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1. Atosil
2. Diphergan
3. Diprazin
4. Hydrochloride, Promethazine
5. Isopromethazine
6. Phenargan
7. Phenergan
8. Phensedyl
9. Pipolfen
10. Pipolphen
11. Proazamine
12. Promet
13. Prometazin
14. Promethazine
15. Prothazin
16. Pyrethia
17. Remsed
18. Rumergan
1. 58-33-3
2. Promethazine Hcl
3. Phenergan
4. N,n-dimethyl-1-(10h-phenothiazin-10-yl)propan-2-amine Hydrochloride
5. Fenergan
6. Remsed
7. Promethazine (hydrochloride)
8. Diprasine
9. Diprazin
10. Fellozine
11. Pipolfen
12. Pipolphen
13. Ganphen
14. Plletia
15. Prometh Fortis
16. Prometh Plain
17. Promethazine.hcl
18. Mymethazine Fortis
19. Anergan 25
20. Promethacon
21. Promethegan
22. Romergan
23. Promethazine Chloride
24. Promethiazin
25. Zipan-25
26. V Gan
27. Lergigan
28. Pyrethia
29. Zipan-50
30. Promethazine Monohydrochloride
31. Hl 8700
32. N-(2-dimethylaminopropyl-1)phenothiazine Hydrochloride
33. 10-[2-(dimethylamino)propyl]phenothiazine Hydrochloride
34. N,n-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydrochloride
35. N-(2'-dimethylamino-2'-methyl)ethylphenothiazine Hydrochloride
36. R61zeh7i1i
37. 10-(3-dimethylaminoisopropyl)phenothiazine Hydrochloride
38. 3277 R.p.
39. Mls000069398
40. 10-(2-dimethylamino-1-propyl)phenothiazine Hydrochloride
41. Chebi:8462
42. Farganesse
43. Avomine
44. Nsc-231688
45. 58-33-3 (hcl)
46. Allerfen
47. Duplamin
48. Frinova
49. Goodnight
50. Hibechin
51. Histantil
52. Kinetosin
53. Phenadoz
54. Phencen
55. Primine
56. Promantine
57. Promine
58. Proneurin
59. Smr000058379
60. Soporil
61. Bonnox
62. Closin
63. Dorme
64. Prome
65. (+-)-10-(2-(dimethylamino)propyl)phenothiazine Monohydrochloride
66. Eusedon Mono
67. Phenergan Fortis
68. Dsstox_cid_1192
69. Pms Promethazine
70. Promethazine Plain
71. Dsstox_rid_76002
72. Dsstox_gsid_21192
73. 1435933-86-0
74. Anergan 50
75. Promethazine Hydrochloride 100 Microg/ml In Acetonitrile
76. Phenergan Plain
77. Promethiazin [german]
78. Ccris 5873
79. Phenergan Hydrochloride
80. Promethazine Hydrochloride [jan]
81. Promethazinehydrochloride
82. Einecs 200-375-2
83. Mfcd00012652
84. Unii-r61zeh7i1i
85. Nsc 231688
86. Genphen
87. Sr-01000002993
88. Phanergan D
89. Phenergan (tn)
90. Promethegan (tn)
91. 10-(2-dimethylaminopropyl)phenothiazine Hydrochloride
92. Component Of Mepergan
93. Promethazine Hydrochloride [usp:jan]
94. Promethazine-d3 Hcl
95. 10-(2-(dimethylamino)propyl)phenothiazine Monohydrochloride
96. Cpd000058379
97. Phenothiazine, 10-(2-(dimethylamino)-propyl)-, Hydrochloride
98. Pronase [jan]
99. Promethazine Hydrochlorine
100. Cas-58-33-3
101. Opera_id_1745
102. 10h-phenothiazine-10-ethanamine, N,n,alpha-trimethyl-, Monohydrochloride
103. Diprazinum [who-ip]
104. Schembl41904
105. Mls001074184
106. Mls002548850
107. Spectrum1500510
108. Chembl1200750
109. Dtxsid3021192
110. Promethazine Hydrochloride Solution
111. Hms1570b18
112. Hms1920l16
113. Pharmakon1600-01500510
114. Hy-b0781
115. N,n-dimethyl-1-phenothiazin-10-yl-propan-2-amine Hydrochloride
116. Phenothiazine, 10-(2-(dimethylamino)propyl)-, Monohydrochloride
117. Promethazine For Peak Identification
118. Tox21_202264
119. Tox21_302878
120. Tox21_500899
121. Nsc231688
122. Nsc757301
123. S4293
124. 10h-phenothiazine-10-ethanamine, N,n,.alpha.-trimethyl-, Monohydrochloride
125. Akos016339657
126. Ccg-207895
127. Cs-3543
128. Ks-1385
129. Lp00899
130. Nc00471
131. Nsc-757301
132. Promethazine Hydrochloride (jp17/usp)
133. Promethazine Hydrochloride [mi]
134. Rp-3389
135. 10h-phenothiazine-10-ethanamine, N,n,alpha-trimethyl-, Monohydrochloride, (+-)-
