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DRUG PRODUCT COMPOSITIONS0
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1. 2-t-butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol
2. Albuterol
3. Proventil
4. Salbutamol
5. Sultanol
6. Ventolin
1. Salbutamol Sulfate
2. 51022-70-9
3. Salbutamol Hemisulfate
4. Proventil
5. Venetlin
6. Loftan
7. Albuterol Hemisulfate
8. Bronchospray
9. Ventolin
10. Accuneb
11. Proventil-hfa
12. Salbutamol Sulphate
13. Sch 13949w Sulfate
14. Proair
15. Ventolin Rotacaps
16. Proair Respiclick
17. Vospire Er
18. Sultanol
19. Ventilastin
20. Ecovent
21. Salbumol
22. Vospire
23. Albuterol Sulfate(2:1)
24. Albuterol Sulphate
25. 36519-31-0
26. Buventol
27. Salamol
28. Salbutamol (as Sulfate)
29. Sch 13949w Sulphate
30. Sch-13949w Sulphate
31. Sulbutamol (as Sulphate)
32. Sch-13949w Sulfate
33. 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric Acid
34. R03ac02
35. R03cc02
36. Aerolin
37. Airomir
38. 021sef3731
39. Nsc-289928
40. Aerotec
41. Aloprol
42. Amocasin
43. Broncodil
44. Dipulmin
45. Fartolin
46. Inspiryl
47. Emican
48. Proventil (tn)
49. Epaq
50. Broncho Inhalat
51. Huma-salmol
52. Ventolin Hfa
53. Dl-salbutamol Sulfate
54. (+-)-salbutamol Sulfate
55. 2-(tert-butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Hemisulfate
56. 5-[2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxybenzyl Alcohol Hemisulfate
57. Albuterol Sulfate [usan]
58. Proair Hfa
59. Ah-3365
60. Einecs 256-916-8
61. Salbutamol Hemisulfate Salt
62. Nsc 289928
63. Accuvent
64. Pediavent
65. Torpex
66. Volare
67. Albuterol Sulfate [usan:usp]
68. Ventolin Nebules
69. Ventolin Sulfate
70. Unii-021sef3731
71. Salbutamol Diskus
72. Salbutamoli Sulfas
73. Buventol Easyhaler
74. Proventil Repetabs
75. Pulvinal Salbutamol
76. Sulbutamol Sulphate
77. Proventil Repetabs, Solution, Syrup, And Tablets
78. Ventolin (tn)
79. Accuneb (tn)
80. Salbutamol Easyhaler
81. Ventolin Easy-breathe
82. Albuterol Sulfate,(s)
83. Albuterol Sulfate (usp)
84. Albuterol Sulfate- Bio-x
85. 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol Sulfate
86. Salbutamol Sulfate (jp17)
87. Tbs-7
88. Schembl33279
89. Alpha(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol Sulfate (2:1) (salt)
90. Albuterol Sulfate [mi]
91. Chebi:2550
92. (+-)-ysulfate(2:1)(salt)
