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1. 1,8-diacetoxy-3-carboxyanthraquinone
2. 2-anthracenecarboxylic Acid, 4,5-bis(acetyloxy)-9,10-dihydro-9,10-dioxo-
3. 4,5-bis(acetyloxy)-9,10-dihydro-9,10-dioxo-2-anthracenecarboxylic Acid
4. 4,5-diacetoxyanthraquinone-2-carboxylic Acid
5. 9,10-dihydro-4,5-dihydroxy-9,10-dioxo-2-anthroic Acid, Diacetate
6. Ac-201
7. Ac-203
8. Artrodar
9. Diacerhein
10. Diacetyl-rhein
11. Diacetylrhein
12. Diora
13. Fisiodar
14. M-01ax21
15. M01ax21
16. Rhein Diacetate
17. Sf-277
18. Sf277
19. Verboril
20. Zondar
1. 13739-02-1
2. Diacerhein
3. Diacetylrhein
4. Artrodar
5. Fisiodar
6. 1,8-diacetoxy-3-carboxyanthraquinone
7. Diacerin
8. Sf-277
9. Verboril
10. Zondar
11. Diora
12. 4,5-diacetyloxy-9,10-dioxoanthracene-2-carboxylic Acid
13. M01ax21
14. Ac-201
15. 2-anthracenecarboxylic Acid, 4,5-bis(acetyloxy)-9,10-dihydro-9,10-dioxo-
16. 4,5-bis(acetyloxy)-9,10-dihydro-9,10-dioxo-2-anthracenecarboxylic Acid
17. 4,5-diacetoxyanthraquinone-2-carboxylic Acid
18. M-01ax21
19. Diacerhein; Diacetylrhein
20. Mfcd00468030
21. Nsc-758147
22. Mls000028577
23. 4hu6j11el5
24. 4,5-diacetoxy-9,10-dioxo-9,10-dihydroanthracene-2-carboxylic Acid
25. 9,10-dihydro-4,5-dihydroxy-9,10-dioxo-2-anthroic Acid, Diacetate
26. 4,5-diacetylrhein
27. Ncgc00018274-04
28. Smr000058958
29. 4,5-bis(acetyloxy)-9,10-dioxo-9,10-dihydroanthracene-2-carboxylic Acid
30. Dsstox_cid_25636
31. Dsstox_rid_81017
32. Diacerein [inn]
33. Dsstox_gsid_45636
34. Diacereine [french]
35. Diacereinum [latin]
36. Diacereina [spanish]
37. 4,5-diacetoxy-9,10-diketo-anthracene-2-carboxylic Acid
38. 4,5-diacetyloxy-9,10-dioxo-2-anthracenecarboxylic Acid
39. Diacereina
40. Diacereine
41. Diacereinum
42. Rhein Diacetate
43. Rhein, Diacetate
44. Cas-13739-02-1
45. Sr-01000003156
46. Einecs 237-310-2
47. Brn 2184909
48. Unii-4hu6j11el5
49. Gesamtmatrix
50. Art 50
51. 1,8-diacetoxyanthraquinone-3-carboxylic Acid
52. Diacerein- Bio-x
53. Zondar (tn)
54. Spectrum_001876
55. Specplus_000643
56. 4,5-diacetoxy-9,10-dihydro-9,10-dioxo-2-anthrylcarbonsaeure
57. 9,10-dihydro-4,5-diacetoxy-9,10-2-anthracenecarboxylic Acid
58. Diacerein [mi]
59. Diacerein (usan/inn)
60. Diacerein [usan:inn]
61. Diacerein [usan]
62. 9,10-dihydro-4,5-dihydroxy-9,10-dioxo-2-anthroic Acid Diacetate
63. Spectrum2_000823
64. Spectrum3_000937
65. Spectrum4_001036
66. Spectrum5_001819
67. Diacerein Impurity Mixture
68. Diacerein [mart.]
69. Diacerein [who-dd]
70. Schembl25784
71. Kbiogr_001591
72. Kbioss_002400
73. Rhein Diacetate [mi]
74. 3-10-00-04790 (beilstein Handbook Reference)
75. Cid_26248
76. Chembl41286
77. Divk1c_006739
78. Spectrum1502010
