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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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BY:ONEIRO LIFECARE PVT LTD.(VADODARA-GUJARAT); MFGR.GST: 24AAACO7069C1ZN,TAX INV:","address":"UNIT NO.229,2 ND FLOOR, WADALA UDYOG BHAVAN,PLOT 8,","city":"MUMBAI","supplier":"GRADIENT PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"MANILA NORTH HARBOR","customer":"UNDISCLOSED","customerCountry":"PHILIPPINES","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"90","totalValueFC":"8827.7","currency":"USD","unitRateINR":7801.0962,"date":"01-Oct-2025","totalValueINR":"780109.62","totalValueInUsd":"8827.7","indian_port":"JNPT","hs_no":"29339990","bill_no":"5823579","productDescription":"API","marketType":"","country":"PHILIPPINES","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"UNIT NO.229,2 ND FLOOR, WADALA UDYOG BHAVAN,PLOT 8,, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1759775400,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP (PHARMACEUTICAL ALLOPATHIC RAW MATERIAL)","address":"1ST FLOOR ABS TOWERS","city":"BARODA","supplier":"ONEIRO LIFECARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"UNDISCLOSED","customerCountry":"PAKISTAN","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"135","totalValueFC":"2539.3","currency":"USD","unitRateINR":11220,"date":"07-Oct-2025","totalValueINR":"224400","totalValueInUsd":"2539.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"5954498","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"1ST FLOOR ABS TOWERS, BARODA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1760121000,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP (MFG:ONEIRO LIFECARE PVT.LTD GST:24AAACO7069C1ZN TAX INV: 579\/25-26 , DATE: 30.08.20","address":"UNIT NO.229,2 ND FLOOR, WADALA UDYOG BHAVAN,PLOT 8,","city":"MUMBAI","supplier":"GRADIENT PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"LIMA -","customer":"UNDISCLOSED","customerCountry":"PERU","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"80","totalValueFC":"15932.9","currency":"USD","unitRateINR":7040.0003500000003,"date":"11-Oct-2025","totalValueINR":"1408000.07","totalValueInUsd":"15932.9","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6075241","productDescription":"API","marketType":"","country":"PERU","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"UNIT NO.229,2 ND FLOOR, WADALA UDYOG BHAVAN,PLOT 8,, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1761244200,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP","address":"PLOT NO.174,PROGRESSIVE INDUSTRIAL","city":"TALUQ,MEDAK DIST.,A.P.","supplier":"HY GRO CHEMICALS PHARMTEK PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"UNDISCLOSED","customerCountry":"INDONESIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"75","totalValueFC":"110755.4","currency":"USD","unitRateINR":6525,"date":"24-Oct-2025","totalValueINR":"9787500","totalValueInUsd":"110755.4","indian_port":"Hyderabad ICD","hs_no":"29339990","bill_no":"6396487","productDescription":"API","marketType":"","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad ICD","supplierAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL, TALUQ,MEDAK DIST.,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1761762600,"product":"BULK DRUGS - DEXTROMETHORPHAN HYDROBROMIDE USP","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"WOCKHARDT LTD","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"SIZA INTERNATIONAL PVT LTD","customerCountry":"PAKISTAN","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"75","totalValueFC":"7217.4","currency":"N\/A","unitRateINR":6378.0396000000001,"date":"30-Oct-2025","totalValueINR":"637803.96","totalValueInUsd":"7217.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6561066","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"WOCKHARDT TOWERS, BANDRA KURLA, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1761849000,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP(TAX INV. NO. H\/25-26\/288 DT. 13.10.2025, MFG- HY-GRO CHEMICALS ,GSTIN-36AAACH6012J1ZT)","address":"203 SEFA HOUSE A,PALI MALLA ROAD","city":"BANDRA WEST,MAHARASHTRA","supplier":"CRIMSON INTERNATIONAL","supplierCountry":"INDIA","foreign_port":"BAGDAD, METROPOLITAN","customer":"AL ALAMEAH CO FOR HUMAN","customerCountry":"IRAQ","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"100","totalValueFC":"48.9","currency":"USD","unitRateINR":8641.3999999999996,"date":"31-Oct-2025","totalValueINR":"4320.7","totalValueInUsd":"48.9","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6571156","productDescription":"API","marketType":"","country":"IRAQ","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"203 SEFA HOUSE A,PALI MALLA ROAD, BANDRA WEST,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746642600,"product":"(RE-IMPORT CARGO) DEXTROMETHORPHAN HYDROBROMIDE BP (25KGS X05 DRMS)(22.277KGS X 01 DRUM)(14.739 X 01 DRM) & (8.10 KGS X(RE-IMPORT CARGO) DEXTROMETHORPHAN HYDROBROMIDE BP (25KGS X","address":"A-201\/202, NAVBHARAT EST.,","city":"MUMBAI ,MAHARASHTRA","supplier":"SUNWARD PHARMACEUTICAL PTE LTD","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"GEMINI EXPORTS","customerCountry":"INDIA","quantity":"170.10","actualQuantity":"170.101","unit":"KGS","unitRateFc":"117.3","totalValueFC":"20040.2","currency":"USD","unitRateINR":"10037.8","date":"08-May-2025","totalValueINR":"1707438.58","totalValueInUsd":"20040.2","indian_port":"JNPT","hs_no":"29339990","bill_no":"9934700","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SINGAPORE","supplierAddress":"11 WAN LEE ROAD,SINGAPORE 627943 SDNF SDNF SINGAPORE","customerAddress":"A-201\/202, NAVBHARAT EST.,"}]
    03-Jan-2022
    31-Oct-2025
    KGS
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    Drugs in Development