93. Chembl1441059
94. Salbutamol Sulfate [jan]
95. Albuterol Sulfate [vandf]
96. Dtxsid10881180
97. Hms3263k18
98. Hms3266d17
99. Torpex (albuterol Sulfate)
100. Albuterol Sulfate [usp-rs]
101. Salbutamol Sulfate [mart.]
102. Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) Sulphate
103. Salbutamol Sulfate [who-dd]
104. Salbutamol Sulfate [who-ip]
105. Tox21_501098
106. Mfcd00055200
107. Salbutamol Hemisulfate Salt, >=98%
108. Akos015994719
109. Albuterol Sulfate [green Book]
110. Albuterol Sulfate [orange Book]
111. Ccg-222402
112. Ks-5056
113. Lp01098
114. Tq-1016
115. Albuterol Sulfate [usp Impurity]
116. Salbutamol Sulfate [ep Impurity]
117. Salbutamol Sulphate (albuterol Sulphate)
118. Albuterol Sulfate [usp Monograph]
119. Duoneb Component Albuterol Sulfate
120. Ncgc00094370-01
121. Ncgc00261783-01
122. Salbutamol Sulfate [ep Monograph]
123. 1,3-benzenedimethanol, Alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
124. 1,3-benzenedimethanol, Alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
125. Ba164388
126. Salbutamoli Sulfas [who-ip Latin]
127. Combivent Component Albuterol Sulfate
128. Albuterol Sulfate Component Of Duoneb
129. Eu-0101098
130. Ft-0650809
131. S0531
132. Salbutamol Sulfate 100 Microg/ml In Methanol
133. A51088
134. Albuterol Sulfate Component Of Combivent
135. D00683
136. S 5013
137. 022s709
138. A828402
139. Q27231480
140. Salbutamol Hemisulfate Salt, Vetranal(tm), Analytical Standard
141. Salbutamol Sulfate, British Pharmacopoeia (bp) Reference Standard
142. Salbutamol Sulfate, European Pharmacopoeia (ep) Reference Standard
143. Albuterol Sulfate, United States Pharmacopeia (usp) Reference Standard
144. Albuterol Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material
145. Salbutamol Sulfate For System Suitability, European Pharmacopoeia (ep) Reference Standard
146. Salbutamol Sulphate (albuterol Sulphate) 1.0 Mg/ml In Methanol (as Free Base)
147. (+/-)-2-tert-butylamino-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Sulfate Salt (2:1)
148. .alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Sulfate (2:1) (salt)
149. .alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Sulphate (2:1) (salt)
150. 1,3-benzenedimethanol,.alpha.(sup 1)-(((1,1 Dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
151. 1,3-benzenedimethanol,.alpha.(sup 1)-(((1,1 Dimethylethyl)amino)methyl)-4-hydroxy-, Sulphate (2:1) (salt)
152. 1,3-benzenedimethanol,.alpha.1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
| Molecular Weight | 576.7 g/mol |
|---|---|
| Molecular Formula | C26H44N2O10S |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 10 |
| Exact Mass | 576.27166678 g/mol |
| Monoisotopic Mass | 576.27166678 g/mol |
| Topological Polar Surface Area | 228 Ų |
| Heavy Atom Count | 39 |
| Formal Charge | 0 |
| Complexity | 309 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 12 | |
|---|---|
| Drug Name | Accuneb |
| PubMed Health | Albuterol (By breathing) |
| Drug Classes | Bronchodilator |
| Drug Label | Albuterol Sulfate Inhalation Solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name 1-[(tert-Butylamino)methyl]-4-hydroxy... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Solution |
| Route | Inhalation |
| Strength | eq 0.021% base; eq 0.042% base |
| Market Status | Prescription |
| Company | Mylan Speclt |
| 2 of 12 | |
|---|---|
| Drug Name | Albuterol sulfate |
| PubMed Health | Albuterol |
| Drug Classes | Bronchodilator, Cardiovascular Agent |
| Drug Label | The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-,... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release; Tablet; Syrup; Solution |
| Route | Inhalation; Oral |
| Strength | eq 4mg base; eq 0.083% base; eq 2mg base; eq 0.021% base; eq 0.5% base; eq 2mg base/5ml; eq 0.042% base; eq 8mg base |
| Market Status | Prescription |
| Company | Watson Labs; Amneal Pharms; Vistapharm; Teva Pharms; Hi Tech Pharma; Ritedose; Actavis Mid Atlantic; Mutual Pharm; Teva; Vintage; Bausch And Lomb; Landela Pharm; Nephron; Mylan Speclt; Mylan |
| 3 of 12 | |
|---|---|
| Drug Name | Proair hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Teva Branded Pharm |
| 4 of 12 | |
|---|---|
| Drug Name | Proventil-hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | 3m |
| 5 of 12 | |
|---|---|
| Drug Name | Ventolin hfa |
| Drug Label | Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name () 1-[(tert-butyla... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 6 of 12 | |
|---|---|
| Drug Name | Vospire er |
| Drug Label | The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name 1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-,'-diol sulfate (2:1) (salt),... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 4mg base; eq 8mg base |
| Market Status | Prescription |
| Company | Dava Pharms |
| 7 of 12 | |
|---|---|
| Drug Name | Accuneb |
| PubMed Health | Albuterol (By breathing) |
| Drug Classes | Bronchodilator |
| Drug Label | Albuterol Sulfate Inhalation Solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name 1-[(tert-Butylamino)methyl]-4-hydroxy... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Solution |
| Route | Inhalation |
| Strength | eq 0.021% base; eq 0.042% base |
| Market Status | Prescription |
| Company | Mylan Speclt |
| 8 of 12 | |
|---|---|
| Drug Name | Albuterol sulfate |
| PubMed Health | Albuterol |
| Drug Classes | Bronchodilator, Cardiovascular Agent |
| Drug Label | The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-,... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release; Tablet; Syrup; Solution |
| Route | Inhalation; Oral |
| Strength | eq 4mg base; eq 0.083% base; eq 2mg base; eq 0.021% base; eq 0.5% base; eq 2mg base/5ml; eq 0.042% base; eq 8mg base |
| Market Status | Prescription |
| Company | Watson Labs; Amneal Pharms; Vistapharm; Teva Pharms; Hi Tech Pharma; Ritedose; Actavis Mid Atlantic; Mutual Pharm; Teva; Vintage; Bausch And Lomb; Landela Pharm; Nephron; Mylan Speclt; Mylan |
| 9 of 12 | |
|---|---|
| Drug Name | Proair hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Teva Branded Pharm |
| 10 of 12 | |
|---|---|
| Drug Name | Proventil-hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | 3m |
