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Diclofenac Sodium

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 21 USDMF, 16 CEP/COS, 13 JDMF, 8 EU WC, 20 KDMF, 30 NDC API, 43 Listed Suppliers, $ API Reference Price

73 API Suppliers
21 USDMF
16 CEP/COS
13 JDMF
8 EU WC
20 KDMF
30 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

479 FDF Dossiers, 99 FDA Orange Book, 100 Europe, 38 Canada, 60 South Africa, 182 Listed Dossiers

479 FDF Dossiers
99 FDA Orange Book
100 Europe
38 Canada
60 South Africa
182 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TOPICAL - 1%
SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 Rochem International Inc, 11 SPI Pharma, 2 Seqens, 5 DKSH, 6 Faran Shimi Pharmaceutical, 12 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 1 ACG Worldwide, 15 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 48 BASF, 1 BioSpectra, 18 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 14 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 15 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

relatedExcipients
2 Evonik
1 Rochem International Inc
11 SPI Pharma
2 Seqens
5 DKSH
6 Faran Shimi Pharmaceutical
12 Boai NKY Pharmaceuticals Ltd
14 Gangwal Healthcare
11 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 Capital Farma
1 ACG Worldwide
15 Actylis
3 Aeon Procare
4 Alcedo Pharmachem
9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
48 BASF
1 BioSpectra
18 Corel Pharma Chem
7 DFE Pharma
3 Doshion Polyscience
3 Finar
12 Gangwal Chemicals
1 Huzhou Sunflower Pharmaceutical
14 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
38 Kerry
3 Kima Chemical
6 Lonza Capsugel
2 Lubrizol Life Science Health
16 Microlex e.U
2 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
4 Pharmatrans-Sanaq
7 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
24 Roquette
15 Seppic
2 Shandong Focus Biotechnology Co., Ltd
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
12 Sigachi Industries
2 The Dow Chemical Company
3 Ulanqab Kema New Material
2 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 73 Coating Systems & Additives, 50 Controlled & Modified Release, 49 Direct Compression, 46 Solubilizers, 40 Disintegrants & Superdisintegrants, 39 Topical, 38 Thickeners and Stabilizers, 35 Granulation, 27 Parenteral, 25 Lubricants & Glidants, 24 Film Formers & Plasticizers, 23 Co-Processed Excipients, 20 Taste Masking, 19 Emulsifying Agents, 10 Chewable & Orodispersible Aids, 9 API Stability Enhancers, 8 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 63 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
63 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

96 Finished Drug Prices, 5 Annual Reports

globalSalesInformation
96 Finished Drug Prices
5 Annual Reports

MARKET PLACE

62 APIs, 23 FDF Dossiers

marketPlace
62 APIs
23 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 3 Health Canada Patents

patents
26 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 1 Others

otherSolutions
2 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)

$ 25

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

479

FDF Dossiers

FDA Orange Book

100

Europe

Canada

Australia

South Africa

182

Listed Dossiers

5DRUGS 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)

Annual Reports (USD Million)

261

Finished Drug Prices

372 RELATED EXCIPIENT COMPANIES

638EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Qtg126297q, Voltaren, 15307-79-6, Diclofenac sodium salt, Sodium diclofenac, Prophenatin