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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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    01

    Reckitt Benckiser

    United Kingdom
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    DDL Conference
    Not Confirmed

    Reckitt Benckiser

    United Kingdom
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    Not Confirmed
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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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    02

    ANI Pharmaceuticals Inc

    U.S.A
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    Not Confirmed

    ANI Pharmaceuticals Inc

    U.S.A
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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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    03

    GSK

    United Kingdom
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    Not Confirmed

    GSK

    United Kingdom
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    Not Confirmed
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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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    Dextromethorphan Pediatric Acute Cough Study

    Details:

    Dextromethorphan HBr is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Cough.


    Lead Product(s): Dextromethorphan Hydrobromide,Inapplicable

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 08, 2016

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    04

    Pfizer Inc

    U.S.A
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    DDL Conference
    Not Confirmed

    Pfizer Inc

    U.S.A
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    Lead Product(s) : Dextromethorphan Hydrobromide,Inapplicable

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dextromethorphan Pediatric Acute Cough Study

    Details : Dextromethorphan HBr is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Cough.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    January 08, 2016

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    Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)

    Details:

    Dextromethorphan HBr is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pseudobulbar Palsy.


    Lead Product(s): Dextromethorphan Hydrobromide,Quinidine

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 14, 2015

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    05

    Otsuka Holdings

    Japan
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    Not Confirmed

    Otsuka Holdings

    Japan
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    Not Confirmed
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    Lead Product(s) : Dextromethorphan Hydrobromide,Quinidine

    Therapeutic Area : Neurology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With P...

    Details : Dextromethorphan HBr is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pseudobulbar Palsy.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    July 14, 2015

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    Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

    Details:

    Dextromethorphan HBr is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Arthritis, Rheumatoid.


    Lead Product(s): Dextromethorphan Hydrobromide,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Controlled Substance

    Sponsor: TSH Biopharm Corporation Limited

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 20, 2015

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    06

    Taichung Veterans General Hospital

    Country
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    DDL Conference
    Not Confirmed

    Taichung Veterans General Hospital

    Country
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    Not Confirmed
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    Lead Product(s) : Dextromethorphan Hydrobromide,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : TSH Biopharm Corporation Limited

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

    Details : Dextromethorphan HBr is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Arthritis, Rheumatoid.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    February 20, 2015

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    Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextrome...

    Details:

    BIRT 2584 XX is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): BIRT 2584 XX,Warfarin Sodium,Omeprazole,Dextromethorphan Hydrobromide,Caffeine,Midazolam Hydrochloride,Vitamin K1

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Undisclosed

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 06, 2014

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    07

    Boehringer Ingelheim GmbH

    Germany
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    DDL Conference
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Not Confirmed
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    Lead Product(s) : BIRT 2584 XX,Warfarin Sodium,Omeprazole,Dextromethorphan Hydrobromide,Caffeine,Midazolam Hydrochloride,Vitamin K1

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Para...

