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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 11 USDMF, 6 CEP/COS, 5 EU WC, 1 KDMF, 7 NDC API, 20 Listed Suppliers, $ API Reference Price

31 API Suppliers
11 USDMF
6 CEP/COS
5 EU WC
1 KDMF
7 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

107 FDF Dossiers, 24 FDA Orange Book, 20 Europe, 5 Canada, 8 South Africa, 50 Listed Dossiers

107 FDF Dossiers
24 FDA Orange Book
20 Europe
5 Canada
8 South Africa
50 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG

drugProductComposition
TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 25MG

RELATED EXCIPIENT COMPANIES

5 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 8 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 15 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 10 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 25 BASF, 1 Bioplus Life Sciences, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
5 Rochem International Inc
17 SPI Pharma
2 Seqens
8 DKSH
1 Pharm-RX Chemical
8 Faran Shimi Pharmaceutical
4 Boai NKY Pharmaceuticals Ltd
15 Gangwal Healthcare
5 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
10 Actylis
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
25 BASF
1 Bioplus Life Sciences
2 Clariant
11 Corel Pharma Chem
7 DFE Pharma
1 Doshion Polyscience
1 Finar
10 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
37 Kerry
3 Kima Chemical
6 Lonza Capsugel
14 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
2 Novo Excipients
3 Pharmatrans-Sanaq
9 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
29 Roquette
13 Seppic
8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
2 The Dow Chemical Company
1 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

95 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 43 Direct Compression, 32 Disintegrants & Superdisintegrants, 30 Thickeners and Stabilizers, 29 Taste Masking, 28 Granulation, 28 Controlled & Modified Release, 25 Solubilizers, 24 Parenteral, 22 Co-Processed Excipients, 21 Film Formers & Plasticizers, 17 Chewable & Orodispersible Aids, 16 Lubricants & Glidants, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 7 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

13 NEWS #PharmaBuzz

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13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 6 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
6 Finished Drug Prices

MARKET PLACE

19 APIs, 5 FDF Dossiers

marketPlace
19 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 1 US Exclusivities, 1 Health Canada Patents

patents
10 US Patents
1 US Exclusivities
1 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 1 Others

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1 EDQM
1 USP
1 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
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)

$ 14

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

107

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS 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)

48,320,907

Annual Reports (USD Million)

Finished Drug Prices

315 RELATED EXCIPIENT COMPANIES

518EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 15307-81-0, Cataflam, Cgp 45840b, Voltfast, Cambia, Zipsor

Molecular Formula

C₁₄H₁₀Cl₂KNO₂

Molecular Weight

334.2 g/mol

InChI Key

KXZOIWWTXOCYKR-UHFFFAOYSA-M

FDA UNII

L4D5UA6CB4

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

1 2D Structure

Diclofenac Potassium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

potassium;2-[2-(2,6-dichloroanilino)phenyl]acetate

2.1.2 InChI

InChI=1S/C14H11Cl2NO2.K/c15-10-5-3-6-11(16)14(10)17-12-7-2-1-4-9(12)8-13(18)19;/h1-7,17H,8H2,(H,18,19);/q;+1/p-1

2.1.3 InChI Key

KXZOIWWTXOCYKR-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C1=CC=C(C(=C1)CC(=O)[O-])NC2=C(C=CC=C2Cl)Cl.[K+]

