Synopsis
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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.)
API SUPPLIERS
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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.
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Drugs in Development
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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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Fillers, Diluents & Binders
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Pregelatinized Corn Starch
Application : Fillers, Diluents & Binders
Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
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Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Capsule, Injectable / Parenteral, Tablet
Grade : Oral, Parenteral
Category : Fillers, Diluents & Binders, Parenteral
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders, Parenteral
Excipient Details : Lactose Monohydrate is widely used as a filler and diluent in tablets and capsules and in the production of lyophilized and parenteral products.
Application : Fillers, Diluents & Binders
Excipient Details : Corn Starch is used as a filler and binder in pharmaceutical oral solid dosage forms including tablets and capsules.
Coating Systems & Additives
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
Brand Name : Hydroxypropyl Methyl Cellulose
Application : Coating Systems & Additives
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : Hydroxypropyl Methyl Cellulose
Application : Coating Systems & Additives
Excipient Details : Hydroxypropyl Methyl Cellulose (HPMC) is used as a coating agent in pharmaceutical tablets.
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Film Forming Agent, Wet/Dry Granulation- Binder,Thickening & Suspension Agent, Non-Gelatin Capsule Manufacturing & Enteric Film Coating Systems
Pharmacopoeia Ref : USP, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Emulsion, Tablet
Grade : Oral, Ophthalmic
Category : Disintegrants & Superdisintegrants, Emulsifying Agents, Film Formers & Plasticizers, Thickeners and Stabilizers
Brand Name : Hydroxypropyl Methyl Cellulose
Application : Disintegrants & Superdisintegrants, Emulsifying Agents, Film Formers & Plasticizers, Thickeners and Stabilizers
Excipient Details : Hydroxypropyl Methyl Cellulose is used as a film-former, disintegrant, thickener, and emulsifier in tablets, emulsions, and ophthalmic formulations.
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Sustained Release Tablet Matrix
Pharmacopoeia Ref : USP, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Fillers, Diluents & Binders, Film Formers & Plasticizers
Application : Coating Systems & Additives, Fillers, Diluents & Binders, Film Formers & Plasticizers
Excipient Details : Ethyl Cellulose is used as a binding, film-forming, and coating agent in the production of tablets, sustained-release tablets, and pellets.
Controlled & Modified Release
Thickeners and Stabilizers
Direct Compression
Granulation
Film Formers & Plasticizers
Taste Masking
Disintegrants & Superdisintegrants
Lubricants & Glidants
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Magnesium stearate is the magnesium salt of stearic acid. It acts as a lubricating agent in tablet manufacturing.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Sodium Dodecyl Sulfate
Application : Granulation
Excipient Details : Sodium dodecyl sulfate is used in wet granulation tableting applications for the production of antacid tablets and digestive aids.
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Magnesium stearate is the magnesium salt of stearic acid. It acts as a lubricating agent in tablet manufacturing.
Dosage Form : Tablet
Grade : Oral
Category : Granulation, Lubricants & Glidants, Surfactant & Foaming Agents
Brand Name : Sodium Dodecyl Sulfate
Application : Granulation, Lubricants & Glidants, Surfactant & Foaming Agents
Excipient Details : Sodium Dodecyl Sulfate is used as an ionic surfactant, lubricant, and granulating agent in the solid dosage forms such as tablets.
Grade : Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Most popular excipient for the production of tablets and capsules. Offering an efficient and low dosage in capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Specific Surface Area-6-10 m2/g; Particle Size-7-11 µm
Ingredient(s) : Magnesium Stearate
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Magnesium stearate is the magnesium salt of stearic acid. It acts as a lubricating agent in tablet manufacturing.
Pharmacopoeia Ref : USP/BP/EP/PH.EUR
Technical Specs : Not Available
Ingredient(s) : Magnesium Stearate
Grade : Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Higher specific surface area and a smaller median particle size. This product is preferred for more critical and very fine herbal formulations.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Specific Surface Area-8-12 m2/g; Particle Size-5-9 µm
Ingredient(s) : Magnesium Stearate
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Magnesium stearate is the magnesium salt of stearic acid. It acts as a lubricating agent and stabilizer in tablet manufacturing.
Grade : Oral
Category : Disintegrants & Superdisintegrants, Granulation, Lubricants & Glidants
Application : Disintegrants & Superdisintegrants, Granulation, Lubricants & Glidants
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Lubricants, Anti-adhesive, Glidant
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
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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 Volmax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Volmax, including repackagers and relabelers. The FDA regulates Volmax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Volmax 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 Volmax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Volmax supplier is an individual or a company that provides Volmax active pharmaceutical ingredient (API) or Volmax finished formulations upon request. The Volmax suppliers may include Volmax API manufacturers, exporters, distributors and traders.
click here to find a list of Volmax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Volmax DMF (Drug Master File) is a document detailing the whole manufacturing process of Volmax active pharmaceutical ingredient (API) in detail. Different forms of Volmax DMFs exist exist since differing nations have different regulations, such as Volmax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Volmax DMF submitted to regulatory agencies in the US is known as a USDMF. Volmax USDMF includes data on Volmax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Volmax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Volmax 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 Volmax Drug Master File in Japan (Volmax JDMF) empowers Volmax 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 Volmax JDMF during the approval evaluation for pharmaceutical products. At the time of Volmax 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 Volmax 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 Volmax Drug Master File in Korea (Volmax KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Volmax. The MFDS reviews the Volmax KDMF as part of the drug registration process and uses the information provided in the Volmax KDMF to evaluate the safety and efficacy of the drug.
After submitting a Volmax 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 Volmax API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Volmax suppliers with KDMF on PharmaCompass.
A Volmax CEP of the European Pharmacopoeia monograph is often referred to as a Volmax Certificate of Suitability (COS). The purpose of a Volmax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Volmax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Volmax to their clients by showing that a Volmax CEP has been issued for it. The manufacturer submits a Volmax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Volmax CEP holder for the record. Additionally, the data presented in the Volmax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Volmax DMF.
A Volmax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Volmax 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 Volmax suppliers with CEP (COS) on PharmaCompass.
A Volmax written confirmation (Volmax WC) is an official document issued by a regulatory agency to a Volmax manufacturer, verifying that the manufacturing facility of a Volmax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Volmax APIs or Volmax finished pharmaceutical products to another nation, regulatory agencies frequently require a Volmax WC (written confirmation) as part of the regulatory process.
click here to find a list of Volmax 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 Volmax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Volmax 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 Volmax 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 Volmax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Volmax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Volmax suppliers with NDC on PharmaCompass.
Volmax 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 Volmax 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 Volmax GMP manufacturer or Volmax GMP API supplier for your needs.
A Volmax CoA (Certificate of Analysis) is a formal document that attests to Volmax's compliance with Volmax specifications and serves as a tool for batch-level quality control.
Volmax CoA mostly includes findings from lab analyses of a specific batch. For each Volmax 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.
Volmax may be tested according to a variety of international standards, such as European Pharmacopoeia (Volmax EP), Volmax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Volmax USP).