    Details : BIRT 2584 XX is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : Inapplicable

    October 06, 2014

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    The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subj...

    Details:

    Acetaminophen is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Common Cold.


    Lead Product(s): Paracetamol,Pseudoephedrine Hydrochloride,Dextromethorphan Hydrobromide,Chlorpheniramine Maleate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Sino-American Tianjin Smith Kline & French Laboratories Ltd

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 22, 2014

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    08

    GSK

    United Kingdom
    arrow
    DDL Conference
    Not Confirmed

    GSK

    United Kingdom
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    DDL Conference
    Not Confirmed
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    Lead Product(s) : Paracetamol,Pseudoephedrine Hydrochloride,Dextromethorphan Hydrobromide,Chlorpheniramine Maleate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Sino-American Tianjin Smith Kline & French Laboratories Ltd

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorp...

    Details : Acetaminophen is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Common Cold.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 22, 2014

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    Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers

    Details:

    Tipranavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Tipranavir,Ritonavir,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Dextromethorphan Hydrobromide,Midazolam,

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 18, 2014

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    09

    Boehringer Ingelheim GmbH

    Germany
    arrow
    DDL Conference
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    DDL Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Tipranavir,Ritonavir,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Dextromethorphan Hydrobromide,Midazolam,

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-gly...

    Details : Tipranavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 18, 2014

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    Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

    Details:

    Faldaprevir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Faldaprevir,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Dextromethorphan Hydrobromide,Midazolam Hydrochloride,Digoxin

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 08, 2014

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    10

    Boehringer Ingelheim GmbH

    Germany
    arrow
    DDL Conference
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    DDL Conference
    Not Confirmed
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    Lead Product(s) : Faldaprevir,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Dextromethorphan Hydrobromide,Midazolam Hydrochloride,Digoxin

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail...

    Details : Faldaprevir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 08, 2014

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    01

    Aspen Pharmacare Holdings

    South Africa
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    DDL Conference
    Not Confirmed
    • fda
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dextromethorphan Hydrobromide

    Brand Name : Sinuclear Cough Syrup

    Dosage Form : SOL

    Dosage Strength : 10mg/5ml

    Packaging : 100X1mg/5ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Dr. Reddy's Laboratories

    India
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    CPhI Milan
    Booth #5D18
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

    Packaging :

    Approval Date : 2018-12-04

    Application Number : 207676

    Regulatory Info : RX

    Registration Country : USA

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    03

    Dr. Reddy's Laboratories

    India
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    CPhI Milan
    Booth #5D18
    • fda
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    Regulatory Info : OTC

    Registration Country : USA

    DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

    Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 30MG;600MG

    Packaging :

    Approval Date : 2023-08-01

    Application Number : 217340

    Regulatory Info : OTC

    Registration Country : USA

    Dr Reddy Company Banner

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    04

    Dr. Reddy's Laboratories

    India
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    CPhI Milan
    Booth #5D18
    • fda
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    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
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    Regulatory Info : OTC

    Registration Country : USA

    DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

    Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 60MG;1.2GM

    Packaging :

    Approval Date : 2023-08-01

    Application Number : 217340

    Regulatory Info : OTC

    Registration Country : USA

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    05

    Octavius Pharma Pvt. Ltd

    India
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    DDL Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Regulatory Info :

    Registration Country : India

    Paracetamol; Caffeine; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide

    Brand Name : Paracetamol; Caffeine; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide

    Dosage Form : Tablet

    Dosage Strength : 500MG; 30MG; 10MG; 2MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    06

    Ah Robins

    Colombia
    DDL Conference
    Not Confirmed
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    Ah Robins

    Colombia
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    DDL Conference
    Not Confirmed
    • fda
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    • WHO-GMP
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    Regulatory Info : DISCN

    Registration Country : USA

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : DIMETANE-DX

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Packaging :

