"1506557.7","totalValueInUsd":"17852.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5518924","productDescription":"API","marketType":"REGULATED MARKET","country":"BULGARIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"206, ERIC HOUSE, 16TH ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"METHADONE HCL EP (EXP.AUTH.NO.N-EXP-324\/2024 DT.22.11.2024. IMP.AUTH.NO.I\/2024\/1686\/N DT.24.09.2024.)","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"FAGRON GROUP","customerCountry":"NETHERLANDS","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"365","totalValueFC":"53040.4","currency":"USD","unitRateINR":30045.239466666666,"date":"23-Dec-2024","totalValueINR":"4506785.92","totalValueInUsd":"53040.4","indian_port":"Bombay Air","hs_no":"29223100","bill_no":"6684436","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737916200,"product":"METHADONE HCL USP (EXP.AUTH.NO.N-EXP-386\/2024 DT.24.12.2024. IMP.AUTH.NO.IMP\/1832\/2024 DT.08.10.2024.)","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"CHEMO AG- VIENNA, LUGANO BRANCH","customerCountry":"SWITZERLAND","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"1314","totalValueFC":"7367.3","currency":"USD","unitRateINR":105878.995,"date":"27-Jan-2025","totalValueINR":"635273.97","totalValueInUsd":"7367.3","indian_port":"Bombay Air","hs_no":"29223100","bill_no":"7626501","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738693800,"product":"METHADONE HCL EP (EXP.AUTH.NO.P-EXP-00021\/2025 DT.15.01.2025. IMP.AUTH.NO.I-2024-1810 DT.18.11.2024.)","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"PHARMA CHEMICALS SA","customerCountry":"BELGIUM","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"407","totalValueFC":"9536.2","currency":"USD","unitRateINR":33172.130799999999,"date":"05-Feb-2025","totalValueINR":"829303.27","totalValueInUsd":"9536.2","indian_port":"Bombay Air","hs_no":"29223100","bill_no":"7902042","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""}]
    23-Feb-2021
    05-Feb-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CONCENTRATE;ORAL - 10MG/ML

    USFDA APPLICATION NUMBER - 17116

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    DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 6134

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    DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 6134

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    ABOUT THIS PAGE

    Looking for 1095-90-5 / Methadone Hydrochloride API manufacturers, exporters & distributors?

    Methadone Hydrochloride manufacturers, exporters & distributors 1

    44

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

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

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

    API | Excipient name

    Methadone Hydrochloride

    Synonyms

    Algolysin, Butalgin, Fenadone, Mecodin, Depridol, Dolophine

    Cas Number

    1095-90-5

    Unique Ingredient Identifier (UNII)

    229809935B

    About Methadone Hydrochloride

    A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

    Methadone HCl Manufacturers

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

    Methadone HCl Suppliers

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

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

    Methadone HCl USDMF

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

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

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

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

    Methadone HCl CEP

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

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

    Methadone HCl WC

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

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

    Methadone HCl 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 Methadone HCl as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Methadone HCl GMP

    Methadone HCl 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 Methadone HCl 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 Methadone HCl GMP manufacturer or Methadone HCl GMP API supplier for your needs.

    Methadone HCl CoA

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

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

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