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    Also known as: 61-76-7, Phenylephrine hcl, Biomydrin, Nostril, (r)-phenylephrine hydrochloride, L-phenylephrine hydrochloride
    Molecular Formula
    C9H14ClNO2
    Molecular Weight
    203.66  g/mol
    InChI Key
    OCYSGIYOVXAGKQ-FVGYRXGTSA-N
    FDA UNII
    04JA59TNSJ
    Phenylephrine Hydrochloride
    An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
    1 2D Structure

    Phenylephrine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol;hydrochloride
    2.1.2 InChI
    InChI=1S/C9H13NO2.ClH/c1-10-6-9(12)7-3-2-4-8(11)5-7;/h2-5,9-12H,6H2,1H3;1H/t9-;/m0./s1
    2.1.3 InChI Key
    OCYSGIYOVXAGKQ-FVGYRXGTSA-N
    2.1.4 Canonical SMILES
    CNCC(C1=CC(=CC=C1)O)O.Cl
    2.1.5 Isomeric SMILES
    CNC[C@@H](C1=CC(=CC=C1)O)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    04JA59TNSJ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (r)-3-hydroxy-alpha-((methylamino)methyl)benzenemethanol

    2. Metaoxedrin

    3. Metasympatol

    4. Mezaton

    5. Neo Synephrine

    6. Neo-synephrine

    7. Neosynephrine

    8. Phenylephrine

    9. Phenylephrine Tannate

    10. Tannate, Phenylephrine

    2.3.2 Depositor-Supplied Synonyms

    1. 61-76-7

    2. Phenylephrine Hcl

    3. Biomydrin

    4. Nostril

    5. (r)-phenylephrine Hydrochloride

    6. L-phenylephrine Hydrochloride

    7. (r)-(-)-phenylephrine Hydrochloride

    8. Phenylephrine.hcl

    9. Mydfrin

    10. Metaoxedrine Chloride

    11. Vazculep

    12. Neo-synephrine

    13. Adrianol

    14. Neophryn

    15. Prefrin

    16. Rhinall

    17. Alcon Efrin

    18. (-)-phenylephrine Hydrochloride

    19. Nci-c55641

    20. Efricel

    21. Isopto Frin

    22. Prefrin Liquifilm

    23. (r)-3-(1-hydroxy-2-(methylamino)ethyl)phenol Hydrochloride

    24. 3-[(1r)-1-hydroxy-2-(methylamino)ethyl]phenol;hydrochloride

    25. Afrin 4 Hour Nasal Spray

    26. Nsc-757273

    27. 04ja59tnsj

    28. Phenylephrine (hydrochloride)

    29. Mls000069696

    30. Ncgc00024257-04

    31. Neosympatol

    32. Synethenate

    33. Almefrin

    34. Consdrin

    35. Emagrin

    36. Fenilfar

    37. Histabid

    38. Idrianol

    39. Lexatol

    40. Oftalfrine

    41. Phenistan

    42. Pyristan

    43. Smr000058497

    44. Stanephrin

    45. Sucraphen

    46. Synasal

    47. Fenox

    48. Meta-sympatol

    49. Alcon-efrin

    50. (r)-(-)-1-(3-hydroxyphenyl)-2-methylaminoethanol Hydrochloride

    51. [(2r)-2-hydroxy-2-(3-hydroxyphenyl)ethyl]-methylazanium;chloride

    52. Dsstox_cid_1142

    53. Op-isophrin

    54. Dsstox_rid_75972

    55. Neo-synesin 1

    56. Dsstox_gsid_21142

    57. Neooxedrine Chloride

    58. 3-[(1r)-1-hydroxy-2-(methylamino)ethyl]phenol Hydrochloride

    59. Consdrin Hydrochloride

    60. Isophrin Hydrochloride

    61. Vasosulf

    62. Relief

    63. Metaoxedrine Hydrochloride

    64. Neosynephrine Hydrochloride

    65. Sudafed Pe

    66. Chebi:8094

    67. Op-isophrin-z

    68. Cas-61-76-7

    69. Meta-synephrine Hydrochloride

    70. Ccris 219

    71. Levophenylephrine Hydrochloride

    72. Phenylephrine Hydrochloride, L-

    73. R-(-)-m-synephrine Hydrochloride

    74. D-(-)-phenylephrine Hydrochloride

    75. Einecs 200-517-3

    76. Unii-04ja59tnsj

    77. M-methylaminoethanolphenol Hydrochloride

    78. Benzedrex Nasal Spray, Regular

    79. Sr-01000075286

    80. Mfcd00012605

    81. Phenylephrine Hydrochloride [usp:jan]

    82. Vicks Sinex Vapospray

    83. Neo-synephrine (tn)

    84. L-1-(m-hydroxyphenyl)-2-methyl-aminoethanol Hydrochloride

    85. Vicks Sinex Nasal Spray

    86. 1-m-hydroxy-alpha-(methylaminomethyl)benzyl Alcohol Hydrochloride

    87. Opera_id_1786

    88. (-)-m-hydroxy-alpha-((methylamino)methyl)benzyl Alcohol Hydrochloride

    89. (r)-3-hydroxy-alpha-((methylamino)methyl)benzenemethanol Hydrochloride

    90. (-)-alpha-hydroxy-beta-(methylamino)ethyl-alpha-(3-hydroxybenzene) Hydrochloride