| 11 of 12 | |
|---|---|
| Drug Name | Ventolin hfa |
| Drug Label | Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name () 1-[(tert-butyla... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 12 of 12 | |
|---|---|
| Drug Name | Vospire er |
| Drug Label | The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name 1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-,'-diol sulfate (2:1) (salt),... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 4mg base; eq 8mg base |
| Market Status | Prescription |
| Company | Dava Pharms |
Adrenergic beta-2 Receptor Agonists
Compounds bind to and activate ADRENERGIC BETA-2 RECEPTORS. (See all compounds classified as Adrenergic beta-2 Receptor Agonists.)
Tocolytic Agents
Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)
Bronchodilator Agents
Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)
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DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 20503
DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20950
DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 20983
DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 21457
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PharmaCompass offers a list of Salbutamol Sulphate 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 Salbutamol Sulphate manufacturer or Salbutamol Sulphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salbutamol Sulphate manufacturer or Salbutamol Sulphate supplier.
PharmaCompass also assists you with knowing the Salbutamol Sulphate API Price utilized in the formulation of products. Salbutamol Sulphate API Price is not always fixed or binding as the Salbutamol Sulphate Price is obtained through a variety of data sources. The Salbutamol Sulphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid, including repackagers and relabelers. The FDA regulates 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid supplier is an individual or a company that provides 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid active pharmaceutical ingredient (API) or 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid finished formulations upon request. The 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid suppliers may include 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid API manufacturers, exporters, distributors and traders.
click here to find a list of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid active pharmaceutical ingredient (API) in detail. Different forms of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid DMFs exist exist since differing nations have different regulations, such as 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid DMF submitted to regulatory agencies in the US is known as a USDMF. 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid USDMF includes data on 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid Drug Master File in Japan (4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid JDMF) empowers 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid JDMF during the approval evaluation for pharmaceutical products. At the time of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid Drug Master File in Korea (4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid. The MFDS reviews the 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid KDMF as part of the drug registration process and uses the information provided in the 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid API can apply through the Korea Drug Master File (KDMF).
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A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP of the European Pharmacopoeia monograph is often referred to as a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid Certificate of Suitability (COS). The purpose of a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid to their clients by showing that a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP has been issued for it. The manufacturer submits a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP holder for the record. Additionally, the data presented in the 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid DMF.
A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid written confirmation (4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid WC) is an official document issued by a regulatory agency to a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid manufacturer, verifying that the manufacturing facility of a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid APIs or 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid finished pharmaceutical products to another nation, regulatory agencies frequently require a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid WC (written confirmation) as part of the regulatory process.
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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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid NDC to their finished compounded human drug products, they may choose to do so.
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4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid GMP manufacturer or 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid GMP API supplier for your needs.
A 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CoA (Certificate of Analysis) is a formal document that attests to 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid's compliance with 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid specifications and serves as a tool for batch-level quality control.
4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid CoA mostly includes findings from lab analyses of a specific batch. For each 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid 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.
4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid may be tested according to a variety of international standards, such as European Pharmacopoeia (4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid EP), 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid USP).
