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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]

    API Reference Price

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    04-Jan-2022
    31-Dec-2025
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    Drugs in Development

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    Dr. Reddy's Laboratories Announces the Launch of Over-The-Counter Diclofenac Sodium Topical Gel 1%, The Store Brand Version of Voltaren® Arthritis Pain...

    Details:

    The launch of Dr. Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is an important addition to the Pain/ Analgesics portfolio of OTC products, and represents the continued commitment to the Private Label OTC space.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Musculoskeletal Brand Name: Diclofenac Sodium-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 09, 2020

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    Dr. Reddy's Laboratories

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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of Over-The-Counter Diclofenac Sodium Topical Gel 1%...

    Details : The launch of Dr. Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is an important addition to the Pain/ Analgesics portfolio of OTC products, and represents the continued commitment to the Private Label OTC space.

    Product Name : Diclofenac Sodium-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 09, 2020

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    Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After R...

    Details:

    Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 11, 2024

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    Amzell

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    Amzell

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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diet...

    Details : Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 11, 2024

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    A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain

    Details:

    Voltaren (Diclofenac Sodium) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pain.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Neurology Brand Name: Voltaren

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 23, 2024

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    Haleon

    United Kingdom
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Lif...

    Details : Voltaren (Diclofenac Sodium) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pain.

    Product Name : Voltaren

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 23, 2024

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    Daré Bioscience Announces Positive Topline Pharmacokinetic and Exploratory Efficacy Results from the DARE-PDM1 Phase 1 Clinical Study

    Details:

    DARE-PDM1 (diclofenac) is a vaginal hydrogel which inhibits Cox-1 and Cox-2. It is being evaluated in phase 1 clinical trials for the treatment of primary dysmenorrhea.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 20, 2023

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    04

    Daré Bioscience

    U.S.A
    arrow
    World Health Expo
    Not Confirmed

    Daré Bioscience

    U.S.A
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    Not Confirmed
    • fda
    • EDQM
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Daré Bioscience Announces Positive Topline Pharmacokinetic and Exploratory Efficacy Results from ...

    Details : DARE-PDM1 (diclofenac) is a vaginal hydrogel which inhibits Cox-1 and Cox-2. It is being evaluated in phase 1 clinical trials for the treatment of primary dysmenorrhea.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 20, 2023

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    Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants

    Details:

    Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 01, 2023

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    05

    Amzell

    Country
    arrow
    World Health Expo
    Not Confirmed

    Amzell

    Country
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    World Health Expo
    Not Confirmed
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofe...

    Details : Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 01, 2023

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    Daré Bioscience Announces Start of a Phase 1 Study for its Potential First-in-Category Treatment for Primary Dysmenorrhea, DARE-PDM1

    Details:

    DARE-PDM1 is a novel delivery of the diclofenac sodium, a NSAID drug which inhibits COX-1 and COX-2 responsible for producing PGs which contributes in inflammation and pain signalling. It uses Daré’s proprietary hydrogel technology targeted at treating primary dysmenorrhea.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 22, 2023

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    06

    Daré Bioscience

    U.S.A
    arrow
    World Health Expo
    Not Confirmed

    Daré Bioscience

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Daré Bioscience Announces Start of a Phase 1 Study for its Potential First-in-Category Treatment ...

    Details : DARE-PDM1 is a novel delivery of the diclofenac sodium, a NSAID drug which inhibits COX-1 and COX-2 responsible for producing PGs which contributes in inflammation and pain signalling. It uses Daré’s proprietary hydrogel technology targeted at treatin...

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    February 22, 2023

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    Dare Bioscience Announces New Development Program, DARE-PDM1, as a Potential First-in-Category Treatment for Primary Dysmenorrhea

    Details:

    Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 12, 2022

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    07

    Daré Bioscience

    U.S.A
    arrow
    World Health Expo
    Not Confirmed

    Daré Bioscience

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dare Bioscience Announces New Development Program, DARE-PDM1, as a Potential First-in-Category Tre...

    Details : Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 12, 2022

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    Lupin Launches Authorized Generic Version of PENNSAID® 2% w/w in the United States

    Details:

    Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees. Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID®) had estimated annual sales of USD 509 million in the U.S.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Musculoskeletal Brand Name: Diclofenac Sodium-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 09, 2022

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    08

    Lupin Ltd

    India
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    CPhI Milan
    Exhibiting
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lupin Launches Authorized Generic Version of PENNSAID® 2% w/w in the United States

    Details : Diclofenac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees. Diclofenac Sodium Topical Solution, 2% w/w (RLD PENNSAID®) had estimated annual sales of USD 509 million in the U.S.

    Product Name : Diclofenac Sodium-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 09, 2022

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    Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs

    Details:

    Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Wounds and Injuries.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 26, 2021

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    09

    Fidia Farmaceutici Spa

    Italy
    arrow
    World Health Expo
    Not Confirmed

    Fidia Farmaceutici Spa

    Italy
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    World Health Expo
    Not Confirmed
    • fda
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Li...

