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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 9 USDMF, 1 CEP/COS, 2 EU WC, 1 KDMF, 9 NDC API, 9 Listed Suppliers, $ API Reference Price

16 API Suppliers
9 USDMF
1 CEP/COS
2 EU WC
1 KDMF
9 NDC API
9 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

42 FDF Dossiers, 25 FDA Orange Book, 2 Europe, 1 Canada, 12 South Africa, 2 Listed Dossiers

42 FDF Dossiers
25 FDA Orange Book
2 Europe
1 Canada
12 South Africa
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 6 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 35 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 The Dow Chemical Company, 4 Vasa Pharmachem

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71 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 33 Direct Compression, 26 Controlled & Modified Release, 25 Granulation, 20 Lubricants & Glidants, 20 Disintegrants & Superdisintegrants, 15 Thickeners and Stabilizers, 15 Co-Processed Excipients, 12 Film Formers & Plasticizers, 11 Taste Masking, 7 Solubilizers, 6 Chewable & Orodispersible Aids, 6 Parenteral, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Rheology Modifiers, 2 Topical, 2 Coloring Agents, 1 Surfactant & Foaming Agents

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5 NEWS #PharmaBuzz

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5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Finished Drug Prices

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1 US Medicaid Prescriptions
4 Finished Drug Prices

MARKET PLACE

11 APIs, 2 FDF Dossiers

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11 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 3 USP , 6 Others

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1 EDQM
3 USP
6 Others

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 25

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

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GLOBAL SALES INFORMATION

US Medicaid (USD)

749,468

Annual Reports (USD Million)

Finished Drug Prices

208 RELATED EXCIPIENT COMPANIES

339EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 4682-36-4, Norflex, Banflex, Orphenadrine dihydrogen citrate, Flexon, Orphenadrine (citrate)

Molecular Formula

C₂₄H₃₁NO₈

Molecular Weight

461.5 g/mol

InChI Key

MMMNTDFSPSQXJP-UHFFFAOYSA-N

FDA UNII

X0A40N8I4S

A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.

1 2D Structure

Orphenadrine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N,N-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid

2.1.2 InChI

InChI=1S/C18H23NO.C6H8O7/c1-15-9-7-8-12-17(15)18(20-14-13-19(2)3)16-10-5-4-6-11-16;7-3(8)1-6(13,5(11)12)2-4(9)10/h4-12,18H,13-14H2,1-3H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)

2.1.3 InChI Key

MMMNTDFSPSQXJP-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CC=CC=C1C(C2=CC=CC=C2)OCCN(C)C.C(C(=O)O)C(CC(=O)O)(C(=O)O)O

2.2 Other Identifiers

2.2.1 UNII

X0A40N8I4S

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Citrate, Norflex Orphenadrine

2. Citrate, Orphenadrine

3. Disipal

4. Hydrochloride, Orphenadrine

5. Lysantin

6. Mefenamine

7. Mefenamine, Sodium

8. Mephenamine

9. Methyldiphenylhydramine

10. Norflex

11. Norflex Orphenadrine Citrate

12. Orphenadrine

13. Orphenadrine Citrate, Norflex

14. Orphenadrine Hydrochloride

15. Sodium Mefenamine

2.3.2 Depositor-Supplied Synonyms

1. 4682-36-4

2. Norflex

3. Banflex

4. Orphenadrine Dihydrogen Citrate

5. Flexon

6. Orphenadrine (citrate)

7. Flexoject

8. X-otag

9. Orphenadrine Citrate Salt

10. 2-hydroxypropane-1,2,3-tricarboxylic Acid; Dimethyl({2-[(2-methylphenyl)(phenyl)methoxy]ethyl})amine

11. 4596-23-0

12. Nsc-757238

13. Orphenadrine Citrate [usp]

14. N,n-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid

15. Orphenadrine Citrate (norflex)

16. Chebi:7790

17. X0a40n8i4s

18. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethanamine 2-hydroxypropane-1,2,3-tricarboxylate

19. Ncgc00094745-01

20. Plenactol

21. Euflex

22. Flexor

23. Tega-flex

24. Orphenadrine Citrate (usp)

25. Dsstox_cid_24678

26. Dsstox_rid_80390

27. Dsstox_gsid_44678

28. Norflex (pharmaceutical)

29. Orphenadrinecitrate

30. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethan-1-amine 2-hydroxypropane-1,2,3-tricarboxylate