    Approval Date : 1984-08-24

    Application Number : 19279

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    ANI Pharmaceuticals Inc

    U.S.A
    DDL Conference
    Not Confirmed
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    ANI Pharmaceuticals Inc

    U.S.A
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    DDL Conference
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

    Brand Name : PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 15MG/5ML;6.25MG/5ML

    Packaging :

    Approval Date : 1984-04-02

    Application Number : 11265

    Regulatory Info : RX

    Registration Country : USA

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    08

    AVANIR PHARMS

    U.S.A
    DDL Conference
    Not Confirmed
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    AVANIR PHARMS

    U.S.A
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    DDL Conference
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

    Brand Name : NUEDEXTA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 20MG;10MG

    Packaging :

    Approval Date : 2010-10-29

    Application Number : 21879

    Regulatory Info : RX

    Registration Country : USA

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    09

    Reckitt Benckiser

    United Kingdom
    DDL Conference
    Not Confirmed
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    Reckitt Benckiser

    United Kingdom
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    DDL Conference
    Not Confirmed
    • fda
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    Regulatory Info : OTC

    Registration Country : USA

    DEXTROMETHORPHAN POLISTIREX

    Brand Name : DELSYM

    Dosage Form : SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 30MG HYDROBROMIDE/5ML

    Packaging :

    Approval Date : 1982-10-08

    Application Number : 18658

    Regulatory Info : OTC

    Registration Country : USA

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    10

    Reckitt Benckiser

    United Kingdom
    DDL Conference
    Not Confirmed
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    Reckitt Benckiser

    United Kingdom
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    DDL Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : OTC

    Registration Country : USA

    DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

    Brand Name : MUCINEX DM

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 60MG;1.2GM

    Packaging :

    Approval Date : 2004-04-29

    Application Number : 21620

    Regulatory Info : OTC

    Registration Country : USA

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    FDA Orange Book

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    01

    DR REDDYS LABS SA

    India
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    CPhI Milan
    Booth #5D18
    • fda
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    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
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    RLD : No

    TE Code : AA

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

    Approval Date : 2018-12-04

    Application Number : 207676

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    02

    DR REDDYS

    India
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    CPhI Milan
    Booth #5D18
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    RLD : No

    TE Code :

    DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

    Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 30MG;600MG

    Approval Date : 2023-08-01

    Application Number : 217340

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

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    03

    DR REDDYS

    India
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    CPhI Milan
    Booth #5D18
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
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    RLD : No

    TE Code :

    DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

    Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 60MG;1.2GM

    Approval Date : 2023-08-01

    Application Number : 217340

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

    Dr Reddy Company Banner

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    04

    ACELLA

    U.S.A
    DDL Conference
    Not Confirmed
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    ACELLA

    U.S.A
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    DDL Conference
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    Virtual Booth Virtual Booth
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    RLD : No

    TE Code : AA

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

    Approval Date : 2016-09-20

    Application Number : 203375

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    05

    ROBINS AH

    Colombia
    DDL Conference
    Not Confirmed
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    ROBINS AH

    Colombia
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    DDL Conference
    Not Confirmed
    • fda
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    RLD : Yes

    TE Code :

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : DIMETANE-DX

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1984-08-24

    Application Number : 19279

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    06

    ALKEM LABS LTD

    India
    DDL Conference
    Not Confirmed
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    ALKEM LABS LTD

    India
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    DDL Conference
    Not Confirmed
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    RLD : No

    TE Code : AA

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

    Approval Date : 2020-07-14

    Application Number : 210647

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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    07

    AMNEAL

    U.S.A
    DDL Conference
    Not Confirmed
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    AMNEAL

    U.S.A
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code :

    DEXTROMETHORPHAN POLISTIREX

    Brand Name : DEXTROMETHORPHAN POLISTIREX

    Dosage Form : SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 30MG HYDROBROMIDE/5ML

    Approval Date : 2017-07-28

    Application Number : 203133

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

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    08

    RB HLTH

    United Kingdom
    DDL Conference
    Not Confirmed
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    RB HLTH

    United Kingdom
    arrow
    DDL Conference
    Not Confirmed
    • fda
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    RLD : Yes

    TE Code :

    DEXTROMETHORPHAN POLISTIREX

    Brand Name : DELSYM

    Dosage Form : SUSPENSION, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 30MG HYDROBROMIDE/5ML