79. Spbio_000745
80. 4,5-diacetoxy-9,10-dioxo-anthracene-2-carboxylic Acid
81. Diacerein [ep Monograph]
82. Diacerein, >=95% (hplc)
83. Dtxsid4045636
84. Bdbm32018
85. Chebi:94708
86. Gtpl10800
87. Kbio1_001683
88. Kbio2_002395
89. Kbio2_004963
90. Kbio2_007531
91. Kbio3_001974
92. Hms3652d06
93. Hms3714b20
94. Pharmakon1600-01502010
95. Bcp10834
96. Hy-n0283
97. Who 5371
98. Zinc3812842
99. Tox21_110856
100. Bbl011075
101. Ccg-40287
102. Nsc758147
103. S4267
104. Stk802271
105. 2-anthroic Acid, 9,10-dihydro-4,5-dihydroxy-9,10-dioxo-, Diacetate
106. Akos005622705
107. Tox21_110856_1
108. Db11994
109. Ks-5088
110. Kw-4800
111. Nsc 758147
112. Ncgc00018274-01
113. Ncgc00018274-02
114. Ncgc00018274-03
115. Ncgc00018274-05
116. Ncgc00022114-03
117. Am807992
118. Bd164367
119. Sbi-0052833.p002
120. B1726
121. D4061
122. Ft-0603096
123. Sw199355-2
124. D07270
125. Ab00053327_14
126. 739d021
127. A807252
128. Q413178
129. Sr-01000003156-2
130. Sr-01000003156-3
131. Sr-01000003156-4
132. W-108237
133. Diacerein, European Pharmacopoeia (ep) Reference Standard
134. 4,5-diacetoxy-9,10-dihydro-9,10-dioxoanthracene-2-carboxylic Acid
135. 4,5-diacetyloxy-9,10-bis(oxidanylidene)anthracene-2-carboxylic Acid
136. 4,5-bis(acetoxy)-9,10-dihydro-9,10-dioxo-2-anthracenecarboxylic Acid
137. 112118-18-0
| Molecular Weight | 368.3 g/mol |
|---|---|
| Molecular Formula | C19H12O8 |
| XLogP3 | 1.9 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 5 |
| Exact Mass | 368.05321734 g/mol |
| Monoisotopic Mass | 368.05321734 g/mol |
| Topological Polar Surface Area | 124 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 683 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
For the treatment of osteoarthritis affecting the hip or knee.
Decreases inflammation and cartilage destruction and also corrects altered osteoblast acitivity.
Anti-Inflammatory Agents
Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)
M - Musculo-skeletal system
M01 - Antiinflammatory and antirheumatic products
M01A - Antiinflammatory and antirheumatic products, non-steroids
M01AX - Other antiinflammatory and antirheumatic agents, non-steroids
M01AX21 - Diacerein
Absorption
Bioavailability of 50-60%. Entirely converted to the active metabolite rhein [DB13174] before reaching systemic circulation.
Route of Elimination
37% excreted in urine and 53% in feces as estimated in rats.
Volume of Distribution
15-60L.
Clearance
Total CL is 1.5L/h and renal CL is 0.1L/h.
Entirely converted to rhien [DB13174] through double deacetylation before reaching systemic circulation. Rhein [DB13174] is further metabolized to rhein glucuronide and rhein sulfate.
4-10h.