136. Ncgc00089735-04
137. Ncgc00094215-01
138. Ncgc00094215-02
139. Ncgc00094215-03
140. Ncgc00094215-04
141. Ncgc00094215-05
142. Ncgc00256588-01
143. Ncgc00259813-01
144. Ncgc00261584-01
145. Ac-12482
146. Bp166198
147. Promethazine Hydrochloride [mart.]
148. Promethazine Hydrochloride [vandf]
149. Promethazine Hydrochloride [usp-rs]
150. Promethazine Hydrochloride [who-dd]
151. Promethazine Hydrochloride [who-ip]
152. Db-053186
153. Eu-0100899
154. P2029
155. Sw197234-3
156. D00480
157. D92182
158. P 4651
159. Promethazine Hydrochloride [orange Book]
160. Promethazine Hydrochloride [ep Monograph]
161. Promethazine Hydrochloride [usp Impurity]
162. Wln: T C666 Bn Isj B1y1&n1&1 &gh
163. A831833
164. Promethazine Hydrochloride [usp Monograph]
165. Promethazini Hydrochloridum [who-ip Latin]
166. Mepergan Component Promethazine Hydrochloride
167. Sr-01000002993-2
168. Sr-01000002993-7
169. W-105399
170. Promethazine Hydrochloride Component Of Mepergan
171. Q27108086
172. F0138-3355
173. Phenergan Vc Component Promethazine Hydrochloride
174. Pherazine Dm Component Promethazine Hydrochloride
175. Pherazine Vc Component Promethazine Hydrochloride
176. Z1259273234
177. ((c)i)-promethazine-d4 Hcl (phenothiazine-1,3,7,9-d4)
178. Promethazine Dm Component Promethazine Hydrochloride
179. Promethazine Hydrochloride Component Of Phenergan Vc
180. Promethazine Hydrochloride Component Of Pherazine Dm
181. Promethazine Hydrochloride Component Of Pherazine Vc
182. Promethazine Vc Component Promethazine Hydrochloride
183. N,n-dimethyl-1-(10-phenothiazinyl)-2-propanamine Hydrochloride
184. N-(2'-dimethylamino-2'-methylaethyl)-phenothiazin Hydrochlorid
185. N-(2'-dimethylamino-2-methylethyl)phenothiazine Hydrochloride
186. Promethazine Hydrochloride Component Of Promethazine Dm
187. Promethazine Hydrochloride Component Of Promethazine Vc
188. Promethazine Hydrochloride, Vetranal(tm), Analytical Standard
189. N,n-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydron;chloride
190. (+/-)-10-(2-(dimethylamino)propyl)phenothiazine Monohydrochloride
191. 10h-phenothiazine-10-ethanamine,n,.alpha.-trimethyl-, Monohydrochloride
192. Dimethyl[1-(10h-phenothiazin-10-yl)propan-2-yl]amine Hydrochloride
193. N,n-dimethyl-1-(10h-phenothiazin-10-yl)-2-propanamine Hydrochloride
194. Promethazine Hydrochloride 1.0 Mg/ml In Dimethyl Sulfoxide (as Free Base)
195. Promethazine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
196. Promethazine Hydrochloride, Vial Of 25 Mg, Certified Reference Material
197. 10h-phenothiazine-10-ethanamine, N,n,.alpha.-trimethyl-, Monohydrochloride, (+/-)-
198. 10h-phenothiazine-10-ethanamine, N,n,alpha-trimethyl-, Hydrochloride (1:1)
199. Promethazine For Peak Identification, European Pharmacopoeia (ep) Reference Standard
200. Promethazine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
201. Promethazine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
| Molecular Weight | 320.9 g/mol |
|---|---|
| Molecular Formula | C17H21ClN2S |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 320.1113975 g/mol |
| Monoisotopic Mass | 320.1113975 g/mol |
| Topological Polar Surface Area | 31.8 Ų |
| Heavy Atom Count | 21 |
| Formal Charge | 0 |
| Complexity | 298 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Promethazine hydrochloride |
| Drug Label | DESCRIPTIONPromethazine hydrochloride is a racemic compound.Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,-trimethyl-, monohydrochloride, ()-with the following structural... |
| Active Ingredient | Promethazine hydrochloride |
| Dosage Form | Tablet; Syrup; Suppository; Injectable |
| Route | Rectal; Injection; Oral |
| Strength | 25mg; 50mg/ml; 25mg/ml; 6.25mg/5ml; 50mg; 12.5mg |
| Market Status | Prescription |
| Company | Vintage Pharms; Amneal Pharms; Wockhardt; Hospira; Sun Pharm Inds; Teva Pharms Usa; Taro; Sandoz; Watson Labs; Amneal Pharms Ny; Hi Tech Pharma; Caraco; Hikma Maple; Kvk Tech; X-gen Pharms; Vintage; Emcure Pharms Usa; Perrigo New York; Luitpold; Zydus Pha |
| 2 of 4 | |
|---|---|
| Drug Name | Promethazine plain |
| Active Ingredient | Promethazine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 6.25mg/5ml |
| Market Status | Prescription |
| Company | Wockhardt |
| 3 of 4 | |
|---|---|
| Drug Name | Promethazine hydrochloride |
| Drug Label | DESCRIPTIONPromethazine hydrochloride is a racemic compound.Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,-trimethyl-, monohydrochloride, ()-with the following structural... |
| Active Ingredient | Promethazine hydrochloride |
| Dosage Form | Tablet; Syrup; Suppository; Injectable |
| Route | Rectal; Injection; Oral |
| Strength | 25mg; 50mg/ml; 25mg/ml; 6.25mg/5ml; 50mg; 12.5mg |
| Market Status | Prescription |
| Company | Vintage Pharms; Amneal Pharms; Wockhardt; Hospira; Sun Pharm Inds; Teva Pharms Usa; Taro; Sandoz; Watson Labs; Amneal Pharms Ny; Hi Tech Pharma; Caraco; Hikma Maple; Kvk Tech; X-gen Pharms; Vintage; Emcure Pharms Usa; Perrigo New York; Luitpold; Zydus Pha |
