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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 12 USDMF, 2 CEP/COS, 4 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

23 API Suppliers
12 USDMF
2 CEP/COS
4 EU WC
9 NDC API
13 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers, 38 FDA Orange Book, 2 Europe, 6 Canada, 2 South Africa, 23 Listed Dossiers

71 FDF Dossiers
38 FDA Orange Book
2 Europe
6 Canada
2 South Africa
23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 50MG/ML, CAPSULE;ORAL - 100MG EXTENDED, CAPSULE;ORAL - 30MG EXTENDED

drugProductComposition
INJECTABLE;INJECTION - 50MG/ML
CAPSULE;ORAL - 100MG EXTENDED
CAPSULE;ORAL - 30MG EXTENDED

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 11 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 32 Direct Compression, 25 Controlled & Modified Release, 24 Thickeners and Stabilizers, 21 Granulation, 16 Co-Processed Excipients, 15 Lubricants & Glidants, 15 Taste Masking, 12 Chewable & Orodispersible Aids, 11 Parenteral, 10 Film Formers & Plasticizers, 10 Solubilizers, 9 Empty Capsules, 9 Topical, 7 Disintegrants & Superdisintegrants, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

11 APIs, 3 FDF Dossiers

marketPlace
11 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 2 USP , 2 Others

otherSolutions
1 EDQM
2 USP
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 31

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

32,711,638

Annual Reports (USD Million)

Finished Drug Prices

208 RELATED EXCIPIENT COMPANIES

358EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 630-93-3, 5,5-diphenylhydantoin sodium salt, Dilantin sodium, Diphenylhydantoin sodium, Diphantoine, Tacosal

Molecular Formula

C₁₅H₁₁N₂NaO₂

Molecular Weight

274.25 g/mol

InChI Key

FJPYVLNWWICYDW-UHFFFAOYSA-M

FDA UNII

4182431BJH

An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.

1 2D Structure

Phenytoin Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;5,5-diphenylimidazolidin-3-ide-2,4-dione

2.1.2 InChI

InChI=1S/C15H12N2O2.Na/c18-13-15(17-14(19)16-13,11-7-3-1-4-8-11)12-9-5-2-6-10-12;/h1-10H,(H2,16,17,18,19);/q;+1/p-1

2.1.3 InChI Key

FJPYVLNWWICYDW-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C1=CC=C(C=C1)C2(C(=O)[N-]C(=O)N2)C3=CC=CC=C3.[Na+]