Molecular Formula

C₁₄H₁₀Cl₂NNaO₂

Molecular Weight

318.1 g/mol

InChI Key

KPHWPUGNDIVLNH-UHFFFAOYSA-M

FDA UNII

QTG126297Q

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

1 2D Structure

Diclofenac Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

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

2.1.2 InChI

InChI=1S/C14H11Cl2NO2.Na/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

KPHWPUGNDIVLNH-UHFFFAOYSA-M

2.1.4 Canonical SMILES

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

2.2 Other Identifiers

2.2.1 UNII

QTG126297Q

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dichlofenal

2. Diclofenac

3. Diclofenac Potassium

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. Qtg126297q

2. Voltaren

3. 15307-79-6

4. Diclofenac Sodium Salt

5. Sodium Diclofenac

6. Prophenatin

7. Neriodin

8. Diclophenac Sodium

9. Abitren

10. Solaraze

11. Diclofenac (sodium)

12. Gp 45840

13. Benfofen

14. Dyloject

15. Ecofenac

16. Feloran

17. Pennsaid

18. Orthophen

19. Voltarol

20. Voltaren-xr

21. Diclophlogont

22. Duravolten

23. Novapirina

24. Primofenac

25. Dealgic

26. Deflamat

27. Delphinac

28. Diclomax

29. Dicloreum

30. Effekton

31. Lexobene

32. Rewodina

33. Voldal

34. Xenid

35. Sodium (o-(2,6-dichloroanilino)phenyl)acetate

36. Arthrotec

37. Olfen

38. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Monosodium Salt

39. Sodium (o-((2,6-dichlorophenyl)amino)phenyl)acetate

40. Sodium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate

41. (o-(2,6-dichloroanilino)phenyl)acetic Acid Sodium Salt

42. Sodium 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate

43. Mls000028386

44. Chebi:4509

45. (o-(2,6-dichloroanilino)phenyl)acetic Acid Monosodium Salt

46. 2-[(2,6-dichlorophenyl)amino]benzeneacetic Acid Sodium Salt

47. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid Monosodium Salt

48. Benzeneacetic Acid, 2-[(2,6-dichlorophenyl)amino]-, Monosodium Salt

49. Sodium;2-[2-(2,6-dichloroanilino)phenyl]acetate

50. Nsc-756725

51. Ncgc00017082-02

52. Anthraxiton

53. Allvoran

54. Batafil

55. Delimon

56. Delphimix

57. Dichronic

58. Gp-45840

59. Kriplex

60. Ortofen

61. Smr000058567

62. Tsudohmin

63. Valetan

64. Voltarene

65. Vonafec

66. Blesin

67. Urigon

68. Vurdon

69. Solaraze (tn)

70. Cas-15307-79-6

71. Diclofenac Sodium 100 Microg/ml In Acetonitrile

72. Dsstox_cid_17208

73. Dsstox_rid_79308

74. Voltaren Ophthalmic

75. Dsstox_gsid_37208

76. Diclofenac Diethylammonium

77. Sodium (2-((2,6-dichlorophenyl)amino)phenyl)acetate

78. Diclofenac Diethylamine Salt

79. Assaren

80. Voltaren Gel

81. Benzeneacetic Acid, 2-[(2,6-dichlorophenyl)amino]-, Monosodium Salt [cas]

82. Smr000449318

83. Ccris 1909

84. Einecs 239-346-4

85. Ba 47210

86. Diclofenac Sodium Injection

87. Sodium 2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetate

88. Diclofenac Sodium Topical Gel

89. Berifen

90. Dic075v

91. Rhumalgan

92. Diclofenac Sod

93. Unii-qtg126297q

94. Sodium 2-(2-(2,6-dichlorophenylamino)phenyl)acetate

95. Tds 943

96. Sodium (o-(2,6-dichloroanilino)phenyl) Acetate

97. Voltaren (tn)

98. Diclofenac Sodium [usan:usp:jan]

99. Mfcd00082251

100. Dicloflex

101. Diclofenac Sodium,(s)

102. Opera_id_564

103. Sodium Dichlofenac

104. Lopac-d-6899

105. Ec 239-346-4

106. Chembl1034

107. Schembl24009

108. Mls000758255

109. Mls001148587

110. Mls001423970

111. Mls002222163

112. Mls003882590

