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Farmak Bromfenac Sodium

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ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 10 USDMF, 3 JDMF, 5 EU WC, 12 NDC API, 13 Listed Suppliers, $ API Reference Price

19 API Suppliers
10 USDMF
3 JDMF
5 EU WC
12 NDC API
13 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 20 FDA Orange Book, 1 Europe, 1 Listed Dossiers

22 FDF Dossiers
20 FDA Orange Book
1 Europe
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 DKSH, 1 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 8 Actylis, 12 BASF, 1 Curia, 1 Finar, 5 Gangwal Chemicals, 1 Lubrizol Life Science Health, 1 Microlex e.U, 2 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

23 Solubilizers, 11 Parenteral, 10 Fillers, Diluents & Binders, 6 Thickeners and Stabilizers, 6 Granulation, 6 Direct Compression, 6 Topical, 6 Controlled & Modified Release, 4 Co-Processed Excipients, 3 Film Formers & Plasticizers, 3 Emulsifying Agents, 2 Lubricants & Glidants, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents, 1 Coating Systems & Additives, 1 Disintegrants & Superdisintegrants, 1 Rheology Modifiers, 1 Chewable & Orodispersible Aids

excipientsByApplications
23 Solubilizers
11 Parenteral
10 Fillers, Diluents & Binders
6 Thickeners and Stabilizers
6 Granulation
6 Direct Compression
6 Topical
6 Controlled & Modified Release
4 Co-Processed Excipients
3 Film Formers & Plasticizers
3 Emulsifying Agents
2 Lubricants & Glidants
2 API Stability Enhancers
2 Surfactant & Foaming Agents
1 Coating Systems & Additives
1 Disintegrants & Superdisintegrants
1 Rheology Modifiers
1 Chewable & Orodispersible Aids

DIGITAL CONTENT

11 NEWS #PharmaBuzz

media
11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 1 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
1 Finished Drug Prices

MARKET PLACE

6 APIs

marketPlace
6 APIs

PATENTS & EXCLUSIVITIES

12 US Patents, 1 US Exclusivities

patents
12 US Patents
1 US Exclusivities

Farmak Bromfenac Sodium

Synopsis

ACTIVE PHARMA INGREDIENTS

19

API Suppliers

10

USDMF

0

CEP/COS

CEP/COS Certifications

3

JDMF

5

EU WC

0

KDMF

12

NDC API

0

VMF

13

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 45,862

MARKET PLACE

6

API

0

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

22

FDF Dossiers

20

FDA Orange Book

FDA (Orange Book)

1

Europe

0

Canada

0

Australia

0

South Africa

1

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

12

US Patents

1

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

11

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

13,157,422

Annual Reports (USD Million)

NA

Finished Drug Prices

53 RELATED EXCIPIENT COMPANIES

94EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 91714-93-1, 120638-55-3, Bromfenac (sodium), Bronuck, Bromfenac sodium salt, Bromsite

Molecular Formula

C₁₅H₁₁BrNNaO₃

Molecular Weight

356.15 g/mol

InChI Key

HZFGMQJYAFHESD-UHFFFAOYSA-M

FDA UNII

9X8YF771OU

Bromfenac Sodium

Bromfenac Sodium is the sodium salt form of bromfenac, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory activities. Upon ophthalmic administration, bromfenac binds to and inhibits the activity of cyclooxygenase II (COX II), an enzyme which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins (PG). By inhibiting PG formation, bromfenac is able to inhibit PG-induced inflammation, thereby preventing vasodilation, leukocytosis, disruption of the blood-aqueous humor barrier, an increase in vascular permeability and an increase in intraocular pressure (IOP).

1 2D Structure

Bromfenac Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate

2.1.2 InChI

InChI=1S/C15H12BrNO3.Na/c16-11-6-4-9(5-7-11)15(20)12-3-1-2-10(14(12)17)8-13(18)19;/h1-7H,8,17H2,(H,18,19);/q;+1/p-1