2.2 Other Identifiers

2.2.1 UNII

4182431BJH

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 5,5-diphenylhydantoin

2. 5,5-diphenylimidazolidine-2,4-dione

3. Antisacer

4. Difenin

5. Dihydan

6. Dilantin

7. Diphenylhydantoin

8. Diphenylhydantoinate, Sodium

9. Epamin

10. Epanutin

11. Fenitoin

12. Hydantol

13. Phenhydan

14. Phenytoin

15. Sodium Diphenylhydantoinate

2.3.2 Depositor-Supplied Synonyms

1. 630-93-3

2. 5,5-diphenylhydantoin Sodium Salt

3. Dilantin Sodium

4. Diphenylhydantoin Sodium

5. Diphantoine

6. Tacosal

7. Antisacer

8. Phenytoin Sodium Salt

9. Diphentoin

10. Epanutin

11. Solantoin

12. Solantyl

13. Eptoin

14. Sodium Phenytoin

15. Diphenylan Sodium

16. Sodium 2,5-dioxo-4,4-diphenylimidazolidin-1-ide

17. Phenytek

18. Sodium Diphenylhydantoin

19. 5,5-diphenylhydantoin Sodium

20. Mls000554076

21. 2,4-imidazolidinedione, 5,5-diphenyl-, Monosodium Salt

22. 4182431bjh

23. Citrullamon

24. Fenidantoin

25. Novodiphenyl

26. Aladdin

27. Alepsin

28. Cumatil

29. Decatona

30. Dihydan

31. Ditomed

32. Enkefal

33. Epdantoin

34. Epileptin

35. Epsolin

36. Eptolin

37. Fenigramon

38. Fenitron

39. Fenytoin

40. Hidantin

41. Phenilep

42. Smr000146393

43. Ditoin

44. Episar

45. Muldis

46. Fenitoin Sodium

47. Hidantal Sodium

48. Lepitoin Sodium

49. Denyl Sodium

50. Aleviatin Sodium

51. Diphenine Sodium

52. Epilantin-e

53. Fenitoina Sodica

54. Soluble Phenytoin

55. Dilantin Infatabs

56. Metinal Idantoina

57. Di-len

58. Dilantin Injection

59. Dilantin Suspension

60. Om-hydantoine Sodium

61. Sdph

62. Prompt Phenytoin Sodium

63. Sodium;5,5-diphenylimidazolidin-3-ide-2,4-dione

64. Mls000028562

65. Sodium Diphenyl Hydantoinate

66. Diphenylhydantoin Sodium Salt

67. Sodium 5,5-diphenylhydantoinate

68. Phenytoin, Sodium Salt

69. Sodium 5,5-diphenyl Hydantoinate

70. Nsc-757274

71. Extended Phenytoin Sodium

72. Smr000058987

73. Einecs 211-148-2

74. Mfcd00069674

75. Hydantoin, 5,5-diphenyl-, Sodium Salt

76. Phenytoin Sodium [usp:jan]

77. Sodium 5,5-diphenylhydantoin

78. Diphenylhydantoin, Sodium Salt

79. Sodium 5,5-diphenyl-2,4-imidazolidinedione

80. Unii-4182431bjh

81. Hydantoin, 5,5-diphenyl-, Monosodium Salt

82. Opera_id_1233

83. Dsstox_cid_3775

84. Dsstox_rid_77190

85. Dsstox_gsid_23775

86. Spectrum1500485

87. Schembl3051683

88. Dtxsid2023775

89. Phenytoin Sodium [vandf]

90. Hms501j09

91. 5,5-diphenylhydatoin Sodium Salt

92. Phenytoin Sodium [mart.]

93. Phenytoin Sodium [usp-rs]

94. Phenytoin Sodium [who-dd]

95. Phenytoin Sodium [who-ip]

96. Hms1920h10

97. Hms2091p14

98. Hms2233k24

99. Hms3259h11

100. Hms3373o11

101. Phenytoin Sodium Salt [mi]

102. Tox21_302338

103. Ccg-39219

104. Akos003273947

105. Akos015951389

106. Akos025310163

107. Phenytoin Sodium [ep Impurity]

108. Phenytoin Sodium [orange Book]

109. Nc00642

110. Nsc 757274

111. Phenytoin Sodium [ep Monograph]

112. 5,5-diphenylhydantoin Sodium Sigmaultra

113. Phenytoin Sodium [usp Monograph]

114. Ncgc00094758-01

115. Ncgc00094758-02

116. Ncgc00164434-01

117. Ncgc00255285-01

118. As-13308

119. Cas-630-93-3

120. 5,5-diphenylhydantoin Sodium Salt, >=99%

121. Phenytoinum Natricum [who-ip Latin]

122. D1331

123. Diphenylhydantoin Sodium [green Book]

124. Phenytoin Sodium For Injection [jan]

125. En300-49847

126. H12023

127. A834211

128. Sr-05000001698

129. Q-201564

130. Sr-05000001698-1

131. Q27258415

132. 2,4-imidazolidinedione, 5,5-diphenyl-, Sodium Salt (1:1)

133. Phenytoin Sodium, European Pharmacopoeia (ep) Reference Standard

134. Phenytoin Sodium, United States Pharmacopeia (usp) Reference Standard

135. Phenytoin Sodium, Pharmaceutical Secondary Standard; Certified Reference Material

2.3.3 Other Synonyms

1. Phenylhydantoin

2.4 Create Date

2005-06-29

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₁N₂NaO₂
Molecular Weight	274.25 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	2
Exact Mass	274.07182188 g/mol
Monoisotopic Mass	274.07182188 g/mol
Topological Polar Surface Area	47.2 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	356
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
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	Phenytoin sodium
Drug Label	Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula:...
Active Ingredient	Phenytoin sodium
Dosage Form	Injectable
Route	Injection
Strength	50mg/ml
Market Status	Prescription
Company	Hospira; Hikma Maple; X-gen Pharms; Luitpold

2 of 2
Drug Name	Phenytoin sodium
Drug Label	Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula:...
Active Ingredient	Phenytoin sodium
Dosage Form	Injectable
Route	Injection
Strength	50mg/ml
Market Status	Prescription
Company	Hospira; Hikma Maple; X-gen Pharms; Luitpold

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

Cytochrome P-450 CYP1A2 Inducers

Drugs and compounds that induce the synthesis of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inducers.)