    91. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride, (-)-

    92. Ec 200-517-3

    93. Schembl24654

    94. Mls006012005

    95. Spectrum1500483

    96. Phenylephrine Hydrochloride,(s)

    97. Chembl1200339

    98. Dtxsid3021142

    99. L(-)-phenylephrine Hydrochloride

    100. Hms1920h08

    101. Pharmakon1600-01500483

    102. Bcp23410

    103. Hy-b0471

    104. Tox21_110897

    105. Tox21_201261

    106. Tox21_302846

    107. Tox21_500920

    108. Ccg-39113

    109. Nsc757273

    110. S2569

    111. Akos022190146

    112. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride (r)-

    113. Benzyl Alcohol, M-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride, (-)-

    114. Tox21_110897_1

    115. Lp00920

    116. Nsc 757273

    117. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride, (alphar)-

    118. Phenylephrine Hydrochloride (jp17/usp)

    119. Phenylephrine Hydrochloride [mi]

    120. Ncgc00024257-08

    121. Ncgc00094231-01

    122. Ncgc00256496-01

    123. Ncgc00258813-01

    124. Ncgc00261605-01

    125. Phenylephrine Hydrochloride [jan]

    126. Bp166231

    127. Bcp0726000237

    128. Phenylephrine Hydrochloride [mart.]

    129. Phenylephrine Hydrochloride [vandf]

    130. Phenylephrine Hydrochloride [usp-rs]

    131. Phenylephrine Hydrochloride [who-dd]

    132. (r)-(-)-phenylephrine Hydrochloride, Powder

    133. Eu-0100920

    134. P0398

    135. Sw219446-1

    136. Vu0239753-6

    137. D00511

    138. D70603

    139. P 6126

    140. Phenylephrine Hydrochloride [orange Book]

    141. A833410

    142. Phenylephrine Hydrochloride [ep Monograph]

    143. Phenylephrine Hydrochloride [usp Monograph]

    144. Omidria Component Phenylephrine Hydrochloride

    145. Q-201561

    146. Sr-01000075286-1

    147. Phenylephrine Hydrochloride Component Of Omidria

    148. Prefrin-a Component Phenylephrine Hydrochloride

    149. Q27107758

    150. (r)-(-)-phenylephrine Hydrochloride, Analytical Standard

    151. Cyclomydril Component Phenylephrine Hydrochloride

    152. Phenergan Vc Component Phenylephrine Hydrochloride

    153. Phenylephrine Hydrochloride Component Of Prefrin-a

    154. Pherazine Vc Component Phenylephrine Hydrochloride

    155. Phenylephrine Hydrochloride Component Of Cyclomydril

    156. Phenylephrine Hydrochloride Component Of Phenergan Vc

    157. Phenylephrine Hydrochloride Component Of Pherazine Vc

    158. Promethazine Vc Component Phenylephrine Hydrochloride

    159. Phenylephrine Hydrochloride Component Of Promethazine Vc

    160. (r)-(-)-phenylephrine Hydrochloride, Tested According To Ph.eur.

    161. Advil Congestion Relief Component Phenylephrine Hydrochloride

    162. Benzenemethanol, 3-hydroxy-a-[(methylamino)methyl]-, Hydrochloride,(ar)-

    163. Phenylephrine Hydrochloride Component Of Advil Congestion Relief

    164. Phenylephrine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    165. Phenylephrine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    166. (-)-m-hydroxy-.alpha.-((methylamino)methyl)benzyl Alcohol Hydrochloride

    167. Benzenemethanol, 3-hydroxy-.alpha.-((methylamino)methyl)-, Hydrochloride (r)-

    168. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride (1:1), (alphar)-

    169. Phenylephrine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    170. Phenylephrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    171. Phenylephrine Hydrochloride For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    172. R-(-)-phenylephrine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-11-20
    3 Chemical and Physical Properties
    Molecular Weight 203.66 g/mol
    Molecular Formula C9H14ClNO2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass203.0713064 g/mol
    Monoisotopic Mass203.0713064 g/mol
    Topological Polar Surface Area52.5 Ų
    Heavy Atom Count13
    Formal Charge0
    Complexity130
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 2  
    Drug NamePhenylephrine hydrochloride
    Drug LabelNEO-SYNEPHRINE hydrochloride, brand of phenylephrine hydrochloride injectino, is a vasoconstrictor and pressor drug chemically related to epinephrine and ephedrine. NEO-SYNEPHRINE hydrochloride is a synthetic sympathomimetic agent in sterile form f...
    Active IngredientPhenylephrine hydrochloride
    Dosage FormSolution/drops; Solution
    RouteOphthalmic; Iv (infusion)
    Strength10mg/ml (10mg/ml); 10%; 2.5%
    Market StatusPrescription
    CompanyWest Ward Pharm; Paragon Bioteck

