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Chemistry

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Also known as: Pseudoephedrine hcl, 345-78-8, Otrinol, Rhinalair, Tussaphed, Novafed
Molecular Formula
C10H16ClNO
Molecular Weight
201.69  g/mol
InChI Key
BALXUFOVQVENIU-KXNXZCPBSA-N
FDA UNII
6V9V2RYJ8N

Pseudoephedrine Hydrochloride
A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.
1 2D Structure

Pseudoephedrine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,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-KXNXZCPBSA-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
6V9V2RYJ8N
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ephedrine Threo Isomer

2. Isoephedrine

3. Pseudoephedrine

4. Pseudoephedrine Hcl

5. Sudafed

6. Threo Isomer Of Ephedrine

2.3.2 Depositor-Supplied Synonyms

1. Pseudoephedrine Hcl

2. 345-78-8

3. Otrinol

4. Rhinalair

5. Tussaphed

6. Novafed

7. Sudafed

8. Sudomyl

9. First Sign

10. D-pseudoephedrine Hydrochloride

11. Besan

12. Sudafed Hydrochloride

13. (+)-pseudoephedrine Hydrochloride

14. Pseudophedrine Hydrochloride

15. Galsud

16. Efidac 24

17. 1s,2s-(+)-pseudoephedrine Hydrochloride

18. Nsc-33634

19. Nsc-106567

20. 6v9v2ryj8n

21. L(+)-pseudoephedrine Hydrochloride

22. Sinufed

23. Coadvil

24. Symptom 2

25. D-(alpha-(1-methylamino)ethyl)benzyl Alcohol Hydrochloride

26. Sudafed 12 Hour

27. Pseudoephedrine, (+)-

28. Pseudoephedrine, L-(+)-

29. Suphedrine

30. Nexafed

31. Dorcol

32. Histalet Syrup

33. L-(+)-pseudoephedrine Hydrochloride

34. Sun Mark Sinus

35. Deconsal Ii

36. Chebi:8604

37. Sudafed Liquid, Children's

38. Pediacare Decongestant Drops

39. Sudafed 24 Hour

40. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol Hydrochloride

41. Benzenemethanol, Hydrochloride, S-(r,r)-

42. Wln: Qyr & Y1 & M1 & Gh-l

43. Dimetapp Decongestant

44. Actifed Sinus Daytime

45. Cpdd 0050

46. Benzenemethanol, Hydrochloride, [s-(r*,r*)]-

47. Einecs 206-462-1

48. Pseudoephedrine Hydrochloride [usan]

49. Nsc 33634

50. Unii-6v9v2ryj8n

51. Nsc 106567

52. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride

53. Topcare 12 Hour Decongestant

54. D-[.alpha.-(1-methylamino)ethyl]benzyl Alcohol Hydrochloride

55. Ornex And Maximum Strength Ornex

56. Sudafed (tn)

57. Galpseud

58. Pseudoephedrine, Hydrochloride, L-(+)-

59. Pseudoephedrine Hydrochloride [usan:usp]

60. Tylenol Sinus Medication, Maximum Strength

61. Isoephedrine Hydrochloride

62. Contac Day & Night Allergy Sinus Day Caplets

63. Psi-ephedrine Hydrochloride

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

65. Ec 206-462-1

66. Schembl33285

67. Mls001304069

68. Spectrum1500516

69. Chembl1200724

70. Sine-off Maximum Strength No Drowsiness Formula Caplets

71. Dtxsid10889343

72. Hms1920n04

73. Pharmakon1600-01500516

74. Nsc33634

75. Pseudoephedrine Hydrochloride (usp)

76. Ccg-39241

77. Nsc106567

78. Nsc759616

79. Akos027383893

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

81. Nsc-759616

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

83. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride, (alphas)-

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

85. Pseudoephedrine Hydrochloride [mi]

86. Smr000718787

87. (+)-pseudoephedrine Hydrochloride, >=98%

88. P1654

89. Pseudoephedrine Hydrochloride [mart.]

90. Pseudoephedrine Hydrochloride [vandf]

91. Pseudoephedrine Hydrochloride [usp-rs]

92. Pseudoephedrine Hydrochloride [who-dd]

93. D00485

94. 345p788

95. Pseudoephedrine Hydrochloride [orange Book]

96. Myfed Component Pseudoephedrine Hydrochloride

97. Pseudoephedrine Hydrochloride [ep Monograph]

98. Pseudoephedrine Hydrochloride [usp Monograph]

99. W-106727

100. Actahist Component Pseudoephedrine Hydrochloride

101. Actifed Component Pseudoephedrine Hydrochloride