Voltage-Gated Sodium Channel Blockers

A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cytochrome P450 1A2 Inducers [MoA]; Cytochrome P450 2B6 Inducers [MoA]; Cytochrome P450 2C19 Inducers [MoA]; Cytochrome P450 2C8 Inducers [MoA]; Cytochrome P450 2C9 Inducers [MoA]; Cytochrome P450 2D6 Inducers [MoA]; Cytochrome P450 3A Inducers [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]

API SUPPLIERS

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USDMF

01

Cadila Laboratories Pvt Ltd

India

Duphat

Not Confirmed

02

Divis Laboratories Ltd

India

Duphat

Not Confirmed

03

Eastman Kodak Co

U.S.A

Duphat

Not Confirmed

Not Confirmed

Only 10 entries up to this point, click to access all

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CEP/COS

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EU WC

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NDC API

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Listed Suppliers

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API Reference Price

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CIVITALI, 1-20148 MILANO ITALIASDNF Italy","customerAddress":"INDOCO HOUSE,166 CST RD.VIDYANAGRI,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703615400,"product":"PHENYTOIN SODIUM","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"XXORDXXI IXXUSTXXA CXXMICXXFARXXCEUXXCA XXA","supplierCountry":"ITALY","foreign_port":"FIUMICINO APT\/ROMA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"65","totalValueFC":"261739.2","currency":"USD","unitRateINR":"5447","date":"27-Dec-2023","totalValueINR":"21788000","totalValueInUsd":"261739.2","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29332100","bill_no":"1003656","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"FIUMICINO APT\/ROMA","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711391400,"product":"PHENYTOIN SODIUM (QTY.200 KGS)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"XXORDXXI IXXUSTXXA CXXMICXXFARXXCEUXXCA XXP.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"64.9","totalValueFC":"13111.8","currency":"USD","unitRateINR":"5443.8","date":"26-Mar-2024","totalValueINR":"1088750","totalValueInUsd":"13111.8","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29332100","bill_no":"1000895","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721154600,"product":"PHENYTOIN SODIUM","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"RECORDATI","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"2906.00","actualQuantity":"2906","unit":"KGS","unitRateFc":"79","totalValueFC":"231932.9","currency":"USD","unitRateINR":"6671.6","date":"17-Jul-2024","totalValueINR":"19387524","totalValueInUsd":"231932.9","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29332100","bill_no":"1002309","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"VIA M, CIVITALI, 1 20148 MILANO, ITALIA IT","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722882600,"product":"PHENYTOIN SODIUM","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"RECORDATI INDUSTRIA CHIMICA EFARMACEUTICA S.P.A","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"869.00","actualQuantity":"869","unit":"KGS","unitRateFc":"79","totalValueFC":"69241.5","currency":"USD","unitRateINR":"6683.4","date":"06-Aug-2024","totalValueINR":"5807874.6","totalValueInUsd":"69241.5","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29332100","bill_no":"4901694","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"VIA MEDIANA CISTERNA 404011 CAMPOVE ITALY SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 50MG/ML

USFDA APPLICATION NUMBER - 84307

DOSAGE - CAPSULE;ORAL - 100MG EXTENDED

USFDA APPLICATION NUMBER - 84349

DOSAGE - CAPSULE;ORAL - 30MG EXTENDED

USFDA APPLICATION NUMBER - 84349

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

01

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannitol

Application : Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

Pharmatech Expo 2025

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

Pharmatech Expo 2025

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

04

DKSH

Switzerland

CPhI WW Frankfurt

Booth #8.0P66

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Thickeners and Stabilizers

Brand Name : GELATIN BOVINE 140B 6M

Application : Fillers, Diluents & Binders, Thickeners and Stabilizers

Excipient Details : Gelatin bovine 140B 6M is used as a stabilizer in parenteral drug products and as a binder and filler in capsules, tablets, granules, and pellets.

