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    Chemistry

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    Also known as: Dextromethorphan hydrobromide, 125-69-9, Antussan, Demorphan, Dormethan, Metrorat
    Molecular Formula
    C18H26BrNO
    Molecular Weight
    352.3  g/mol
    InChI Key
    MISZALMBODQYFT-URVXVIKDSA-N
    FDA UNII
    Z0CG3115FG
    Dextromethorphan Hydrobromide
    Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    1 2D Structure

    Dextromethorphan Hydrobromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,9S,10S)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide
    2.1.2 InChI
    InChI=1S/C18H25NO.BrH/c1-19-10-9-18-8-4-3-5-15(18)17(19)11-13-6-7-14(20-2)12-16(13)18;/h6-7,12,15,17H,3-5,8-11H2,1-2H3;1H/t15-,17+,18+;/m1./s1
    2.1.3 InChI Key
    MISZALMBODQYFT-URVXVIKDSA-N
    2.1.4 Canonical SMILES
    CN1CCC23CCCCC2C1CC4=C3C=C(C=C4)OC.Br
    2.1.5 Isomeric SMILES
    CN1CC[C@@]23CCCC[C@@H]2[C@@H]1CC4=C3C=C(C=C4)OC.Br
    2.2 Other Identifiers
    2.2.1 UNII
    Z0CG3115FG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. D-methorphan

    2. Dextromethorphan

    3. Dextromethorphan Hydrobromide

    4. Dextromethorphan Hydrobromide, (+-)-isomer

    5. Dextromethorphan Hydrobromide, Monohydrate

    6. Dextromethorphan Hydrochloride

    7. Dextromethorphan, (+-)-isomer

    8. Hydrobromide, Dextromethorphan

    9. Hydrochloride, Dextromethorphan

    10. L-methorphan

    11. Levomethorphan

    12. Racemethorphan

    2.3.2 Depositor-Supplied Synonyms

    1. Dextromethorphan Hydrobromide

    2. 125-69-9

    3. Antussan

    4. Demorphan

    5. Dormethan

    6. Metrorat

    7. Medicon

    8. Tusilan

    9. Tussade

    10. D-methorphan Hydrobromide

    11. Romilar

    12. Methorate Hydrobromide

    13. Dextromethorphan Bromide

    14. Dextromethorphan (hydrobromide)

    15. Dextromethorphan Hydrobromide Anhydrous

    16. Ro 1-5470/5

    17. Dextromethorphan Hbr

    18. D-3-methoxy-n-methylmorphinan Hydrobromide

    19. Z0cg3115fg

    20. Benylin Dm

    21. (1s,9s,10s)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide

    22. Romilar Hydrobromide

    23. (9?,13?,14?)-3-methoxy-17-methylmorphinan Hydrobromide

    24. Dextroramin P

    25. Demorphine

    26. Dextrometorphan Hydrobromide

    27. Allfen-dm

    28. (1s,9s,10r)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide

    29. Nsc-756723

    30. Demorphan Hydrobromide

    31. Einecs 204-750-1

    32. Dextromethorphan Polistirex

    33. (9alpha,13alpha,14alpha)-3-methoxy-17-methylmorphinan Hydrobromide

    34. Unii-z0cg3115fg

    35. Canfodion

    36. Cosylan

    37. Dormetan

    38. Hihustan M.

    39. Ro 1-5470

    40. Dxm Hbr

    41. 9-alpha,13-alpha,14-alpha-morphinan, 3-methoxy-17-methyl-, Hydrobromide

    42. Schembl121924

    43. Morphinan, 3-methoxy-n-methyl-, Hydrobromide, (+)-

    44. Chembl1201004

    45. Dtxsid60872346

    46. Bcp06595

    47. Hy-b0620

    48. Dextromethorphan Hbr Anhydrous

    49. Mfcd00269810

    50. Akos022186323

    51. Ccg-212567

    52. Nsc 756723

    53. Dextromethorphan Hydrobromide [mi]

    54. Dextromethorphan Hydrobromide [who-dd]

    55. Q27294835

    56. (9alpha,13alpha,14alpha)-3-methoxy-17-methylmorphinan Hbr

    57. 3-methoxy-17-methyl-9.alpha.,13.alpha.,14.alpha.-morphinan Hbr

    58. Morphinan, 3-methoxy-17-methyl-, (9alpha,13alpha,14alpha)-, Hydrobromide

    59. 3-methoxy-17-methyl-9.alpha.,13.alpha.,14.alpha.-morphinan Hydrobromide

    60. 9alpha,13alpha,14alpha-morphinan, 3-methoxy-17-methyl-, Hydrobromide (8ci)