31. Cas-4682-36-4

32. Einecs 225-137-5

33. Unii-x0a40n8i4s

34. Norflex (tn)

35. Orphenadine Citrate

36. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)

37. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

38. Mls000069549

39. Schembl119470

40. Spectrum1500447

41. Chembl1200395

42. Dtxsid8044678

43. Hms502k15

44. Hy-b0369a

45. Orphenadrine Citrate [mi]

46. Hms1920d10

47. Hms2091l10

48. Hms2231j06

49. Hms3259m21

50. Hms3370m12

51. Hms3651a10

52. Hms3884m22

53. Pharmakon1600-01500447

54. Citric Acid; N,n-dimethyl-2-[o-tolyl(phenyl)methoxy]ethanamine

55. O-methyldiphenhydramine Citrate Salt

56. Orphenadrine Citrate [vandf]

57. Tox21_111323

58. Tox21_113543

59. Tox21_301079

60. Ccg-40242

61. Nsc757238

62. Orphenadrine Citrate [mart.]

63. Orphenadrine Citrate [who-dd]

64. Akos008132385

65. Tox21_111323_1

66. Nc00525

67. Nsc 757238

68. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)

69. Ethylamine, N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)-, Citrate (1:1)

70. Ncgc00015771-13

71. Ncgc00094745-02

72. Ncgc00094745-03

73. Ncgc00254980-01

74. As-74807

75. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

76. Orphenadrine Citrate [ep Impurity]

77. Orphenadrine Citrate [orange Book]

78. Smr000058817

79. Orphenadrine Citrate [ep Monograph]

80. Orphenadrine Citrate [usp Monograph]

81. Ft-0655842

82. Ft-0673305

83. S2054

84. Sw102176-4

85. En300-53019

86. Norgesic Component Orphenadrine Citrate

87. C75247

88. D00774

89. Invagesic Component Orphenadrine Citrate

90. Orphenadrine Citrate Component Of Norgesic

91. Orphengesic Component Orphenadrine Citrate

92. A826945

93. Orphenadrine Citrate Component Of Invagesic

94. Orphenadrine Citrate Component Of Orphengesic

95. Sr-01000002975-5

96. Invagesic Forte Component Orphenadrine Citrate

97. Orphengesic Forte Component Orphenadrine Citrate

98. Q27107584

99. Orphenadrine Citrate Component Of Invagesic Forte

100. Orphenadrine Citrate Component Of Orphengesic Forte

101. Beta-dimethylaminoethyl 2-methylbenzhydryl Ether Citrate Salt

102. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate

103. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate

104. (+/-)-n,n-dimethyl-2-((o-methyl-.alpha.-phenylbenzyl)oxy)ethylamine Citrate (1:1)

105. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+/-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

106. Ethanamine, N,n-dimethyl-2-[(2-methylphenyl)phenylmethoxy]-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)

107. N,n-dimethyl-2-[(2-methylphenyl)(phenyl)methoxy]ethanamine 2-hydroxypropane-1,2,3-tricarboxylate

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₃₁NO₈
Molecular Weight	461.5 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	11
Exact Mass	461.20496695 g/mol
Monoisotopic Mass	461.20496695 g/mol
Topological Polar Surface Area	145 Å²
Heavy Atom Count	33
Formal Charge	0
Complexity	488
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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 4
Drug Name	Norflex
PubMed Health	Orphenadrine
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl...
Active Ingredient	Orphenadrine citrate
Dosage Form	Injectable
Route	Injection
Strength	30mg/ml
Market Status	Prescription
Company	Medicis

2 of 4
Drug Name	Orphenadrine citrate
PubMed Health	Orphenadrine Citrate/Aspirin/Caffeine (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
Drug Label	Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i...
Active Ingredient	Orphenadrine citrate
Dosage Form	Tablet, extended release; Injectable
Route	Injection; Oral
Strength	30mg/ml; 100mg
Market Status	Prescription
Company	Impax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn

3 of 4
Drug Name	Norflex
PubMed Health	Orphenadrine
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting
Drug Label	Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl...
Active Ingredient	Orphenadrine citrate
Dosage Form	Injectable
Route	Injection
Strength	30mg/ml
Market Status	Prescription
Company	Medicis

4 of 4
Drug Name	Orphenadrine citrate
PubMed Health	Orphenadrine Citrate/Aspirin/Caffeine (By mouth)
Drug Classes	Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination
Drug Label	Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i...
Active Ingredient	Orphenadrine citrate
Dosage Form	Tablet, extended release; Injectable
Route	Injection; Oral
Strength	30mg/ml; 100mg
Market Status	Prescription
Company	Impax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Cytochrome P-450 CYP2B6 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2B6. (See all compounds classified as Cytochrome P-450 CYP2B6 Inhibitors.)