Pharmacopoeia Ref : CEP, GMP, EP, USP/NF

Technical Specs : N/A

Ingredient(s) : Gelatin Excipient

05

Faran Shimi Pharmaceutical

Iran

Pharmatech Expo 2025

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Polyvinylpyrrolidone

Application : Fillers, Diluents & Binders

Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

06

Faran Shimi Pharmaceutical

Iran

Pharmatech Expo 2025

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Lactose Monohydrate

Application : Fillers, Diluents & Binders

Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

07

Boai NKY Pharmaceuticals Ltd

China

Pharmatech Expo 2025

Not Confirmed

Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Dosage Form : Capsule, Tablet

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K25

Application : Fillers, Diluents & Binders

Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

08

Gangwal Healthcare

India

Pharmatech Expo 2025

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

09

Nanjing Well Pharmaceutical

China

Pharmatech Expo 2025

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Lactose Monohydrate

Application : Parenteral

Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

10

Pfanstiehl

U.S.A

Pharmatech Expo 2025

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral, Tablet

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Brand Name : D-Mannitol

Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

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Coating Systems & Additives

Direct Compression

Controlled & Modified Release

Thickeners and Stabilizers

Granulation

Co-Processed Excipients

Lubricants & Glidants

Taste Masking

Chewable & Orodispersible Aids

Parenteral

Film Formers & Plasticizers

Solubilizers

Empty Capsules

Topical

Disintegrants & Superdisintegrants

API Stability Enhancers

Coloring Agents

Emulsifying Agents

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Vegetarian Capsules

Surfactant & Foaming Agents

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Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Market Place

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APIs

Phenytoin Sodium (3 kg) API needed in Turkey [ENA21454]

A company that focuses on the development & manufacturing of parenteral solutions in PP bags, PVC bags, PP bottles and ampoules is looking for suppliers of Phenytoin Sodium (3 kg) API for commercial purposes. The suppliers must support this enquiry with DMF, GMP & CoA.

17 Dec 2024

Phenytoin Sodium (500 kg - 600 kg/ annum) API needed in India [ENA20936]

A company that focuses on development and manufacturing of various finished formualtions and active pharmaceutical ingredients is looking for suppliers of Phenytoin Sodium (500 kg - 600 kg/ annum) API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.

24 Oct 2024

Various APIs needed in India [ENA17356]

A company that focuses on the manufacturing of tablets, capsules, syrups, ointments, suppositories & injectables is looking for suppliers of Various APIs for development purposes. The required quantity is 250 g for each. The suppliers must support this enquiry with DMF & CoA. 1. USP Grade Azathioprine API 2. USP Grade Emtricitabine API 3. USP Grade Tenofovir API 4. USP Grade Ethambutol HCl API 5. USP Grade Hydroxycarbamide API 6. USP Grade Isoniazid API 7. USP Grade Lithium Carbonate API 8. USP Grade Lopinavir API 9. USP Grade Ritonavir API 10. USP Grade Phenytoin Sodium API 11. USP Grade Pyrazinamide API

20 Jun 2023

USP/ Injectable Grade APIs needed in Bahrain [ENA15372]

A contract manufacturing organization that specializes in the manufacturing of parenteral formulations is looking for suppliers of USP/ Injectable Grade APIs for development purpose. The suppliers must support this enquiry with CEP (optional), GMP & CoA. 1. Ondansetron HCl (20 g) API 2. Paracetamol (50 g) API 3. Phenylephrine Hydrochloride (45 g) API 4. Phenytoin Sodium (180 g) API 5. Phytonadione (50 g) API

20 Oct 2022

BP Grade Phenytoin Sodium API needed in Sri Lanka [ENA14639]

A company that deals in the distribution of various pharmaceutical products is looking for suppliers of BP Grade Phenytoin Sodium API for commercial purpose. The suppliers must support this enquiry with CoA.

10 Aug 2022

Various APIs needed in India [ENA11704]

A company that deals in the manufacturing & development of pharmaceutical formulations such as tablets, capsules, powder for injection, syrup, suspensions, ointments, creams & ophthalmic preparations is looking for suppliers of Various APIs for development purpose. The suppliers must support this enquiry with CoA. 1. Atazanavir API 2. Sulbactam Pivoxil API 3. Ritonavir API 4. Colistimethate Sodium API 5. Teicoplanin API 6. Niacinamide API 7. Phenytoin Sodium API 8. Methylergonovine Maleate API 9. Mefloquine HCl API 10. Ethambutol API

21 Oct 2021

USP Grade Phenytoin Sodium API needed in Thailand [ENA11438]

A company specializing in the manufacturing and distribution of pharmaceutical and health care products is looking for suppliers of USP Grade Phenytoin Sodium API for both development & commercial purpose. The suppliers must support this enquiry with PICS/ GMP.

20 Sep 2021

Phenytoin Sodium API (25 kg) needed in Spain [ENA03634]

DC Fine Chemicals, a reputable supplier of fine chemicals for commercial bioscience applications is looking for suppliers of Phenytoin Sodium API (25 kg) with GMP and WC support.

09 Mar 2019

Phenytoin Sodium API (MOQ) needed in Bangladesh [ENA03275]

The world-class healthcare solution provider which is engaged in the manufacture and marketing of a wide range of therapeutic drugs is looking for suppliers of Phenytoin Sodium API (MOQ) for formulation development.

29 Jan 2019

Phenytoin Sodium API (450 kg) needed in Iran [ENA03162]

Atlas Healthcare, a life sciences company based in Iran is looking for suppliers of Phenytoin Sodium API (450 kg) for domestic consumption. Interested suppliers must support the product with COA and GMP certificate.

16 Jan 2019

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FDF DOSSIERS

Phenytoin Sodium 250 mg Injections needed in Palestine [ENA06858]

Al-Razi Drug Store, a limited private company that is one of the main pharmaceutical products provider to the ministry of health as well as to the Palestinian market is looking for suppliers of Phenytoin Sodium 250 mg Injections. The required quantity is 2000 injections. Interested suppliers can contact them via their email: khalid@al-razi.ps.

16 Mar 2020

Tender// Various Formulations needed in Mauritius [ENA05763]

16 Nov 2019

In-licensing request// Injectable Products Required for the United Kingdom [EN00315][EN00316][EN00317][EN00318][EN00319][EN00320][EN00321]

A global leader in clinical packaging supplies is searching for partners who can provide the following injectable solutions – Phenytoin, 250mg/5ml, 10000 packs/year Haloperidol, 50mg/ml, 1000 packs/year Haloperidol, 100mg/ml, 2000 packs/year Neostigmine, 10mg/10ml (1mg/ml), 22000 packs/year Neostigmine, 5mg/10ml (0.5mg/ml), 22000 packs/year Phenylepherine, 10mg/ml, 6000 packs/year Glycopyrronium Bromide, 0.2mg/ml, 33000 packs/year

03 Mar 2016

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REF. STANDARDS & IMPURITIES

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EDQM

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USP

01

USP

U.S.A

Duphat

Not Confirmed

02

USP

U.S.A

Duphat

Not Confirmed

Others

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ABOUT THIS PAGE

Phenytoin Sodium Manufacturers

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

Phenytoin Sodium Suppliers

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

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

Phenytoin Sodium USDMF

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

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

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

Phenytoin Sodium CEP

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

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

Phenytoin Sodium WC

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

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

Phenytoin Sodium 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 Phenytoin Sodium as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Phenytoin Sodium GMP

Phenytoin Sodium 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 Phenytoin Sodium 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 Phenytoin Sodium GMP manufacturer or Phenytoin Sodium GMP API supplier for your needs.

Phenytoin Sodium CoA

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

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

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

Find Phenytoin Sodium manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers

12 USDMF

2 CEP/COS

4 EU WC

9 NDC API

13 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers

38 FDA Orange Book

2 Europe

6 Canada

2 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 50MG/ML

CAPSULE;ORAL - 100MG EXTENDED

CAPSULE;ORAL - 30MG EXTENDED

RELATED EXCIPIENT COMPANIES

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3 Kima Chemical

6 Lonza Capsugel

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2 Novo Excipients

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2 Qualicaps

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EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders

48 Coating Systems & Additives

32 Direct Compression

25 Controlled & Modified Release

24 Thickeners and Stabilizers

21 Granulation

16 Co-Processed Excipients

15 Lubricants & Glidants

15 Taste Masking

12 Chewable & Orodispersible Aids

11 Parenteral

10 Film Formers & Plasticizers

10 Solubilizers

9 Empty Capsules

9 Topical

7 Disintegrants & Superdisintegrants

5 API Stability Enhancers