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Also known as: 50-98-6, (-)-ephedrine hydrochloride, L-ephedrine hydrochloride, 1-ephedrine hydrochloride, Ephedrine hcl, Ephedrine (hydrochloride)
Molecular Formula
C10H16ClNO
Molecular Weight
201.69  g/mol
InChI Key
BALXUFOVQVENIU-GNAZCLTHSA-N
FDA UNII
NLJ6390P1Z

Ephedrine Hydrochloride
A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.
1 2D Structure

Ephedrine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,2S)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride
2.1.2 InChI
InChI=1S/C10H15NO.ClH/c1-8(11-2)10(12)9-6-4-3-5-7-9;/h3-8,10-12H,1-2H3;1H/t8-,10-;/m0./s1
2.1.3 InChI Key
BALXUFOVQVENIU-GNAZCLTHSA-N
2.1.4 Canonical SMILES
CC(C(C1=CC=CC=C1)O)NC.Cl
2.1.5 Isomeric SMILES
C[C@@H]([C@@H](C1=CC=CC=C1)O)NC.Cl
2.2 Other Identifiers
2.2.1 UNII
NLJ6390P1Z
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ephedrine

2. Ephedrine Erythro Isomer

3. Ephedrine Renaudin

4. Ephedrine Sulfate

5. Erythro Isomer Of Ephedrine

6. Hydrochloride, Ephedrine

7. Renaudin, Ephedrine

8. Sal Phedrine

9. Sal-phedrine

10. Salphedrine

11. Sulfate, Ephedrine

2.3.2 Depositor-Supplied Synonyms

1. 50-98-6

2. (-)-ephedrine Hydrochloride

3. L-ephedrine Hydrochloride

4. 1-ephedrine Hydrochloride

5. Ephedrine Hcl

6. Ephedrine (hydrochloride)

7. Nlj6390p1z

8. Nsc-759611

9. Ephedronguent

10. (1r,2s)-2-(methylamino)-1-phenylpropan-1-ol Hydrochloride

11. Altusin

12. Dsstox_cid_25825

13. Dsstox_rid_81156

14. Dsstox_gsid_45825

15. Ephedrinium Chloride

16. L-ephedrine, Hydrochloride

17. (-)-ephedrin Hydrochloride

18. Cas-50-98-6

19. Einecs 200-074-6

20. (1r,2s)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride

21. Unii-nlj6390p1z

22. Ephedrine Hydrochloride [usan:ban:jan]

23. Ncgc00094665-01

24. Rezipres

25. (1r,2s)-(-)-ephedrine Hydrochloride

26. Ephedrini Hydrochloridum

27. N-methyl-beta-oxy-beta-phenylisopropylaminhydrochlorid [german]

28. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (r-(r*,s*))-

29. Ec 200-074-6

30. Schembl22822

31. Ephedrine Hydrochloride (tn)

32. Ephedrine Hydrochloride Racemic

33. N-methyl-beta-oxy-beta-phenylisopropylaminhydrochlorid

34. Chembl2146102

35. Dtxsid1045825

36. Chebi:31541

37. Hy-b1195a

38. Str01942

39. Ephedrine Hydrochloride [mi]

40. Tox21_111310

41. Ephedrine Hydrochloride (jp17/usp)

42. Ephedrine Hydrochloride [jan]

43. Akos015895154

44. Tox21_111310_1

45. Ccg-229523

46. Cs-4803

47. Ephedrine Hydrochloride [mart.]

48. Ephedrine Hydrochloride [vandf]

49. Nsc 759611

50. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride, (.alpha.r)-

51. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride, (alphar)-

52. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (theta-(theta,s))-

53. Ephedrine Hydrochloride [usp-rs]

54. Ephedrine Hydrochloride [who-dd]

55. Ephedrine Hydrochloride [who-ip]

56. Ncgc00015408-03

57. (1r,2s)-(-)-ephedrinehydrochloride

58. Ephedrine Hydrochloride [ep Impurity]

59. Ephedrine Hydrochloride [orange Book]

60. (-)-ephedrine Hydrochloride [who-ip]

