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1. Pred Forte
2. Prednisolone 21-acetate
3. Scherisolone-kristall Suspension
1. 52-21-1
2. Prednisolone 21-acetate
3. Omnipred
4. Econopred
5. Pricortin
6. Cormalone
7. Cortipred
8. Deltilen
9. Durapred
10. Predicort
11. Prednidoren
12. Supercortyl
13. Prenema
14. Meticortelone Acetate
15. Prednelan-n
16. Delcort-e
17. Pred Mild
18. Pred Forte
19. Flo-pred
20. Prediacortine
21. Nisolone
22. Prednisolone-21-acetate
23. Predalone 50
24. Predonine Injection
25. Nsc-10966
26. Mls000028512
27. Chebi:8380
28. [2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Acetate
29. Prednisolone (21-acetate)
30. Smr000058326
31. Econopred Plus
32. 8b2807733d
33. Nsc 10966
34. Dsstox_cid_3502
35. Dsstox_rid_77056
36. Dsstox_gsid_23502
37. Prednisoloneacetate
38. 21-acetoxy-1,4-pregnadiene-11beta,17alpha-diol-3,20-dione
39. Pred-forte
40. Cetapred Ointment
41. Pred-g Liquifilm
42. Vasocidin Ointment
43. Cas-52-21-1
44. Blephamide Liquifilm
45. Einecs 200-134-1
46. Prednisolone Acetate (omnipred)
47. Brn 3111798
48. Prednisolone Acetate [usp:jan]
49. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-
50. Econopred (tn)
51. Prednisoloni Acetas
52. Unii-8b2807733d
53. Ncgc00094765-01
54. Prednisolone-acetate
55. Pred Forte (tn)
56. Component Of Metimyd
57. Mfcd00037710
58. Sterane Im And Ia
59. Blephamide S.o.p.
60. Component Of Composone
61. Pred Forte Tm 1%
62. Opera_id_332
63. Pred-g S.o.p.
64. 11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate
65. Schembl7999
66. Chembl1152
67. Component Of Isopto Cetapred
68. 4-08-00-03468 (beilstein Handbook Reference)
69. Mls001148097
70. Mls002207146
71. Mls002548870
72. Component Of Neo-delta-cortef
73. Dtxsid3023502
74. Hms2234f18
75. Hms3259o07
76. Prednisolone Acetate [jan]
77. Prednisolone 21-acetate, >=97%
78. Prednisone Impurity L [ep]
79. 2-((8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Acetate
80. Bcp18958
81. Hy-b1214
82. Nsc10966
83. Zinc3875348
84. Prednisolone Acetate [vandf]
85. Tox21_111328
86. Prednisolone Acetate [mart.]
87. Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-, 21-acetate
88. S2570
89. Prednisolone Acetate [usp-rs]
90. Prednisolone Acetate [who-dd]
91. Prednisolone Acetate [who-ip]
92. Akos007930677
93. Akos015960469
94. Prednisolone 21-acetate [mi]
95. Pregna-1,4-diene-3,20-dione, 11-beta,17,21-trihydroxy-, 21-acetate
96. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11beta)-
97. Tox21_111328_1
98. Ac-2176
99. Ccg-268673
100. Cs-4642
101. Db15566
102. Nc00470
103. Prednisolone Acetate (jp17/usp/inn)
104. Ncgc00021925-03
105. Ncgc00021925-05
106. Prednisolone Acetate [green Book]
107. 2-((1s,10s,11s,15s,17s,2r,14r)-14,17-dihydroxy-2,15-dimethyl-5-oxotetracyclo[8 .7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-oxoethyl Acetate
108. As-11673
109. Prednisolone Acetate [orange Book]
110. Prednisolone Acetate [ep Monograph]
111. Prednisolone Acetate [usp Impurity]
112. Prednisoloni Acetas [who-ip Latin]
113. Prednisolone Acetate [usp Monograph]
114. Prednisolone Acetate For Peak Identification
115. Metimyd Component Prednisolone Acetate
116. P1283
117. Pred-g Component Prednisolone Acetate
118. Prednisolone Impurity C [ep Impurity]
119. Cetapred Component Prednisolone Acetate
120. Sulphrin Component Prednisolone Acetate
121. Blephamide Component Prednisolone Acetate
122. C08180
123. D00980
124. Poly-pred Component Prednisolone Acetate
125. Predamide Component Prednisolone Acetate
126. Prednisolone Acetate 100 Microg/ml In Methanol
127. Prednisolone Acetate Component Of Pred-g
128. Ab00443788-11
129. Ab00443788_13
130. Prednisolone Acetate 1000 Microg/ml In Methanol
131. Prednisolone Acetate Component Of Cetapred
132. Prednisolone Acetate Component Of Metimyd
133. Prednisolone Acetate Component Of Sulphrin
134. Predsulfair Component Prednisolone Acetate
135. 037p710
136. A828982
137. Prednisolone Acetate Component Of Blephamide
138. Prednisolone Acetate Component Of Poly-pred
139. Prednisolone Acetate Component Of Predamide
140. Prednisolone Acetate Component Of Predsulfair
141. Q-201614
142. Hydrocortisone Acetate Impurity C [ep Impurity]
143. Isopto Cetapred Component Prednisolone Acetate
