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1. 2-amino-3-benzoylbenzeneacetamide
2. Nevanac
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
| Molecular Weight | 254.28 g/mol |
|---|---|
| Molecular Formula | C15H14N2O2 |
| 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 Ų |
| 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 |
| 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 |
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.
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.
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.)
S01BC10
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
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.
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.
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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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.3%
USFDA APPLICATION NUMBER - 203491
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%
USFDA APPLICATION NUMBER - 21862
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PharmaCompass offers a list of Nepafenac API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nepafenac manufacturer or Nepafenac supplier for your needs.
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PharmaCompass also assists you with knowing the Nepafenac API Price utilized in the formulation of products. Nepafenac API Price is not always fixed or binding as the Nepafenac Price is obtained through a variety of data sources. The Nepafenac Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ILEVRO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ILEVRO, including repackagers and relabelers. The FDA regulates ILEVRO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ILEVRO 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 ILEVRO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ILEVRO supplier is an individual or a company that provides ILEVRO active pharmaceutical ingredient (API) or ILEVRO finished formulations upon request. The ILEVRO suppliers may include ILEVRO API manufacturers, exporters, distributors and traders.
click here to find a list of ILEVRO suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ILEVRO DMF (Drug Master File) is a document detailing the whole manufacturing process of ILEVRO active pharmaceutical ingredient (API) in detail. Different forms of ILEVRO DMFs exist exist since differing nations have different regulations, such as ILEVRO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ILEVRO DMF submitted to regulatory agencies in the US is known as a USDMF. ILEVRO USDMF includes data on ILEVRO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ILEVRO USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ILEVRO suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The ILEVRO Drug Master File in Japan (ILEVRO JDMF) empowers ILEVRO API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the ILEVRO JDMF during the approval evaluation for pharmaceutical products. At the time of ILEVRO JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of ILEVRO suppliers with JDMF on PharmaCompass.
A ILEVRO written confirmation (ILEVRO WC) is an official document issued by a regulatory agency to a ILEVRO manufacturer, verifying that the manufacturing facility of a ILEVRO active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ILEVRO APIs or ILEVRO finished pharmaceutical products to another nation, regulatory agencies frequently require a ILEVRO WC (written confirmation) as part of the regulatory process.
click here to find a list of ILEVRO suppliers with Written Confirmation (WC) on PharmaCompass.
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 ILEVRO as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ILEVRO API and other APIs are published in this directory by the FDA.
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 ILEVRO 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.
The NDC directory also contains data on finished compounded human drug products that contain ILEVRO and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ILEVRO NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ILEVRO suppliers with NDC on PharmaCompass.
ILEVRO 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 ILEVRO 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 ILEVRO GMP manufacturer or ILEVRO GMP API supplier for your needs.
A ILEVRO CoA (Certificate of Analysis) is a formal document that attests to ILEVRO's compliance with ILEVRO specifications and serves as a tool for batch-level quality control.
ILEVRO CoA mostly includes findings from lab analyses of a specific batch. For each ILEVRO 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.
ILEVRO may be tested according to a variety of international standards, such as European Pharmacopoeia (ILEVRO EP), ILEVRO JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ILEVRO USP).
