Synopsis
Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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1. Salmeterol
2. Serevent
3. Xinafoate, Salmeterol
1. 94749-08-3
2. Salmetedur
3. Arial
4. Gr 33343x Xinafoate
5. Salmeterol 1-hydroxy-2-naphthoate
6. Salmeterolo
7. Salmeterol (xinafoate)
8. 4-(1-hydroxy-2-((6-(4-phenylbutoxy)hexyl)amino)ethyl)-2-(hydroxymethyl)phenol 1-hydroxy-2-naphthoate
9. Gr 33343 G
10. 2-(hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]phenol;1-hydroxynaphthalene-2-carboxylic Acid
11. Serevent Diskus
12. 6ew8q962a5
13. Gr-33343x
14. Gr-33343 G
15. Ncgc00094372-03
16. Asmerole
17. Betamican
18. Dilamax
19. Inaspir
20. Ultrabeta
21. Beglan
22. Dsstox_cid_25798
23. Dsstox_rid_81137
24. Dsstox_gsid_45798
25. Serevent Inhaler And Disks
26. Salmeterol Xinafoate [usan]
27. Smr000875207
28. Cas-94749-08-3
29. Unii-6ew8q962a5
30. Salmeterol Xinafoate [usan:usp]
31. Serevent (tn)
32. 4-[1-hydroxy-2-[[6-(4-phenylbutoxy)hexyl]amino]ethyl]-2-(hydroxymethyl)phenol 1-hydroxy-2-naphthoate
33. Salmeterol, 1-hydroxy-2-naphthoate
34. Mfcd00897708
35. Schembl18070
36. (+-)-4-hydroxy-alpha(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-m-xylene-alpha,alpha'-diol 1-hydroxy-2-naphthoate (salt)
37. Mls001332577
38. Mls001332578
39. Chebi:9012
40. Lipo-202
41. Chembl1082607
42. Dtxsid1045798
43. Salmeterol Xinafoate (jan/usp)
44. Hms2232i16
45. Hms3263k22
46. Hms3676p13
47. Hms3749i03
48. Hms3885j19
49. Salmeterol Xinafoate [jan]
50. Amy23373
51. Bcp04778
52. Salmeterol Xinafoate [vandf]
53. Tox21_111270
54. Tox21_501100
55. S4296
56. Salmeterol Xinafoate [mart.]
57. Salmeterol Xinafoate [usp-rs]
58. Salmeterol Xinafoate [who-dd]
59. Akos016004957
60. Tox21_111270_1
61. Ccg-270203
62. Cs-1527
63. Ks-1140
64. Lp01100
65. Ncgc00015938-05
66. Ncgc00094372-01
67. Ncgc00094372-02
68. Ncgc00094372-04
69. Ncgc00261785-01
70. 1,3-benzenedimethanol, 4-hydroxy-alpha(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-, (+-)-, 1-hydroxy-2-naphthalenecarboxylate (salt)
71. Hy-17453
72. Salmeterol Xinafoate [ep Impurity]
73. Salmeterol Xinafoate [orange Book]
74. Bcp0726000003
75. Salmeterol Xinafoate [ep Monograph]
76. Advair Component Salmeterol Xinafoate
77. Db-057527
78. Salmeterol Xinafoate [usp Monograph]
79. Eu-0101100
80. Ft-0642283
81. Salmeterol Xinafoate, >=98% (hplc), Solid
82. D00687
83. Lipo-102 Component Salmeterol Xinafoate
84. R10007
85. Salmeterol 1-hydroxy-2-naphthoate [mi]
86. Salmeterol Xinafoate Component Of Advair
87. Advair Hfa Component Salmeterol Xinafoate
88. A916443
89. Sr-01000597359
90. Q-201697
91. Salmeterol Xinafoate Component Of Advair Hfa
92. Sr-01000597359-1
93. Airduo Respiclick Component Salmeterol Xinafoate
94. Q27264747
95. Salmeterol Xinafoate Component Of Airduo Respiclick
96. Salmeterol Xinafoate, European Pharmacopoeia (ep) Reference Standard
97. Salmeterol Xinafoate, United States Pharmacopeia (usp) Reference Standard
98. Salmeterol Xinafoate For System Suitability, European Pharmacopoeia (ep) Reference Standard
99. Salmeterol Xinafoate, Pharmaceutical Secondary Standards; Certified Reference Material
100. (+/-)-4-hydroxy-.alpha.(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-m-xylene-.alpha.,.alpha.'-diol 1-hydroxy-2-naphthoate
101. 1,3-benzenedimethanol, 4-hydroxy-.alpha.(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-, (+/-)-, 1-hydroxy-2-naphthalenecarboxylate
102. 4-(1-hydroxy-2-(6-(4-phenylbutoxy)hexylamino)ethyl)-2-(hydroxymethyl)phenol 1-hydroxy-2-naphthoate
103. 4-hydroxy-?1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol 1-hydroxy-2-naphthalenecarboxylic Acid Salt
| Molecular Weight | 603.7 g/mol |
|---|---|
| Molecular Formula | C36H45NO7 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 17 |
| Exact Mass | 603.31960277 g/mol |
| Monoisotopic Mass | 603.31960277 g/mol |
| Topological Polar Surface Area | 140 Ų |
| Heavy Atom Count | 44 |
| Formal Charge | 0 |
| Complexity | 629 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Bronchodilator Agents
Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)
Adrenergic beta-2 Receptor Agonists
Compounds bind to and activate ADRENERGIC BETA-2 RECEPTORS. (See all compounds classified as Adrenergic beta-2 Receptor Agonists.)