    2 of 2  
    Drug NamePhenylephrine hydrochloride
    Drug LabelNEO-SYNEPHRINE hydrochloride, brand of phenylephrine hydrochloride injectino, is a vasoconstrictor and pressor drug chemically related to epinephrine and ephedrine. NEO-SYNEPHRINE hydrochloride is a synthetic sympathomimetic agent in sterile form f...
    Active IngredientPhenylephrine hydrochloride
    Dosage FormSolution/drops; Solution
    RouteOphthalmic; Iv (infusion)
    Strength10mg/ml (10mg/ml); 10%; 2.5%
    Market StatusPrescription
    CompanyWest Ward Pharm; Paragon Bioteck

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Mydriatics

    Agents that dilate the pupil. They may be either sympathomimetics or parasympatholytics. (See all compounds classified as Mydriatics.)

    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.)

    Sympathomimetics

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

    Vasoconstrictor Agents

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

    Adrenergic alpha-1 Receptor Agonists

    Compounds that bind to and activate ADRENERGIC ALPHA-1 RECEPTORS. (See all compounds classified as Adrenergic alpha-1 Receptor Agonists.)

    Cardiotonic Agents

    Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE). (See all compounds classified as Cardiotonic Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    alpha-1 Adrenergic Agonist [EPC]; Adrenergic alpha1-Agonists [MoA]

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OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"SOMERSET THERAPEUTICS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1200","unit":"MGS","unitRateFc":"1.4","totalValueFC":"1699.1","currency":"USD","unitRateINR":"121.7","date":"17-Jun-2025","totalValueINR":"145993.6","totalValueInUsd":"1699.1","indian_port":"Bangalore Air","hs_no":"29225090","bill_no":"2707455","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK","supplierAddress":"12601 TWINBROOK PARKWAY ROCKWILLE M D 20852-1790 USA New York, New York , United States United States","customerAddress":"REGD. OFFICE: NO. 16\/2,"}]
    06-Jan-2022
    30-Jun-2025
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0....DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)

    USFDA APPLICATION NUMBER - 203826

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    DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML)

    USFDA APPLICATION NUMBER - 203826

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

    USFDA APPLICATION NUMBER - 203826

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    DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1...DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML)

    USFDA APPLICATION NUMBER - 203826

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    DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10M...DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML)

    USFDA APPLICATION NUMBER - 203826

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    DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML)

    USFDA APPLICATION NUMBER - 204300

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    USFDA APPLICATION NUMBER - 204300

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    DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10M...DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML)

    USFDA APPLICATION NUMBER - 204300

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 10%

    USFDA APPLICATION NUMBER - 207926

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 2.5%

    USFDA APPLICATION NUMBER - 207926

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    DOSAGE - TABLET;ORAL - 4MG;200MG;10MG

    USFDA APPLICATION NUMBER - 22113

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    DOSAGE - TABLET;ORAL - 200MG;10MG

    USFDA APPLICATION NUMBER - 22565

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    DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.2%;1%

    USFDA APPLICATION NUMBER - 84300

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    DOSAGE - SYRUP;ORAL - 5MG/5ML;6.25MG/5ML

    USFDA APPLICATION NUMBER - 88761

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    ABOUT THIS PAGE

    Looking for 61-76-7 / Phenylephrine Hydrochloride API manufacturers, exporters & distributors?

    Phenylephrine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Phenylephrine Hydrochloride

    Synonyms

    61-76-7, Phenylephrine hcl, Biomydrin, Nostril, (r)-phenylephrine hydrochloride, L-phenylephrine hydrochloride

    Cas Number

    61-76-7

    Unique Ingredient Identifier (UNII)

    04JA59TNSJ

    About Phenylephrine Hydrochloride

    An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

    Sudafed PE Manufacturers

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

    Sudafed PE Suppliers

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

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

    Sudafed PE USDMF

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

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

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

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

    Sudafed PE KDMF

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

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

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

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

    Sudafed PE CEP

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

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

    Sudafed PE WC

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

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

    Sudafed PE 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 Sudafed PE as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sudafed PE GMP

    Sudafed PE 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 Sudafed PE 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 Sudafed PE GMP manufacturer or Sudafed PE GMP API supplier for your needs.

    Sudafed PE CoA

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

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

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