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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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LTD","supplierCountry":"INDIA","foreign_port":"NAPLES(ITALY)","customer":"UNDISCLOSED","customerCountry":"ITALY","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"292.5","totalValueFC":"288321.7","currency":"USD","unitRateINR":24680.84735,"date":"23-Apr-2025","totalValueINR":"24680847.35","totalValueInUsd":"288321.7","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"1182335","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"DC-SEZ Unit at Choutuppal Telangana","supplierAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD, HYDERABAD,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745605800,"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":"TAIPEI","customer":"JIM ROYAL TRADING COLTD","customerCountry":"TAIWAN","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"103","totalValueFC":"15016.8","currency":"USD","unitRateINR":8569.775866666665,"date":"26-Apr-2025","totalValueINR":"1285466.38","totalValueInUsd":"15016.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"1289500","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL, TALUQ,MEDAK DIST.,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746210600,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP 43","address":"PLOT NO.174,PROGRESSIVE INDUSTRIAL","city":"TALUQ,MEDAK DIST.,A.P.","supplier":"HY GRO CHEMICALS PHARMTEK PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"DONG NAI PHARMACEUTICAL JOINT STOCK","customerCountry":"VIETNAM","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"75","totalValueFC":"36092.1","currency":"USD","unitRateINR":6150.1360000000004,"date":"03-May-2025","totalValueINR":"3075068","totalValueInUsd":"36092.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"1502604","productDescription":"API","marketType":"","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL, TALUQ,MEDAK DIST.,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746469800,"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":"BANCOUVER","customer":"CRL SYNERGY","customerCountry":"CANADA","quantity":"52.00","actualQuantity":"52","unit":"KGS","unitRateFc":"275","totalValueFC":"13555.3","currency":"USD","unitRateINR":22210,"date":"06-May-2025","totalValueINR":"1154920","totalValueInUsd":"13555.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"1566993","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL, TALUQ,MEDAK DIST.,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747765800,"product":"DEXTROMETHORPHAN HBR PH.EUR","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"DIVIS LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"MILANO","customer":"UNDISCLOSED","customerCountry":"ITALY","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"332.5","totalValueFC":"28946.4","currency":"EURO","unitRateINR":30828.144,"date":"21-May-2025","totalValueINR":"2466251.52","totalValueInUsd":"28946.4","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"2005883","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"DC-SEZ Unit at Choutuppal Telangana","supplierAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD, HYDERABAD,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749666600,"product":"DEXTROMETHORPHAN HYDROBROMIDE JP (WE INTEDND TO CLAIM REWARDS UNDER MERCHANDISE EXPORT FROM INDIA SCHEME ARN","address":"D\/607 SAHAR PLAZA, BLDG-3, A TO H,","city":"ANDHERI EAST,MAHARASHTRA","supplier":"OCEANIC PHARMACHEM PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"TOKYO - NARITA","customer":"THE BANK OF TOKYO","customerCountry":"JAPAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"500","totalValueFC":"444.4","currency":"USD","unitRateINR":38187.449999999997,"date":"12-Jun-2025","totalValueINR":"38187.45","totalValueInUsd":"444.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"2635215","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"D\/607 SAHAR PLAZA, BLDG-3, A TO H,, ANDHERI EAST,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750357800,"product":"BULK DRUGS - DEXTROMETHORPHAN HYDROBROMIDE USP","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"WOCKHARDT LTD","supplierCountry":"INDIA","foreign_port":"ASUNCION","customer":"SWISS PHARMA GROUP S A","customerCountry":"PARAGUAY","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"110","totalValueFC":"15737.6","currency":"USD","unitRateINR":9015.0777333333335,"date":"20-Jun-2025","totalValueINR":"1352261.66","totalValueInUsd":"15737.6","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"2880945","productDescription":"API","marketType":"","country":"PARAGUAY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"WOCKHARDT TOWERS, BANDRA KURLA, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750876200,"product":"DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE PH.EUR","address":"PLOT NO.174,PROGRESSIVE INDUSTRIAL","city":"TALUQ,MEDAK DIST.,A.P.","supplier":"HY GRO CHEMICALS PHARMTEK PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"LISBON","customer":"LUSOMEDICAMENTA S A","customerCountry":"PORTUGAL","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"170","totalValueFC":"16178.7","currency":"USD","unitRateINR":13901.639999999999,"date":"26-Jun-2025","totalValueINR":"1390164","totalValueInUsd":"16178.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3038969","productDescription":"API","marketType":"REGULATED MARKET","country":"PORTUGAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL, TALUQ,MEDAK DIST.,A.P.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"DEXTROMETHORPHAN HBR USP","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"SUN PHARMACEUTICAL INDUSTRIES LTD","customerCountry":"INDIA","quantity":"498.55","actualQuantity":"498.55","unit":"KGS","unitRateFc":"229.1","totalValueFC":"115115.2","currency":"USD","unitRateINR":"20000","date":"26-Mar-2025","totalValueINR":"9971000","totalValueInUsd":"115115.2","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"9102499","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"CHOUTUPPAL MANDAL,LINGOJIGUDEM (V) YADADRI-BHUVANAGIRI SDNF India","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748370600,"product":"DEXTROMETHORPHAN HBR USP","address":"11TH FLOOR, LOTUS BUSINESS PARK,","city":"MUMBAI,MAHARASHTRA","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"MARKSANS PHARMA LTD","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"123.8","totalValueFC":"18837.9","currency":"USD","unitRateINR":"10700","date":"28-May-2025","totalValueINR":"1605000","totalValueInUsd":"18837.9","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"2325538","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"CHOUTUPPAL MANDAL,LINGOJIGUDEM (V) YADADRI-BHUVANAGIRI SDNF India","customerAddress":"11TH FLOOR, LOTUS BUSINESS PARK,"}]
    07-Feb-2022
    26-Jun-2025
    KGS
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    DRUG PRODUCT COMPOSITIONS

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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.

    MUCINEX DM Manufacturers

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

    MUCINEX DM Suppliers

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

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

    MUCINEX DM USDMF

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

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

    click here to find a list of MUCINEX DM suppliers with USDMF on PharmaCompass.

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

    MUCINEX DM KDMF

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

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

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

    click here to find a list of MUCINEX DM suppliers with KDMF on PharmaCompass.

    MUCINEX DM CEP

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

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

    MUCINEX DM WC

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

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

    MUCINEX DM 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 MUCINEX DM as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of MUCINEX DM suppliers with NDC on PharmaCompass.

    MUCINEX DM GMP

    MUCINEX DM 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 MUCINEX DM 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 MUCINEX DM GMP manufacturer or MUCINEX DM GMP API supplier for your needs.

    MUCINEX DM CoA

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

    MUCINEX DM CoA mostly includes findings from lab analyses of a specific batch. For each MUCINEX DM 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.

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