2.1.3 InChI Key

HZFGMQJYAFHESD-UHFFFAOYSA-M

2.1.4 Canonical SMILES

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

2.2 Other Identifiers

2.2.1 UNII

9X8YF771OU

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Ahr-10282

2. Bromfenac

3. Duract

4. Isv-303

5. Sodium Bromfenac

6. Xibrom

2.3.2 Depositor-Supplied Synonyms

1. 91714-93-1

2. 120638-55-3

3. Bromfenac (sodium)

4. Bronuck

5. Bromfenac Sodium Salt

6. Bromsite

7. Bromfenac Sodium Anhydrous

8. Xibrom

9. Chebi:140536

10. Ahr 10282b

11. Bromfenac Monosodium Salt Sesquihydrate

12. Bromfenac (sodium Hydrate)

13. Benzeneacetic Acid, 2-amino-3-(4-bromobenzoyl)-, Monosodium Salt

14. Sodium;2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate

15. 9x8yf771ou

16. Bromday

17. Prolensa

18. Sodium 2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate

19. Ahr-10282b

20. Bromfenac Sodium Hydrate

21. Sodium 2-[2-amino-3-(4-bromobenzoyl)phenyl]acetate

22. 2-amino-3-(4-bromobenzoyl)benzeneacetic Acid Sodium Salt

23. Bromfenac Sodium Salt Sesquihydrate

24. Unii-9x8yf771ou

25. Sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate

26. Mfcd03701673

27. Benzeneacetic Acid, 2-amino-3-(4-bromobenzoyl)-, Sodium Salt (1:1)

28. Bromfenac Monosodium Salt

29. Chembl751

30. Schembl56644

31. Hy-b1888a

32. Dtxsid70273981

33. Bromfenac Sodium [who-dd]

34. Ahr 10282r

35. Hms3652d21

36. Hms3885l13

37. Amy22137

38. Bcp05811

39. Bromfenac Sodium, >=98% (hplc)

40. Ac-149

41. Bdbm50225143

42. S4248

43. Akos000280377

44. Bromfenac Monosodium Salt [mi]

45. Ac-9334

46. Ccg-268104

47. Sb17363

48. Bb164264

49. Cs-0014295

50. Ft-0602701

51. Ft-0660252

52. Sw219148-1

53. Sodium 2-amino-3-(4-bromobenzoyl) Phenylacetate

54. J-004372

55. Q-200752

56. Sodium2-(2-amino-3-(4-bromobenzoyl)phenyl)acetate

57. Q27225685

58. Sodium (-amino-3-(p-bromobenzoyl)phenyl)acetate

59. Sodium; [2-amino-3-(4-bromo-benzoyl)-phenyl]-acetate

60. Benzeneacetic Acid,2-amino-3-(4-bromobenzoyl)-,monosodium Salt

61. Ahr 10282b;ahr-10282; Ahr10282; Ahr 10282;sodium Bromfenac

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₁BrNNaO₃
Molecular Weight	356.15 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	4
Exact Mass	354.98200 g/mol
Monoisotopic Mass	354.98200 g/mol
Topological Polar Surface Area	83.2 Å²
Heavy Atom Count	21
Formal Charge	0
Complexity	372
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	Bromfenac sodium
Drug Label	Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfen...
Active Ingredient	Bromfenac sodium
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.09% acid
Market Status	Prescription
Company	Apotex; Hi-tech Pharmacal; Luitpold; Coastal Pharms

2 of 2
Drug Name	Bromfenac sodium
Drug Label	Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfen...
Active Ingredient	Bromfenac sodium
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.09% acid
Market Status	Prescription
Company	Apotex; Hi-tech Pharmacal; Luitpold; Coastal Pharms

5 Pharmacology and Biochemistry

5.1 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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

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

API SUPPLIERS

01

FARMAK, a.s

Czech Republic

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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ChemWerth Inc

U.S.A

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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LGM Pharma

U.S.A

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Jai Radhe Sales

India

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FARMAK, a.s

Czech Republic

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Micro Labs Limited

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Viatris

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08

SENJU PHARMACEUTICAL CO LTD

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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09

Yonsung Fine Chemicals

South Korea

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Lonza Group

Switzerland

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NDC API

01

APICORE PHARMACEUTICALS PRIVATE LIM...

India

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02

Archimica S.p.A.

Italy

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03

AX Pharmaceutical Corp.

Canada

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04

DARMERICA, LLC

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05

Enaltec Labs Private Limited

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06

Indoco Remedies Limited

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07

Medilux Laboratories Private Limite...

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Micro Labs Limited

India

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Regis Technologies Inc

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Spectrum Laboratory Products, Inc.

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API Reference Price

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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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INTERMEDIATES SUPPLIERS

01

Jinan Tantu Chemicals

China

Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

7-(4-Bromobenzoyl)indole

CAS Number : 91714-50-0

End Use API : Bromfenac Sodium

Jinan Tantu Chemicals

Product Web Link

Digital Content

02

Jinan Tantu Chemicals

China

Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

3-chloro-7-(4-bromobenzoyl)-indole

CAS Number : 91714-51-1

End Use API : Bromfenac Sodium

Jinan Tantu Chemicals

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Europe

01

Pharma Swiss Ceska republika sro

Country

BIO Partnering at JPM

Not Confirmed

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Patents & EXCLUSIVITIES

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US Patents

01

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

02

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

03

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

04

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

05

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

06

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

07

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

08

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

09

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

10

BAUSCH AND LOMB

BROMFENAC SODIUM

BIO Partnering at JPM

Not Confirmed

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ABOUT THIS PAGE

Bromfenac Sodium Manufacturers

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

Bromfenac Sodium Suppliers

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

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

Bromfenac Sodium USDMF

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

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

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

Bromfenac Sodium JDMF

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 Bromfenac Sodium Drug Master File in Japan (Bromfenac Sodium JDMF) empowers Bromfenac Sodium 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 Bromfenac Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Bromfenac Sodium 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 Bromfenac Sodium suppliers with JDMF on PharmaCompass.

Bromfenac Sodium WC

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

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

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

Finished drug products

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

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

Bromfenac Sodium GMP

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

Bromfenac Sodium CoA

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

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

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

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