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

Muscle Relaxants, Central

A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

Parasympatholytics

Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Muscle Relaxant [EPC]; Centrally-mediated Muscle Relaxation [PE]

5.3 ATC Code

M - Musculo-skeletal system

M03 - Muscle relaxants

M03B - Muscle relaxants, centrally acting agents

M03BC - Ethers, chemically close to antihistamines

M03BC01 - Orphenadrine (citrate)

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API Reference Price

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INGRAM","customerCountry":"INDIA","quantity":"357.00","actualQuantity":"357","unit":"KGS","unitRateFc":"78","totalValueFC":"31156.3","currency":"EUR","unitRateINR":"7320.3","date":"31-Aug-2024","totalValueINR":"2613347.1","totalValueInUsd":"31156.3","indian_port":"Madras Sea","hs_no":"29221190","bill_no":"5348424","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"CASELLA\/GENOVA","supplierAddress":"VIA MATTEOTTI 249 28062 CAMERI (NO)SDNFSDNF ITALY","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"ORPHENADRINE CITRATE","address":"NO.49D, BOMMASANDRA INDUSTRIAL","city":"BANGALORE","supplier":"PROCOS","supplierCountry":"ITALY","foreign_port":"GENOA","customer":"ADCOCK INGRAM","customerCountry":"INDIA","quantity":"178.00","actualQuantity":"178","unit":"KGS","unitRateFc":"78","totalValueFC":"15689.7","currency":"EUR","unitRateINR":"7386.6","date":"24-Sep-2024","totalValueINR":"1314814.8","totalValueInUsd":"15689.7","indian_port":"Madras Sea","hs_no":"29221190","bill_no":"5776508","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"GENOA","supplierAddress":"VIA MATTEOTTI 249 28062 CAMERI ( NO)- ITALY SDNF SDNF","customerAddress":"NO.49D, BOMMASANDRA INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728239400,"product":"ORPHENADRINE CITRATE,0000373049","address":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB","city":"HYDERABAD,TELANGANA","supplier":"PROCOS","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"CRONUS PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"200","totalValueFC":"403.9","currency":"USD","unitRateINR":"16970","date":"07-Oct-2024","totalValueINR":"33940","totalValueInUsd":"403.9","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29221990","bill_no":"5991007","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILANO","supplierAddress":"Via Matteotti 249 Cameri (NO)-I SDNF Italy","customerAddress":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728239400,"product":"ORPHENADRINE CITRATE,0000373293","address":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB","city":"HYDERABAD,TELANGANA","supplier":"PROCOS","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"CRONUS PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"200","totalValueFC":"403.9","currency":"USD","unitRateINR":"16970","date":"07-Oct-2024","totalValueINR":"33940","totalValueInUsd":"403.9","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29221990","bill_no":"5991007","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILANO","supplierAddress":"Via Matteotti 249 Cameri (NO)-I SDNF Italy","customerAddress":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB"}]

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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Orphenadrine Citrate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers

9 USDMF

1 CEP/COS

2 EU WC

1 KDMF

9 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

42 FDF Dossiers

25 FDA Orange Book

2 Europe

1 Canada

12 South Africa

2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

1 DKSH

6 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

16 BASF

11 Corel Pharma Chem

6 DFE Pharma

7 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

35 Kerry

4 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

2 Novo Excipients

2 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 The Dow Chemical Company

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders

47 Coating Systems & Additives

33 Direct Compression

26 Controlled & Modified Release

25 Granulation

20 Lubricants & Glidants

20 Disintegrants & Superdisintegrants

15 Thickeners and Stabilizers

15 Co-Processed Excipients

12 Film Formers & Plasticizers

11 Taste Masking

7 Solubilizers

6 Chewable & Orodispersible Aids

6 Parenteral

5 Empty Capsules

4 Emulsifying Agents

4 Vegetarian Capsules

4 API Stability Enhancers

3 Rheology Modifiers

2 Topical

2 Coloring Agents