144. Neo-delta-cortef Component Prednisolone Acetate
145. Q27108063
146. Blephamide S.o.p. Component Prednisolone Acetate
147. Prednisolone Acetate Component Of Isopto Cetapred
148. Prednisolone Acetate Component Of Neo-delta-cortef
149. Methylprednisolone Acetate Impurity E [ep Impurity]
150. Prednisolone 21-acetate, Vetranal(tm), Analytical Standard
151. Prednisolone Acetate Component Of Blephamide S.o.p.
152. 11b,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate
153. Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-, 21-acetate
154. Prednisolone Acetate, British Pharmacopoeia (bp) Reference Standard
155. Prednisolone Acetate, European Pharmacopoeia (ep) Reference Standard
156. (11beta)-11,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl Acetate
157. 11.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate
158. 11.beta.,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl Acetate
159. Prednisolone Acetate, United States Pharmacopeia (usp) Reference Standard
160. Pregna-1,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-
161. Prednisolone Acetate For Peak Identification, European Pharmacopoeia (ep) Reference Standard
162. Prednisolone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material
163. [2-[(8s,9s,10r,11s,13s,14s,17r)-10,13-dimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] Ethanoate
164. Acetic Acid [2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Ester
| Molecular Weight | 402.5 g/mol |
|---|---|
| Molecular Formula | C23H30O6 |
| XLogP3 | 2.4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 4 |
| Exact Mass | 402.20423867 g/mol |
| Monoisotopic Mass | 402.20423867 g/mol |
| Topological Polar Surface Area | 101 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 827 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 7 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 10 | |
|---|---|
| Drug Name | Blephamide s.o.p. |
| PubMed Health | Prednisolone |
| Drug Classes | Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent |
| Drug Label | Flo-Pred (prednisolone acetate oral suspension) contains prednisolone which is the acetate ester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from... |
| Active Ingredient | sulfacetamide sodium; Prednisolone acetate |
| Dosage Form | Ointment |
| Route | Ophthalmic |
| Strength | 0.2%; 10% |
| Market Status | Prescription |
| Company | Allergan |
| 2 of 10 | |
|---|---|
| Drug Name | Flo-pred |
| PubMed Health | Prednisolone |
| Drug Classes | Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent |
| Drug Label | OMNIPRED (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:Established name: Prednisolone AcetateChemical name... |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension |
| Route | Oral |
| Strength | eq 15mg base/5ml |
| Market Status | Prescription |
| Company | Taro |
| 3 of 10 | |
|---|---|
| Drug Name | Omnipred |
| PubMed Health | Prednisolone (Into the eye) |
| Drug Classes | Ophthalmologic Agent |
| Drug Label | PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is a topical anti-inflammatory agent for ophthalmic use.... |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension/drops |
| Route | Ophthalmic |
| Strength | 1% |
| Market Status | Prescription |
| Company | Alcon |
| 4 of 10 | |
|---|---|
| Drug Name | Pred forte |
| Drug Label | PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12% is a topical anti-inflammatory agent for ophthalmic use. Structural Formula:... |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension/drops |
| Route | Ophthalmic |
| Strength | 1% |
| Market Status | Prescription |
| Company | Allergan |
| 5 of 10 | |
|---|---|
| Drug Name | Pred mild |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension/drops |
| Route | Ophthalmic |
| Strength | 0.12% |
| Market Status | Prescription |
| Company | Allergan |
| 6 of 10 | |
|---|---|
| Drug Name | Blephamide s.o.p. |
| PubMed Health | Prednisolone |
| Drug Classes | Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent |
| Drug Label | Flo-Pred (prednisolone acetate oral suspension) contains prednisolone which is the acetate ester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from... |
