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Nepafenac

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 8 USDMF, 1 JDMF, 6 EU WC, 10 NDC API, 14 Listed Suppliers, $ API Reference Price

21 API Suppliers
8 USDMF
1 JDMF
6 EU WC
10 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers, 2 FDA Orange Book, 10 Europe, 2 Canada, 2 South Africa, 5 Listed Dossiers

21 FDF Dossiers
2 FDA Orange Book
10 Europe
2 Canada
2 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OPHTHALMIC - 0.3%, SUSPENSION/DROPS;OPHTHALMIC - 0.1%

drugProductComposition
SUSPENSION/DROPS;OPHTHALMIC - 0.3%
SUSPENSION/DROPS;OPHTHALMIC - 0.1%

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 12 SPI Pharma, 2 DKSH, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Actylis, 2 BASF, 1 Curia, 2 Finar, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 1 Kima Chemical, 5 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 3 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

20 Fillers, Diluents & Binders, 11 Chewable & Orodispersible Aids, 10 Thickeners and Stabilizers, 10 Taste Masking, 9 Direct Compression, 9 Parenteral, 8 Solubilizers, 5 Disintegrants & Superdisintegrants, 4 Topical, 4 Rheology Modifiers, 4 Co-Processed Excipients, 3 Granulation, 3 Film Formers & Plasticizers, 2 Coating Systems & Additives, 2 API Stability Enhancers, 1 Emulsifying Agents

excipientsByApplications
20 Fillers, Diluents & Binders
11 Chewable & Orodispersible Aids
10 Thickeners and Stabilizers
10 Taste Masking
9 Direct Compression
9 Parenteral
8 Solubilizers
5 Disintegrants & Superdisintegrants
4 Topical
4 Rheology Modifiers
4 Co-Processed Excipients
3 Granulation
3 Film Formers & Plasticizers
2 Coating Systems & Additives
2 API Stability Enhancers
1 Emulsifying Agents

DIGITAL CONTENT

8 NEWS #PharmaBuzz

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8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 9 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
9 Finished Drug Prices

MARKET PLACE

5 APIs, 1 FDF Dossiers

marketPlace
5 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 4 Health Canada Patents

patents
6 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 Others

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3 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 17,662

MARKET PLACE

API

FDF

0INTERMEDIATES

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

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

22,136,947

Annual Reports (USD Million)

Finished Drug Prices

53 RELATED EXCIPIENT COMPANIES

105EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 78281-72-8, Nevanac, 2-(2-amino-3-benzoylphenyl)acetamide, 2-amino-3-benzoylbenzeneacetamide, Ahr-9434, Ilevro

Molecular Formula

C₁₅H₁₄N₂O₂

Molecular Weight

254.28 g/mol

InChI Key

QEFAQIPZVLVERP-UHFFFAOYSA-N

FDA UNII

0J9L7J6V8C

Nepafenac is a topical nonsteroidal anti-inflammatory drug that is used in eye drops for the treatment of eye pain and swelling.

Nepafenac is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of nepafenac is as a Cyclooxygenase Inhibitor.

1 2D Structure

Nepafenac

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-(2-amino-3-benzoylphenyl)acetamide

2.1.2 InChI

InChI=1S/C15H14N2O2/c16-13(18)9-11-7-4-8-12(14(11)17)15(19)10-5-2-1-3-6-10/h1-8H,9,17H2,(H2,16,18)

2.1.3 InChI Key

QEFAQIPZVLVERP-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1=CC=C(C=C1)C(=O)C2=CC=CC(=C2N)CC(=O)N

2.2 Other Identifiers

2.2.1 UNII

0J9L7J6V8C

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-amino-3-benzoylbenzeneacetamide