    61. Morphinan, 3-methoxy-17-methyl-, (9.alpha.,13.alpha.,14.alpha.)-, Hbr

    62. Morphinan, 3-methoxy-17-methyl-, (9.alpha.,13.alpha.,14.alpha.)-, Hydrobromide

    63. Morphinan, 3-methoxy-17-methyl-, Hydrobromide (1:1),(9.alpha.,13.alpha.,14.alpha.)-

    64. (4bs,8as,9s)-3-methoxy-11-methyl-6,7,8,8a,9,10-hexahydro-5h-9,4b-(epiminoethano)phenanthrene Hydrobromide

    65. 1887136-04-0

    2.4 Create Date
    2005-06-08
    3 Chemical and Physical Properties
    Molecular Weight 352.3 g/mol
    Molecular Formula C18H26BrNO
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count1
    Exact Mass351.11978 g/mol
    Monoisotopic Mass351.11978 g/mol
    Topological Polar Surface Area12.5 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity370
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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 NameDelsym
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyReckitt Benckiser

    2 of 4  
    Drug NameDextromethorphan polistirex
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyTris Pharma

    3 of 4  
    Drug NameDelsym
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyReckitt Benckiser

    4 of 4  
    Drug NameDextromethorphan polistirex
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyTris Pharma

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Excitatory Amino Acid Antagonists

    Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Sigma-1 Receptor Agonists [MoA]; Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Uncompetitive NMDA Receptor Antagonists [MoA]; Sigma-1 Agonist [EPC]

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    03-Jan-2022
    30-Sep-2025
    KGS
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    Drugs in Development

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    • Development Update
    • fda
    • EDQM
    • WHO-GMP
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    Mucinex Children's Launches Mighty Chews

    Details:

    Mighty Chews consisting, Dextromethorphan HBr, is the first and only over-the-counter medicated children's soft chew for cough relief.


    Lead Product(s): Dextromethorphan Hydrobromide,Inapplicable

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Mighty Chews

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 30, 2024

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    Reckitt Benckiser

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    AIChE Annual Meeting
    Not Confirmed

    Reckitt Benckiser

    United Kingdom
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    AIChE Annual Meeting
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    • fda
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    Lead Product(s) : Dextromethorphan Hydrobromide,Inapplicable

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mucinex Children's Launches Mighty Chews

    Details : Mighty Chews consisting, Dextromethorphan HBr, is the first and only over-the-counter medicated children's soft chew for cough relief.

    Product Name : Mighty Chews

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    September 30, 2024

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    ANI Pharmaceuticals Launches Oral Solution For Cough And Allergy Relief

    Details:

    Promethazine HCl and Dextromethorphan Hydrobromide-Generic is an approved oral solution, which is indicated for the patients suffering from cough.


    Lead Product(s): Promethazine Hydrochloride,Dextromethorphan Hydrobromide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Promethazine HCl-Dextromethorphan HBr-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 13, 2024

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    ANI Pharmaceuticals Inc

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    Lead Product(s) : Promethazine Hydrochloride,Dextromethorphan Hydrobromide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    ANI Pharmaceuticals Launches Oral Solution For Cough And Allergy Relief

    Details : Promethazine HCl and Dextromethorphan Hydrobromide-Generic is an approved oral solution, which is indicated for the patients suffering from cough.

    Product Name : Promethazine HCl-Dextromethorphan HBr-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 13, 2024

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    Foundation Consumer Healthcare to Add Seven Over-the-Counter Brands to Expanding Portfolio of Healthcare Products

    Details:

    This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, Primatene Tablets® and FiberCon®.


    Lead Product(s): Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Dimetapp

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Foundation Consumer Healthcare

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement July 16, 2020

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    GSK

    United Kingdom
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    GSK

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    Lead Product(s) : Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Foundation Consumer Healthcare

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Foundation Consumer Healthcare to Add Seven Over-the-Counter Brands to Expanding Portfolio of Heal...

    Details : This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, P...

    Product Name : Dimetapp

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    July 16, 2020

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    Europe

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    Bayer Hispania Sl

    Germany
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    Germany
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    Regulatory Info : Authorized

    Registration Country : Spain

    Paracetamol; Chlorphenamine Maleate; Phenylephrine Hydrochloride; Vitamin C; Dextrometorphan Hydrobromide

    Brand Name : Propalgina Plus Powder For Oral Solution

    Dosage Form : Oral Solution

    Dosage Strength :

    Packaging :

    Approval Date : 1987-03-01

    Application Number : 56999

    Regulatory Info : Authorized

    Registration Country : Spain

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    Cinfa Laboratories Sa

    Spain
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    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Cinfatos

    Dosage Form : Dispersible Tablet

    Dosage Strength : 15MG

    Packaging :

