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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
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)
| Molecular Weight | 318.1 g/mol |
|---|---|
| Molecular Formula | C14H10Cl2NNaO2 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 4 |
| Exact Mass | 316.9986282 g/mol |
| Monoisotopic Mass | 316.9986282 g/mol |
| Topological Polar Surface Area | 52.2 Ų |
| Heavy Atom Count | 20 |
| Formal Charge | 0 |
| Complexity | 310 |
| 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 | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Diclofenac sodium |
| Drug Label | Diclofenac 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 Ingredient | Diclofenac sodium |
| Dosage Form | Gel; Tablet, extended release; Solution/drops; Spray; Tablet, delayed release; Solution |
| Route | Topical; Ophthalmic; oral; Oral |
| Strength | 75mg; 100mg; 25mg; 1.5%; 50mg; 0.1%; 3% |
| Market Status | Tentative Approval; Prescription |
| Company | Watson 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 Name | Diclofenac sodium |
| Drug Label | Diclofenac 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 Ingredient | Diclofenac sodium |
| Dosage Form | Gel; Tablet, extended release; Solution/drops; Spray; Tablet, delayed release; Solution |
| Route | Topical; Ophthalmic; oral; Oral |
| Strength | 75mg; 100mg; 25mg; 1.5%; 50mg; 0.1%; 3% |
| Market Status | Tentative Approval; Prescription |
| Company | Watson 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 |
Treatment of inflammation, Treatment of pain
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.)
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-19
Pay. Date : 2013-06-10
DMF Number : 8192
Submission : 1989-08-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 6689
Submission : 1986-11-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9115
Submission : 1991-04-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8121
Submission : 1989-06-13
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-13
Pay. Date : 2014-06-06
DMF Number : 8924
Submission : 1991-01-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-03-27
DMF Number : 9899
Submission : 1992-10-05
Status : Active
Type : II
GDUFA
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Rev. Date :
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DMF Number : 8583
Submission : 1990-05-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8688
Submission : 1990-08-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-11
DMF Number : 6981
Submission : 1987-05-27
Status : Active
Type : II
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : PANAMOR 50 mg DISPERSIBLE TABLET
Dosage Form : DSP
Dosage Strength : 50mg
Packaging : 9X1mg
Approval Date :
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Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Diclofenac Sodium
Dosage Form : DSP
Dosage Strength : 50mg
Packaging : 30X1mg
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Registration Country : South Africa
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Brand Name : Panamor 25
Dosage Form : TAB
Dosage Strength : 25mg
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Brand Name : Panamor - 75 Injection
Dosage Form : INJ
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Brand Name : Fortfen Injection/Inspuiting
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Brand Name : Panamor 100 Sr
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Brand Name : A-Lennon Diclofenac
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RLD : No
TE Code : AB
Brand Name : DICLOFENAC SODIUM
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 100MG
Approval Date : 2002-11-06
Application Number : 76201
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : DICLOFENAC SODIUM
Dosage Form : SOLUTION;TOPICAL
Dosage Strength : 1.5%
Approval Date : 2015-07-08
Application Number : 202769
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DICLOFENAC SODIUM
Dosage Form : GEL;TOPICAL
Dosage Strength : 1%
Approval Date : 2019-05-16
Application Number : 211253
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code : AB
DICLOFENAC SODIUM; MISOPROSTOL
Brand Name : ARTHROTEC
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 50MG;0.2MG
Approval Date : 1997-12-24
Application Number : 20607
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code :
DICLOFENAC SODIUM; MISOPROSTOL
Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 75MG;0.2MG
Approval Date : 2013-05-09
Application Number : 200158
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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Regulatory Info :
Registration Country : Switzerland
Brand Name : Grofenac
Dosage Form : Inj L?s
Dosage Strength : 75mg/3ml
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Regulatory Info :
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Brand Name : Grofenac Retard
Dosage Form : Ret Filmtabl
Dosage Strength : 100mg
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Brand Name : Pennsaid
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Brand Name : Olfen
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Regulatory Info :
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Several substances refer to content
Brand Name : Arthrotec
Dosage Form : MODIFIED-RELEASE TABLET
Dosage Strength : -
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Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Diclofenacum natricum; Misoprostolum
Brand Name : Arthrotec 50
Dosage Form : Bitabs
Dosage Strength : 50mg
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ecofenac
Dosage Form : Filmtabl
Dosage Strength : 50mg
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ecofenac
Dosage Form : Filmtabl
Dosage Strength : 25mg
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Switzerland
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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
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
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
USFDA APPLICATION NUMBER - 20607
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
USFDA APPLICATION NUMBER - 20607
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
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
DOSAGE - GEL;TOPICAL - 1%
USFDA APPLICATION NUMBER - 22122
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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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.
A Dichronic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dichronic, including repackagers and relabelers. The FDA regulates Dichronic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dichronic API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Dichronic manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dichronic supplier is an individual or a company that provides Dichronic active pharmaceutical ingredient (API) or Dichronic finished formulations upon request. The Dichronic suppliers may include Dichronic API manufacturers, exporters, distributors and traders.
click here to find a list of Dichronic suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dichronic DMF (Drug Master File) is a document detailing the whole manufacturing process of Dichronic active pharmaceutical ingredient (API) in detail. Different forms of Dichronic DMFs exist exist since differing nations have different regulations, such as Dichronic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dichronic DMF submitted to regulatory agencies in the US is known as a USDMF. Dichronic USDMF includes data on Dichronic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dichronic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dichronic suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dichronic Drug Master File in Japan (Dichronic JDMF) empowers Dichronic API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dichronic JDMF during the approval evaluation for pharmaceutical products. At the time of Dichronic JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dichronic suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dichronic Drug Master File in Korea (Dichronic KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dichronic. The MFDS reviews the Dichronic KDMF as part of the drug registration process and uses the information provided in the Dichronic KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dichronic KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dichronic API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dichronic suppliers with KDMF on PharmaCompass.
A Dichronic CEP of the European Pharmacopoeia monograph is often referred to as a Dichronic Certificate of Suitability (COS). The purpose of a Dichronic CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dichronic EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dichronic to their clients by showing that a Dichronic CEP has been issued for it. The manufacturer submits a Dichronic CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dichronic CEP holder for the record. Additionally, the data presented in the Dichronic CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dichronic DMF.
A Dichronic CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dichronic CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Dichronic suppliers with CEP (COS) on PharmaCompass.
A Dichronic written confirmation (Dichronic WC) is an official document issued by a regulatory agency to a Dichronic manufacturer, verifying that the manufacturing facility of a Dichronic active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dichronic APIs or Dichronic finished pharmaceutical products to another nation, regulatory agencies frequently require a Dichronic WC (written confirmation) as part of the regulatory process.
click here to find a list of Dichronic suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dichronic as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dichronic 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 Dichronic as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Dichronic and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dichronic NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dichronic suppliers with NDC on PharmaCompass.
Dichronic Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Dichronic GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dichronic GMP manufacturer or Dichronic GMP API supplier for your needs.
A Dichronic CoA (Certificate of Analysis) is a formal document that attests to Dichronic's compliance with Dichronic specifications and serves as a tool for batch-level quality control.
Dichronic CoA mostly includes findings from lab analyses of a specific batch. For each Dichronic CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Dichronic may be tested according to a variety of international standards, such as European Pharmacopoeia (Dichronic EP), Dichronic JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dichronic USP).