2. Nevanac

2.3.2 Depositor-Supplied Synonyms

1. 78281-72-8

2. Nevanac

3. 2-(2-amino-3-benzoylphenyl)acetamide

4. 2-amino-3-benzoylbenzeneacetamide

5. Ahr-9434

6. Ilevro

7. Al 6515

8. Al-6515

9. Ahr 9434

10. Benzeneacetamide, 2-amino-3-benzoyl-

11. Chebi:75922

12. 0j9l7j6v8c

13. Ahr 9434;al 6515

14. Ncgc00185741-01

15. Dsstox_cid_28564

16. Dsstox_rid_82836

17. Dsstox_gsid_48638

18. Nepafenac [usan]

19. Amfenac Amide

20. Smr002529588

21. Cas-78281-72-8

22. Nepafenaco

23. Nepafenacum

24. Unii-0j9l7j6v8c

25. Nepafena

26. Nepafenac [usan:inn:ban:jan]

27. Nevanac (tn)

28. Mfcd08067732

29. 2-(2-amino-3-benzoyl-phenyl)acetamide

30. 2-[2-amino-3-(benzoyl)phenyl]acetamide

31. Nepafenac [inn]

32. Nepafenac [jan]

33. Nepafenac [mi]

34. Nepafenac [vandf]

35. Nepafenac [mart.]

36. Nepafenac [usp-rs]

37. Nepafenac [who-dd]

38. Chembl1021

39. Schembl93835

40. Nepafenac [ema Epar]

41. Mls003915618

42. Mls004774140

43. Mls006010644

44. Nepafenac (jan/usan/inn)

45. Gtpl7564

46. Nepafenac [orange Book]

47. Dtxsid0048638

48. Nepafenac, >=98% (hplc)

49. 2-amino-3-benzoyl-phenylacetamide

50. Hms3654p07

51. Hms3884e07

52. Act02914

53. Amy10899

54. Bcp21333

55. Ex-a1350

56. Wzb81453

57. Zinc5162311

58. Tox21_112985

59. Bdbm50228731

60. S1255

61. Stl451069

62. Akos005146108

63. Tox21_112985_1

64. Ac-6949

65. Ccg-267004

66. Cs-0899

67. Db06802

68. Ncgc00185741-02

69. 2-(2-amino-3-benzoyl-phenyl)-acetamide

70. As-19176

71. Hy-17357

72. 2-amino-3-benzoylbenzeneacetamide;nepafenac

73. Ft-0603701

74. N0932

75. Sw219197-1

76. 2-[2-amino-3-(phenylcarbonyl)phenyl]acetamide

77. A26218

78. D05143

79. Ab01274763-01

80. Ab01274763_02

81. 281n728

82. A890381

83. Q684379

84. Sr-01000931908

85. J-507774

86. Sr-01000931908-2

87. Brd-k04112579-001-02-1

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₄N₂O₂
Molecular Weight	254.28 g/mol
XLogP3	1.9
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	254.105527694 g/mol
Monoisotopic Mass	254.105527694 g/mol
Topological Polar Surface Area	86.2 Å²
Heavy Atom Count	19
Formal Charge	0
Complexity	337
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	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Nevanac
Drug Label	NEVANAC (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of NEVANAC suspension contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-ben...
Active Ingredient	Nepafenac
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	0.1%
Market Status	Prescription
Company	Alcon Pharms

2 of 2
Drug Name	Nevanac
Drug Label	NEVANAC (nepafenac ophthalmic suspension) 0.1% is a sterile, topical, nonsteroidal anti-inflammatory (NSAID) prodrug for ophthalmic use. Each mL of NEVANAC suspension contains 1 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-ben...
Active Ingredient	Nepafenac
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	0.1%
Market Status	Prescription
Company	Alcon Pharms

4.2 Drug Indication

For the treatment of pain and inflammation associated with cataract surgery.

FDA Label

Nevanac is indicated for:

- prevention and treatment of postoperative pain and inflammation associated with cataract surgery;

- reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours postdose, respectively, following bilateral topical ocular TID dosing of nepafenac ophthalmic suspension, 0.1%. The mean steady-state Cmax for nepafenac and for amfenac were 0.310 0.104 ng/ml and 0.422 0.121 ng/ml, respectively, following ocular administration.

5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents, Non-Steroidal

Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

NEPAFENAC

5.3.2 FDA UNII

0J9L7J6V8C

5.3.3 Pharmacological Classes

Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

5.4 ATC Code

S01BC10

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

S - Sensory organs

S01 - Ophthalmologicals

S01B - Antiinflammatory agents

S01BC - Antiinflammatory agents, non-steroids

S01BC10 - Nepafenac

5.5 Absorption, Distribution and Excretion

Absorption

Nepafenac rapidly cross the cornea (6 times faster than diclofenac in vitro).