Diacerein's active metabolite rhein [DB13174] reduces cartilage destruction by decreasing expression of matrix metalloproteinase (MMP)-1 and -3 as well as upregulating tissue inhibitor of matrix metalloproteinases which serve to reduce the activity of several MMPs. The anti-inflammatory action of rhein reduces the level of interleukin-1beta activity which plays a large role in reduction of extracellular matrix production, MMP activity, and continued inflammation. Rhein reduces abnormal osteoblast synthetic activity through an unknown mechanism.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38766
Submission : 2023-09-15
Status : Active
Type : II
Certificate Number : CEP 2015-173 - Rev 03
Issue Date : 2024-12-03
Type : Chemical
Substance Number : 2409
Status : Valid
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
NDC Package Code : 59680-014
Start Marketing Date : 2024-04-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Huseeed Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20180515-209-J-27(6)
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, Gujarat, India
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23960
Submission : 2010-07-13
Status : Active
Type : II
Certificate Number : R1-CEP 2014-247 - Rev 00
Issue Date : 2021-06-24
Type : Chemical
Substance Number : 2409
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23961
Submission : 2010-07-13
Status : Active
Type : II
Certificate Number : R0-CEP 2014-248 - Rev 00
Issue Date : 2016-07-21
Type : Chemical
Substance Number : 2409
Status : Expired
Date of Issue : 2019-08-05
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075A
Address of the Firm :
Certificate Number : R0-CEP 2021-483 - Rev 00
Issue Date : 2023-05-30
Type : Chemical
Substance Number : 2409
Status : Valid
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-11-23
Registration Number : 20211123-209-J-1075
Manufacturer Name : Interpretation of SA of CV
Manufacturer Address : Guillermo Marconi No. 16, Fraccionamiento Parque Industrial Cuamatla, CP 54730, Cuautitlan Izcalli, Mexico
Date of Issue : 2013-08-30
Valid Till : 2016-07-02
Written Confirmation Number : WC-249
Address of the Firm :
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USDMF
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38766
Submission : 2023-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23961
Submission : 2010-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23960
Submission : 2010-07-13
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Certificate Number : CEP 2015-173 - Rev 03
Status : Valid
Issue Date : 2024-12-03
Type : Chemical
Substance Number : 2409
Certificate Number : R1-CEP 2014-247 - Rev 00
Status : Valid
Issue Date : 2021-06-24
Type : Chemical
Substance Number : 2409
Certificate Number : R0-CEP 2014-248 - Rev 00
Status : Expired
Issue Date : 2016-07-21
Type : Chemical
Substance Number : 2409
Certificate Number : CEP 2017-148 - Rev 03
Status : Valid
Issue Date : 2024-03-26
Type : Chemical
Substance Number : 2409
Certificate Number : R0-CEP 2021-483 - Rev 00
Status : Valid
Issue Date : 2023-05-30
Type : Chemical
Substance Number : 2409
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Diacerein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diacerein, including repackagers and relabelers. The FDA regulates Diacerein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diacerein 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 Diacerein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diacerein supplier is an individual or a company that provides Diacerein active pharmaceutical ingredient (API) or Diacerein finished formulations upon request. The Diacerein suppliers may include Diacerein API manufacturers, exporters, distributors and traders.
click here to find a list of Diacerein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diacerein DMF (Drug Master File) is a document detailing the whole manufacturing process of Diacerein active pharmaceutical ingredient (API) in detail. Different forms of Diacerein DMFs exist exist since differing nations have different regulations, such as Diacerein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diacerein DMF submitted to regulatory agencies in the US is known as a USDMF. Diacerein USDMF includes data on Diacerein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diacerein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diacerein suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Diacerein Drug Master File in Korea (Diacerein KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diacerein. The MFDS reviews the Diacerein KDMF as part of the drug registration process and uses the information provided in the Diacerein KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diacerein 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 Diacerein API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diacerein suppliers with KDMF on PharmaCompass.
A Diacerein CEP of the European Pharmacopoeia monograph is often referred to as a Diacerein Certificate of Suitability (COS). The purpose of a Diacerein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Diacerein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Diacerein to their clients by showing that a Diacerein CEP has been issued for it. The manufacturer submits a Diacerein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Diacerein CEP holder for the record. Additionally, the data presented in the Diacerein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Diacerein DMF.
A Diacerein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diacerein 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 Diacerein suppliers with CEP (COS) on PharmaCompass.
A Diacerein written confirmation (Diacerein WC) is an official document issued by a regulatory agency to a Diacerein manufacturer, verifying that the manufacturing facility of a Diacerein active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diacerein APIs or Diacerein finished pharmaceutical products to another nation, regulatory agencies frequently require a Diacerein WC (written confirmation) as part of the regulatory process.
click here to find a list of Diacerein suppliers with Written Confirmation (WC) on PharmaCompass.
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 Diacerein as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diacerein API and other APIs are published in this directory by the FDA.
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 Diacerein 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.
The NDC directory also contains data on finished compounded human drug products that contain Diacerein and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diacerein NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diacerein suppliers with NDC on PharmaCompass.
Diacerein 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 Diacerein 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 Diacerein GMP manufacturer or Diacerein GMP API supplier for your needs.
A Diacerein CoA (Certificate of Analysis) is a formal document that attests to Diacerein's compliance with Diacerein specifications and serves as a tool for batch-level quality control.
Diacerein CoA mostly includes findings from lab analyses of a specific batch. For each Diacerein 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.
Diacerein may be tested according to a variety of international standards, such as European Pharmacopoeia (Diacerein EP), Diacerein JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diacerein USP).
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