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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]

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MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"TO THE ORDER OF","customerCountry":"UNITED STATES","quantity":"10.50","actualQuantity":"10.5","unit":"KGS","unitRateFc":"60","totalValueFC":"615.6","currency":"USD","unitRateINR":5077.9552380952382,"date":"26-Mar-2025","totalValueINR":"53318.53","totalValueInUsd":"615.6","indian_port":"JNPT","hs_no":"29394200","bill_no":"9381510","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE USP, BATCH NO. 203525 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":"NEW YORK - JOHN F. K","customer":"TO THE ORDER OF","customerCountry":"UNITED STATES","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"66","totalValueFC":"15159.4","currency":"USD","unitRateINR":5252.2995999999994,"date":"26-Mar-2025","totalValueINR":"1313074.9","totalValueInUsd":"15159.4","indian_port":"Bombay Air","hs_no":"29394200","bill_no":"9357827","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE USP, BATCH NO.204025, MFG. DT. MARCH 2025, EXP.\/RETEST DT. FEBRUARY 2030","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. 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MAHARASTRA","supplier":"EMBIO LIMITED","supplierCountry":"INDIA","foreign_port":"EL ISKANDARIYA (= AL","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"50.5","totalValueFC":"49668.4","currency":"USD","unitRateINR":4302.1609800000006,"date":"27-Mar-2025","totalValueINR":"4302160.98","totalValueInUsd":"49668.4","indian_port":"JNPT","hs_no":"29394200","bill_no":"9428206","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE BP BATCH NO:204225B 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":"BEIRUT","customer":"TO THE ORDER OF","customerCountry":"LEBANON","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"58","totalValueFC":"10853.1","currency":"USD","unitRateINR":4700.3431,"date":"27-Mar-2025","totalValueINR":"940068.62","totalValueInUsd":"10853.1","indian_port":"Bombay Air","hs_no":"29394200","bill_no":"9427668","productDescription":"API","marketType":"","country":"LEBANON","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"501, SENTINEL, HIRANANDANI GARDENS, POWAI, MUMBAI. MAHARASTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE USP, BATCH NO. 204425, MFG. DT.MARCH 2025, EXP.\/RETEST DT. FEBRUARY 2030","address":"501, SENTINEL, HIRANANDANI GARDENS","city":"POWAI, MUMBAI. 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11-Jan-2022
25-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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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

35

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.

TRIACIN-C-1 Manufacturers

A TRIACIN-C-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRIACIN-C-1, including repackagers and relabelers. The FDA regulates TRIACIN-C-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRIACIN-C-1 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 TRIACIN-C-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

TRIACIN-C-1 Suppliers

A TRIACIN-C-1 supplier is an individual or a company that provides TRIACIN-C-1 active pharmaceutical ingredient (API) or TRIACIN-C-1 finished formulations upon request. The TRIACIN-C-1 suppliers may include TRIACIN-C-1 API manufacturers, exporters, distributors and traders.

click here to find a list of TRIACIN-C-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

TRIACIN-C-1 USDMF

A TRIACIN-C-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of TRIACIN-C-1 active pharmaceutical ingredient (API) in detail. Different forms of TRIACIN-C-1 DMFs exist exist since differing nations have different regulations, such as TRIACIN-C-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A TRIACIN-C-1 DMF submitted to regulatory agencies in the US is known as a USDMF. TRIACIN-C-1 USDMF includes data on TRIACIN-C-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRIACIN-C-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of TRIACIN-C-1 suppliers with USDMF on PharmaCompass.

TRIACIN-C-1 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 TRIACIN-C-1 Drug Master File in Japan (TRIACIN-C-1 JDMF) empowers TRIACIN-C-1 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 TRIACIN-C-1 JDMF during the approval evaluation for pharmaceutical products. At the time of TRIACIN-C-1 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 TRIACIN-C-1 suppliers with JDMF on PharmaCompass.

TRIACIN-C-1 KDMF

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

Pharmaceutical companies submit a TRIACIN-C-1 Drug Master File in Korea (TRIACIN-C-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TRIACIN-C-1. The MFDS reviews the TRIACIN-C-1 KDMF as part of the drug registration process and uses the information provided in the TRIACIN-C-1 KDMF to evaluate the safety and efficacy of the drug.

After submitting a TRIACIN-C-1 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 TRIACIN-C-1 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of TRIACIN-C-1 suppliers with KDMF on PharmaCompass.

TRIACIN-C-1 CEP

A TRIACIN-C-1 CEP of the European Pharmacopoeia monograph is often referred to as a TRIACIN-C-1 Certificate of Suitability (COS). The purpose of a TRIACIN-C-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TRIACIN-C-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TRIACIN-C-1 to their clients by showing that a TRIACIN-C-1 CEP has been issued for it. The manufacturer submits a TRIACIN-C-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a TRIACIN-C-1 CEP holder for the record. Additionally, the data presented in the TRIACIN-C-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TRIACIN-C-1 DMF.

A TRIACIN-C-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TRIACIN-C-1 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 TRIACIN-C-1 suppliers with CEP (COS) on PharmaCompass.

TRIACIN-C-1 WC

A TRIACIN-C-1 written confirmation (TRIACIN-C-1 WC) is an official document issued by a regulatory agency to a TRIACIN-C-1 manufacturer, verifying that the manufacturing facility of a TRIACIN-C-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRIACIN-C-1 APIs or TRIACIN-C-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a TRIACIN-C-1 WC (written confirmation) as part of the regulatory process.

click here to find a list of TRIACIN-C-1 suppliers with Written Confirmation (WC) on PharmaCompass.

TRIACIN-C-1 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 TRIACIN-C-1 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for TRIACIN-C-1 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 TRIACIN-C-1 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 TRIACIN-C-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRIACIN-C-1 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of TRIACIN-C-1 suppliers with NDC on PharmaCompass.

TRIACIN-C-1 GMP

TRIACIN-C-1 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 TRIACIN-C-1 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 TRIACIN-C-1 GMP manufacturer or TRIACIN-C-1 GMP API supplier for your needs.

TRIACIN-C-1 CoA

A TRIACIN-C-1 CoA (Certificate of Analysis) is a formal document that attests to TRIACIN-C-1's compliance with TRIACIN-C-1 specifications and serves as a tool for batch-level quality control.

TRIACIN-C-1 CoA mostly includes findings from lab analyses of a specific batch. For each TRIACIN-C-1 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.

TRIACIN-C-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (TRIACIN-C-1 EP), TRIACIN-C-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRIACIN-C-1 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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