    Approval Date : 1982-10-08

    Application Number : 18658

    RX/OTC/DISCN : OTC

    RLD : Yes

    TE Code :

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    09

    WOCKHARDT

    India
    DDL Conference
    Not Confirmed
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    WOCKHARDT

    India
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    RLD : No

    TE Code :

    BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

    Brand Name : BROMFED-DM

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML

    Approval Date : 1988-12-22

    Application Number : 89681

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    HALSEY

    Country
    DDL Conference
    Not Confirmed
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    HALSEY

    Country
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    DDL Conference
    Not Confirmed
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    RLD : No

    TE Code :

    DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

    Brand Name : PHERAZINE DM

    Dosage Form : SYRUP;ORAL

    Dosage Strength : 15MG/5ML;6.25MG/5ML

    Approval Date : 1987-03-02

    Application Number : 88913

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Europe

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    01

    Bayer Hispania Sl

    Germany
    DDL Conference
    Not Confirmed
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    Bayer Hispania Sl

    Germany
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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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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    02

    Bayer Hispania Sl

    Germany
    DDL Conference
    Not Confirmed
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    Bayer Hispania Sl

    Germany
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    DDL Conference
    Not Confirmed
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Paracetamol; Pseudoephedrine Sulfate; Dextromethorphan Hydrobromide

    Brand Name : Larobeta

    Dosage Form : Powder For Oral Solution

    Dosage Strength : 500MG; 30MG; 15 MG

    Packaging :

    Approval Date : 2012-04-15

    Application Number : 75767

    Regulatory Info : Cancelled

    Registration Country : Spain

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    03

    Bayer Hispania Sl

    Germany
    DDL Conference
    Not Confirmed
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    Bayer Hispania Sl

    Germany
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    DDL Conference
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Sodium Benzoate; Dextromethorphan Hydrobromide

    Brand Name : Dr. Andreu'S Pills

    Dosage Form : Lozenge

    Dosage Strength : 2MG; 15 MG

    Packaging :

    Approval Date : 1989-06-01

    Application Number : 57875

    Regulatory Info : Cancelled

    Registration Country : Spain

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    04

    Cinfa Laboratories Sa

    Spain
    DDL Conference
    Not Confirmed
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    Cinfa Laboratories Sa

    Spain
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    DDL Conference
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide; Diphenhydramine Hydrochloride

    Brand Name : Cinfatos Night

    Dosage Form : Solution

    Dosage Strength : 1.33MG; 2MG

    Packaging :

    Approval Date : 2020-12-22

    Application Number : 85664

    Regulatory Info : Authorized

    Registration Country : Spain

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    05

    Cinfa Laboratories Sa

    Spain
    DDL Conference
    Not Confirmed
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    Cinfa Laboratories Sa

    Spain
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Cinfatos

    Dosage Form : Oral Solution

    Dosage Strength : 2MG

    Packaging :

    Approval Date : 1988-07-01

    Application Number : 57623

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Normon Laboratories Sa

    Spain
    DDL Conference
    Not Confirmed
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    Normon Laboratories Sa

    Spain
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    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Paracetamol; Chlorphenamine Maleate; Dextromethorphan Hydrobromide

    Brand Name : Normogrip Antitusive Granulated For Oral Solution

    Dosage Form : Oral Solution

    Dosage Strength :

    Packaging :

    Approval Date : 2023-03-01

    Application Number : 88698

    Regulatory Info : Authorized

    Registration Country : Spain

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    07

    Medochemie Limited

    Cyprus
    DDL Conference
    Not Confirmed
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    Medochemie Limited

    Cyprus
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Minustosan

    Dosage Form : Syrup

    Dosage Strength : 1.5MG

    Packaging :

    Approval Date : 2021-06-04

    Application Number : 84688

    Regulatory Info : Authorized

    Registration Country : Spain

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    08

    TAD Pharma GmbH

    Germany
    DDL Conference
    Not Confirmed
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    TAD Pharma GmbH

    Germany
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    DDL Conference
    Not Confirmed
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    Regulatory Info : Authorised