113. Spectrum1500237

114. Diclofenac Sodium [jan]

115. Diclofenac Sodium (jp17/usp)

116. Diclofenac Sodium [usan]

117. Dtxsid3037208

118. Diclofenac For System Suitability

119. Hms500n14

120. Diclofenac Sodium [vandf]

121. Diclofenac Sodium [mart.]

122. Regid_for_cid_5018304

123. Acetic Acid, O-(2,6-dichloroanilino)phenyl-, Monosodium Salt

124. Hms1569h10

125. Hms1920e16

126. Hms2051m05

127. Hms2091m06

128. Hms2096h10

129. Hms2235o06

130. Hms2236d03

131. Hms3261i04

132. Hms3369k11

133. Hms3371j05

134. Hms3393m05

135. Hms3650b13

136. Hms3655a22

137. Hms3713h10

138. Hms3884c16

139. Kuc112363n

140. Diclofenac Sodium [usp-rs]

141. Diclofenac Sodium [who-dd]

142. Bcp02915

143. Diclofenac Sodium Salt [mi]

144. Tox21_110770

145. Tox21_300265

146. Tox21_500441

147. Ccg-39754

148. S1903

149. Stk400073

150. Akos000310014

151. Akos005267222

152. Akos024278942

153. Diclofenac Sodium [green Book]

154. Tox21_110770_1

155. Ac-1487

156. Bcp9000605

157. Ccg-100765

158. Diclofenac Sodium [orange Book]

159. Ks-5038

160. Lp00441

161. Nc00015

162. Nsc 756725

163. Sdccgsbi-0050426.p002

164. Diclofenac Sodium [ep Monograph]

165. Ksc-322-017

166. Diclofenac Sodium [usp Monograph]

167. Ncgc00015361-01

168. Ncgc00015361-02

169. Ncgc00015361-03

170. Ncgc00015361-04

171. Ncgc00017082-01

172. Ncgc00017082-03

173. Ncgc00021125-03

174. Ncgc00093858-01

175. Ncgc00093858-02

176. Ncgc00094648-01

177. Ncgc00094648-02

178. Ncgc00253928-01

179. Ncgc00261126-01

180. Bd166162

181. Cpd000449318

182. Hy-15037

183. Bcp0726000303

184. Arthrotec Component Diclofenac Sodium

185. B1457

186. D-181

187. D2508

188. Eu-0100441

189. Ft-0624732

190. Sodium 2-(2,6-dichloroanilino)phenylacetate

191. Sw196404-3

192. Sodium 2-(2,6-dichloroanilino)-phenylacetate

193. Bim-0051341.0001

194. D 6899

195. D00904

196. D78205

197. Diclofenac Sodium Component Of Arthrotec

198. A809387

199. Sodium 2-[(2,6-dichlorophenyl)amino]phenylacetate

200. Q-200965

201. Sodium 2-[(2,6-dichlorophenyl)-amino]phenylacetate

202. Sodium;2-[2-(2,6-dichloroanilino)phenyl]acetate.

203. 2-(2,6-dichloroanilino)phenylacetic Acid Sodium Salt

204. Q12430631

205. Sodium 2-[(2,6-dichlorophenyl)-amino]-phenyl-acetate

206. Sodium 2-[(2,6-dichlorophenyl)-amino]-phenylacetate

207. Sodium;2-[2-(2,6-dichloroanilino)phenyl]acetic Acid

208. 2-[(2,6-dichlorophenyl)amino]benzeneacetic Acid Sodium

209. Diclofenac Sodium 1.0 Mg/ml In Methanol (as Free Acid)

210. Benzeneacetic Acid, 2-[(2,6-dichlorophenyl)amino]-, Sodium Salt (1:1)

2.4 Create Date

2005-09-18

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₁₀Cl₂NNaO₂
Molecular Weight	318.1 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	316.9986282 g/mol
Monoisotopic Mass	316.9986282 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 2
Drug Name	Diclofenac sodium
Drug Label	Diclofenac sodium delayed-release tablets are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has...
Active Ingredient	Diclofenac sodium
Dosage Form	Gel; Tablet, extended release; Solution/drops; Spray; Tablet, delayed release; Solution
Route	Topical; Ophthalmic; oral; Oral
Strength	75mg; 100mg; 25mg; 1.5%; 50mg; 0.1%; 3%
Market Status	Tentative Approval; Prescription
Company	Watson Labs; Nexus Pharms; Mylan Pharms; Actavis Elizabeth; Igi Labs; Paddock; Valeant Intl; Apotex; Bausch And Lomb; Alcon Pharms; Tolmar; Unique Pharm Labs; Carlsbad; Sandoz; Mylan; Dexcel; Akorn