Route of Elimination

After oral administration of 14C-nepafenac to healthy volunteers, urinary excretion was found to be the major route of radioactivity elimination, accounting for approximately 85% of the dose, while fecal excretion represented approximately 6% of the dose. Nepafenac (prodrug) and amfenac (active compound) were not quantifiable in the urine.

5.6 Metabolism/Metabolites

Nepafenac (prodrug) is deaminated to amfenac (active compound) in the ciliary body epithelium, retina, and choroid by intraocular hydrolases. Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving hydroxylation of the aromatic ring leading to glucuronide conjugate formation.

5.7 Mechanism of Action

Nepafenac is a prodrug. After penetrating the cornea, nepafenac undergoes rapid bioactivation to amfenac, which is a potent NSAID that uniformly inhibits the COX1 and COX2 activity.

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API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"0.45","actualQuantity":"450","unit":"GMS","unitRateFc":"250","totalValueFC":"113790.6","currency":"USD","unitRateINR":"21137.5","date":"25-Jul-2024","totalValueINR":"9511875","totalValueInUsd":"113790.6","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"4697586","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT,6-8 PLANTA8 08970, SANT JOAN DESPIBARCELONA SPAIN ES","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728585000,"product":"NEPAFENAC :-FOR EXAMINATION,TEST,OR ANALYSIS PURPOSE ONLY","address":"COMMERCE HOUSE V,BESIDES VODAFONE","city":"AHMEDABAD, GUJARAT. INDIA.","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ACULIFE HEALTHCARE","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"300000","totalValueFC":"3029.4","currency":"USD","unitRateINR":"25455000","date":"11-Oct-2024","totalValueINR":"254550","totalValueInUsd":"3029.4","indian_port":"Ahmedabad Air","hs_no":"29242990","bill_no":"6067077","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8, PLANTA 8 08970, SANT JOAN DESPI, BARCELONA, SPAIN","customerAddress":"COMMERCE HOUSE V,BESIDES VODAFONE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"NEPAFENAC - QTY - 0.05 KGS - LOT NO: A-220234 - AS PER INVOICE","address":"5th FLOOR, 5001-5002, PRERNA AARTIKA,","city":"AHMEDABAD","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AUXILLA PHARMACEUTICALS AND ","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"250000","totalValueFC":"12637.4","currency":"USD","unitRateINR":"21237500","date":"24-Oct-2024","totalValueINR":"1061875","totalValueInUsd":"12637.4","indian_port":"Ahmedabad Air","hs_no":"29242990","bill_no":"6316089","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CALLE FRUCTUOS GELABERT 6-8 08970 S ANT JOAN DESPI BARCELONA SDNF SPAIN","customerAddress":"5th FLOOR, 5001-5002, PRERNA AARTIKA,"}]

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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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.3%

USFDA APPLICATION NUMBER - 203491

DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%

USFDA APPLICATION NUMBER - 21862

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers

8 USDMF

1 JDMF

6 EU WC

10 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

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FINISHED DOSAGE FORMULATIONS

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5 Listed Dossiers

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SUSPENSION/DROPS;OPHTHALMIC - 0.3%

SUSPENSION/DROPS;OPHTHALMIC - 0.1%

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EXCIPIENTS BY APPLICATIONS

20 Fillers, Diluents & Binders

11 Chewable & Orodispersible Aids

10 Thickeners and Stabilizers

10 Taste Masking

9 Direct Compression

9 Parenteral

8 Solubilizers

5 Disintegrants & Superdisintegrants

4 Topical

4 Rheology Modifiers

4 Co-Processed Excipients

3 Granulation

3 Film Formers & Plasticizers

2 Coating Systems & Additives

2 API Stability Enhancers

1 Emulsifying Agents

DIGITAL CONTENT

8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

9 Finished Drug Prices

MARKET PLACE

5 APIs

1 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 Others