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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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OF BULK DRUG DICLOFENAC SODIUM EP (SODICO).(SB NO. 3695760 DT. 04.09.2023).","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"LABORATORIOS BASI INDUSTRIA FARMACEUTICA S A","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"UMEDICA LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"40","totalValueFC":"41604.8","currency":"USD","unitRateINR":"3486.5","date":"28-Sep-2024","totalValueINR":"3486537.2","totalValueInUsd":"41604.8","indian_port":"JNPT","hs_no":"29225090","bill_no":"5850932","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"Parque Industrial Manuel Lourenco F erreira Lote 15, 3450 Mortagua, Por tugal Portugal","customerAddress":"PLOT NO. 221, G.I.D.C.,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742236200,"product":"DICLOFENAC SODIUM USP","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"ANYANG DONGTAI PHARMACEUTICAL TECHNOLOGY LTD C","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"2500.00","actualQuantity":"2500","unit":"KGS","unitRateFc":"20","totalValueFC":"50682.6","currency":"USD","unitRateINR":"1756","date":"18-Mar-2025","totalValueINR":"4390000","totalValueInUsd":"50682.6","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29224990","bill_no":"8941857","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 6002 INNOVATION BUILDING Baiyi Township, Tangyin County, Anyang Ci SDNF China","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754591400,"product":"DICLOFENAC SODIUM USP","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"M\/S. ANYANG DONGTAI PHARMACEUTICAL TECHNOLOGY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"APL HEALTHCARE LTD","customerCountry":"INDIA","quantity":"2550.00","actualQuantity":"2550","unit":"KGS","unitRateFc":"20","totalValueFC":"51629.5","currency":"USD","unitRateINR":"1772","date":"08-Aug-2025","totalValueINR":"4518600","totalValueInUsd":"51629.5","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29224990","bill_no":"3764473","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 6002 INNOVATION BUILDING Baiyi Township, Tangyin County, Anyang SDNF China","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1760466600,"product":"DICLOFENAC SODIUM BP\/USP\/EP DICLOFENAC SODIUM BP\/USP\/EP","address":"8, SAVANI APARTMENT, M.G.ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"SHANGHAI MOONSHINE TECHNOLOGY PVT LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"VIDACARE MEDICA PRIVATE LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"6.3","totalValueFC":"12688.1","currency":"USD","unitRateINR":"560.6","date":"15-Oct-2025","totalValueINR":"1121250","totalValueInUsd":"12688.1","indian_port":"JNPT","hs_no":"29225090","bill_no":"5126796","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO 789 TIANZHU ROAD JIADING DISTRICT SHANGHAI CN","customerAddress":"8, SAVANI APARTMENT, M.G.ROAD,"}]
    04-Jan-2022
    31-Dec-2025
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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

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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.

    Berifen Manufacturers

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

    Berifen Suppliers

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

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

    Berifen USDMF

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

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

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

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

    Berifen KDMF

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

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

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

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

    Berifen CEP

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

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

    Berifen WC

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

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

    Berifen 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 Berifen as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Berifen GMP

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

    Berifen CoA

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

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

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