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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TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 25MG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TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Controlled & Modified Release, 28 Granulation, 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

media
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

otherSolutions
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]

API SUPPLIERS

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USDMF

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CEP/COS

01

AMOLI ORGANICS PRIVATE LIMITED Mumb...

India

Pharma, Lab & Chemical Expo

Not Confirmed

02

Farchemia S.r.l. Treviglio IT

Italy

Pharma, Lab & Chemical Expo

Not Confirmed

03

HENAN DONGTAI PHARM CO., LTD. Anyan...

China

Pharma, Lab & Chemical Expo

Not Confirmed

04

J.B. CHEMICALS & PHARMACEUTICALS LI...

India

Pharma, Lab & Chemical Expo

Not Confirmed

05

KAIRAV CHEMICALS LIMITED Ahmedabad ...

India

Pharma, Lab & Chemical Expo

Not Confirmed

06

OLON S.P.A. Rodano IT

Italy

Pharma, Lab & Chemical Expo

Not Confirmed

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EU WC

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KDMF

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Listed Suppliers

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API Reference Price

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LTD","supplierCountry":"INDIA","foreign_port":"LA GUAIRA","customer":"TO THE ORDER OF","customerCountry":"VENEZUELA","quantity":"11000.00","actualQuantity":"11000","unit":"KGS","unitRateFc":"8.8","totalValueFC":"92676.5","currency":"USD","unitRateINR":710.9818181818182,"date":"07-Nov-2024","totalValueINR":"7820800","totalValueInUsd":"92676.5","indian_port":"JNPT","hs_no":"29225090","bill_no":"5426390","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VENEZUELA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"3, BOTAWALA BLDG., 1ST FLOOR,, FORT, MUMBAI MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731004200,"product":"DRUG & DRUG INTERMEDIATES - DICLOFENAC POTASSIUM B.P","address":"MAHENDRA INDL.ESTATE,III FLR.,PLOT","city":"MUMBAI ,MAHARASHTRA","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"MUSCAT","customer":"SOHAR PHARMA","customerCountry":"OMAN","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"14.5","totalValueFC":"941.6","currency":"USD","unitRateINR":794.59500000000003,"date":"08-Nov-2024","totalValueINR":"79459.5","totalValueInUsd":"941.6","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"5462678","productDescription":"Intermediate","marketType":"LESS REGULATED MARKET","country":"OMAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MAHENDRA INDL.ESTATE,III FLR.,PLOT, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"DICLOFENAC POTASSIUM BP (TAX INVOICE NO: EG60\/2425\/0730 DT: 15\/11\/2024 ) CASNO- 15307-81-0","address":"MAHENDRA INDL.ESTATE,III FLR.,PLOT","city":"MUMBAI ,MAHARASHTRA","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"ALEXANDRA(EGYPT)","customer":"EGYPT PHARMA","customerCountry":"EGYPT","quantity":"6000.00","actualQuantity":"6000","unit":"KGS","unitRateFc":"10.4","totalValueFC":"60690.8","currency":"USD","unitRateINR":853.59780000000001,"date":"15-Nov-2024","totalValueINR":"5121586.8","totalValueInUsd":"60690.8","indian_port":"JNPT","hs_no":"29225090","bill_no":"5631971","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"MAHENDRA INDL.ESTATE,III FLR.,PLOT, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732213800,"product":"HARMLESS BULK DRUG HS CODE- 29420090 DICLOFENAC POTASSIUM PH.EUR (*LUT ARN NO. 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ORGANICS","supplierCountry":"INDIA","foreign_port":"PANAMA CITY -","customer":"TO THE ORDER OF","customerCountry":"PANAMA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"34","totalValueFC":"3344.5","currency":"USD","unitRateINR":2822.3359999999998,"date":"28-Nov-2024","totalValueINR":"282233.6","totalValueInUsd":"3344.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5988588","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PANAMA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO. 221, G.I.D.C.,, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"HARMLESS BULK DRUG DICLOFENAC POTASSIUMPH.EUR (LUT ARN NO AD2403241438355)","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"AMOLI ORGANICS","supplierCountry":"INDIA","foreign_port":"JEDDAH","customer":"TO THE ORDER 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INT\\'L","customer":"VIATRIS","customerCountry":"INDIA","quantity":"478.60","actualQuantity":"478.6","unit":"KGS","unitRateFc":"170","totalValueFC":"84583.9","currency":"USD","unitRateINR":"12945.5","date":"05-May-2021","totalValueINR":"6195716.3","totalValueInUsd":"84583.9","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"3829208","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642357800,"product":"DICLOFENAC POTASSIUM RE IMPORT OF REJECTEDGOODS EXPORTED VIDE SB NO : 4000282 DT : 09.05.2020 (FOR DESTRUCTION OF THE GO","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"NOVARTIS PHARMACEUTICALS CORPORATION","supplierCountry":"BELGIUM","foreign_port":"ANTWERPEN","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"4240.00","actualQuantity":"4240","unit":"KGS","unitRateFc":"62.7","totalValueFC":"270892.9","currency":"USD","unitRateINR":"4759.4","date":"17-Jan-2022","totalValueINR":"20179744","totalValueInUsd":"270892.9","indian_port":"Vizag-HIPL SEZ","hs_no":"29224990","bill_no":"1000027","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"ANTWERPEN","supplierAddress":"LICHSTRASSE 35 CH-4056 BASEL SWITZERLAND CH","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650825000,"product":"DICLOFENAC POTASSIUM USP","address":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"YUNG ZIP CHEMICAL INDUSTRIAL","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"105","totalValueFC":"5368.4","currency":"USD","unitRateINR":"8100.8","date":"25-Apr-2022","totalValueINR":"405037.5","totalValueInUsd":"5368.4","indian_port":"BANGALORE AIR","hs_no":"29224990","bill_no":"8419401","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1656959400,"product":"DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM EP (FOR PHARMACEUTICAL USE ONLY.)","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"429.65","actualQuantity":"429.65","unit":"KGS","unitRateFc":"178","totalValueFC":"75932.8","currency":"USD","unitRateINR":"14053.1","date":"05-Jul-2022","totalValueINR":"6037914.42","totalValueInUsd":"75932.8","indian_port":"BOMBAY AIR","hs_no":"29224990","bill_no":"9424137","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1664562600,"product":"DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM EP ( FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"70.35","actualQuantity":"70.35","unit":"KGS","unitRateFc":"178","totalValueFC":"12945.2","currency":"USD","unitRateINR":"15141.3","date":"01-Oct-2022","totalValueINR":"1065186.64","totalValueInUsd":"12945.2","indian_port":"BOMBAY AIR","hs_no":"29224990","bill_no":"2700254","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730658600,"product":"DICLOFENAC POTASSIUM EP","address":"102,TITAN HOUSE,60 FEET RD,","city":"MUMBAI, MAHARASHTRA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"TITAN 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RIVOLTANA KM 6\/7 20053 RODANO (MI) Milano, , Italy Italy","customerAddress":"102,TITAN HOUSE,60 FEET RD,"}]