102. Aleve-d Component Pseudoephedrine Hydrochloride

103. Allerfed Component Pseudoephedrine Hydrochloride

104. Corphed Component Pseudoephedrine Hydrochloride

105. Histafed Component Pseudoephedrine Hydrochloride

106. Isoclor Component Pseudoephedrine Hydrochloride

107. Pseudoephedrine Hydrochloride Component Of Myfed

108. Q27108108

109. Triphed Component Pseudoephedrine Hydrochloride

110. Zyrtec-d Component Pseudoephedrine Hydrochloride

111. Allegra-d Component Pseudoephedrine Hydrochloride

112. Bromfed-dm Component Pseudoephedrine Hydrochloride

113. Mucinex D Component Pseudoephedrine Hydrochloride

114. Pseudoephedrine Hydrochloride Component Of Actifed

115. Pseudoephedrine Hydrochloride Component Of Aleve-d

116. Pseudoephedrine Hydrochloride Component Of Corphed

117. Pseudoephedrine Hydrochloride Component Of Isoclor

118. Pseudoephedrine Hydrochloride Component Of Triphed

119. Semprex-d Component Pseudoephedrine Hydrochloride

120. Triacin-c Component Pseudoephedrine Hydrochloride

121. Trilitron Component Pseudoephedrine Hydrochloride

122. (+)-pseudoephedrine Hydrochloride, Sigma Reference Standard

123. Bromanate Dm Component Pseudoephedrine Hydrochloride

124. Dimetane-dx Component Pseudoephedrine Hydrochloride

125. Hycofenix Component Of Pseudoephedrine Hydrochloride

126. Pseudoephedrine Hydrochloride Component Of Actahist

127. Pseudoephedrine Hydrochloride Component Of Allegra-d

128. Pseudoephedrine Hydrochloride Component Of Allerfed

129. Pseudoephedrine Hydrochloride Component Of Bromfed-dm

130. Pseudoephedrine Hydrochloride Component Of Histafed

131. Pseudoephedrine Hydrochloride Component Of Hycofenix

132. Pseudoephedrine Hydrochloride Component Of Mucinex D

133. Pseudoephedrine Hydrochloride Component Of Semprex-d

134. Pseudoephedrine Hydrochloride Component Of Triacin-c

135. Pseudoephedrine Hydrochloride Component Of Trilitron

136. Pseudoephedrine Hydrochloride Component Of Zyrtec-d

137. Pseudoephedrine Hydrochloride; Threo-ephedrine Hydrochloride

138. Sine-aid Ib Component Pseudoephedrine Hydrochloride

139. (1s,2s)-2-(methylamino)-1-phenyl-1-propanol Hydrochloride

140. Codimal-l.a. 12 Component Pseudoephedrine Hydrochloride

141. Pseudoephedrine Hydrochloride Component Of Bromanate Dm

142. Pseudoephedrine Hydrochloride Component Of Dimetane-dx

143. Pseudoephedrine Hydrochloride Component Of Sine-aid Ib

144. Advil Allergy Sinus Component Pseudoephedrine Hydrochloride

145. Children's Advil Cold Component Pseudoephedrine Hydrochloride

146. Children's Motrin Cold Component Pseudoephedrine Hydrochloride

147. Pseudoephedrine Hydrochloride Component Of Advil Allergy Sinus

148. Pseudoephedrine Hydrochloride Component Of Codimal-l.a. 12

149. (+)-pseudoephedrine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

150. Pseudoephedrine Hydrochloride Component Of Children's Advil Cold

151. Pseudoephedrine Hydrochloride Component Of Children's Motrin Cold

152. Pseudoephedrine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

153. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride (1:1), (.alpha.s)-

154. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride (1:1), (alphas)-

155. Pseudoephedrine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

156. Pseudoephedrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

157. Pseudoephedrine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

2.3.3 Other Synonyms

1. L-pseudoephedrine Hydrochloride

2. 670-40-6

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 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NamePseudoephedrine hydrochloride
Drug LabelActive ingredient (in each 5 mL) Purpose Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant...
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyRanbaxy; Perrigo

