Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.)
API SUPPLIERS
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Click Us!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30708
Submission : 2016-06-27
Status : Active
Type : II
Certificate Number : CEP 2019-037 - Rev 01
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 687
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-3700
Start Marketing Date : 2019-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Jai Radhe Sales is your partner for all your sourcing needs.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
With Virupaksha, you get a quality product with on-time delivery.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Product Not Available For Sales
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16104
Submission : 2002-08-16
Status : Active
Type : II
Certificate Number : R1-CEP 2000-143 - Rev 07
Issue Date : 2022-03-15
Type : Chemical
Substance Number : 687
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0002
Start Marketing Date : 2017-11-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-05-11
Registration Number : 20210511-209-J-985
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit 1, Sy. No. 347, 473, 474, 490/2, Bonthapalli Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District 502313, Telangana State, India
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30708
Submission : 2016-06-27
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-26
Pay. Date : 2013-08-29
DMF Number : 16371
Submission : 2003-01-20
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16104
Submission : 2002-08-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6524
Submission : 1986-08-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-07
Pay. Date : 2015-09-24
DMF Number : 6522
Submission : 1986-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6886
Submission : 1987-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6885
Submission : 1987-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5885
Submission : 1985-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7082
Submission : 1987-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6143
Submission : 1985-01-04
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Certificate Number : CEP 2019-037 - Rev 01
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 687
Neuland Laboratories- A dedicated 100% API provider.
Neuland Laboratories- A dedicated 100% API provider.
Certificate Number : R1-CEP 2000-143 - Rev 07
Status : Valid
Issue Date : 2022-03-15
Type : Chemical
Substance Number : 687
Certificate Number : CEP 1997-004 - Rev 05
Status : Valid
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 687
Certificate Number : CEP 2011-314 - Rev 03
Status : Valid
Issue Date : 2024-03-07
Type : Chemical
Substance Number : 687
Certificate Number : CEP 2005-080 - Rev 06
Status : Valid
Issue Date : 2024-03-07
Type : Chemical
Substance Number : 687
Certificate Number : CEP 2015-212 - Rev 02
Status : Valid
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 687
Certificate Number : CEP 2005-235 - Rev 03
Status : Valid
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 687
Salbutamol Sulfate, Micronised
Certificate Number : CEP 2020-063 - Rev 02
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 687
Certificate Number : CEP 2014-193 - Rev 01
Status : Valid
Issue Date : 2024-03-18
Type : Chemical
Substance Number : 687
Certificate Number : CEP 2021-191 - Rev 01
Status : Valid
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 687
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 219MF10285
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2007-09-10
Latest Date of Registration : 2020-06-11
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
Details:
The agreement will support development of DP007 (albuterol) inhalation aerosol indicated for bronchospasm in patients 4 years of age & older with reversible obstructive airway disease.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: DP007
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: DevPro Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 10, 2024
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : DevPro Biopharma
Deal Size : Undisclosed
Deal Type : Agreement
Honeywell to Power DevPro’s Next-generation Low-Emission Respiratory Inhaler
Details : The agreement will support development of DP007 (albuterol) inhalation aerosol indicated for bronchospasm in patients 4 years of age & older with reversible obstructive airway disease.
Product Name : DP007
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 10, 2024
Details:
Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is being investigated in patients with intermittent or mild persistent asthma.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Airsupra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 10, 2024
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Airsupra Demonstrates Significant Reduction in Severe Exacerbations in Asthma Patients
Details : Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is being investigated in patients with intermittent or mild persistent asthma.
Product Name : Airsupra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 10, 2024
Details:
Proair HFA-Generic aerosol is a beta2-adrenergic agonist indicated for the treatment of bronchospasm in patients 4 years of age & older with reversible obstructive airway disease.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Proair HFA-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 22, 2024
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amphastar Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol
Details : Proair HFA-Generic aerosol is a beta2-adrenergic agonist indicated for the treatment of bronchospasm in patients 4 years of age & older with reversible obstructive airway disease.
Product Name : Proair HFA-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 22, 2024
Details:
DP007 inhalation aerosol is a beta2-adrenergic agonist indicated for the treatment of bronchospasm in patients 4 years of age & older with reversible obstructive airway disease.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: DP007
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 11, 2024
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Early feasibility studies on climate-friendly albuterol inhaler completed
Details : DP007 inhalation aerosol is a beta2-adrenergic agonist indicated for the treatment of bronchospasm in patients 4 years of age & older with reversible obstructive airway disease.