| Active Ingredient | sulfacetamide sodium; Prednisolone acetate |
| Dosage Form | Ointment |
| Route | Ophthalmic |
| Strength | 0.2%; 10% |
| Market Status | Prescription |
| Company | Allergan |
| 7 of 10 | |
|---|---|
| Drug Name | Flo-pred |
| PubMed Health | Prednisolone |
| Drug Classes | Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent |
| Drug Label | OMNIPRED (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:Established name: Prednisolone AcetateChemical name... |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension |
| Route | Oral |
| Strength | eq 15mg base/5ml |
| Market Status | Prescription |
| Company | Taro |
| 8 of 10 | |
|---|---|
| Drug Name | Omnipred |
| PubMed Health | Prednisolone (Into the eye) |
| Drug Classes | Ophthalmologic Agent |
| Drug Label | PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is a topical anti-inflammatory agent for ophthalmic use.... |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension/drops |
| Route | Ophthalmic |
| Strength | 1% |
| Market Status | Prescription |
| Company | Alcon |
| 9 of 10 | |
|---|---|
| Drug Name | Pred forte |
| Drug Label | PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12% is a topical anti-inflammatory agent for ophthalmic use. Structural Formula:... |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension/drops |
| Route | Ophthalmic |
| Strength | 1% |
| Market Status | Prescription |
| Company | Allergan |
| 10 of 10 | |
|---|---|
| Drug Name | Pred mild |
| Active Ingredient | Prednisolone acetate |
| Dosage Form | Suspension/drops |
| Route | Ophthalmic |
| Strength | 0.12% |
| Market Status | Prescription |
| Company | Allergan |
Prednisolone acetate is indicated as an anti-inflammatory or immunosuppressive agent for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, or infectious conditions. Prednisolone acetate is also indicated in organ transplant patients, as well as endocrine or neoplastic conditions.
Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Prednisolone acetate has a short duration of action as the half life is 2-3 hours. Corticosteroids have a wide therapeutic window as patients make require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.
Anti-Inflammatory Agents
Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)
Absorption
Prednisolone acetate oral suspension given at a dose equivalent to 15mg prednisolone has a Cmax of 321.1ng/hr, a Tmaxof 1-2 hours, and an AUC of 1999.4ng\*hr/mL. The absorption pharmacokinetics of prednisolone acetate are not significantly different from a comparable dose of prednisolone.
Route of Elimination
Prednisolone acetate is predominantly excreted in the urine.
Volume of Distribution
The volume of distribution of the active metabolite, prednisolone, is 0.22/0.7L/kg.
Clearance
Data regarding the clearance of prednisolone acetate is not readily available.
Prednisolone acetate undergoes ester hydrolysis to [prednisolone]. After this step, the drug undergoes the normal metabolism of prednisolone. Prednisolone can be reversibly metabolized to [prednisone] which is then metabolized to 17,21-dihydroxy-pregnan-1,4,6-trien-3,11,30-trione (M-XVII), 20-dihydro-prednisone (M-V), 6hydroxy-prednisone (M-XII), 6-hydroxy-prednisone (M-XIII), or 20-dihydro-prednisone (M-IV). 20-dihydro-prednisone is metabolized to 17,20,21-trihydroxy-5-pregn-1-en-3,11-dione(M-XVIII). Prednisolone is metabolized to 6-prednisolone (M-XI), 20-dihydro-prednisolone (M-III), 20-dihydro-prednisolone (M-II), 6hydroxy-prednisolone (M-VII), or 6hydroxy-prednisolone(M-VI). 6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-X). 6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-VIII), 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-IX), and 6,11,17,21-tetrahydroxy-5-pregn-1-en-3,20-dione (M-XIV). MVIII is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XV) and then to MXIV, while MIX is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XVI) and then to MXIV. These metabolites and their glucuronide conjugates are excreted predominantly in the urine.
Oral prednisolone acetate has a plasma half life of 2-3 hours.
The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.