    Details : Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Wounds and Injuries.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 26, 2021

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    A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee

    Details:

    Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Osteoarthritis, Knee.


    Lead Product(s): Diclofenac Sodium,Inapplicable

    Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 24, 2020

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    10

    Noven Pharmaceuticals

    U.S.A
    arrow
    World Health Expo
    Not Confirmed

    Noven Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Diclofenac Sodium,Inapplicable

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pai...

    Details : Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Osteoarthritis, Knee.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 24, 2020

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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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    01

    Evonik

    Germany
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    BioProcess International US West
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    Virtual BoothEvonik Health Care is the innovation hub for leading life science companies

    Brand Name : EUDRAGIT® L 100-55

    Application : Coating Systems & Additives, Controlled & Modified Release, Solubilizers

    Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer

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    SPI Pharma

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    Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

    Dosage Form : Tablet

    Grade : Oral

    Category : Coating Systems & Additives, Controlled & Modified Release

    Brand Name : ACTILLETS™

    Application : Coating Systems & Additives, Controlled & Modified Release

    Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.

    Pharmacopoeia Ref : NA

    Technical Specs : Not Available

    Ingredient(s) : Microcrystalline Cellulose Excipients

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    Evonik

    Germany
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    BioProcess International US West
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    Virtual BoothEvonik Health Care is the innovation hub for leading life science companies

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Category : Coating Systems & Additives, Film Formers & Plasticizers

    Brand Name : EUDRAGIT® L 30 D-55

    Application : Coating Systems & Additives, Film Formers & Plasticizers

    Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer

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    Roquette

    France
    World Health Expo
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    Kima Chemical

    China
    World Health Expo
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    Novo Excipients

    India
    World Health Expo
    Not Confirmed
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    Qianhao Chemical (Hebei) Co., Ltd

    China
    World Health Expo
    Not Confirmed
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    Ideal Cures

    India
    World Health Expo
    Not Confirmed
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    Corel Pharma Chem

    India
    World Health Expo
    Not Confirmed
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    Alcedo Pharmachem

    India
    World Health Expo
    Not Confirmed
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    india-flag.png
    IP Grade Diclofenac Sodium (100 kg) API needed in India [ENA24888]
    A company that focuses on the development and manufacturing of tablets, capsules, creams & lotions in various therapeutic areas is looking for suppliers of IP Grade Diclofenac Sodium (100 kg) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    23 Dec 2025

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    23 Dec 2025

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    23 Dec 2025

    SriLanka.png
    USP Grade Diclofenac Sodium API needed in Sri Lanka [ENA24155]
    A company that focuses on the development and manufacturing of solid dosage forms, oral liquids and parenteral is looking for suppliers of USP Grade Diclofenac Sodium API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    27 Sep 2025

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    27 Sep 2025

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    27 Sep 2025

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    Diclofenac Sodium API needed in India [ENA23981]
    A company specializing in the development and manufacturing of complex dosage forms is looking for suppliers of Diclofenac Sodium API for both development & commercial purposes. The suppliers must support this enquiry with CoA.
    08 Sep 2025

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    08 Sep 2025

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    08 Sep 2025

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    Diclofenac Sodium (1 kg - 5 kg) API needed in India [ENA23218]
    A company that focuses on the development, manufacturing & marketing of various finished topical and oral formulations is looking for suppliers of Diclofenac Sodium (1 kg - 5 kg) API for development purposes. The suppliers must support this enquiry with USDMF & CoA.
    11 Jun 2025

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    11 Jun 2025

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    11 Jun 2025

    india-flag.png
    BP Grade Diclofenac Sodium API needed in India [ENA22374]
    A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of BP Grade Diclofenac Sodium API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    18 Mar 2025

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    18 Mar 2025

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    18 Mar 2025

    japan.png
    Diclofenac Sodium (1.8 MT/ annum) API needed in Japan [ENA21968]
    A company that focuses on marketing and distribution of various pharmaceutical products including active pharmaceutical ingredients, chemicals & food products is looking for suppliers of Diclofenac Sodium (1.8 MT/ annum) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    04 Feb 2025

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    04 Feb 2025

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    04 Feb 2025

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    Diclofenac Sodium (MOQ) API needed in India [ENA21764]
    A company that focuses on the development and manufacturing of various finished formulations majorly in oncology and antiretrovirals areas is looking for suppliers of Diclofenac Sodium (MOQ) API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    16 Jan 2025

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    16 Jan 2025

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    16 Jan 2025

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    Injectable & IP Grade Diclofenac Sodium API needed in India [ENA21566]
    A company that focuses on manufacturing of tablets, capsules, oral suspensions and injectables for human & veterinary use is looking for suppliers of Injectable & IP Grade Diclofenac Sodium API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    26 Dec 2024

