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Also known as: 89796-99-6, Preservex, Aceclofenaco, Aceclofenacum, Aceclofenac betadex, Chebi:31159
Molecular Formula
C16H13Cl2NO4
Molecular Weight
354.2  g/mol
InChI Key
MNIPYSSQXLZQLJ-UHFFFAOYSA-N
FDA UNII
RPK779R03H

Aceclofenac
Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies. Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility. It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation. Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions. In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, [DB00586], via chemical modification in effort to improve the gastrointestinal tolerability of the drug. It is a more commonly prescribed drug in Europe.
1 2D Structure

Aceclofenac

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[2-[2-(2,6-dichloroanilino)phenyl]acetyl]oxyacetic acid
2.1.2 InChI
InChI=1S/C16H13Cl2NO4/c17-11-5-3-6-12(18)16(11)19-13-7-2-1-4-10(13)8-15(22)23-9-14(20)21/h1-7,19H,8-9H2,(H,20,21)
2.1.3 InChI Key
MNIPYSSQXLZQLJ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C(C(=C1)CC(=O)OCC(=O)O)NC2=C(C=CC=C2Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
RPK779R03H
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-((2,6-dichlorophenyl)amino)phenylacetoxyacetic Acid

2. Airtal

3. Airtal Difucrem

4. Aital

5. Beofenac

6. Biofenac

7. Bristaflam

8. Clanza Cr

9. Falcol

10. Falcol Difucrem

11. Gerbin

12. Gerbin Difucrem

13. Preservex

14. Sanein

2.3.2 Depositor-Supplied Synonyms

1. 89796-99-6

2. Preservex

3. Aceclofenaco

4. Aceclofenacum

5. Aceclofenac Betadex

6. Chebi:31159

7. 2-[2-[2-(2,6-dichloroanilino)phenyl]acetyl]oxyacetic Acid

8. Mfcd00864296

9. Airtal

10. Rpk779r03h

11. 2-(2-(2-((2,6-dichlorophenyl)amino)phenyl)acetoxy)acetic Acid

12. Ncgc00016957-01

13. Glycolic Acid [o-(2,6-dichloroanilino)phenyl]acetate Ester

14. 2-(2-(2-(2,6-dichlorophenylamino)phenyl)acetoxy)acetic Acid

15. Glycolic Acid, (o-(2,6-dichloroanilino)phenyl)acetate (ester)

16. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid Carboxymethyl Ester

17. 2-[(2,6-dichlorophenyl)amino]benzeneacetic Acid Carboxymethyl Ester

18. Cas-89796-99-6

19. Dsstox_cid_25522

20. Dsstox_rid_80928

21. Dsstox_gsid_45522

22. 2-[(2',6'-dichlorophenyl)amino]phenylacetoxyacetic Acid

23. Aceclofenacum [latin]

24. Aceclofenaco [spanish]

25. Hifenac

26. 2-[(2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic Acid

27. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Carboxymethyl Ester

28. Smr000718629

29. Sr-01000802972

30. Aceclofenac [inn:ban]

31. Brn 4884476

32. Unii-rpk779r03h

33. Cincofen

34. [({2-[(2,6-dichlorophenyl)amino]phenyl}acetyl)oxy]acetic Acid

35. Clanza

36. Benzeneacetic Acid, 2-[(2,6-dichlorophenyl)amino]-, Carboxymethyl Ester

37. (2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetoxy)acetic Acid

38. Aceclofenac (tn)

39. Prestwick_772

40. 2-(o-(2,6-dichloranilino)phenylacetoxy)essigsaeure

41. Pr-82/3

42. Aceclofenac (jan/inn)

43. Aceclofenac [mi]

44. Prestwick0_000175

45. Prestwick1_000175

46. Prestwick2_000175

47. Prestwick3_000175

48. Aceclofenac [inn]

49. Aceclofenac [jan]

50. Aceclofenac [mart.]

51. Schembl25734

52. Aceclofenac [who-dd]

53. Bspbio_000069

54. Mls001032069

55. Mls001304028

56. Mls002154226

57. Chembl93645

58. Spbio_001990

59. Bpbio1_000077

60. Dtxsid7045522

61. Aceclofenac, >=98% (hplc)

62. Aceclofenac [ep Monograph]

63. Aceclofenac For Peak Identification

64. Hms1568d11

65. Hms2090g07

66. Hms2095d11

67. Hms2231b03

68. Hms3371a10

69. Hms3712d11

70. Hms3873i03

71. Bcp11932

72. Hy-b0634

73. Zinc3805798

74. Tox21_110710

75. Aceclofenac Betadex [who-dd]

76. Bbl010788

77. Bdbm50109016

78. S4835

79. Stk594349

80. Akos005516194

81. Tox21_110710_1

82. Ab07468

83. Ac-5282

84. Aceclofenac 1.0 Mg/ml In Acetonitrile

85. Ccg-213835

86. Db06736

87. Ks-5033

88. Ncgc00016957-02

89. Ncgc00016957-03

90. Ncgc00016957-05

91. Ba164135

92. Aceclofenac 100 Microg/ml In Acetonitrile

93. Ft-0621715

94. D01545

95. 796a996

96. Q481757

97. 2-(2,6-dichlorophenylamine)phenylacetoxyacetic Acid

98. Sr-01000802972-2

99. Sr-01000802972-3

100. 2-[2-(2,6-dichloroanilino)phenylacetoxy]acetic Acid

101. Brd-k68538666-001-03-2

102. Aceclofenac For Peak Identification, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 354.2 g/mol