| 4 of 4 | |
|---|---|
| Drug Name | Promethazine plain |
| Active Ingredient | Promethazine hydrochloride |
| Dosage Form | Syrup |
| Route | Oral |
| Strength | 6.25mg/5ml |
| Market Status | Prescription |
| Company | Wockhardt |
Anti-Allergic Agents
Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)
Histamine H1 Antagonists
Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)
Antipruritics
Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-10
Pay. Date : 2021-06-07
DMF Number : 7882
Submission : 1989-01-24
Status : Active
Type : II
Certificate Number : R1-CEP 2008-279 - Rev 02
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 524
Status : Valid
Registration Number : 307MF10033
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2025-02-07
Latest Date of Registration :
NDC Package Code : 48581-114
Start Marketing Date : 2007-05-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
NDC Package Code : 82298-902
Start Marketing Date : 2011-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 1949
Submission : 1972-06-09
Status : Active
Type : II
Certificate Number : CEP 1992-002 - Rev 07
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 524
Status : Valid
NDC Package Code : 50396-7517
Start Marketing Date : 2011-06-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
Date of Issue : 2022-07-27
Valid Till : 2025-07-29
Written Confirmation Number : WC-0179
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3039
Submission : 1977-10-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1955
Submission : 1972-06-19
Status : Inactive
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 11888
Submission : 1996-03-08
Status : Inactive
Type : II
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18173
Submission : 2005-03-02
Status : Inactive
Type : II
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : R1-CEP 2008-279 - Rev 02
Status : Valid
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 524
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : CEP 1992-002 - Rev 07
Status : Valid
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 524
Certificate Number : R1-CEP 2001-227 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2015-08-25
Type : Chemical
Substance Number : 524
Promethazine Hydrochloride, Process B
Certificate Number : R0-CEP 2022-216 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2022-08-02
Type : Chemical
Substance Number : 524
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Histodor
Dosage Form : TAB
Dosage Strength : 5mg
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Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
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Brand Name : Stilpane
Dosage Form : SYR
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Regulatory Info : Generic
Registration Country : South Africa
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info : RX
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Brand Name : PROMETHAZINE HYDROCHLORIDE
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Dosage Strength : 12.5MG
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Application Number : 209177
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Brand Name : PROMETHAZINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG
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Approval Date : 2017-06-30
Application Number : 209177
Regulatory Info : RX
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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Brand Name : PROMETHAZINE HYDROCHLORIDE
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Approval Date : 2017-06-30
Application Number : 209177
Regulatory Info : RX
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Dosage Strength : 12.5MG
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Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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Registration Country : India
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Dosage Form : Tablet
Dosage Strength : 25MG
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Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG
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Registration Country : India
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Dosage Form : Ampoule
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : PROMETHAZINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 25MG
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Approval Date : 1982-01-01
Application Number : 80949
Regulatory Info : DISCN
Registration Country : USA
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DOSAGE - INJECTABLE;INJECTION - 25MG/ML
USFDA APPLICATION NUMBER - 83312
DOSAGE - INJECTABLE;INJECTION - 50MG/ML