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    26 Dec 2024

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    26 Dec 2024

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    Diclofenac Sodium (75 kg) API needed in India [ENA21203]
    A company that focuses on manufacturing of various finished formulations is looking for suppliers of Injectable & BP/ IP Grade Diclofenac Sodium (75 kg) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    23 Nov 2024

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    23 Nov 2024

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    23 Nov 2024

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    USP/ BP Grade Diclofenac Sodium (50 mg & 100 mg) Pellets needed in Qatar [ENA19756]
    A leading pharmaceutical company that focuses on the development & manufacturing of OSDs, intravenous solutions, eye drops, hemodialysis solutions, creams and lotions is looking for suppliers of USP/ BP Grade Diclofenac Sodium (50 mg & 100 mg) Pellets for commercial purposes. The required quantity is 25 kg. The suppliers must support this enquiry with CoA.
    20 Jun 2024

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    20 Jun 2024

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    20 Jun 2024

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    Patents & EXCLUSIVITIES

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    US Patents

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    01

    HORIZON

    DICLOFENAC SODIUM

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    U.S.A
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    Patent Expiration Date : 2027-10-17

    DICLOFENAC SODIUM

    US Patent Number : 9101591

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204623

    Patent Use Code : U-1488

    Delist Requested :

    Patent Use Description : USE OF TOPICAL DICLOFE...

    Patent Expiration Date : 2027-10-17

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    Patent Expiration Date : 2027-10-17

    DICLOFENAC SODIUM

    US Patent Number : 9220784

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204623

    Patent Use Code : U-1488

    Delist Requested :

    Patent Use Description : USE OF TOPICAL DICLOFE...

    Patent Expiration Date : 2027-10-17

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    HORIZON

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    Patent Expiration Date : 2029-07-10

    DICLOFENAC SODIUM

    US Patent Number : 8741956

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204623

    Patent Use Code : U-1435

    Delist Requested :

    Patent Use Description : COMBINATION USE OF TOP...

    Patent Expiration Date : 2029-07-10

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    Patent Expiration Date : 2029-07-10

    DICLOFENAC SODIUM

    US Patent Number : 9415029

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204623

    Patent Use Code : U-1614

    Delist Requested :

    Patent Use Description : USE OF TOPICAL DICLOFE...

    Patent Expiration Date : 2029-07-10

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    Patent Expiration Date : 2030-08-09

    DICLOFENAC SODIUM

    US Patent Number : 8546450

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204623

    Patent Use Code : U-1435

    Delist Requested :

    Patent Use Description : COMBINATION USE OF TOP...

    Patent Expiration Date : 2030-08-09

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    HORIZON

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    Patent Expiration Date : 2027-10-17

    DICLOFENAC SODIUM

    US Patent Number : 9168304

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204623

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    Patent Expiration Date : 2027-10-17

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    HORIZON

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    Patent Expiration Date : 2027-10-17

    DICLOFENAC SODIUM

    US Patent Number : 9339552

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204623

    Patent Use Code : U-1488

    Delist Requested :

    Patent Use Description : USE OF TOPICAL DICLOFE...

    Patent Expiration Date : 2027-10-17

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    HORIZON

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    Patent Expiration Date : 2029-07-10

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    US Patent Number : 8618164

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    Drug Product Claim :

    Application Number : 204623

    Patent Use Code : U-1477

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    Patent Use Description : USE OF TOPICAL DICLOFE...

    Patent Expiration Date : 2029-07-10

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    NUVO PHARMS INC

    DICLOFENAC SODIUM

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    NUVO PHARMS INC

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    Patent Expiration Date : 2029-07-10

    DICLOFENAC SODIUM

    US Patent Number : 8217078

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 20947

    Patent Use Code : U-1248

    Delist Requested :

    Patent Use Description : USE OF TOPICAL DICLOFE...

    Patent Expiration Date : 2029-07-10

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    NUVO PHARMS INC

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    Patent Expiration Date : 2030-08-09

    DICLOFENAC SODIUM

    US Patent Number : 8546450

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 20947

    Patent Use Code : U-1435

    Delist Requested :

    Patent Use Description : COMBINATION USE OF TOP...

    Patent Expiration Date : 2030-08-09

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    ABOUT THIS PAGE

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

    Diclofenac Sodium manufacturers, exporters & distributors 1

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    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.

    Voltaren Gel Manufacturers

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

    Voltaren Gel Suppliers

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

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

    Voltaren Gel USDMF

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

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

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

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

    Voltaren Gel KDMF

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

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

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

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

    Voltaren Gel CEP

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

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

    Voltaren Gel WC

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

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

    Voltaren Gel 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 Voltaren Gel as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Voltaren Gel GMP

    Voltaren Gel 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 Voltaren Gel 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 Voltaren Gel GMP manufacturer or Voltaren Gel GMP API supplier for your needs.

    Voltaren Gel CoA

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

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

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