61. (1r,2s)-(-)-ephedrine Hydrochloride, 99%

62. Ephedrine Hydrochloride [ep Monograph]

63. D01386

64. Ephedrine Hydrochloride [usp Monograph]

65. Ephedrini Hydrochloridum [who-ip Latin]

66. 066e127

67. Q27284939

68. (1r,2s)-ephedrine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

69. Ephedrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

70. (r-(r*,s*))-.alpha.-(1-(methylamino)ethyl)benzenemethanol Hydrochloride [who-ip]

71. Benzenemethanol, .alpha.-(1-(methylamino)ethyl)-, Hydrochloride, (r-(r*,s*))-

72. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride (1:1), (alphar)-

73. Ephedrine Hydrochloride, Drug Precursor, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 201.69 g/mol
Molecular Formula C10H16ClNO
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count2
Rotatable Bond Count3
Exact Mass201.0920418 g/mol
Monoisotopic Mass201.0920418 g/mol
Topological Polar Surface Area32.3 Ų
Heavy Atom Count13
Formal Charge0
Complexity121
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Adrenergic Agents

Drugs that act on adrenergic receptors or affect the life cycle of adrenergic transmitters. Included here are adrenergic agonists and antagonists and agents that affect the synthesis, storage, uptake, metabolism, or release of adrenergic transmitters. (See all compounds classified as Adrenergic Agents.)


Sympathomimetics

Drugs that mimic the effects of stimulating postganglionic adrenergic sympathetic nerves. Included here are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters. (See all compounds classified as Sympathomimetics.)


Central Nervous System Stimulants

A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)


Vasoconstrictor Agents

Drugs used to cause constriction of the blood vessels. (See all compounds classified as Vasoconstrictor Agents.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Adrenergic beta-Agonists [MoA]; Increased Norepinephrine Activity [PE]; Norepinephrine Releasing Agent [EPC]; alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [EPC]; Adrenergic alpha-Agonists [MoA]

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ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650565800,"product":"RE-IMPORT OF PSEUDOEPHEDRINE HYDROCHLORIDE USP\/BP BATCH NO.210920 MFG DT.JUNE 2020,EXP DT.MAY 2025(INDIAN ORIGIN GOODS)","address":"501, SENTINEL, HIRANANDANI GARDENS ,POWAI","city":"POWAI MUMBAI,MAHARASHTRA","supplier":"ACETO PTE LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"EMBIO LTD","customerCountry":"INDIA","quantity":"999.84","actualQuantity":"999.837","unit":"KGS","unitRateFc":"50","totalValueFC":"52842.7","currency":"USD","unitRateINR":"3987.6","date":"22-Apr-2022","totalValueINR":"3986925.17","totalValueInUsd":"52842.7","indian_port":"JNPT","hs_no":"29394200","bill_no":"8383463","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"501, SENTINEL, HIRANANDANI GARDENS ,POWAI"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669055400,"product":"RE-IMPORT OF RE-IMPORT- DL-NOREPHEDRINE HYDROCHLORIDE BATCH NO.7500521 MFG DT.NOV 2021\/RETEST DT.OCT 2022 (INDIAN ORIGIN","address":"501, SENTINEL, HIRANANDANI GARDENS ,POWAI","city":"POWAI MUMBAI,MAHARASHTRA","supplier":"ACETO US LLC","supplierCountry":"INDIA","foreign_port":"NA","customer":"EMBIO LTD","customerCountry":"INDIA","quantity":"349.88","actualQuantity":"349.88","unit":"KGS","unitRateFc":"68.5","totalValueFC":"24800.5","currency":"USD","unitRateINR":"5784.9","date":"22-Nov-2022","totalValueINR":"2024030.92","totalValueInUsd":"24800.5","indian_port":"JNPT","hs_no":"29394400","bill_no":"3409188","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"501, SENTINEL, HIRANANDANI GARDENS ,POWAI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720031400,"product":"RE-IMPORT OF PSEUDOEPHEDRINE HYDROCHLORIDE (SB NO:4374660 DT:10.08.20 \/\/ NOC :PC-IMP-49\/2024 DT:19.01.2024)","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"HIKMA PHARMACEUTICAL CO LTD","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"MALLADI DRUGS AND PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"53","totalValueFC":"102.5","currency":"USD","unitRateINR":"857002","date":"04-Jul-2024","totalValueINR":"8570.02","totalValueInUsd":"102.5","indian_port":"Madras Air","hs_no":"29394200","bill_no":"4318644","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"INDUSTRIAL AREA, BAYADER WADI EL-SEER, 1118 AMMANSDNF JORDAN","customerAddress":"NO.9, G.S.T. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"RE-IMPORT OF PSEUDOEPHEDRINE HYDROCHLORIDE BATCH NO.208521 MFG DT.DECEMBER 2021 EXP DT. NOVEMBER 2026 (INDIAN ORIGIN GO","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"KYOWA PHARMA CHMICAL CO LTD","supplierCountry":"INDIA","foreign_port":"KOBE","customer":"EMBIO LTD","customerCountry":"INDIA","quantity":"994.04","actualQuantity":"994.043","unit":"KGS","unitRateFc":"61.7","totalValueFC":"63857.9","currency":"USD","unitRateINR":"5388.4","date":"28-Aug-2024","totalValueINR":"5356303.58","totalValueInUsd":"63857.9","indian_port":"JNPT","hs_no":"29394200","bill_no":"5300496","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KOBE","supplierAddress":"530 CHOKEIJI,TAKAOKA,TOYAMA 933-8511,JAPANSDNF JAPAN","customerAddress":"501, SENTINEL, HIRANANDANI GARDENS"}]
06-Jan-2022
31-Jul-2025
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FDF Dossiers