USFDA APPLICATION NUMBER - 83312
DOSAGE - SYRUP;ORAL - 6.25MG/5ML
USFDA APPLICATION NUMBER - 87953
DOSAGE - SYRUP;ORAL - 5MG/5ML;6.25MG/5ML
USFDA APPLICATION NUMBER - 88761
DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML
USFDA APPLICATION NUMBER - 88763
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PharmaCompass offers a list of Promethazine Hydrochloride 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 Promethazine Hydrochloride manufacturer or Promethazine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Promethazine Hydrochloride manufacturer or Promethazine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Promethazine Hydrochloride API Price utilized in the formulation of products. Promethazine Hydrochloride API Price is not always fixed or binding as the Promethazine Hydrochloride Price is obtained through a variety of data sources. The Promethazine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PROMETH VC W/ CODEINE-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PROMETH VC W/ CODEINE-2, including repackagers and relabelers. The FDA regulates PROMETH VC W/ CODEINE-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PROMETH VC W/ CODEINE-2 supplier is an individual or a company that provides PROMETH VC W/ CODEINE-2 active pharmaceutical ingredient (API) or PROMETH VC W/ CODEINE-2 finished formulations upon request. The PROMETH VC W/ CODEINE-2 suppliers may include PROMETH VC W/ CODEINE-2 API manufacturers, exporters, distributors and traders.
click here to find a list of PROMETH VC W/ CODEINE-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PROMETH VC W/ CODEINE-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of PROMETH VC W/ CODEINE-2 active pharmaceutical ingredient (API) in detail. Different forms of PROMETH VC W/ CODEINE-2 DMFs exist exist since differing nations have different regulations, such as PROMETH VC W/ CODEINE-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PROMETH VC W/ CODEINE-2 DMF submitted to regulatory agencies in the US is known as a USDMF. PROMETH VC W/ CODEINE-2 USDMF includes data on PROMETH VC W/ CODEINE-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 Drug Master File in Japan (PROMETH VC W/ CODEINE-2 JDMF) empowers PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 JDMF during the approval evaluation for pharmaceutical products. At the time of PROMETH VC W/ CODEINE-2 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A PROMETH VC W/ CODEINE-2 CEP of the European Pharmacopoeia monograph is often referred to as a PROMETH VC W/ CODEINE-2 Certificate of Suitability (COS). The purpose of a PROMETH VC W/ CODEINE-2 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PROMETH VC W/ CODEINE-2 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PROMETH VC W/ CODEINE-2 to their clients by showing that a PROMETH VC W/ CODEINE-2 CEP has been issued for it. The manufacturer submits a PROMETH VC W/ CODEINE-2 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PROMETH VC W/ CODEINE-2 CEP holder for the record. Additionally, the data presented in the PROMETH VC W/ CODEINE-2 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PROMETH VC W/ CODEINE-2 DMF.
A PROMETH VC W/ CODEINE-2 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 suppliers with CEP (COS) on PharmaCompass.
A PROMETH VC W/ CODEINE-2 written confirmation (PROMETH VC W/ CODEINE-2 WC) is an official document issued by a regulatory agency to a PROMETH VC W/ CODEINE-2 manufacturer, verifying that the manufacturing facility of a PROMETH VC W/ CODEINE-2 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PROMETH VC W/ CODEINE-2 APIs or PROMETH VC W/ CODEINE-2 finished pharmaceutical products to another nation, regulatory agencies frequently require a PROMETH VC W/ CODEINE-2 WC (written confirmation) as part of the regulatory process.
click here to find a list of PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PROMETH VC W/ CODEINE-2 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PROMETH VC W/ CODEINE-2 suppliers with NDC on PharmaCompass.
PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 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 PROMETH VC W/ CODEINE-2 GMP manufacturer or PROMETH VC W/ CODEINE-2 GMP API supplier for your needs.
A PROMETH VC W/ CODEINE-2 CoA (Certificate of Analysis) is a formal document that attests to PROMETH VC W/ CODEINE-2's compliance with PROMETH VC W/ CODEINE-2 specifications and serves as a tool for batch-level quality control.
PROMETH VC W/ CODEINE-2 CoA mostly includes findings from lab analyses of a specific batch. For each PROMETH VC W/ CODEINE-2 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.
PROMETH VC W/ CODEINE-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (PROMETH VC W/ CODEINE-2 EP), PROMETH VC W/ CODEINE-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PROMETH VC W/ CODEINE-2 USP).