Molecular Formula C16H13Cl2NO4
XLogP34.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count7
Exact Mass353.0221633 g/mol
Monoisotopic Mass353.0221633 g/mol
Topological Polar Surface Area75.6 Ų
Heavy Atom Count23
Formal Charge0
Complexity411
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Aceclofenac is a NSAID that inhibits both isoforms of COX enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Aceclofenac displays more selectivity towards COX-2 (IC50 of 0.77uM) than COX-1 (IC50 of >100uM), which promotes its gastric tolerance compared to other NSAIDs. The primary metabolite, 4'-hydroxyaceclofenac, also minimally inhibits COX-2 with IC50 value of 36uM. Although the mode of action of aceclofenac is thought to mainly arise from the inhibition of synthesis of prostaglandins (PGE2), aceclofenac also inhibits the production of inflammatory cytokines, interleukins (IL-1, IL-6), and tumor necrosis factors (TNF). It is also reported that aceclofenac also affects the cell adhesion molecules from neutrophils. Aceclofenac also targets the synthesis of glycosaminoglycan and mediates chrondroprotective effects.


5.2 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.)


5.3 ATC Code

M01AB16

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01A - Antiinflammatory and antirheumatic products, non-steroids

M01AB - Acetic acid derivatives and related substances

M01AB16 - Aceclofenac


M - Musculo-skeletal system

M02 - Topical products for joint and muscular pain

M02A - Topical products for joint and muscular pain

M02AA - Antiinflammatory preparations, non-steroids for topical use

M02AA25 - Aceclofenac


5.4 Absorption, Distribution and Excretion

Absorption

Aceclofenac is rapidly and completely absorbed from the gastrointestinal tract and circulates mainly as unchanged drug following oral administration. Peak plasma concentrations are reached around 1.25 to 3 hours post-ingestion, and the drug penetrates into the synovial fluid where the concentration may reach up to 60% of that in the plasma. There is no accumulation in regular dosing, with similar maximum plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax) after single and multiple doses.


Route of Elimination

The main route of elimination is via the urine where the elimination accounts for 70-80% of clearance of the drug. Approximately two thirds of the administered dose is excreted via the urine, mainly as glucuronidated and hydroxylated forms of aceclofenac. About 20% of the dose is excreted into feces.


Volume of Distribution

The volume of distribution is approximately 25 L.


Clearance

The mean clearance rate is approximately 5 L/h.


5.5 Metabolism/Metabolites

4'-hydroxyaceclofenac is the main metabolite detected in plasma however other minor metabolites include diclofenac, 5-hydroxyaceclofenac, 5-hydroxydiclofenac, and 4'-hydroxydiclofenac. It is probable that the metabolism of aceclofenac is mediated by CYP2C9.


Aceclofenac has known human metabolites that include 4'-hydroxy-aceclofenac, 5-hydroxy-aceclofenac, and diclofenac.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.6 Biological Half-Life

The mean plasma elimination half-life is approximately 4 hours.


5.7 Mechanism of Action

Through COX-2 inhibition, aceclofenac downregulates the production of various inflammatory mediators including prostaglandin E2 (PGE2), IL-1, and TNF from the arachidonic acid (AA) pathway. Inhibition of IL-6 is thought to be mediated by diclofenac converted from aceclofenac. Suppressed action of inflammatory cytokines decreases the production of reactive oxygen species. Aceclofenac is shown to decreased production of nitrous oxide in human articular chondrocytes. In addition, aceclofenac interferes with neutrophil adhesion to endothelium by decreasing the expression of L-selectin (CD62L), which is a cell adhesion molecule expressed on lymphocytes. Aceclofenac is proposed to stimulate the synthesis of glycosaminoglycan in human osteoarthritic cartilage which may be mediated through its inhibitory action on IL-1 production and activity. The chrondroprotective effects are generated by 4'-hydroxyaceclofenac which suppresses IL-1 mediated production of promatrix metalloproteinase-1 and metalloproteinase-3 and interferes with the release of proteoglycan from chrondrocytes.


