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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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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 LIMITED","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.ASI0624056(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"}]
03-Jan-2022
30-Apr-2025
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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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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.

Volmax Manufacturers

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.

Volmax Suppliers

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.

Volmax USDMF

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.

Volmax 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 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.

Volmax KDMF

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.

Volmax CEP

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.

Volmax WC

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.

Volmax 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 Volmax as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Volmax 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 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.

Compounded drug products

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 GMP

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.

Volmax CoA

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).

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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