API SUPPLIERS
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USDMF
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-19
Pay. Date : 2020-04-13
DMF Number : 32728
Submission : 2018-06-04
Status : Active
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-29
Pay. Date : 2020-09-22
DMF Number : 32896
Submission : 2018-07-16
Status : Active
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-01
Pay. Date : 2023-01-30
DMF Number : 3529
Submission : 1979-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4597
Submission : 1982-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3949
Submission : 1980-07-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-04
Pay. Date : 2023-09-01
DMF Number : 28518
Submission : 2014-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1454
Submission : 1969-12-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5504
Submission : 1984-06-23
Status : Inactive
Type : II
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DOSAGE - SUSPENSION;OPHTHALMIC - 0.2%;10%
USFDA APPLICATION NUMBER - 12813
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 1%
USFDA APPLICATION NUMBER - 17011
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.12%
USFDA APPLICATION NUMBER - 17100
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 1%
USFDA APPLICATION NUMBER - 17469
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3% BASE;1%
USFDA APPLICATION NUMBER - 50586
DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0...DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0.6%
USFDA APPLICATION NUMBER - 50612
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PharmaCompass offers a list of Prednisolone Acetate 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 Prednisolone Acetate manufacturer or Prednisolone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisolone Acetate manufacturer or Prednisolone Acetate supplier.
PharmaCompass also assists you with knowing the Prednisolone Acetate API Price utilized in the formulation of products. Prednisolone Acetate API Price is not always fixed or binding as the Prednisolone Acetate Price is obtained through a variety of data sources. The Prednisolone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Omnipred manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omnipred, including repackagers and relabelers. The FDA regulates Omnipred manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omnipred 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 Omnipred manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omnipred supplier is an individual or a company that provides Omnipred active pharmaceutical ingredient (API) or Omnipred finished formulations upon request. The Omnipred suppliers may include Omnipred API manufacturers, exporters, distributors and traders.
click here to find a list of Omnipred suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omnipred DMF (Drug Master File) is a document detailing the whole manufacturing process of Omnipred active pharmaceutical ingredient (API) in detail. Different forms of Omnipred DMFs exist exist since differing nations have different regulations, such as Omnipred USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omnipred DMF submitted to regulatory agencies in the US is known as a USDMF. Omnipred USDMF includes data on Omnipred's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omnipred USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Omnipred Drug Master File in Japan (Omnipred JDMF) empowers Omnipred 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 Omnipred JDMF during the approval evaluation for pharmaceutical products. At the time of Omnipred 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 Omnipred 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 Omnipred Drug Master File in Korea (Omnipred KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Omnipred. The MFDS reviews the Omnipred KDMF as part of the drug registration process and uses the information provided in the Omnipred KDMF to evaluate the safety and efficacy of the drug.
After submitting a Omnipred 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 Omnipred API can apply through the Korea Drug Master File (KDMF).
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A Omnipred CEP of the European Pharmacopoeia monograph is often referred to as a Omnipred Certificate of Suitability (COS). The purpose of a Omnipred CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Omnipred EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Omnipred to their clients by showing that a Omnipred CEP has been issued for it. The manufacturer submits a Omnipred CEP (COS) as part of the market authorization procedure, and it takes on the role of a Omnipred CEP holder for the record. Additionally, the data presented in the Omnipred CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Omnipred DMF.
A Omnipred CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Omnipred 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 Omnipred suppliers with CEP (COS) on PharmaCompass.
A Omnipred written confirmation (Omnipred WC) is an official document issued by a regulatory agency to a Omnipred manufacturer, verifying that the manufacturing facility of a Omnipred active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Omnipred APIs or Omnipred finished pharmaceutical products to another nation, regulatory agencies frequently require a Omnipred WC (written confirmation) as part of the regulatory process.
click here to find a list of Omnipred 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 Omnipred as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Omnipred 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 Omnipred 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 Omnipred and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omnipred NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Omnipred suppliers with NDC on PharmaCompass.
Omnipred 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 Omnipred 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 Omnipred GMP manufacturer or Omnipred GMP API supplier for your needs.
A Omnipred CoA (Certificate of Analysis) is a formal document that attests to Omnipred's compliance with Omnipred specifications and serves as a tool for batch-level quality control.
Omnipred CoA mostly includes findings from lab analyses of a specific batch. For each Omnipred 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.
Omnipred may be tested according to a variety of international standards, such as European Pharmacopoeia (Omnipred EP), Omnipred JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omnipred USP).