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Regulatory Info : DISCN

Registration Country : USA

EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 23.5MG/5ML (4.7MG/ML)

Packaging :

Approval Date : 2021-06-14

Application Number : 213536

Regulatory Info : DISCN

Registration Country : USA

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EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 47MG/ML (47MG/ML)

Packaging :

Approval Date : 2021-06-14

Application Number : 213536

Regulatory Info : DISCN

Registration Country : USA

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Regulatory Info : DISCN

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EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 47MG/5ML (9.4MG/ML)

Packaging :

Approval Date : 2021-06-14

Application Number : 213536

Regulatory Info : DISCN

Registration Country : USA

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Regulatory Info : DISCN

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EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 47MG/10ML (4.7MG/ML)

Packaging :

Approval Date : 2023-12-07

Application Number : 213536

Regulatory Info : DISCN

Registration Country : USA

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Ethypharm

France
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Regulatory Info :

Registration Country : France

Ephedrine Hydrochloride

Brand Name :

Dosage Form : Ampoule

Dosage Strength : 30MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

06

Adcock Ingram

South Africa
CPhI Korea
Not Confirmed
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Adcock Ingram

South Africa
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CPhI Korea
Not Confirmed

Ephedrine HCl

Brand Name : Colcleer

Dosage Form : TAB

Dosage Strength : 6mg

Packaging : 120X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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07

Atabay

Turkey
CPhI Korea
Not Confirmed
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Atabay

Turkey
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CPhI Korea
Not Confirmed

Ephedrine Hydrochloride; Guaifenesin

Brand Name : BRONKOFLU

Dosage Form : Syrup

Dosage Strength : 6.66MG; 100MG

Packaging : 150 ml Glass Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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08

Bahrain Pharma

Bahrain
CPhI Korea
Not Confirmed
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Bahrain Pharma

Bahrain
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CPhI Korea
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Ammonium Chloride; Sodium Citrate; Ephedronguent; Chlorpheniramine Maleate

Brand Name : Clomadrin

Dosage Form : SYRUP

Dosage Strength : 100MG/5ML; 60MG/5ML; 7MG/5ML; 2MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Bahrain

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09

CPhI Korea
Not Confirmed
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Ephedrine Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 30MG/ML

Packaging : 1ml Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

Stragen Pharma SA

Switzerland
CPhI Korea
Not Confirmed
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Stragen Pharma SA

Switzerland
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CPhI Korea
Not Confirmed

ephedrine hydrochloride

Brand Name : Ephedrine Stragen

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 3 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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FDA Orange Book

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RLD : Yes

TE Code :

EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 23.5MG/5ML (4.7MG/ML)

Approval Date : 2021-06-14

Application Number : 213536

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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

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RLD : Yes

TE Code :

EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 47MG/ML (47MG/ML)

Approval Date : 2021-06-14

Application Number : 213536

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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RLD : Yes

TE Code :

EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 47MG/5ML (9.4MG/ML)

Approval Date : 2021-06-14

Application Number : 213536

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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RLD : Yes

TE Code :

EPHEDRINE HYDROCHLORIDE

Brand Name : REZIPRES

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 47MG/10ML (4.7MG/ML)

Approval Date : 2023-12-07

Application Number : 213536

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Europe

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CPhI Korea
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Ephedronguent; Guaifenesin

Brand Name : BRONKOFLU

Dosage Form : Syrup

Dosage Strength : 6.66MG; 100MG

Packaging : 150 ml Glass Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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Stragen Nordic A / S,

Switzerland
CPhI Korea
Not Confirmed
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Stragen Nordic A / S,

Switzerland
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Not Confirmed

ephedrine hydrochloride

Brand Name : Ephedrine Stragen

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 3 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Mylan AB

U.S.A
CPhI Korea
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Mylan AB

U.S.A
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CPhI Korea
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ephedrine hydrochloride

Brand Name : Ephedrine Mylan

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 50 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Canada

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EPHEDRINE HYDROCHLORIDE

Brand Name : ANTIHISTAMINE ORAL

Dosage Form : POWDER

Dosage Strength : 20MG/G

Packaging : 454 GM

Approval Date :

Application Number : 2020874

Regulatory Info :

Registration Country : Canada

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DOSAGE - SOLUTION;INTRAVENOUS - 23.5MG/5ML (4...DOSAGE - SOLUTION;INTRAVENOUS - 23.5MG/5ML (4.7MG/ML)

USFDA APPLICATION NUMBER - 213536

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DOSAGE - SOLUTION;INTRAVENOUS - 47MG/10ML (4....DOSAGE - SOLUTION;INTRAVENOUS - 47MG/10ML (4.7MG/ML)

USFDA APPLICATION NUMBER - 213536

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DOSAGE - SOLUTION;INTRAVENOUS - 47MG/ML (47MG...DOSAGE - SOLUTION;INTRAVENOUS - 47MG/ML (47MG/ML)

USFDA APPLICATION NUMBER - 213536

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DOSAGE - SOLUTION;INTRAVENOUS - 47MG/5ML (9.4...DOSAGE - SOLUTION;INTRAVENOUS - 47MG/5ML (9.4MG/ML)

USFDA APPLICATION NUMBER - 213536

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ABOUT THIS PAGE

Looking for 50-98-6 / Ephedrine Hydrochloride API manufacturers, exporters & distributors?

Ephedrine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ephedrine Hydrochloride 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 Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Ephedrine Hydrochloride API Price utilized in the formulation of products. Ephedrine Hydrochloride API Price is not always fixed or binding as the Ephedrine Hydrochloride Price is obtained through a variety of data sources. The Ephedrine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ephedrine Hydrochloride

Synonyms

50-98-6, (-)-ephedrine hydrochloride, L-ephedrine hydrochloride, 1-ephedrine hydrochloride, Ephedrine hcl, Ephedrine (hydrochloride)

Cas Number

50-98-6

Unique Ingredient Identifier (UNII)

NLJ6390P1Z

About Ephedrine Hydrochloride

A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.

L-EPHEDRINE HCL Manufacturers

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

L-EPHEDRINE HCL Suppliers

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

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

L-EPHEDRINE HCL USDMF

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

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

click here to find a list of L-EPHEDRINE HCL suppliers with USDMF on PharmaCompass.

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

L-EPHEDRINE HCL KDMF

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

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

After submitting a L-EPHEDRINE HCL 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 L-EPHEDRINE HCL API can apply through the Korea Drug Master File (KDMF).

click here to find a list of L-EPHEDRINE HCL suppliers with KDMF on PharmaCompass.

L-EPHEDRINE HCL CEP

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

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

L-EPHEDRINE HCL WC

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

click here to find a list of L-EPHEDRINE HCL suppliers with Written Confirmation (WC) on PharmaCompass.

L-EPHEDRINE HCL 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 L-EPHEDRINE HCL as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of L-EPHEDRINE HCL suppliers with NDC on PharmaCompass.

L-EPHEDRINE HCL GMP

L-EPHEDRINE HCL 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 L-EPHEDRINE HCL 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 L-EPHEDRINE HCL GMP manufacturer or L-EPHEDRINE HCL GMP API supplier for your needs.

L-EPHEDRINE HCL CoA

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

L-EPHEDRINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each L-EPHEDRINE HCL 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.

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