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CODE NO. 29420090 ACECLOFENAC BP","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"UMEDICA LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"UNDISCLOSED","customerCountry":"PAKISTAN","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"22","totalValueFC":"838.4","currency":"USD","unitRateINR":1443.2,"date":"25-Jul-2025","totalValueINR":"72160","totalValueInUsd":"838.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"3880985","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO. 221, G.I.D.C.,, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753813800,"product":"PHARMACEUTICAL RAW MATERIALS: ACECLOFENAC BP BATCH NO.: SCT\/ACF\/274\/25-26 MFG. DT : JUL, 2025 EXP. 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ESTATE, VALSAD DIST.","city":"VAPI, GUJARAT","supplier":"RANKE QUIMICA S A","supplierCountry":"INDIA","foreign_port":"NA","customer":"RICHTER THEMIS MEDICARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"74.20","actualQuantity":"74.2","unit":"KGS","unitRateFc":"87.9","totalValueFC":"7416.2","currency":"EURO","unitRateINR":"8236.5","date":"02-Dec-2022","totalValueINR":"611145.32","totalValueInUsd":"7416.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"3559154","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT.NO.69\/A-2, G.I.D.C.INDL. ESTATE, VALSAD DIST."},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669919400,"product":"ACECLOFENAC RTML MICRONIZED REF CODE 70002692 (RE-IMPORT) EXPORTED VIDE SB NO 7633405 DT 21-01-2022","address":"PLOT.NO.69\/A-2, G.I.D.C.INDL. ESTATE, VALSAD DIST.","city":"VAPI, GUJARAT","supplier":"RANKE QUIMICA S A","supplierCountry":"INDIA","foreign_port":"NA","customer":"RICHTER THEMIS MEDICARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"36.30","actualQuantity":"36.3","unit":"KGS","unitRateFc":"87.9","totalValueFC":"3628.2","currency":"EURO","unitRateINR":"8236.5","date":"02-Dec-2022","totalValueINR":"298983.49","totalValueInUsd":"3628.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"3559154","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT.NO.69\/A-2, G.I.D.C.INDL. ESTATE, VALSAD DIST."},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671647400,"product":"ACECLOFENAC RTML MICRONIZED REF CODE 70002692 (RE-IMPORT) EXPORTED VIDE SB NO 4745339 DATE 21\/09\/2021","address":"PLOT.NO.69\/A-2, G.I.D.C.INDL. ESTATE, VALSAD DIST.","city":"VAPI, GUJARAT","supplier":"RANKE QUIMICA S A","supplierCountry":"INDIA","foreign_port":"NA","customer":"RICHTER THEMIS MEDICARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"74.20","actualQuantity":"74.2","unit":"KGS","unitRateFc":"87.9","totalValueFC":"7710.2","currency":"EURO","unitRateINR":"8562.9","date":"22-Dec-2022","totalValueINR":"635365.4","totalValueInUsd":"7710.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"3852508","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT.NO.69\/A-2, G.I.D.C.INDL. ESTATE, VALSAD DIST."},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675967400,"product":"ACECLOFENAC EP8(FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"JIANGXI SYNERGY PHARMACEUTICAL IMPORT AND EXPORT C","supplierCountry":"CHINA","foreign_port":"NA","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"126.5","totalValueFC":"19011.8","currency":"USD","unitRateINR":"10467.9","date":"10-Feb-2023","totalValueINR":"1570181.25","totalValueInUsd":"19011.8","indian_port":"BOMBAY AIR","hs_no":"29224990","bill_no":"4581238","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"ACECLOFENAC EP8 (FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"JIANGXI SYNERGY PHARMACEUTICAL IMPORT AND EXPORT C","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"MYLAN LABORATORIES LTD","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"126.5","totalValueFC":"32001.1","currency":"USD","unitRateINR":"10638.7","date":"31-Jan-2024","totalValueINR":"2659662.5","totalValueInUsd":"32001.1","indian_port":"Bombay Air","hs_no":"29224990","bill_no":"9908719","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"O.LTD FENGXIN INDUSTRIAL PARK FENGXIN JIANGXI 330700 P. 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31-Jul-2025
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ABOUT THIS PAGE

Looking for 89796-99-6 / Aceclofenac API manufacturers, exporters & distributors?

Aceclofenac manufacturers, exporters & distributors 1

27

PharmaCompass offers a list of Aceclofenac 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 Aceclofenac manufacturer or Aceclofenac supplier for your needs.

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

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

API | Excipient name

Aceclofenac

Synonyms

89796-99-6, Preservex, Aceclofenaco, Aceclofenacum, Aceclofenac betadex, Chebi:31159

Cas Number

89796-99-6

Unique Ingredient Identifier (UNII)

RPK779R03H

About Aceclofenac

Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies. Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility. It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation. Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions. In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, [DB00586], via chemical modification in effort to improve the gastrointestinal tolerability of the drug. It is a more commonly prescribed drug in Europe.

Biofenac Manufacturers

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

Biofenac Suppliers

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

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

Biofenac USDMF

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

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

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

Biofenac KDMF

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

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

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

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

Biofenac CEP

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

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

Biofenac WC

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

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

Biofenac GMP

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

Biofenac CoA

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

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

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