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

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Europe

01

Orion Corporation Orion Pharma

Finland

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Regulatory Info :

Registration Country : Sweden

diclofenac potassium

Brand Name : Inst Antin

Dosage Form : POWDER FOR ORAL SOLUTION IN SACHET

Dosage Strength : 50 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

Actavis Nordic A / S,

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Alfa Wasserman SpA,

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Alfa Wasserman SpA,

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Novartis Pharma Schweiz AG

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06

Novartis Pharma Schweiz AG

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07

Orifarm Generics A / S

Denmark

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08

ratiopharm GmbH

Germany

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09

ratiopharm GmbH

Germany

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10

Spirig HealthCare AG

Switzerland

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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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ABOUT THIS PAGE

Diclofenac Potassium Manufacturers

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

Diclofenac Potassium Suppliers

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

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

Diclofenac Potassium USDMF

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

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

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Diclofenac Potassium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Diclofenac Potassium Drug Master File in Korea (Diclofenac Potassium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diclofenac Potassium. The MFDS reviews the Diclofenac Potassium KDMF as part of the drug registration process and uses the information provided in the Diclofenac Potassium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Diclofenac Potassium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Diclofenac Potassium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Diclofenac Potassium suppliers with KDMF on PharmaCompass.

Diclofenac Potassium CEP

A Diclofenac Potassium CEP of the European Pharmacopoeia monograph is often referred to as a Diclofenac Potassium Certificate of Suitability (COS). The purpose of a Diclofenac Potassium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Diclofenac Potassium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Diclofenac Potassium to their clients by showing that a Diclofenac Potassium CEP has been issued for it. The manufacturer submits a Diclofenac Potassium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Diclofenac Potassium CEP holder for the record. Additionally, the data presented in the Diclofenac Potassium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Diclofenac Potassium DMF.

A Diclofenac Potassium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diclofenac Potassium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Diclofenac Potassium suppliers with CEP (COS) on PharmaCompass.

Diclofenac Potassium WC

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

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

Diclofenac Potassium 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 Diclofenac Potassium as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Diclofenac Potassium suppliers with NDC on PharmaCompass.

Diclofenac Potassium GMP

Diclofenac Potassium 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 Diclofenac Potassium 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 Diclofenac Potassium GMP manufacturer or Diclofenac Potassium GMP API supplier for your needs.

Diclofenac Potassium CoA

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

Diclofenac Potassium CoA mostly includes findings from lab analyses of a specific batch. For each Diclofenac Potassium 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.

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

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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

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

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

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EXCIPIENTS BY APPLICATIONS

95 Fillers, Diluents & Binders

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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