2 of 6  
Drug NameSudafed 12 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyMcneil Cons

3 of 6  
Drug NameSudafed 24 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength240mg
Market StatusOver the Counter
CompanyMcneil Cons

4 of 6  
Drug NamePseudoephedrine hydrochloride
Drug LabelActive ingredient (in each 5 mL) Purpose Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant...
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyRanbaxy; Perrigo

5 of 6  
Drug NameSudafed 12 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyMcneil Cons

6 of 6  
Drug NameSudafed 24 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength240mg
Market StatusOver the Counter
CompanyMcneil Cons

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)


Nasal Decongestants

Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
alpha-Adrenergic Agonist [EPC]; Adrenergic alpha-Agonists [MoA]

API Reference Price

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MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE USP, BATCH NO. 204625, MFG. DT.MARCH 2025, EXP.\/RETEST DT. FEBRUARY 2030","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"PARIS - CHARLES DE G","customer":"TO THE ORDER OF","customerCountry":"FRANCE","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"71","totalValueFC":"67495.5","currency":"USD","unitRateINR":5846.2979500000001,"date":"29-Mar-2025","totalValueINR":"5846297.95","totalValueInUsd":"67495.5","indian_port":"Bombay Air","hs_no":"29394200","bill_no":"9516675","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743705000,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE BP\/EP-(NOCNO.PC\/EXP-10117\/2025 DT:27.01.2025)","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"MALLADI DRUGS AND PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"LONDON METROPOLITAN","customer":"TO THE ORDER OF","customerCountry":"UNITED KINGDOM","quantity":"800.00","actualQuantity":"800","unit":"KGS","unitRateFc":"63","totalValueFC":"46989.9","currency":"USD","unitRateINR":5028.0237500000003,"date":"04-Apr-2025","totalValueINR":"4022419","totalValueInUsd":"46989.9","indian_port":"Madras Air","hs_no":"29394200","bill_no":"9668225","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.9, G.S.T. ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744309800,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE BP\/ PHARM EUR BATCH NO. B204925B MFG DT MARCH 2025 EXP DT FEBRUARY 2030","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"LIVERPOOL","customer":"TO THE ORDER OF","customerCountry":"UNITED KINGDOM","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"54","totalValueFC":"53352.8","currency":"USD","unitRateINR":4567.0961600000001,"date":"11-Apr-2025","totalValueINR":"4567096.16","totalValueInUsd":"53352.8","indian_port":"JNPT","hs_no":"29394200","bill_no":"9879233","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE PHARM. EUR. BATCH NO. 201525 MFG DT: JAN. 2025, EXP.\/RETEST DT. DEC. 2029","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"TO THE ORDER","customerCountry":"UNITED ARAB EMIRATES","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"60","totalValueFC":"1404.4","currency":"USD","unitRateINR":4808.7359999999999,"date":"15-Apr-2025","totalValueINR":"120218.4","totalValueInUsd":"1404.4","indian_port":"Bombay Air","hs_no":"29394200","bill_no":"9965473","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744828200,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE USP -(NOCNO.PC\/EXP-10546\/2025 DT: 27.03.2025)","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"MALLADI DRUGS AND PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"BEIRUT","customer":"TO THE ORDER OF","customerCountry":"LEBANON","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"58.5","totalValueFC":"10586.5","currency":"USD","unitRateINR":4531.0950000000003,"date":"17-Apr-2025","totalValueINR":"906219","totalValueInUsd":"10586.5","indian_port":"Madras Air","hs_no":"29394200","bill_no":"1020553","productDescription":"API","marketType":"","country":"LEBANON","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.9, G.S.T. ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745519400,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE BP\/USP-(NOC NO.PC\/EXP-10378\/2025 DT: 11.03.2025)","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"MALLADI DRUGS AND PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"LAGOS","customer":"TO THE ORDER OF","customerCountry":"NIGERIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"55","totalValueFC":"12175.2","currency":"USD","unitRateINR":4168.8760000000002,"date":"25-Apr-2025","totalValueINR":"1042219","totalValueInUsd":"12175.2","indian_port":"Madras Air","hs_no":"29394200","bill_no":"1260650","productDescription":"API","marketType":"","country":"NIGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.9, G.S.T. ROAD, CHENNAI, TAMIL NADU","customerAddress":""},{"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 LIMITED","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. 209821MFG.DT.DECEMBER 2021 EXP. DT. NOVEMBER 2026, BATCH NO. 2001","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. MAHARASTRA","supplier":"KYOWA PHARMA CHMICAL CO LTD","supplierCountry":"INDIA","foreign_port":"KOBE","customer":"EMBIO LIMITED","customerCountry":"INDIA","quantity":"2844.13","actualQuantity":"2844.13","unit":"KGS","unitRateFc":"65","totalValueFC":"192574.1","currency":"USD","unitRateINR":"5679.4","date":"28-Aug-2024","totalValueINR":"16152838.97","totalValueInUsd":"192574.1","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"},{"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 LIMITED","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"}]
13-Jan-2021
25-Apr-2025
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DOSAGE - TABLET;ORAL - 200MG;30MG

