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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":"COLOMBO","customer":"ASTRON LTD","customerCountry":"SRI LANKA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"135","totalValueFC":"3194.5","currency":"USD","unitRateINR":10979.6828,"date":"17-Jun-2025","totalValueINR":"274492.07","totalValueInUsd":"3194.5","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"2786104","productDescription":"API","marketType":"","country":"SRI LANKA","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 Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1751049000,"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":"ZURICH","customer":"SELECTCHEMIE AG","customerCountry":"SWITZERLAND","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"215","totalValueFC":"925","currency":"USD","unitRateINR":15895.65,"date":"28-Jun-2025","totalValueINR":"79478.25","totalValueInUsd":"925","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3126380","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL, TALUQ,MEDAK DIST.,A.P.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704133800,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP(AS INV)(REJECT & RETURN VIDE SB NO.9188803 DT.10.04.2023)","address":"PLOT NO.174,PROGRESSIVE INDUSTRIAL","city":"TALUQ,MEDAK DIST.,A.P.","supplier":"JIM ROYAL TRADING COLTD","supplierCountry":"TAIWAN","foreign_port":"KEELUNG (CHILUNG)","customer":"HY GRO CHEMICALS PHARMTEK PRIVATE LTD","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"113","totalValueFC":"34180.7","currency":"USD","unitRateINR":"9469.4","date":"02-Jan-2024","totalValueINR":"2840820","totalValueInUsd":"34180.7","indian_port":"Hyderabad ICD","hs_no":"29339990","bill_no":"9507337","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KEELUNG (CHILUNG)","supplierAddress":"6-2 FL NO.341,SEC.4THHSIN-YI RD,106 TAIPEI,TAIWAN,R.O.C TW","customerAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"DEXTROMETHORPHAN HBR USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"214.7","totalValueFC":"108739.5","currency":"USD","unitRateINR":"18225","date":"09-Sep-2024","totalValueINR":"9112500","totalValueInUsd":"108739.5","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"5493216","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE, CHOUTUPPAL MA YADADRI BHUVANAGIRI DISTRICT, SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728412200,"product":"DEXTROMETHORPHAN HBR USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"292.2","totalValueFC":"590.2","currency":"USD","unitRateINR":"24795","date":"09-Oct-2024","totalValueINR":"49590","totalValueInUsd":"590.2","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"6024485","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737916200,"product":"DEXTROMETHORPHAN HBR IP","address":"PFIZER CENTRE,5,PATEL ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PFIZER LTD","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"74.2","totalValueFC":"29997","currency":"USD","unitRateINR":"6466.5","date":"27-Jan-2025","totalValueINR":"2586616","totalValueInUsd":"29997","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"8015034","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF","customerAddress":"PFIZER CENTRE,5,PATEL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748543400,"product":"DEXTROMETHORPHAN HBR BP","address":"PNO 67 68 1STFLR RAMAKRISHNA","city":"KORATTUR NORTH CHENNAI","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PHARMARULE","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"75.2","totalValueFC":"9536.3","currency":"USD","unitRateINR":"6500","date":"30-May-2025","totalValueINR":"812500","totalValueInUsd":"9536.3","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"2363569","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE,CHOUTUPPAL (M) YADADRI-BHUVANAGIRI (D) SDNF India","customerAddress":"PNO 67 68 1STFLR RAMAKRISHNA"}]
    19-Jan-2022
    28-Jun-2025
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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.

    Delsym Manufacturers

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

    Delsym Suppliers

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

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

    Delsym USDMF

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

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

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

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

    Delsym KDMF

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

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

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

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

    Delsym CEP

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

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

    Delsym WC

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

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

    Delsym 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 Delsym as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Delsym GMP

    Delsym 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 Delsym 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 Delsym GMP manufacturer or Delsym GMP API supplier for your needs.

    Delsym CoA

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

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

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