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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 B NO.5301625 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":"CAIRO","customer":"TO THE ORDER","customerCountry":"EGYPT","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"52.5","totalValueFC":"50452.4","currency":"USD","unitRateINR":4370.0666100000008,"date":"29-Mar-2025","totalValueINR":"4370066.61","totalValueInUsd":"50452.4","indian_port":"Bombay Air","hs_no":"29394200","bill_no":"9496772","productDescription":"API","marketType":"","country":"EGYPT","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. 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":"Q1","strtotime":1743359400,"product":"PSEUDOEPHEDRINE HYDROCHLORIDE BP -(EXPORT NOC NO.PC\/EXP-10271\/2025 DT:19.02.2025","address":"NO.9, G.S.T. ROAD","city":"CHENNAI, TAMIL NADU","supplier":"MALLADI DRUGS & PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"47.5","totalValueFC":"234668.6","currency":"USD","unitRateINR":4065.2856000000002,"date":"31-Mar-2025","totalValueINR":"20326428","totalValueInUsd":"234668.6","indian_port":"Madras Air","hs_no":"29394200","bill_no":"9561825","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.9, G.S.T. 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":"ACTYLIS","supplierCountry":"INDIA","foreign_port":"NA","customer":"EMBIO LIMITED","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":"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"}]
    14-Jan-2021
    31-Mar-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

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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.

    Sinufed Manufacturers

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

    Sinufed Suppliers

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

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

    Sinufed USDMF

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

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

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

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

    Sinufed KDMF

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

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

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

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

    Sinufed CEP

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

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

    Sinufed WC

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

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

    Sinufed 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 Sinufed as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sinufed GMP

    Sinufed 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 Sinufed 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 Sinufed GMP manufacturer or Sinufed GMP API supplier for your needs.

    Sinufed CoA

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

    Sinufed CoA mostly includes findings from lab analyses of a specific batch. For each Sinufed 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.

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