Product Name : DP007
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 11, 2024
Details:
Airsupra is a combination of albuterol, a beta2-adrenergic agonist & budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Airsupra
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 05, 2024
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Combination Albuterol/Budesonide Rescue Medication for Adults with Asthma Now Available
Details : Airsupra is a combination of albuterol, a beta2-adrenergic agonist & budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction.
Product Name : Airsupra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 05, 2024
Details:
Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is now available as the first and only FDA-approved anti-inflammatory rescue option for asthma.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: PT027
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 22, 2024
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Airsupra Now Available as FDA-Approved Anti-Inflammatory Asthma Rescue Option
Details : Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is now available as the first and only FDA-approved anti-inflammatory rescue option for asthma.
Product Name : PT027
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 22, 2024
Details:
The net proceeds will be used to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for asthma.
Lead Product(s): Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: TEV-56248
Study Phase: Phase IProduct Type: Steroid
Sponsor: Abingworth
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 04, 2024
Lead Product(s) : Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Abingworth
Deal Size : $150.0 million
Deal Type : Financing
Teva, Launch Therapeutics Partner for Dual-Action Asthma Inhaler Development
Details : The net proceeds will be used to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for asthma.
Product Name : TEV-56248
Product Type : Steroid
Upfront Cash : Undisclosed
January 04, 2024
Details:
The collaboration aims to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for asthma.
Lead Product(s): Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: TEV-56248
Study Phase: Phase IProduct Type: Steroid
Sponsor: Launch Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 04, 2024
Lead Product(s) : Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Launch Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Teva And Launch Therapeutics Collaborates For Dual-Action Asthma Rescue Inhaler Program
Details : The collaboration aims to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for asthma.
Product Name : TEV-56248
Product Type : Steroid
Upfront Cash : Undisclosed
January 04, 2024
Details:
Airsupra (albuterol/budesonide), is a first-in-class SABA/ICS rescue treatment for asthma in the US. It is an inhaled, fixed-dose combination of albuterol, a SABA, and budesonide, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery technology.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: PT027
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Avillion LLP
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 01, 2023
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Avillion LLP
Deal Size : Inapplicable
Deal Type : Inapplicable
Airsupra (PT027) Approved in the US for Asthma
Details : Airsupra (albuterol/budesonide), is a first-in-class SABA/ICS rescue treatment for asthma in the US. It is an inhaled, fixed-dose combination of albuterol, a SABA, and budesonide, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery...
Product Name : PT027
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 01, 2023
Details:
Albuterol sulfate inhalation powder is first and only breath-actuated, digital SABA inhaler, which is used for prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Proair HFA-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 26, 2023
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics
Details : Albuterol sulfate inhalation powder is first and only breath-actuated, digital SABA inhaler, which is used for prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.
Product Name : Proair HFA-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 26, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
3-acetoxymethyl-4-acetoxyacetophenone
CAS Number : 24085-06-1
End Use API : Salbutamol Sulphate
About The Company : Keminntek Laboratories is a Hyderabad (India) based Contract Research Organization in Pharmaceutical sector in specific Pharmaceutical Intermediates, Speciality...
CAS Number : 3378-72-1
End Use API : Salbutamol Sulphate
About The Company : Keminntek Laboratories is a Hyderabad (India) based Contract Research Organization in Pharmaceutical sector in specific Pharmaceutical Intermediates, Speciality...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Thickeners and Stabilizers
Direct Compression
Granulation
Film Formers & Plasticizers
Taste Masking
Disintegrants & Superdisintegrants
Lubricants & Glidants
Topical
Co-Processed Excipients
Solubilizers
Parenteral
Chewable & Orodispersible Aids
Emulsifying Agents
Rheology Modifiers
Empty Capsules
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Soft Gelatin
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
01 Nov 2024
Reply
25 Sep 2024
Reply
20 Sep 2024
Reply
31 Aug 2024
Reply
17 Jul 2024
Reply
22 May 2024
Reply
10 Aug 2023
Reply
03 Aug 2023
Reply
06 Feb 2023
Reply
03 Nov 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2030-10-16
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US Patent Number : 8733341
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 21747
Patent Use Code :
Delist Requested : Y
Patent Use Description :
Patent Expiration Date : 2030-10-16
Patent Expiration Date : 2031-05-18
US Patent Number : 10086156
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 21457
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-05-18
Patent Expiration Date : 2035-08-28
US Patent Number : 9782550
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205636
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2035-08-28
Patent Expiration Date : 2040-07-06
US Patent Number : 11173259
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205636
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-07-06
Patent Expiration Date : 2031-05-18
US Patent Number : 9463289
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 21457
Patent Use Code :
Delist Requested : Y
Patent Use Description :
Patent Expiration Date : 2031-05-18
Patent Expiration Date : 2032-01-01
US Patent Number : 10561808
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 21457
Patent Use Code :
Delist Requested : Y
Patent Use Description :
Patent Expiration Date : 2032-01-01
Patent Expiration Date : 2039-09-26
US Patent Number : 11344685
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205636
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-09-26
Patent Expiration Date : 2038-12-18
US Patent Number : 11000653
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205636
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-18
Patent Expiration Date : 2025-05-19
US Patent Number : 10765820
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205636
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-19
Patent Expiration Date : 2032-01-13
US Patent Number : 8978966
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205636
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-01-13
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
51
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 Ventolin Rotacaps manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ventolin Rotacaps, including repackagers and relabelers. The FDA regulates Ventolin Rotacaps manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ventolin Rotacaps 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 Ventolin Rotacaps manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ventolin Rotacaps supplier is an individual or a company that provides Ventolin Rotacaps active pharmaceutical ingredient (API) or Ventolin Rotacaps finished formulations upon request. The Ventolin Rotacaps suppliers may include Ventolin Rotacaps API manufacturers, exporters, distributors and traders.
