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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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PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"CALLAO","customer":"UNDISCLOSED","customerCountry":"PERU","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"73","totalValueFC":"14266.1","currency":"USD","unitRateINR":6339.9375,"date":"13-Nov-2025","totalValueINR":"1267987.5","totalValueInUsd":"14266.1","indian_port":"JNPT","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"","country":"PERU","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":1763058600,"product":"DEXTROMETHORPHAN HYDROBROMIDE BP (PHARMACEUTICAL RAW MATERIAL)","address":"1ST FLOOR ABS TOWERS","city":"BARODA","supplier":"ONEIRO LIFECARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"UNDISCLOSED","customerCountry":"BANGLADESH","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"77","totalValueFC":"6812.2","currency":"USD","unitRateINR":6054.75,"date":"14-Nov-2025","totalValueINR":"605475","totalValueInUsd":"6812.2","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"9","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"1ST FLOOR ABS TOWERS, BARODA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1763145000,"product":"DEXTROMETHORPHAN HYDROBROMIDE IP","address":"26, Ghanshyam Park Society,","city":"Ahmedabad","supplier":"SPIRANTI","supplierCountry":"INDIA","foreign_port":"BIRGUNJ","customer":"CUREX PHARMACEUTICALS PVTLTD","customerCountry":"NEPAL","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"5565","totalValueFC":"1565.3","currency":"INR","unitRateINR":5565,"date":"15-Nov-2025","totalValueINR":"139125","totalValueInUsd":"1565.3","indian_port":"Raxaul","hs_no":"29339990","bill_no":"731","productDescription":"API","marketType":"","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"26, Ghanshyam Park Society,, Ahmedabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1763404200,"product":"DEXTROMETHORPHAN HYDROBROMIDE BP (PHARMACEUTICAL RAW MATERIAL)","address":"PLOT NO.174,PROGRESSIVE INDUSTRIAL","city":"TALUQ,MEDAK DIST.,A.P.","supplier":"HY GRO CHEMICALS PHARMTEK PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"PUBALI BANK PLC","customerCountry":"BANGLADESH","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"85","totalValueFC":"8143.6","currency":"USD","unitRateINR":7238.1499999999996,"date":"18-Nov-2025","totalValueINR":"723815","totalValueInUsd":"8143.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"","country":"BANGLADESH","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":"Q4","strtotime":1764095400,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP -BULKDRUGS","address":"WOCKHARDT TOWERS, BANDRA KURLA","city":"MUMBAI, MAHARASHTRA.","supplier":"WOCKHARDT LTD","supplierCountry":"INDIA","foreign_port":"CAT LAI","customer":"PHUC THAI PHARMA JOINT STOCK COMPAN","customerCountry":"VIETNAM","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"82","totalValueFC":"80800","currency":"USD","unitRateINR":7181.5834400000003,"date":"26-Nov-2025","totalValueINR":"7181583.44","totalValueInUsd":"80800","indian_port":"JNPT","hs_no":"29339990","bill_no":"56993","productDescription":"API","marketType":"","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"WOCKHARDT TOWERS, BANDRA KURLA, MUMBAI, MAHARASHTRA.","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":1721327400,"product":"SAMPLE - XF051, XF052 DEXTROMETHORPHAN HYDROBROMIDE BASE USP(FOC) (LICENCE NUMBER: TL\/WZ\/21\/005061 DT:24-NOV-2021)","address":"C-112, PAWANE, TTC, MIDC,INDUSTRIA","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"PROSLYN JEANSTSURIN","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK","customer":"FIRST TIME US PHARMACEUTICALS INDIA PRIVATE LIMI","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"60","totalValueFC":"139.1","currency":"USD","unitRateINR":"5815.8","date":"19-Jul-2024","totalValueINR":"11631.69","totalValueInUsd":"139.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4598837","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK","supplierAddress":"13900 NW 57TH COURT MIAMI LAKES Miami Lakes - 0, , United StatesSDNF United States","customerAddress":"C-112, PAWANE, TTC, MIDC,INDUSTRIA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751567400,"product":"DEXTROMETHORPHAN HYDROBROMIDE USP (AS INV)(RETURN TO ORIGINFROM TRANSHIPMENT PORT SB.NO.7115898 DT.08.01.2025)DEXTROMETHORPHAN HYDROBROMIDE USP (AS INV)(RETURN TO ORIGIN","address":"PLOT NO.174,PROGRESSIVE INDUSTRIAL","city":"TALUQ,MEDAK DIST.,A.P.","supplier":"JIM ROYAL TRADING CO., LTD..","supplierCountry":"TAIWAN","foreign_port":"KEELUNG (CHILUNG)","customer":"HY GRO CHEMICALS PHARMTEK PRIVATE LTD","customerCountry":"INDIA","quantity":"900.00","actualQuantity":"900","unit":"KGS","unitRateFc":"101","totalValueFC":"91041.6","currency":"USD","unitRateINR":"8706.2","date":"04-Jul-2025","totalValueINR":"7835580","totalValueInUsd":"91041.6","indian_port":"Hyderabad ICD","hs_no":"29339990","bill_no":"3048528","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KEELUNG (CHILUNG)","supplierAddress":"6-2 FL., NO.341, SEC.4TH HSIN-YI RD, 106 TAIPEI, TAIWAN, R.O.C TW","customerAddress":"PLOT NO.174,PROGRESSIVE INDUSTRIAL"}]
06-Jan-2022
26-Nov-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.

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE Manufacturers

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

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE Suppliers

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

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

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE USDMF

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

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

click here to find a list of PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE suppliers with USDMF on PharmaCompass.

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

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

After submitting a PROMETHAZINE HYDROCHLORIDE; 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 PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE API can apply through the Korea Drug Master File (KDMF).

click here to find a list of PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE suppliers with KDMF on PharmaCompass.

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE CEP

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

A PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PROMETHAZINE HYDROCHLORIDE; 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 PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE suppliers with CEP (COS) on PharmaCompass.

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE WC

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

click here to find a list of PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE suppliers with Written Confirmation (WC) on PharmaCompass.

PROMETHAZINE HYDROCHLORIDE; 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 PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE suppliers with NDC on PharmaCompass.

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE GMP

PROMETHAZINE HYDROCHLORIDE; 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 PROMETHAZINE HYDROCHLORIDE; 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 PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE GMP manufacturer or PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE GMP API supplier for your needs.

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE CoA

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

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE CoA mostly includes findings from lab analyses of a specific batch. For each PROMETHAZINE HYDROCHLORIDE; 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.

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