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Chemistry

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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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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663785000,"product":"ENZYME PROTEIN SOLUTION PHENYLEPHRINE LIQUID ENZYME","address":"10D NISARGA SHOPPING COMPLEX,NISAR GA LAYOUT BG ROAD JIGANI HOBLI","city":"BANGALORE,KARNATAKA","supplier":"SYNCOZYMES(SHANGHAI)CO.LTD.,","supplierCountry":"CHINA","foreign_port":"NA","customer":"IOSYNTH LABS PRIVATE ","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"98.5","totalValueFC":"2469.8","currency":"USD","unitRateINR":"7917.2","date":"22-Sep-2022","totalValueINR":"197928.72","totalValueInUsd":"2469.8","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"2557417","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"10D NISARGA SHOPPING COMPLEX,NISAR GA LAYOUT BG ROAD JIGANI HOBLI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682620200,"product":"PHENYLEPHRINE HYDROCHLORIDE EP","address":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL","city":"MEDCHAL-MALKAKGIRI DISTRICT,TELANGA","supplier":"SPERA NEXUS, INC.,","supplierCountry":"JAPAN","foreign_port":"NA","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"390","totalValueFC":"3956.9","currency":"USD","unitRateINR":"32428.5","date":"28-Apr-2023","totalValueINR":"324285","totalValueInUsd":"3956.9","indian_port":"HYDERABAD AIR","hs_no":"29225090","bill_no":"5715932","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740594600,"product":"PHENYLEPHRINE HCL USP\/PH.EUR ( QTY 20.650 KGS) PHENYLEPHRINE HCL USP\/PH.EUR ( QTY 20.650 KGS)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"SIEGFRIED AG","supplierCountry":"SWITZERLAND","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.65","actualQuantity":"20.65","unit":"KGS","unitRateFc":"495","totalValueFC":"10314.1","currency":"USD","unitRateINR":"43436.3","date":"27-Feb-2025","totalValueINR":"896958.56","totalValueInUsd":"10314.1","indian_port":"Ahmedabad Air","hs_no":"29225090","bill_no":"8593555","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"UNTERE BRUHLSTRASSE 4 4800 ZOFINGEN SWITERLAND SDNF SWITZERLAND","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
02-Jan-2021
28-Feb-2025
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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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DOSAGE - SOLUTION;INTRAVENOUS - 10MG/ML (10MG...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML)

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 - 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.

Phenylephrine.HCl Manufacturers

A Phenylephrine.HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylephrine.HCl, including repackagers and relabelers. The FDA regulates Phenylephrine.HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylephrine.HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Phenylephrine.HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Phenylephrine.HCl Suppliers

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

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

Phenylephrine.HCl USDMF

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

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

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

Phenylephrine.HCl JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Phenylephrine.HCl Drug Master File in Japan (Phenylephrine.HCl JDMF) empowers Phenylephrine.HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Phenylephrine.HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Phenylephrine.HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Phenylephrine.HCl suppliers with JDMF on PharmaCompass.

Phenylephrine.HCl KDMF

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

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

After submitting a Phenylephrine.HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Phenylephrine.HCl API can apply through the Korea Drug Master File (KDMF).

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

Phenylephrine.HCl CEP

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

A Phenylephrine.HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenylephrine.HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Phenylephrine.HCl suppliers with CEP (COS) on PharmaCompass.

Phenylephrine.HCl WC

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

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

Phenylephrine.HCl NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Phenylephrine.HCl as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Phenylephrine.HCl API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Phenylephrine.HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Phenylephrine.HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenylephrine.HCl NDC to their finished compounded human drug products, they may choose to do so.

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

Phenylephrine.HCl GMP

Phenylephrine.HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Phenylephrine.HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Phenylephrine.HCl GMP manufacturer or Phenylephrine.HCl GMP API supplier for your needs.

Phenylephrine.HCl CoA

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

Phenylephrine.HCl CoA mostly includes findings from lab analyses of a specific batch. For each Phenylephrine.HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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