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ACTIVE PHARMA INGREDIENTS

69 API Suppliers, 21 USDMF, 13 CEP/COS, 1 JDMF, 6 EU WC, 19 KDMF, 20 NDC API, 50 Listed Suppliers, $ API Reference Price

69 API Suppliers
21 USDMF
13 CEP/COS
1 JDMF
6 EU WC
19 KDMF
20 NDC API
50 Listed Suppliers
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88 FDA Orange Book
34 Europe
62 Canada
70 South Africa
94 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML), SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML), SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML), SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML), SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML), SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML), SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML), SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML), SOLUTION/DROPS;OPHTHALMIC - 10%, SOLUTION/DROPS;OPHTHALMIC - 2.5%, TABLET;ORAL - 4MG;200MG;10MG, TABLET;ORAL - 200MG;10MG, SYRUP;ORAL - 5MG/5ML;6.25MG/5ML

drugProductComposition
SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)
SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML)
SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML)
SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML)
SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML)
SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML)
SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML)
SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML)
SOLUTION/DROPS;OPHTHALMIC - 10%
SOLUTION/DROPS;OPHTHALMIC - 2.5%
TABLET;ORAL - 4MG;200MG;10MG
TABLET;ORAL - 200MG;10MG
SYRUP;ORAL - 5MG/5ML;6.25MG/5ML

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Phenylephrine Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

69

API Suppliers

21

USDMF

13

CEP/COS

CEP/COS Certifications

1

JDMF

6

EU WC

19

KDMF

20

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0

VMF

50

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API REF. PRICE (USD/KG)

$

$ 159

MARKET PLACE

33

API

4

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

348

FDF Dossiers

88

FDA Orange Book

FDA (Orange Book)

34

Europe

62

Canada

0

Australia

70

South Africa

94

Listed Dossiers

14DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

3

EDQM

6

USP

0

JP

16

Others

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15

US Patents

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US Exclusivities

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DIGITAL CONTENT

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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 Formula	C₉H₁₄ClNO₂
Molecular Weight	203.66 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	203.0713064 g/mol
Monoisotopic Mass	203.0713064 g/mol
Topological Polar Surface Area	52.5 Å²
Heavy Atom Count	13
Formal Charge	0
Complexity	130
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Phenylephrine hydrochloride
Drug Label	NEO-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 Ingredient	Phenylephrine hydrochloride
Dosage Form	Solution/drops; Solution
Route	Ophthalmic; Iv (infusion)
Strength	10mg/ml (10mg/ml); 10%; 2.5%
Market Status	Prescription
Company	West Ward Pharm; Paragon Bioteck

2 of 2
Drug Name	Phenylephrine hydrochloride
Drug Label	NEO-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 Ingredient	Phenylephrine hydrochloride
Dosage Form	Solution/drops; Solution
Route	Ophthalmic; Iv (infusion)
Strength	10mg/ml (10mg/ml); 10%; 2.5%
Market Status	Prescription
Company	West 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]

API SUPPLIERS

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USDMF

01

Transo Pharm Handels Gmbh

Germany

CPhI Worldwide, Milan

Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Digital Content

Phenylephrine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-18

Pay. Date : 2015-04-23

DMF Number : 28754

Submission : 2014-10-15

Status : Active

Type : II

Transo Pharm Handels GmbH

Product Web Link

Digital Content

02

Novus Fine Chemicals Llc

India

CPhI Worldwide, Milan

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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Phenylephrine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18899

Submission : 2005-10-21

Status : Active

Type : II

Product Web Link

Digital Content

03

Malladi Drugs And Pharmaceuticals Lt...

India

CPhI Worldwide, Milan

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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Phenylephrine And Salt

GDUFA

DMF Review : Complete

Rev. Date : 2015-05-29

Pay. Date : 2015-05-15

DMF Number : 18788

Submission : 2005-09-20

Status : Active

Type : II

Product Web Link

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Boehringer Ingelheim Pharma Gmbh And...

Germany

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Cheng Fong Chemical Co Ltd

China

Boulder Peptide 2024

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06

Divi's Labotatories Ltd

India

Boulder Peptide 2024

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07

Kv Pharmaceutical Co

Switzerland

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Spera Nexus Inc

Japan

Boulder Peptide 2024

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09

Organichem Corp

Germany

Boulder Peptide 2024

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10

Vitarine Co Inc Sub West Chemical Pr...

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Boulder Peptide 2024

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CEP/COS

01

TRANSO-PHARM HANDELS GMBH Siek DE

Germany

CPhI Worldwide, Milan

Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Phenylephrine hydrochloride

Certificate Number : R1-CEP 2015-075 - Rev 00

Status : Valid

Issue Date : 2021-03-25

Type : Chemical

Substance Number : 632

Transo Pharm Handels GmbH

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02

TRANSO-PHARM HANDELS GMBH Siek DE

Germany

CPhI Worldwide, Milan

Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Phenylephrine hydrochloride

Certificate Number : R1-CEP 2006-231 - Rev 01

Status : Valid

Issue Date : 2016-10-20

Type : Chemical

Substance Number : 632

Transo Pharm Handels GmbH

Product Web Link

Digital Content

03

MALLADI DRUGS & PHARMACEUTICALS LIM...

India

CPhI Worldwide, Milan

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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Phenylephrine hydrochloride

Certificate Number : R1-CEP 2003-179 - Rev 04

Status : Valid

Issue Date : 2021-09-13

Type : Chemical

Substance Number : 632

Product Web Link

Digital Content

04

MALLADI DRUGS & PHARMACEUTICALS LIM...

India

CPhI Worldwide, Milan

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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Phenylephrine

Certificate Number : R0-CEP 2018-142 - Rev 02

Status : Valid

Issue Date : 2021-09-13

Type : Chemical

Substance Number : 1035

Product Web Link

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05

Boehringer Ingelheim Pharma GmbH & ...

Germany

Boulder Peptide 2024

Not Confirmed

06

Boehringer Ingelheim Pharma GmbH & ...

Germany

Boulder Peptide 2024

Not Confirmed

07

DIVI'S LABORATORIES LIMITED Hyderab...

India

Boulder Peptide 2024

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08

SIEGFRIED PHARMACHEMIKALIEN MINDEN ...

Switzerland

Boulder Peptide 2024

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09

Sintefina Industria E Comercio Ltda...

Brazil

Boulder Peptide 2024

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10

Sintefina Industria E Comercio Ltda...

Brazil

Boulder Peptide 2024

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API Reference Price

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714501800,"product":"PHENYLEPHRINE HCL USP \/PH EUR , BATCH NO:24012247 ( QTY 15KGS)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"SIEGFRIED AG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"495","totalValueFC":"7546.4","currency":"USD","unitRateINR":"41778","date":"01-May-2024","totalValueINR":"626670","totalValueInUsd":"7546.4","indian_port":"Ahmedabad Air","hs_no":"29225090","bill_no":"3284618","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"4800 ZOFINGEN SWITZERLANDSDNFSDNF SWITZERLAND","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]

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