    Registration Country : Malta

    Paracetamol; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide

    Brand Name : Daleron Cold3

    Dosage Form : Film Coated Tablet

    Dosage Strength : 325MG; 30MG; 15MG

    Packaging :

    Approval Date : 2022-01-07

    Application Number :

    Regulatory Info : Authorised

    Registration Country : Malta

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    09

    Aurovitas Spain, Sau

    Country
    DDL Conference
    Not Confirmed
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    Aurovitas Spain, Sau

    Country
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    DDL Conference
    Not Confirmed
    • fda
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    Regulatory Info : Cancelled

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Aurotos

    Dosage Form : Oral Solution

    Dosage Strength : 15MG

    Packaging :

    Approval Date : 2014-04-11

    Application Number : 78676

    Regulatory Info : Cancelled

    Registration Country : Spain

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    10

    Lainco Sa

    Country
    DDL Conference
    Not Confirmed
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    Lainco Sa

    Country
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Authorized

    Registration Country : Spain

    Dextromethorphan Hydrobromide

    Brand Name : Laitos

    Dosage Form : Syrup

    Dosage Strength : 3MG

    Packaging :

    Approval Date : 2009-06-03

    Application Number : 70997

    Regulatory Info : Authorized

    Registration Country : Spain

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    Canada

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    01

    HALEON CANADA ULC

    United Kingdom
    DDL Conference
    Not Confirmed
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    HALEON CANADA ULC

    United Kingdom
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    DDL Conference
    Not Confirmed
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    Flag United Kingdom
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : BUCKLEY'S COLD & SINUS 24 HOUR PACK

    Dosage Form : KIT

    Dosage Strength : 15MG

    Packaging :

    Approval Date :

    Application Number : 2493802

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    02

    HALEON CANADA ULC

    United Kingdom
    DDL Conference
    Not Confirmed
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    HALEON CANADA ULC

    United Kingdom
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : BUCKLEY'S DRY COUGH EXTRA STRENGTH

    Dosage Form : SOLUTION

    Dosage Strength : 15MG/5ML

    Packaging :

    Approval Date :

    Application Number : 2511320

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    03

    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
    DDL Conference
    Not Confirmed
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    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : BENYLIN EXTRA STRENGTH DRY COUGH

    Dosage Form : SYRUP

    Dosage Strength : 30MG/10ML

    Packaging : 100ML/250ML

    Approval Date :

    Application Number : 1944738

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    04

    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
    DDL Conference
    Not Confirmed
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    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
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    DDL Conference
    Not Confirmed
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : CHILDREN'S TYLENOL COLD AND COUGH

    Dosage Form : SUSPENSION

    Dosage Strength : 7.5MG/5ML

    Packaging : 100ML

    Approval Date :

    Application Number : 2039990

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    05

    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
    DDL Conference
    Not Confirmed
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    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
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    DDL Conference
    Not Confirmed
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : BENYLIN EXTRA STRENGTH ALL-IN-ONE COUGH, COLD & FLU

    Dosage Form : SYRUP

    Dosage Strength : 15MG/15ML

    Packaging : 180 ML

    Approval Date :

    Application Number : 2245710

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    06

    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
    DDL Conference
    Not Confirmed
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    MCNEIL CONSUMER HEALTHCARE DIVISION OF J...

    Germany
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    DDL Conference
    Not Confirmed
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : BENYLIN EXTRA STRENGTH COUGH & CHEST CONGESTION

    Dosage Form : SYRUP

    Dosage Strength : 15MG/5ML

    Packaging : 100ML/250ML

    Approval Date :

    Application Number : 2265419

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    07

    PROCTER & GAMBLE INC

    U.S.A
    DDL Conference
    Not Confirmed
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    PROCTER & GAMBLE INC

    U.S.A
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    DDL Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : NYQUIL KIDS COUGH & COLD

    Dosage Form : SYRUP

    Dosage Strength : 15MG/15ML

    Packaging :

    Approval Date :

    Application Number : 2273330

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    08

    PROCTER & GAMBLE INC

    U.S.A
    DDL Conference
    Not Confirmed
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    PROCTER & GAMBLE INC