2 of 2
Drug Name	Diclofenac sodium
Drug Label	Diclofenac sodium delayed-release tablets are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C14H10Cl2NNaO2, and it has...
Active Ingredient	Diclofenac sodium
Dosage Form	Gel; Tablet, extended release; Solution/drops; Spray; Tablet, delayed release; Solution
Route	Topical; Ophthalmic; oral; Oral
Strength	75mg; 100mg; 25mg; 1.5%; 50mg; 0.1%; 3%
Market Status	Tentative Approval; Prescription
Company	Watson Labs; Nexus Pharms; Mylan Pharms; Actavis Elizabeth; Igi Labs; Paddock; Valeant Intl; Apotex; Bausch And Lomb; Alcon Pharms; Tolmar; Unique Pharm Labs; Carlsbad; Sandoz; Mylan; Dexcel; Akorn

4.2 Drug Indication

Treatment of inflammation, Treatment of pain

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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","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"500","totalValueFC":"5058.6","currency":"USD","unitRateINR":"37700","date":"16-Jul-2021","totalValueINR":"377000","totalValueInUsd":"5058.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4707749","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1637001000,"product":"DICLOFENAC SODIUM","address":"101, 1ST FLOOR, GANESH BHUVAN CO-OP OPP PALMACRES SOCIETY, MAHATMA PUHL","city":"MULUND EAST","supplier":"ZHEJIANG CHEMICALS I & E CORP","supplierCountry":"CHINA","foreign_port":"NA","customer":"MURLI KRISHNA PHARMA","customerCountry":"INDIA","quantity":"900.00","actualQuantity":"900","unit":"KGS","unitRateFc":"30.5","totalValueFC":"27847.6","currency":"USD","unitRateINR":"2304.3","date":"16-Nov-2021","totalValueINR":"2073847.5","totalValueInUsd":"27847.6","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"6277476","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"101, 1ST FLOOR, GANESH BHUVAN CO-OP OPP PALMACRES SOCIETY, MAHATMA PUHL"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642357800,"product":"DICLOFENAC SODIUM INJ IMPORT OF REJECTEDGOODS EXPORTED VIDE SB NO : 4000392 DT : 10.07.2018 (FOR DESTRUCTION OF THE GOOD","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":"4808.00","actualQuantity":"4808","unit":"KGS","unitRateFc":"128.9","totalValueFC":"631574.2","currency":"USD","unitRateINR":"9785.4","date":"17-Jan-2022","totalValueINR":"47048137","totalValueInUsd":"631574.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29224990","bill_no":"1000028","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":"Q1","strtotime":1643913000,"product":"DICLOFENAC SODIUM","address":"101, 1ST FLOOR, GANESH BHUVAN CO-OP OPP PALMACRES SOCIETY, MAHATMA PUHL","city":"MULUND EAST","supplier":"ZHEJIANG CHEMICALS I & E CORP","supplierCountry":"CHINA","foreign_port":"","customer":"MURLI KRISHNA PHARMA","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"20","totalValueFC":"40423.2","currency":"USD","unitRateINR":"1515","date":"04-Feb-2022","totalValueINR":"3030000","totalValueInUsd":"40423.2","indian_port":"JNPT","hs_no":"29225090","bill_no":"7359808","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"101, 1ST FLOOR, GANESH BHUVAN CO-OP OPP PALMACRES SOCIETY, MAHATMA PUHL"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671993000,"product":"DICLOFENAC SODIUM EP\/USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"59.38","actualQuantity":"59.38","unit":"KGS","unitRateFc":"430","totalValueFC":"29405.3","currency":"EUR","unitRateINR":"40808","date":"26-Dec-2022","totalValueINR":"2423177.85","totalValueInUsd":"29405.3","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"3915994","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671993000,"product":"DICLOFENAC SODIUM EP\/USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"70.62","actualQuantity":"70.62","unit":"KGS","unitRateFc":"430","totalValueFC":"34971.4","currency":"EUR","unitRateINR":"40808","date":"26-Dec-2022","totalValueINR":"2881859.55","totalValueInUsd":"34971.4","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"3915994","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1672165800,"product":"RE-IMPORT - DICLOFENAC SODIUM INJ\/DS.041 - ( BATCH NO. :-PDS6210002)","address":"NEELAM CENTRE, B WING 4TH FLOOR HIND CYCLE ROAD, WORLI","city":"MUMBAI","supplier":"NOVARTIS PHARMACEUTICALS CORPORATION","supplierCountry":"INDIA","foreign_port":"NA","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"399.96","actualQuantity":"399.96","unit":"KGS","unitRateFc":"76","totalValueFC":"30818.8","currency":"USD","unitRateINR":"6349.8","date":"28-Dec-2022","totalValueINR":"2539666.01","totalValueInUsd":"30818.8","indian_port":"JNPT","hs_no":"29224990","bill_no":"3949316","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NEELAM CENTRE, B WING 4TH FLOOR HIND CYCLE ROAD, WORLI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674325800,"product":"DICLOFENAC SODIUM EP\/USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"81.48","actualQuantity":"81.48","unit":"KGS","unitRateFc":"430","totalValueFC":"38332","currency":"EUR","unitRateINR":"38463.5","date":"22-Jan-2023","totalValueINR":"3134005.98","totalValueInUsd":"38332","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"4307079","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686940200,"product":"DICLOFENAC SODIUM USP","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"ANYANG DONGTAI PHARMACEUTICAL TECHNOLOGY LIMITED C","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"20","totalValueFC":"1161.9","currency":"USD","unitRateINR":"3820.1","date":"17-Jun-2023","totalValueINR":"95507.615","totalValueInUsd":"1161.9","indian_port":"HYDERABAD AIR","hs_no":"29224990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686940200,"product":"DICLOFENAC SODIUM(DCS1) PO NO.SCPL\/0452\/2022-23","address":"FIRST FLOOR SFNO.534\/4A2B NO 102 SAMY APARTMENT","city":"CHENNAI","supplier":"YUNG ZIP CHEMICAL IND CO.LTD","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"STHREE CHEMICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"85","totalValueFC":"17176.6","currency":"USD","unitRateINR":"7058.8","date":"17-Jun-2023","totalValueINR":"1411850.034","totalValueInUsd":"17176.6","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"FIRST FLOOR SFNO.534\/4A2B NO 102 SAMY APARTMENT"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687372200,"product":"DICLOFENAC SODIUM EP\/USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"190.13","actualQuantity":"190.13","unit":"KGS","unitRateFc":"430","totalValueFC":"90015.1","currency":"EUR","unitRateINR":"38915.3","date":"22-Jun-2023","totalValueINR":"7398909.252","totalValueInUsd":"90015.1","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1688063400,"product":"DICLOFENAC SODIUM EP\/USP","address":"ALEMBIC ROAD VADODARA Contact No: 919727727339","city":"GUJARAT","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"430","totalValueFC":"71016","currency":"EUR","unitRateINR":"38915.3","date":"30-Jun-2023","totalValueINR":"5837249.999","totalValueInUsd":"71016","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD VADODARA Contact No: 919727727339"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"DICLOFENAC SODIUM USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"250","totalValueFC":"13776.9","currency":"EUR","unitRateINR":"22862.5","date":"02-Feb-2024","totalValueINR":"1143125","totalValueInUsd":"13776.9","indian_port":"Bombay Air","hs_no":"29224990","bill_no":"9941397","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA BISSONE 5 20021 BARANZATE (MI)ITALY Baranzate, , ItalySDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]

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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Drugs in Development

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FDA Orange Book

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Europe

01

Mepha Pharma AG

Switzerland

Duphat

Not Confirmed

Not Confirmed

05

Novartis Pharma Schweiz AG

Duphat

Not Confirmed

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Listed Dossiers

01

Rusan Pharma

India

CPhI WW Frankfurt

Booth #9.2B82

Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Diclofenac Sodium

Brand Name :

Dosage Form : Dispersible Tablet

Dosage Strength : 50mg

Packaging : Pack Size 10x10; 2x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Product Web Link

02

Rusan Pharma

India

CPhI WW Frankfurt

Booth #9.2B82

Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Diclofenac Sodium

Brand Name :

Dosage Form : Gastro Resistant Table...

Dosage Strength : 50mg

Packaging : Pack Size 10x10; 2x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Product Web Link

03

Rusan Pharma

India

CPhI WW Frankfurt

Booth #9.2B82

Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Diclofenac Sodium

Brand Name :

Dosage Form : Injection

Dosage Strength : 25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Product Web Link

04

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Diclofenac Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

05

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Paracetamol; Diclofenac Sodium

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

06

Strides Pharma Science

India

Pharma, Lab & Chemical Expo

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Diclofenac Sodium

Brand Name :

Dosage Form : Gel

Dosage Strength : 10MG/GM

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

07

Bal Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : India

Diclofenac Sodium

Brand Name : Balnac 50

Dosage Form : Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

08

Bal Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : India

Diclofenac Sodium; Paracetamol

Brand Name : Combigesic Dp

Dosage Form : Tablet

Dosage Strength : 50MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

09

Bal Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : India

Diclofenac Sodium; Paracetamol

Brand Name : Combigesic Plus

Dosage Form : Bilayered Tablet

Dosage Strength : 50MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

10

Bal Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

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India

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : India

Diclofenac Sodium

Brand Name : Lofen

Dosage Form : Gel

Dosage Strength : 1%

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20254

DOSAGE - SOLUTION;TOPICAL - 2% **Federal Regi...DOSAGE - SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 204623

DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG

USFDA APPLICATION NUMBER - 20607

DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG

USFDA APPLICATION NUMBER - 20607

DOSAGE - SOLUTION;TOPICAL - 1.5% **Federal Re...DOSAGE - SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20947

DOSAGE - GEL;TOPICAL - 3% **Federal Register ...DOSAGE - GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21005

DOSAGE - GEL;TOPICAL - 1%

USFDA APPLICATION NUMBER - 22122

DOSAGE - SOLUTION;INTRAVENOUS - 37.5MG/ML (37...DOSAGE - SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22396

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ABOUT THIS PAGE

Diclofenac Sodium Manufacturers

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

Diclofenac Sodium Suppliers

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

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

Diclofenac Sodium USDMF

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

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

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

Diclofenac 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 Diclofenac Sodium Drug Master File in Japan (Diclofenac Sodium JDMF) empowers Diclofenac 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 Diclofenac Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Diclofenac Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

After submitting a Diclofenac Sodium 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 Sodium API can apply through the Korea Drug Master File (KDMF).

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Diclofenac Sodium CEP

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

A Diclofenac Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diclofenac Sodium 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 Sodium suppliers with CEP (COS) on PharmaCompass.

Diclofenac Sodium WC

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

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

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

Finished drug products

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

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

Diclofenac Sodium GMP

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

Diclofenac Sodium CoA

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

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

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

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

73 API Suppliers

21 USDMF

16 CEP/COS

13 JDMF

8 EU WC

20 KDMF

30 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

479 FDF Dossiers

99 FDA Orange Book

100 Europe

38 Canada

60 South Africa

182 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG

TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG

SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TOPICAL - 1%

SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;TOPICAL - 2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;TOPICAL - 1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;TOPICAL - 3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons