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Chemistry

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Also known as: Salbutamol sulfate, 51022-70-9, Salbutamol hemisulfate, Proventil, Venetlin, Loftan
Molecular Formula
C26H44N2O10S
Molecular Weight
576.7  g/mol
InChI Key
BNPSSFBOAGDEEL-UHFFFAOYSA-N
FDA UNII
021SEF3731

Salbutamol Sulphate
A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.
1 2D Structure

Salbutamol Sulphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid
2.1.2 InChI
InChI=1S/2C13H21NO3.H2O4S/c2*1-13(2,3)14-7-12(17)9-4-5-11(16)10(6-9)8-15;1-5(2,3)4/h2*4-6,12,14-17H,7-8H2,1-3H3;(H2,1,2,3,4)
2.1.3 InChI Key
BNPSSFBOAGDEEL-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C)NCC(C1=CC(=C(C=C1)O)CO)O.CC(C)(C)NCC(C1=CC(=C(C=C1)O)CO)O.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
021SEF3731
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-t-butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol

2. Albuterol

3. Proventil

4. Salbutamol

5. Sultanol

6. Ventolin

2.3.2 Depositor-Supplied Synonyms

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)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 576.7 g/mol
Molecular Formula C26H44N2O10S
Hydrogen Bond Donor Count10
Hydrogen Bond Acceptor Count12
Rotatable Bond Count10
Exact Mass576.27166678 g/mol
Monoisotopic Mass576.27166678 g/mol
Topological Polar Surface Area228 Ų
Heavy Atom Count39
Formal Charge0
Complexity309
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 12  
Drug NameAccuneb
PubMed HealthAlbuterol (By breathing)
Drug ClassesBronchodilator
Drug LabelAlbuterol 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 IngredientAlbuterol sulfate
Dosage FormSolution
RouteInhalation
Strengtheq 0.021% base; eq 0.042% base
Market StatusPrescription
CompanyMylan Speclt

2 of 12  
Drug NameAlbuterol sulfate
PubMed HealthAlbuterol
Drug ClassesBronchodilator, Cardiovascular Agent
Drug LabelThe 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 IngredientAlbuterol sulfate
Dosage FormTablet, extended release; Tablet; Syrup; Solution
RouteInhalation; Oral
Strengtheq 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 StatusPrescription
CompanyWatson 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 NameProair hfa
Active IngredientAlbuterol sulfate
Dosage FormAerosol, metered
RouteInhalation
Strengtheq 0.09mg base/inh
Market StatusPrescription
CompanyTeva Branded Pharm

4 of 12  
Drug NameProventil-hfa
Active IngredientAlbuterol sulfate
Dosage FormAerosol, metered
RouteInhalation
Strengtheq 0.09mg base/inh
Market StatusPrescription
Company3m

5 of 12  
Drug NameVentolin hfa
Drug LabelAlbuterol 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 IngredientAlbuterol sulfate
Dosage FormAerosol, metered
RouteInhalation
Strengtheq 0.09mg base/inh
Market StatusPrescription
CompanyGlaxo Grp

6 of 12  
Drug NameVospire er
Drug LabelThe 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 IngredientAlbuterol sulfate
Dosage FormTablet, extended release
RouteOral
Strengtheq 4mg base; eq 8mg base
Market StatusPrescription
CompanyDava Pharms

7 of 12  
Drug NameAccuneb
PubMed HealthAlbuterol (By breathing)
Drug ClassesBronchodilator
Drug LabelAlbuterol 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 IngredientAlbuterol sulfate
Dosage FormSolution
RouteInhalation
Strengtheq 0.021% base; eq 0.042% base
Market StatusPrescription
CompanyMylan Speclt

8 of 12  
Drug NameAlbuterol sulfate
PubMed HealthAlbuterol
Drug ClassesBronchodilator, Cardiovascular Agent
Drug LabelThe 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 IngredientAlbuterol sulfate
Dosage FormTablet, extended release; Tablet; Syrup; Solution
RouteInhalation; Oral
Strengtheq 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 StatusPrescription
CompanyWatson 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 NameProair hfa
Active IngredientAlbuterol sulfate
Dosage FormAerosol, metered
RouteInhalation
Strengtheq 0.09mg base/inh
Market StatusPrescription
CompanyTeva Branded Pharm

10 of 12  
Drug NameProventil-hfa
Active IngredientAlbuterol sulfate
Dosage FormAerosol, metered
RouteInhalation
Strengtheq 0.09mg base/inh
Market StatusPrescription
Company3m

11 of 12  
Drug NameVentolin hfa
Drug LabelAlbuterol 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 IngredientAlbuterol sulfate
Dosage FormAerosol, metered
RouteInhalation
Strengtheq 0.09mg base/inh
Market StatusPrescription
CompanyGlaxo Grp

12 of 12  
Drug NameVospire er
Drug LabelThe 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 IngredientAlbuterol sulfate
Dosage FormTablet, extended release
RouteOral
Strengtheq 4mg base; eq 8mg base
Market StatusPrescription
CompanyDava Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
beta2-Adrenergic Agonist [EPC]; Adrenergic beta2-Agonists [MoA]

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Supriya Lifescience

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LGM Pharma

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Emay Pharmaceuticals

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Vamsi Labs

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Zeon Pharma Industries India Pvt L...

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BePharma
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Cipla Ltd

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Cipla Ltd

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Glaxochem Ltd

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Glaxochem Ltd

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Salbutamol Sulphate

About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...

Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its facilities in Lote and Ambernath are approved by USFDA, EUGMP, Health Canada, and other agencies. Specializing in antihistamines, antiallergics, vitamins, anesthetics, and anti-asthmatics, Supriya serves 1500+ customers in over 86 countries, with 15+ USDMFs, 10+ CEPs, and a 1050 KL manufacturing capacity. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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LGM Pharma

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Salbutamol Sulphate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LGM Pharma CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEmay Pharmaceuticals is a GMP-certified API manufacturing company.

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Salbutamol Sulphate

About the Company : Emay Pharmaceuticals Pvt Ltd operates as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. The company is a GMP-approved API manufacturer with over three decades of...

Emay Pharmaceuticals Pvt Ltd operates as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. The company is a GMP-approved API manufacturer with over three decades of experience in manufacturing and exporting pharmaceutical and allied products. Supported by a team of experienced professionals, Emay Pharmaceuticals specializes in Human Health and Veterinary Health APIs, as well as the trade of raw materials for pharmaceutical applications, with a strong focus on quality and reliability. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Emay Pharmaceuticals

04

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  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Salbutamol Sulphate

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Jai Radhe Sales

05

Vamsi Labs

India
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Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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Salbutamol Sulphate

About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and international markets ...

Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and international markets (50% sales). Anti-asthma products account for 60% of sales. Vamsi maintains high standards in corporate governance, transparency, professionalism, and environmental protection. It is USFDA, EDQM, ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018 certified, with a DSIR-certified R&D lab, supporting continuous innovation and global growth. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Vamsi Labs

06

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  • EDQM
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Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

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Salbutamol Sulphate

About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...

Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-quality products. With 300+ customers in 100 countries, Virupaksha has built a strong global presence and a trusted reputation for reliability. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Virupaksha

07

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Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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Salbutamol Sulphate

About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...

Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, etc.). It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 3 R&D centers and 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
Aarti Industries Company Banner

08

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Albuterol Sulfate

About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...

Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compounds to NCEs and advanced intermediates. It manufactures APIs and intermediates in USFDA-approved facilities, applying advanced process chemistry in a regulatory-compliant environment for clinical and commercial stages. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Neuland

09

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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Salbutamol Sulphate

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Tenatra

10

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Virtual BoothZeon Pharma is a manufacturer and supplier of APIs & Intermediates.

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Salbutamol Sulphate

About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...

Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herbal extracts, semi-finished granules, and finished formulations such as tablets, capsules, and dry suspensions. The company also provides product support through associate manufacturing plants for APIs, pellets, excipients, enzymes, and specialized chemicals, operating in compliance with cGMP, WHO-GMP, and EU-GMP standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Zeon Pharma Industries India Pvt Ltd
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ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"ALBUTEROL SALBUTAMOL SULPHATE","address":"DIFGEN PHARMACEUTICALS PRIVATE LIMITED","city":"MIYAPUR","supplier":"SICOR SRL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"DIFGEN PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"748","totalValueFC":"756.2","currency":"USD","unitRateINR":"63542.6","date":"18-Oct-2024","totalValueINR":"63542.6","totalValueInUsd":"756.2","indian_port":"Hyderabad Air","hs_no":"29225090","bill_no":"6200640","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"Via Terrazzano, 77 - 20017 Rho MI Italy SDNF NL","customerAddress":"DIFGEN PHARMACEUTICALS PRIVATE LIMITED"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"SALBUTAMOL SULPHATE US (ALBUTEROL SULFATE) B.ASI5240140 (MATERIAL ORIGINALLY EXP SB NO.1655999\/13.06.24 REJ & RETRN)SALBUTAMOL SULPHATE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"SANDOZ RUDOLSTADT AEROPHARM GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"NEULAND LABORATORIES LTD","customerCountry":"INDIA","quantity":"11.95","actualQuantity":"11.9527","unit":"KGS","unitRateFc":"913.1","totalValueFC":"11000","currency":"USD","unitRateINR":"79713.5","date":"27-Mar-2025","totalValueINR":"952791.95","totalValueInUsd":"11000","indian_port":"Hyderabad Air","hs_no":"29051420","bill_no":"9145145","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"FRANCOIS-MITTERRAND-ALLEE 1 D-07407 RUDOLSTADT GERMANY SDNF DE","customerAddress":"SANALI INFO PARK, A BLOCK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"SALBUTAMOL SULPHATE US(ALBUTEROL SULFATE)B.ASI0624057(MATERIAL ORIGINALLY EXPORTED SB NO.2798598\/29.07.24 REJ & RETURN)SALBUTAMOL SULPHATE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"SANDOZ RUDOLSTADT AEROPHARM GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"NEULAND LABORATORIES LTD","customerCountry":"INDIA","quantity":"11.96","actualQuantity":"11.9557","unit":"KGS","unitRateFc":"892.5","totalValueFC":"10755.1","currency":"USD","unitRateINR":"77919.2","date":"27-Mar-2025","totalValueINR":"931578.2","totalValueInUsd":"10755.1","indian_port":"Hyderabad Air","hs_no":"29051420","bill_no":"9145024","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"FRANCOIS-MITTERRAND-ALLEE 1 D-07407 RUDOLSTADT GERMANY SDNF DE","customerAddress":"SANALI INFO PARK, A BLOCK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744309800,"product":"ALBUTEROL SULFATE \/SALBUTAMOL SULPHATE 5 MICRON","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"246.95","actualQuantity":"246.95","unit":"KGS","unitRateFc":"2864.4","totalValueFC":"715615.8","currency":"USD","unitRateINR":"248058.3","date":"11-Apr-2025","totalValueINR":"61257984.88","totalValueInUsd":"715615.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29225090","bill_no":"9420967","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILANO","supplierAddress":"Via E curiel 34 20067 Paullo MI SDNF Italy","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1757701800,"product":"ALBUTEROL SULFATE \/SALBUTAMOL SULPHATE 5 MICRON","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CAMBREX PROFARMACO MILANO SRL","supplierCountry":"ITALY","foreign_port":"MILANO","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"318.50","actualQuantity":"318.5","unit":"KGS","unitRateFc":"3056.1","totalValueFC":"981427.1","currency":"USD","unitRateINR":"271992.6","date":"13-Sep-2025","totalValueINR":"86629628.56","totalValueInUsd":"981427.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29225090","bill_no":"4493834","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILANO","supplierAddress":"Via E curiel 34 20067 Paullo MI SDNF Italy","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758393000,"product":"SALBUTAMOL SULPHATE BP (MICRONISED) (RE-IMPORT) SB NO 7033741 DT.25\/01\/2024 BATCH NO SS-0131223(M)SALBUTAMOL SULPHATE BP (MICRONISED) (RE-IMPORT) SB NO 703374","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"","supplier":"LINA MANUFACTURING PVT LTD","supplierCountry":"INDIA","foreign_port":"COLOMBO","customer":"VAMSI LABS LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"258.2","totalValueFC":"1299.7","currency":"N\/A","unitRateINR":"22944.8","date":"21-Sep-2025","totalValueINR":"114724.18","totalValueInUsd":"1299.7","indian_port":"Bombay Air","hs_no":"29051420","bill_no":"4636664","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"COLOMBO","supplierAddress":"60 DHARMAPALA MAWATHACOLOMBO 03 SDNF SDNF SRI LANKA","customerAddress":"A-14 15, MIDC AREA, CHINCHOLI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758393000,"product":"SALBUTAMOL SULPHATE BP (MICRONISED) (RE-IMPORT) SB NO 3887528 DT. 10\/09\/2024 BATCH NO SS-0100424(M)SALBUTAMOL SULPHATE BP (MICRONISED) (RE-IMPORT) SB NO 388752","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"","supplier":"LINA SPIRO (PVT) LTD.","supplierCountry":"INDIA","foreign_port":"COLOMBO","customer":"VAMSI LABS LTD","customerCountry":"INDIA","quantity":"5.97","actualQuantity":"5.974","unit":"KGS","unitRateFc":"280.5","totalValueFC":"1686.9","currency":"N\/A","unitRateINR":"24924.4","date":"21-Sep-2025","totalValueINR":"148898.65","totalValueInUsd":"1686.9","indian_port":"Bombay Air","hs_no":"29051420","bill_no":"4636661","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"COLOMBO","supplierAddress":"60 DHARMAPALA MAWATHACOLOMBO 03 SDNF SDNF SRI LANKA","customerAddress":"A-14 15, MIDC AREA, CHINCHOLI"}]
03-Jan-2022
30-Jan-2026
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

USFDA APPLICATION NUMBER - 20503

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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

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DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

USFDA APPLICATION NUMBER - 20983

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DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

USFDA APPLICATION NUMBER - 21457

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Patents & EXCLUSIVITIES

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US Patents

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01

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ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

US Patent Number : 7396341

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21747

Patent Use Code :

Delist Requested : Y

Patent Use Description :

Patent Expiration Date : 2026-10-10

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ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

US Patent Number : 7837235

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21747

Patent Use Code :

Delist Requested : Y

Patent Use Description :

Patent Expiration Date : 2028-03-13

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03

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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

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04

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ChemTides
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ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

US Patent Number : 9027967

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 21747

Patent Use Code :

Delist Requested : Y

Patent Use Description :

Patent Expiration Date : 2027-03-31

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01

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BePharma
Not Confirmed

IPRATROPIUM BROMIDE, SALBUTAMOL

Brand Name : COMBIVENT RESPIMAT

Patent Number : 2275392

Filing Date : 1997-12-16

Strength per Unit : 20 mcg / 100 mcg

Dosage Form : SOLUTION

Human Or VET : Human

Route of Administration : ORAL

Patent Expiration Date : 2017-12-16

Date Granted : 2004-06-29

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02

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BePharma
Not Confirmed

GlaxoSmithKline Inc.

United Kingdom
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BePharma
Not Confirmed

Salbutamol Sulphate

Brand Name : VENTOLIN HFA

Patent Number : 2125665

Filing Date : 1992-12-04

Strength per Unit : 100mcg per metered dose

Dosage Form : Metered Dose Inhaler

Human Or VET : Human

Route of Administration : Oral Inhalation

Patent Expiration Date : 2012-12-04

Date Granted : 2001-06-12

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03

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BePharma
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GlaxoSmithKline Inc.

United Kingdom
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BePharma
Not Confirmed

Salbutamol Sulphate

Brand Name : VENTOLIN DISKUS

Patent Number : 2125665

Filing Date : 1992-12-04

Strength per Unit : 200 mcg

Dosage Form : Multi-dose Powder Inhaler

Human Or VET : Human

Route of Administration : Oral Inhalation

Patent Expiration Date : 2012-12-04

Date Granted : 2001-06-12

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04

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BePharma
Not Confirmed

GlaxoSmithKline Inc.

United Kingdom
arrow
BePharma
Not Confirmed

Salbutamol Sulphate

Brand Name : VENTOLIN HFA

Patent Number : 2125667

Filing Date : 1992-12-04

Strength per Unit : 100mcg per metered dose

Dosage Form : Metered Dose Inhaler

Human Or VET : Human

Route of Administration : Oral Inhalation

Patent Expiration Date : 2012-12-04

Date Granted : 2000-06-13

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REF. STANDARDS & IMPURITIES

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ABOUT THIS PAGE

Looking for 51022-70-9 / Salbutamol Sulphate API manufacturers, exporters & distributors?

Salbutamol Sulphate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Salbutamol Sulphate

Synonyms

Salbutamol sulfate, 51022-70-9, Salbutamol hemisulfate, Proventil, Venetlin, Loftan

Cas Number

51022-70-9

Unique Ingredient Identifier (UNII)

021SEF3731

About Salbutamol Sulphate

A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.

VoSpire ER Manufacturers

A VoSpire ER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of VoSpire ER, including repackagers and relabelers. The FDA regulates VoSpire ER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. VoSpire ER 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 VoSpire ER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

VoSpire ER Suppliers

A VoSpire ER supplier is an individual or a company that provides VoSpire ER active pharmaceutical ingredient (API) or VoSpire ER finished formulations upon request. The VoSpire ER suppliers may include VoSpire ER API manufacturers, exporters, distributors and traders.

click here to find a list of VoSpire ER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

VoSpire ER USDMF

A VoSpire ER DMF (Drug Master File) is a document detailing the whole manufacturing process of VoSpire ER active pharmaceutical ingredient (API) in detail. Different forms of VoSpire ER DMFs exist exist since differing nations have different regulations, such as VoSpire ER USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A VoSpire ER DMF submitted to regulatory agencies in the US is known as a USDMF. VoSpire ER USDMF includes data on VoSpire ER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The VoSpire ER USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of VoSpire ER suppliers with USDMF on PharmaCompass.

VoSpire ER JDMF

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 VoSpire ER Drug Master File in Japan (VoSpire ER JDMF) empowers VoSpire ER 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 VoSpire ER JDMF during the approval evaluation for pharmaceutical products. At the time of VoSpire ER 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 VoSpire ER suppliers with JDMF on PharmaCompass.

VoSpire ER KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a VoSpire ER Drug Master File in Korea (VoSpire ER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of VoSpire ER. The MFDS reviews the VoSpire ER KDMF as part of the drug registration process and uses the information provided in the VoSpire ER KDMF to evaluate the safety and efficacy of the drug.

After submitting a VoSpire ER 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 VoSpire ER API can apply through the Korea Drug Master File (KDMF).

click here to find a list of VoSpire ER suppliers with KDMF on PharmaCompass.

VoSpire ER CEP

A VoSpire ER CEP of the European Pharmacopoeia monograph is often referred to as a VoSpire ER Certificate of Suitability (COS). The purpose of a VoSpire ER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of VoSpire ER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of VoSpire ER to their clients by showing that a VoSpire ER CEP has been issued for it. The manufacturer submits a VoSpire ER CEP (COS) as part of the market authorization procedure, and it takes on the role of a VoSpire ER CEP holder for the record. Additionally, the data presented in the VoSpire ER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the VoSpire ER DMF.

A VoSpire ER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. VoSpire ER 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 VoSpire ER suppliers with CEP (COS) on PharmaCompass.

VoSpire ER WC

A VoSpire ER written confirmation (VoSpire ER WC) is an official document issued by a regulatory agency to a VoSpire ER manufacturer, verifying that the manufacturing facility of a VoSpire ER active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting VoSpire ER APIs or VoSpire ER finished pharmaceutical products to another nation, regulatory agencies frequently require a VoSpire ER WC (written confirmation) as part of the regulatory process.

click here to find a list of VoSpire ER suppliers with Written Confirmation (WC) on PharmaCompass.

VoSpire ER NDC

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 VoSpire ER as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for VoSpire ER API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 VoSpire ER 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain VoSpire ER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a VoSpire ER NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of VoSpire ER suppliers with NDC on PharmaCompass.

VoSpire ER GMP

VoSpire ER 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 VoSpire ER 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 VoSpire ER GMP manufacturer or VoSpire ER GMP API supplier for your needs.

VoSpire ER CoA

A VoSpire ER CoA (Certificate of Analysis) is a formal document that attests to VoSpire ER's compliance with VoSpire ER specifications and serves as a tool for batch-level quality control.

VoSpire ER CoA mostly includes findings from lab analyses of a specific batch. For each VoSpire ER 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.

VoSpire ER may be tested according to a variety of international standards, such as European Pharmacopoeia (VoSpire ER EP), VoSpire ER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (VoSpire ER USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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