click here to find a list of Ventolin Rotacaps suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ventolin Rotacaps DMF (Drug Master File) is a document detailing the whole manufacturing process of Ventolin Rotacaps active pharmaceutical ingredient (API) in detail. Different forms of Ventolin Rotacaps DMFs exist exist since differing nations have different regulations, such as Ventolin Rotacaps USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ventolin Rotacaps DMF submitted to regulatory agencies in the US is known as a USDMF. Ventolin Rotacaps USDMF includes data on Ventolin Rotacaps's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ventolin Rotacaps USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ventolin Rotacaps 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 Ventolin Rotacaps Drug Master File in Japan (Ventolin Rotacaps JDMF) empowers Ventolin Rotacaps 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 Ventolin Rotacaps JDMF during the approval evaluation for pharmaceutical products. At the time of Ventolin Rotacaps 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 Ventolin Rotacaps 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 Ventolin Rotacaps Drug Master File in Korea (Ventolin Rotacaps KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ventolin Rotacaps. The MFDS reviews the Ventolin Rotacaps KDMF as part of the drug registration process and uses the information provided in the Ventolin Rotacaps KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ventolin Rotacaps 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 Ventolin Rotacaps API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ventolin Rotacaps suppliers with KDMF on PharmaCompass.
A Ventolin Rotacaps CEP of the European Pharmacopoeia monograph is often referred to as a Ventolin Rotacaps Certificate of Suitability (COS). The purpose of a Ventolin Rotacaps CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ventolin Rotacaps EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ventolin Rotacaps to their clients by showing that a Ventolin Rotacaps CEP has been issued for it. The manufacturer submits a Ventolin Rotacaps CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ventolin Rotacaps CEP holder for the record. Additionally, the data presented in the Ventolin Rotacaps CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ventolin Rotacaps DMF.
A Ventolin Rotacaps CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ventolin Rotacaps 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 Ventolin Rotacaps suppliers with CEP (COS) on PharmaCompass.
A Ventolin Rotacaps written confirmation (Ventolin Rotacaps WC) is an official document issued by a regulatory agency to a Ventolin Rotacaps manufacturer, verifying that the manufacturing facility of a Ventolin Rotacaps active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ventolin Rotacaps APIs or Ventolin Rotacaps finished pharmaceutical products to another nation, regulatory agencies frequently require a Ventolin Rotacaps WC (written confirmation) as part of the regulatory process.
click here to find a list of Ventolin Rotacaps 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 Ventolin Rotacaps as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ventolin Rotacaps 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 Ventolin Rotacaps 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 Ventolin Rotacaps and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ventolin Rotacaps NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ventolin Rotacaps suppliers with NDC on PharmaCompass.
Ventolin Rotacaps 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 Ventolin Rotacaps 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 Ventolin Rotacaps GMP manufacturer or Ventolin Rotacaps GMP API supplier for your needs.
A Ventolin Rotacaps CoA (Certificate of Analysis) is a formal document that attests to Ventolin Rotacaps's compliance with Ventolin Rotacaps specifications and serves as a tool for batch-level quality control.
Ventolin Rotacaps CoA mostly includes findings from lab analyses of a specific batch. For each Ventolin Rotacaps 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.
Ventolin Rotacaps may be tested according to a variety of international standards, such as European Pharmacopoeia (Ventolin Rotacaps EP), Ventolin Rotacaps JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ventolin Rotacaps USP).
Comment (4)