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Drugs in Development
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DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH
USFDA APPLICATION NUMBER - 208799
DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH
USFDA APPLICATION NUMBER - 208799
DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH
USFDA APPLICATION NUMBER - 208799
DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH
USFDA APPLICATION NUMBER - 21077
DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH
USFDA APPLICATION NUMBER - 21077
DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH
USFDA APPLICATION NUMBER - 21077
DOSAGE - AEROSOL, METERED;INHALATION - 0.045M...DOSAGE - AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH
USFDA APPLICATION NUMBER - 21254
DOSAGE - AEROSOL, METERED;INHALATION - 0.115M...DOSAGE - AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH
USFDA APPLICATION NUMBER - 21254
DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH
USFDA APPLICATION NUMBER - 21254
Related Excipient Companies
Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Salmeterol Xinafoate 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 Salmeterol Xinafoate manufacturer or Salmeterol Xinafoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salmeterol Xinafoate manufacturer or Salmeterol Xinafoate supplier.
PharmaCompass also assists you with knowing the Salmeterol Xinafoate API Price utilized in the formulation of products. Salmeterol Xinafoate API Price is not always fixed or binding as the Salmeterol Xinafoate Price is obtained through a variety of data sources. The Salmeterol Xinafoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Betamican manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betamican, including repackagers and relabelers. The FDA regulates Betamican manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betamican 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 Betamican manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betamican supplier is an individual or a company that provides Betamican active pharmaceutical ingredient (API) or Betamican finished formulations upon request. The Betamican suppliers may include Betamican API manufacturers, exporters, distributors and traders.
click here to find a list of Betamican suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betamican DMF (Drug Master File) is a document detailing the whole manufacturing process of Betamican active pharmaceutical ingredient (API) in detail. Different forms of Betamican DMFs exist exist since differing nations have different regulations, such as Betamican USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betamican DMF submitted to regulatory agencies in the US is known as a USDMF. Betamican USDMF includes data on Betamican's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betamican USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betamican 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 Betamican Drug Master File in Japan (Betamican JDMF) empowers Betamican 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 Betamican JDMF during the approval evaluation for pharmaceutical products. At the time of Betamican 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 Betamican suppliers with JDMF on PharmaCompass.
A Betamican CEP of the European Pharmacopoeia monograph is often referred to as a Betamican Certificate of Suitability (COS). The purpose of a Betamican CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betamican EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betamican to their clients by showing that a Betamican CEP has been issued for it. The manufacturer submits a Betamican CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betamican CEP holder for the record. Additionally, the data presented in the Betamican CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betamican DMF.
A Betamican CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betamican 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 Betamican suppliers with CEP (COS) on PharmaCompass.
A Betamican written confirmation (Betamican WC) is an official document issued by a regulatory agency to a Betamican manufacturer, verifying that the manufacturing facility of a Betamican active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Betamican APIs or Betamican finished pharmaceutical products to another nation, regulatory agencies frequently require a Betamican WC (written confirmation) as part of the regulatory process.
click here to find a list of Betamican 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 Betamican as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betamican 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 Betamican 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 Betamican and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betamican NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betamican suppliers with NDC on PharmaCompass.
Betamican 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 Betamican 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 Betamican GMP manufacturer or Betamican GMP API supplier for your needs.
A Betamican CoA (Certificate of Analysis) is a formal document that attests to Betamican's compliance with Betamican specifications and serves as a tool for batch-level quality control.
Betamican CoA mostly includes findings from lab analyses of a specific batch. For each Betamican 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.
Betamican may be tested according to a variety of international standards, such as European Pharmacopoeia (Betamican EP), Betamican JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betamican USP).