    U.S.A
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    DDL Conference
    Not Confirmed
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : NYQUIL COLD & FLU ALCOHOL FREE

    Dosage Form : SYRUP

    Dosage Strength : 30MG/30ML

    Packaging :

    Approval Date :

    Application Number : 2551667

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    09

    VITA HEALTH PRODUCTS INC

    Canada
    DDL Conference
    Not Confirmed
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    VITA HEALTH PRODUCTS INC

    Canada
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    DDL Conference
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : COLD AND FLU-IN-ONE EXTRA STRENGTH

    Dosage Form : TABLET

    Dosage Strength : 15MG

    Packaging : Dec-24

    Approval Date :

    Application Number : 2281147

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    10

    VITA HEALTH PRODUCTS INC

    Canada
    DDL Conference
    Not Confirmed
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    VITA HEALTH PRODUCTS INC

    Canada
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    DDL Conference
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    Virtual Booth Virtual Booth
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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    DEXTROMETHORPHAN HYDROBROMIDE

    Brand Name : COLD AND SINUS COMPLETE LIQUID GELS

    Dosage Form : CAPSULE

    Dosage Strength : 10MG

    Packaging : 10/20/30/40

    Approval Date :

    Application Number : 2349523

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    South Africa

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    01

    Pharmacare Limited, Woodmead

    South Africa
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    Virtual Booth Virtual Booth
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dextromethorphan Hydrobromide

    Brand Name : Sinuclear Cough Syrup

    Dosage Form : SOL

    Dosage Strength : 10mg/5ml

    Packaging : 100X1mg/5ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Acino Pharma (Pty) Ltd

    Switzerland
    DDL Conference
    Not Confirmed
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    Acino Pharma (Pty) Ltd

    Switzerland
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    DDL Conference
    Not Confirmed
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    Dextromethorphan Hydrobromide

    Brand Name : Sinustat Flu Syrup

    Dosage Form : SYR

    Dosage Strength : 15mg

    Packaging : 200X1mg

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    Dextromethorphan Hydrobromide

    Brand Name : Dilinct Dry Cough Syrup

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    Brand Name : Dilinct Dry Cough Syrup

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    Dextromethorphan Hydrobromide

    Brand Name : Cepacol Sore Throat And Cough Relief Discs

    Dosage Form : LOZ

    Dosage Strength : 4.98mg

    Packaging : 16X1mg

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    Cipla Medpro (Pty) Ltd

    South Africa
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    Dextromethorphan HBr

    Brand Name : Broncol Cough Linctus

    Dosage Form : SYR

    Dosage Strength : 30mg/10 ml

    Packaging : 200X1mg/10 ml

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    iNova Pharmaceuticals (Pty) Ltd

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    Dextromethorphan Hydrobromide

    Brand Name : Demazin Flu

    Dosage Form : EFT

    Dosage Strength : 20mg

    Packaging : 12X1mg

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    Dextromethorphan Hydrobromide

    Brand Name : Benylin Dry Cough

    Dosage Form : SYR

    Dosage Strength : 15mg/5ml

    Packaging : 100X1mg/5ml

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    Brand Name : Benylin Dry Cough

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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 hydrobromide anhydrous Manufacturers

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

    Dextromethorphan hydrobromide anhydrous Suppliers

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

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

    Dextromethorphan hydrobromide anhydrous USDMF

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

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

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

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

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

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

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

    Dextromethorphan hydrobromide anhydrous CEP

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

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

    Dextromethorphan hydrobromide anhydrous WC

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

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

    Dextromethorphan hydrobromide anhydrous 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 hydrobromide anhydrous as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dextromethorphan hydrobromide anhydrous GMP

    Dextromethorphan hydrobromide anhydrous 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 hydrobromide anhydrous 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 hydrobromide anhydrous GMP manufacturer or Dextromethorphan hydrobromide anhydrous GMP API supplier for your needs.

    Dextromethorphan hydrobromide anhydrous CoA

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

    Dextromethorphan hydrobromide anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Dextromethorphan hydrobromide anhydrous 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 hydrobromide anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (Dextromethorphan hydrobromide anhydrous EP), Dextromethorphan hydrobromide anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dextromethorphan hydrobromide anhydrous 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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