USFDA APPLICATION NUMBER - 19771

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DOSAGE - CAPSULE;ORAL - 8MG;60MG

USFDA APPLICATION NUMBER - 19806

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG

USFDA APPLICATION NUMBER - 20021

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

USFDA APPLICATION NUMBER - 20786

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DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AN...DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

USFDA APPLICATION NUMBER - 21374

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DOSAGE - TABLET;ORAL - 2MG;200MG;30MG

USFDA APPLICATION NUMBER - 21441

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG

USFDA APPLICATION NUMBER - 21585

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG

USFDA APPLICATION NUMBER - 21585

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

USFDA APPLICATION NUMBER - 21704

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DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML

USFDA APPLICATION NUMBER - 22279

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DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22439

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DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **F...DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22442

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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 345-78-8 / Pseudoephedrine Hydrochloride API manufacturers, exporters & distributors?

Pseudoephedrine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pseudoephedrine Hydrochloride

Synonyms

Pseudoephedrine hcl, 345-78-8, Otrinol, Rhinalair, Tussaphed, Novafed

Cas Number

345-78-8

Unique Ingredient Identifier (UNII)

6V9V2RYJ8N

About Pseudoephedrine Hydrochloride

A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

psi-Ephedrine Hydrochloride Manufacturers

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

psi-Ephedrine Hydrochloride Suppliers

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

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

psi-Ephedrine Hydrochloride USDMF

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

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

click here to find a list of psi-Ephedrine Hydrochloride suppliers with USDMF on PharmaCompass.

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

psi-Ephedrine Hydrochloride KDMF

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

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

After submitting a psi-Ephedrine Hydrochloride 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 psi-Ephedrine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of psi-Ephedrine Hydrochloride suppliers with KDMF on PharmaCompass.

psi-Ephedrine Hydrochloride CEP

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

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

psi-Ephedrine Hydrochloride WC

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

click here to find a list of psi-Ephedrine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

psi-Ephedrine Hydrochloride 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 psi-Ephedrine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of psi-Ephedrine Hydrochloride suppliers with NDC on PharmaCompass.

psi-Ephedrine Hydrochloride GMP

psi-Ephedrine Hydrochloride 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 psi-Ephedrine Hydrochloride 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 psi-Ephedrine Hydrochloride GMP manufacturer or psi-Ephedrine Hydrochloride GMP API supplier for your needs.

psi-Ephedrine Hydrochloride CoA

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

psi-Ephedrine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each psi-Ephedrine Hydrochloride 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.

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