2.2 Other Identifiers

2.2.1 UNII

L4D5UA6CB4

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dichlofenal

2. Diclofenac

3. Diclofenac Sodium

4. Diclofenac, Sodium

5. Diclonate P

6. Diclophenac

7. Dicrofenac

8. Feloran

9. Gp 45,840

10. Gp-45,840

11. Gp45,840

12. Novapirina

13. Orthofen

14. Orthophen

15. Ortofen

16. Sodium Diclofenac

17. Sr 38

18. Sr-38

19. Sr38

20. Voltaren

21. Voltarol

2.3.2 Depositor-Supplied Synonyms

1. 15307-81-0

2. Cataflam

3. Cgp 45840b

4. Voltfast

5. Cambia

6. Zipsor

7. Diclofenac Potassium [usan:usp]

8. Potassium Diclofenac

9. Potassium;2-[2-(2,6-dichloroanilino)phenyl]acetate

10. Diclofenac (potassium)

11. Cgp-45840b

12. Diclofenac Potassium Salt

13. L4d5ua6cb4

14. Chebi:4508

15. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Monopotassium Salt

16. Potassium 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate

17. Cataflam; Diclofenac Potassium; K-fenak; Potassium Diclofenac; Prosorb

18. Diclofenac Potassium [usan]

19. Unii-l4d5ua6cb4

20. Cataflam (tn)

21. Potassium (o-(2,6-dichloroanilino)phenyl)acetate

22. Cambia (tn)

23. Zipsor (tn)

24. Diclofenac Potassium (usp)

25. Schembl40784

26. Chembl1200804

27. Dtxsid30165212

28. Hms3656d18

29. Diclofenac Potassium [vandf]

30. Diclofenac Potassium [mart.]

31. S3062

32. Diclofenac Potassium [usp-rs]

33. Diclofenac Potassium [who-dd]

34. Akos015889752

35. Akos015994733

36. Diclofenac Potassium Salt [mi]

37. Ccg-267848

38. Ks-5037

39. Ac-18735

40. Diclofenac Potassium [orange Book]

41. Hy-15038

42. Diclofenac Potassium [ep Monograph]

43. Db-043176

44. Diclofenac Potassium [usp Monograph]

45. Cs-0003712

46. Ft-0603076

47. Sw196404-4

48. D00903

49. Q27106401

50. Potassium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate

51. Potassium 2-(2-(2,6-dichlorophenylamino)phenyl)acetate

52. Potassium (o-((2,6-dichlorophenyl)amino)phenyl)acetate

53. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid, Monopotassium Salt

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₁₀Cl₂KNO₂
Molecular Weight	334.2 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	332.9725654 g/mol
Monoisotopic Mass	332.9725654 g/mol
Topological Polar Surface Area	52.2 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	310
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 8
Drug Name	Cambia
Drug Label	CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buff...
Active Ingredient	Diclofenac potassium
Dosage Form	For solution
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Depomed

2 of 8
Drug Name	Cataflam
PubMed Health	Diclofenac
Drug Classes	Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
Drug Label	Cataflam (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. Cataflam is available as immediate-release tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benz...
Active Ingredient	Diclofenac potassium
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Novartis

3 of 8
Drug Name	Diclofenac potassium
Drug Label	Diclofenac potassium tablets USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,...
Active Ingredient	Diclofenac potassium
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Teva; Apotex; Sandoz; Mylan

4 of 8
Drug Name	Zipsor
PubMed Health	Diclofenac
Drug Classes	Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
Drug Label	Zipsor (diclofenac potassium) Liquid Filled Capsule is a benzeneacetic acid derivative NSAID. Zipsor is available as liquid-filled capsules of 25 mg for oral administration. The chemical name is 2-[(2,6- dichlorophenyl) amino] benzeneacetic acid mono...
Active Ingredient	Diclofenac potassium
Dosage Form	Capsule
Route	Oral
Strength	25mg
Market Status	Prescription
Company	Depomed

5 of 8
Drug Name	Cambia
Drug Label	CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buff...
Active Ingredient	Diclofenac potassium
Dosage Form	For solution
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Depomed

6 of 8
Drug Name	Cataflam
PubMed Health	Diclofenac
Drug Classes	Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
Drug Label	Cataflam (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. Cataflam is available as immediate-release tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benz...
Active Ingredient	Diclofenac potassium
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Novartis

7 of 8
Drug Name	Diclofenac potassium
Drug Label	Diclofenac potassium tablets USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,...
Active Ingredient	Diclofenac potassium
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Teva; Apotex; Sandoz; Mylan

8 of 8
Drug Name	Zipsor
PubMed Health	Diclofenac
Drug Classes	Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
Drug Label	Zipsor (diclofenac potassium) Liquid Filled Capsule is a benzeneacetic acid derivative NSAID. Zipsor is available as liquid-filled capsules of 25 mg for oral administration. The chemical name is 2-[(2,6- dichlorophenyl) amino] benzeneacetic acid mono...
Active Ingredient	Diclofenac potassium
Dosage Form	Capsule
Route	Oral
Strength	25mg
Market Status	Prescription
Company	Depomed

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.)

Cyclooxygenase Inhibitors

Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

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

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API Reference Price

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RIVOLTANA KM 6\/7 20053 RODANO (MI) Milano, , Italy Italy","customerAddress":"102,TITAN HOUSE,60 FEET RD,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

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

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DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20142

DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20142

DOSAGE - CAPSULE;ORAL - 25MG

USFDA APPLICATION NUMBER - 22202

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TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 25MG

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TABLET;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons