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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

Diclofenac Sodium
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 Weight 318.1 g/mol
Molecular Formula C14H10Cl2NNaO2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count4
Exact Mass316.9986282 g/mol
Monoisotopic Mass316.9986282 g/mol
Topological Polar Surface Area52.2 Ų
Heavy Atom Count20
Formal Charge0
Complexity310
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameDiclofenac sodium
Drug LabelDiclofenac 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 IngredientDiclofenac sodium
Dosage FormGel; Tablet, extended release; Solution/drops; Spray; Tablet, delayed release; Solution
RouteTopical; Ophthalmic; oral; Oral
Strength75mg; 100mg; 25mg; 1.5%; 50mg; 0.1%; 3%
Market StatusTentative Approval; Prescription
CompanyWatson 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 NameDiclofenac sodium
Drug LabelDiclofenac 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 IngredientDiclofenac sodium
Dosage FormGel; Tablet, extended release; Solution/drops; Spray; Tablet, delayed release; Solution
RouteTopical; Ophthalmic; oral; Oral
Strength75mg; 100mg; 25mg; 1.5%; 50mg; 0.1%; 3%
Market StatusTentative Approval; Prescription
CompanyWatson 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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LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"7.3","totalValueFC":"36.8","currency":"USD","unitRateINR":"625.2","date":"14-Dec-2024","totalValueINR":"3126.23","totalValueInUsd":"36.8","indian_port":"Delhi PPG ICD","hs_no":"29225090","bill_no":"7240892","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"19-21\/F, GUOTAI BLDG., RENMIN ROAD (M), ZHANGJIAGANG CITY, JIANGSU, CHINA","customerAddress":"D-44 ZAKIR NAGAR WEST"}]
03-Jan-2022
29-Apr-2025
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Number of Transactions

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

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API Imports and Exports

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FDF Dossiers

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01

Diclofenac Sodium

Brand Name : PANAMOR 50 mg DISPERSIBLE TABLET

Dosage Form : DSP

Dosage Strength : 50mg

Packaging : 9X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

02

Diclofenac Sodium

Brand Name : Diclofenac Sodium

Dosage Form : DSP

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

03

Diclofenac Sodium

Brand Name : Panamor 25

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

04

Diclofenac Sodium

Brand Name : Panamor At-50

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

05

Diclofenac Sodium

Brand Name : Panamor At-50

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 9X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

06

Diclofenac Sodium

Brand Name : Panamor - 75 Injection

Dosage Form : INJ

Dosage Strength : 75mg/3ml

Packaging : 3X5mg/3ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

07

Diclofenac Sodium

Brand Name : Fortfen Injection/Inspuiting

Dosage Form : INJ

Dosage Strength : 75mg/3ml

Packaging : 3X50mg/3ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

08

Diclofenac Sodium

Brand Name : Panamor Suppositories - 25

Dosage Form : SUP

Dosage Strength : 25mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

09

Diclofenac Sodium

Brand Name : Panamor 100 Sr

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

10

Diclofenac Sodium

Brand Name : A-Lennon Diclofenac

Dosage Form : TAB

Dosage Strength : 25mg

Packaging : 500X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner
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FDA Orange Book

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01

APOTEX

Canada
FCE Pharma
Not Confirmed
arrow

APOTEX

Canada
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 2%

Approval Date : 2022-05-06

Application Number : 207714

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

CARLSBAD

U.S.A
FCE Pharma
Not Confirmed
arrow

CARLSBAD

U.S.A
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 75MG

Approval Date : 1998-11-13

Application Number : 75185

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

DEXCEL LTD

Israel
FCE Pharma
Not Confirmed
arrow

DEXCEL LTD

Israel
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 100MG

Approval Date : 2002-11-06

Application Number : 76201

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

ENCUBE

India
FCE Pharma
Not Confirmed
arrow

ENCUBE

India
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 2%

Approval Date : 2025-04-09

Application Number : 217646

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

HIKMA

United Kingdom
FCE Pharma
Not Confirmed
arrow

HIKMA

United Kingdom
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : GEL;TOPICAL

Dosage Strength : 1%

Approval Date : 2018-11-21

Application Number : 209484

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1.5%

Approval Date : 2015-07-08

Application Number : 202769

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : GEL;TOPICAL

Dosage Strength : 1%

Approval Date : 2019-05-16

Application Number : 211253

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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08

PFIZER

U.S.A
FCE Pharma
Not Confirmed
arrow

PFIZER

U.S.A
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM; MISOPROSTOL

Brand Name : ARTHROTEC

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 50MG;0.2MG

Approval Date : 1997-12-24

Application Number : 20607

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

SANDOZ

Switzerland
FCE Pharma
Not Confirmed
arrow

SANDOZ

Switzerland
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM; MISOPROSTOL

Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 75MG;0.2MG

Approval Date : 2013-05-09

Application Number : 200158

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

TARO

U.S.A
FCE Pharma
Not Confirmed
arrow

TARO

U.S.A
arrow
FCE Pharma
Not Confirmed

DICLOFENAC SODIUM

Brand Name : DICLOFENAC SODIUM

Dosage Form : GEL;TOPICAL

Dosage Strength : 3%

Approval Date : 2016-04-28

Application Number : 206298

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Europe

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01

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Grofenac

Dosage Form : Inj L?s

Dosage Strength : 75mg/3ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Grofenac Retard

Dosage Form : Ret Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

Gebro Pharma AG

Austria
FCE Pharma
Not Confirmed
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Gebro Pharma AG

Austria
arrow
FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Pennsaid

Dosage Form : Gel

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

04

Mepha Pharma AG

Switzerland
FCE Pharma
Not Confirmed
arrow

Mepha Pharma AG

Switzerland
arrow
FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Olfen

Dosage Form : Gel

Dosage Strength : 1%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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05

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Voltaren

Dosage Form : Drag

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

06

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Voltaren Retard

Dosage Form : Ret Drag

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

07

Pfizer

U.S.A
FCE Pharma
Not Confirmed
arrow

Pfizer

U.S.A
arrow
FCE Pharma
Not Confirmed

Several substances refer to content

Brand Name : Arthrotec

Dosage Form : MODIFIED-RELEASE TABLET

Dosage Strength : -

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Pfizer AG

U.S.A
FCE Pharma
Not Confirmed
arrow

Pfizer AG

U.S.A
arrow
FCE Pharma
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 50

Dosage Form : Bitabs

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

09

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Ecofenac

Dosage Form : Filmtabl

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

Diclofenac sodium

Brand Name : Ecofenac

Dosage Form : Filmtabl

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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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

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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

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

USFDA APPLICATION NUMBER - 20607

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

USFDA APPLICATION NUMBER - 20607

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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

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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

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DOSAGE - GEL;TOPICAL - 1%

USFDA APPLICATION NUMBER - 22122

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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

Looking for 15307-79-6 / Diclofenac Sodium API manufacturers, exporters & distributors?

Diclofenac Sodium manufacturers, exporters & distributors 1

92

PharmaCompass offers a list of Diclofenac Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Diclofenac Sodium manufacturer or Diclofenac Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diclofenac Sodium manufacturer or Diclofenac Sodium supplier.

PharmaCompass also assists you with knowing the Diclofenac Sodium API Price utilized in the formulation of products. Diclofenac Sodium API Price is not always fixed or binding as the Diclofenac Sodium Price is obtained through a variety of data sources. The Diclofenac Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Diclofenac Sodium

Synonyms

Qtg126297q, Voltaren, 15307-79-6, Diclofenac sodium salt, Sodium diclofenac, Prophenatin

Cas Number

15307-79-6

Unique Ingredient Identifier (UNII)

QTG126297Q

About Diclofenac Sodium

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

Dichronic Manufacturers

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

Dichronic Suppliers

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

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

Dichronic USDMF

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

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

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

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

click here to find a list of Dichronic suppliers with JDMF on PharmaCompass.

Dichronic KDMF

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

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

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

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

Dichronic CEP

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

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

Dichronic WC

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

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

Dichronic 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 Dichronic as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Dichronic GMP

Dichronic 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 Dichronic 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 Dichronic GMP manufacturer or Dichronic GMP API supplier for your needs.

Dichronic CoA

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

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

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