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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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CAIRO)","customer":"UNDISCLOSED","customerCountry":"EGYPT","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"90","totalValueFC":"8557.8","currency":"USD","unitRateINR":7353.2954,"date":"09-Jun-2025","totalValueINR":"735329.54","totalValueInUsd":"8557.8","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"2538567","productDescription":"API","marketType":"","country":"EGYPT","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":1749407400,"product":"DEXTROMETHORPHAN HBR IP","address":"BG-533, SANJAY GANDHI TRANSPORT","city":"DELHI","supplier":"DRUG CENTRE DELHI PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BHAIRAWA","customer":"NEPAL REMEDIES LTD","customerCountry":"NEPAL","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"6750","totalValueFC":"394.9","currency":"INR","unitRateINR":6785.5419999999995,"date":"09-Jun-2025","totalValueINR":"33927.71","totalValueInUsd":"394.9","indian_port":"Sonauli","hs_no":"29339990","bill_no":"2549463","productDescription":"API","marketType":"","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Sonauli","supplierAddress":"BG-533, SANJAY GANDHI TRANSPORT, DELHI","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":"2024","qtr":"Q4","strtotime":1728239400,"product":"DEXTROMETHORPHAN HBR IP","address":"A - SHIVSAGAR ESTATE,","city":"MUMBAI, MAHARASHTRA","supplier":"DIVIS LABORATORIES LTD DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PROCTER GAMBLE HEALTH LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"232.2","totalValueFC":"11726.1","currency":"USD","unitRateINR":"19706","date":"07-Oct-2024","totalValueINR":"985300","totalValueInUsd":"11726.1","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"5986146","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"CHOUTUPPAL MANDAL, LINGOJIGUDEM VILLAGE, YADADRI BHUVANGIRI SDNF India","customerAddress":"A - SHIVSAGAR ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728412200,"product":"DEXTROMETHORPHAN HBR IP","address":"21 BHANGWADI SHOPPING ARCADE","city":"MUMBAI","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"API PHARMA","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"61.3","totalValueFC":"37131.1","currency":"USD","unitRateINR":"5200","date":"09-Oct-2024","totalValueINR":"3120000","totalValueInUsd":"37131.1","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"6024595","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF India","customerAddress":"21 BHANGWADI SHOPPING ARCADE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729276200,"product":"DEXTROMETHORPHAN HBR USP","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"CAPLIN POINT LABORATORIES LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"105.9","totalValueFC":"1071.1","currency":"USD","unitRateINR":"9000","date":"19-Oct-2024","totalValueINR":"90000","totalValueInUsd":"1071.1","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"6208473","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF India","customerAddress":"NARBAVI, NO.3,LAKSHMANAN STREET,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744137000,"product":"DEXTROMETHORPHAN HBR IP","address":"A - SHIVSAGAR ESTATE,","city":"MUMBAI, MAHARASHTRA","supplier":"DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PROCTER GAMBLE HEALTH LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"210.2","totalValueFC":"10633","currency":"USD","unitRateINR":"18204","date":"09-Apr-2025","totalValueINR":"910200","totalValueInUsd":"10633","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"9377330","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"CHOUTUPPAL MANDAL, LINGOJIGUDEM VILLAGE, YADADRI-BHUVANAGIRI SDNF India","customerAddress":"A - SHIVSAGAR ESTATE,"}]
01-Feb-2022
26-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

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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 Manufacturers

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

Dextromethorphan Hydrobromide Suppliers

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

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

Dextromethorphan Hydrobromide USDMF

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

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

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

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

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

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

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

Dextromethorphan Hydrobromide CEP

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

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

Dextromethorphan Hydrobromide WC

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

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

Dextromethorphan Hydrobromide 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Dextromethorphan Hydrobromide GMP

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

Dextromethorphan Hydrobromide CoA

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

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