    Approval Date : 2021-03-04

    Application Number : 85817

    Regulatory Info : Authorized

    Registration Country : Spain

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    Salvat Laboratories Sa

    Spain
    AIChE Annual Meeting
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    Spain
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide

    Brand Name : Won Strong

    Dosage Form : Solution

    Dosage Strength : 3MG; 6MG

    Packaging :

    Approval Date : 2007-07-13

    Application Number : 69107

    Regulatory Info : Cancelled

    Registration Country : Spain

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    Opella Healthcare Spain Sl

    France
    AIChE Annual Meeting
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    France
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    Regulatory Info : Authorized

    Registration Country : Spain

    Paracetamol; Chlorphenamine Maleate; Dextromethorphan Hydrobromide

    Brand Name : Bisoltusgrip Junior Powder For Oral Solution

    Dosage Form : Oral Solution

    Dosage Strength :

    Packaging :

    Approval Date : 2022-07-01

    Application Number : 87917

    Regulatory Info : Authorized

    Registration Country : Spain

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    Opella Healthcare Spain Sl

    France
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    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Bisolvon Cough Suppressant

    Dosage Form : Syrup

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 1988-06-01

    Application Number : 57174

    Regulatory Info : Authorized

    Registration Country : Spain

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    Teva Pharma Slu

    Israel
    AIChE Annual Meeting
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    Israel
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    Regulatory Info : Authorized

    Registration Country : Spain

    Guaifenesin; Dextromethorphan Hydrobromide

    Brand Name : Notus Antitusivo Y Expectorante

    Dosage Form : Solution

    Dosage Strength : 2MG; 20MG

    Packaging :

    Approval Date : 2012-09-03

    Application Number : 76436

    Regulatory Info : Authorized

    Registration Country : Spain

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    Jntl Consumer Health (Spain) Sl

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    Regulatory Info : Authorized

    Registration Country : Spain

    Triprolidine Hydrochloride; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide

    Brand Name : Iniston Cough And Congestion Syrup

    Dosage Form : Syrup

    Dosage Strength :

    Packaging :

    Approval Date : 1962-12-01

    Application Number : 38249

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Guaifenesin; Dextromethorphan Hydrobromide

    Brand Name : Broncomedical Con Guaifenesina

    Dosage Form : Oral Solution

    Dosage Strength : 10MG; 100 MG

    Packaging :

    Approval Date : 2011-01-19

    Application Number : 73288

    Regulatory Info : Authorized

    Registration Country : Spain

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    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Novag Tuss

    Dosage Form : Tablet

    Dosage Strength : 15MG

    Packaging :

    Approval Date : 2011-12-13

    Application Number : 75141

    Regulatory Info : Authorized

    Registration Country : Spain

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    Farline Pharmaceutical Products Marketin...

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    Regulatory Info : Authorized

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    Dextromethorphan Hydrobromide

    Brand Name : Fritusil

    Dosage Form : Oral Solution

    Dosage Strength : 3MG

    Packaging :

    Approval Date : 2000-02-24

    Application Number : 62943

    Regulatory Info : Authorized

    Registration Country : Spain

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    DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 30MG HYDROBROMIDE/5ML

    USFDA APPLICATION NUMBER - 18658

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG;600MG

    USFDA APPLICATION NUMBER - 21620

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;1.2GM

    USFDA APPLICATION NUMBER - 21620

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    DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5...DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

    USFDA APPLICATION NUMBER - 88811

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    ABOUT THIS PAGE

    Looking for 125-69-9 / Dextromethorphan Hydrobromide API manufacturers, exporters & distributors?

    Dextromethorphan Hydrobromide manufacturers, exporters & distributors 1

    52

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

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

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

    API | Excipient name

    Dextromethorphan Hydrobromide

    Synonyms

    125-69-9, Antussan, Demorphan, Dormethan, Metrorat, Medicon

    Cas Number

    125-69-9

    Unique Ingredient Identifier (UNII)

    Z0CG3115FG

    About Dextromethorphan Hydrobromide

    Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.

    Dextromethorphan polistirex Manufacturers

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

    Dextromethorphan polistirex Suppliers

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

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

    Dextromethorphan polistirex USDMF

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

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

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

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

    Dextromethorphan polistirex KDMF

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

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

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

    click here to find a list of Dextromethorphan polistirex suppliers with KDMF on PharmaCompass.

    Dextromethorphan polistirex CEP

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

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

    Dextromethorphan polistirex WC

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

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

    Dextromethorphan polistirex 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 Dextromethorphan polistirex as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dextromethorphan polistirex GMP

    Dextromethorphan polistirex 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 Dextromethorphan polistirex 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 Dextromethorphan polistirex GMP manufacturer or Dextromethorphan polistirex GMP API supplier for your needs.

    Dextromethorphan polistirex CoA

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

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

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