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Chemistry

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Also known as: 94749-08-3, Salmetedur, Arial, Gr 33343x xinafoate, Salmeterol 1-hydroxy-2-naphthoate, Salmeterolo
Molecular Formula
C36H45NO7
Molecular Weight
603.7  g/mol
InChI Key
XTZNCVSCVHTPAI-UHFFFAOYSA-N
FDA UNII
6EW8Q962A5

Salmeterol Xinafoate
A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
1 2D Structure

Salmeterol Xinafoate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]phenol;1-hydroxynaphthalene-2-carboxylic acid
2.1.2 InChI
InChI=1S/C25H37NO4.C11H8O3/c27-20-23-18-22(13-14-24(23)28)25(29)19-26-15-7-1-2-8-16-30-17-9-6-12-21-10-4-3-5-11-21;12-10-8-4-2-1-3-7(8)5-6-9(10)11(13)14/h3-5,10-11,13-14,18,25-29H,1-2,6-9,12,15-17,19-20H2;1-6,12H,(H,13,14)
2.1.3 InChI Key
XTZNCVSCVHTPAI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C(C=C1)CCCCOCCCCCCNCC(C2=CC(=C(C=C2)O)CO)O.C1=CC=C2C(=C1)C=CC(=C2O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
6EW8Q962A5
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Salmeterol

2. Serevent

3. Xinafoate, Salmeterol

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 603.7 g/mol
Molecular Formula C36H45NO7
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count8
Rotatable Bond Count17
Exact Mass603.31960277 g/mol
Monoisotopic Mass603.31960277 g/mol
Topological Polar Surface Area140 Ų
Heavy Atom Count44
Formal Charge0
Complexity629
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

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.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
beta2-Adrenergic Agonist [EPC]; Adrenergic beta2-Agonists [MoA]

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PEX\/1164\/24-25 DT: 14.01.2025)","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS LIMITED","supplierCountry":"INDIA","foreign_port":"MILAN","customer":"TO ORDER","customerCountry":"ITALY","quantity":"12.93","actualQuantity":"12.93","unit":"KGS","unitRateFc":"13000","totalValueFC":"168517.7","currency":"EURO","unitRateINR":1123831.5931941222,"date":"21-Jan-2025","totalValueINR":"14531142.5","totalValueInUsd":"168517.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7449320","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737657000,"product":"SALMETEROL XINAFOATE(SUPERFINE) BP (LRMGRADE)","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"20000","totalValueFC":"17772.2","currency":"USD","unitRateINR":1702754.4444444445,"date":"24-Jan-2025","totalValueINR":"1532479","totalValueInUsd":"17772.2","indian_port":"Hyderabad Air","hs_no":"29062990","bill_no":"7577881","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738089000,"product":"SALMETEROL XINAFOATE LRM GRADE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"0.70","actualQuantity":"0.7","unit":"KGS","unitRateFc":"20000","totalValueFC":"13838.9","currency":"USD","unitRateINR":1704734.2857142859,"date":"29-Jan-2025","totalValueINR":"1193314","totalValueInUsd":"13838.9","indian_port":"Hyderabad Air","hs_no":"29062990","bill_no":"7697531","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738607400,"product":"SALMETEROL XINAFOATE EP (MICRONISED)","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"N\/A","supplier":"VAMSI LABS LIMITED","supplierCountry":"INDIA","foreign_port":"MONTEVIDEO -","customer":"TO THE ORDER OF....","customerCountry":"URUGUAY","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"16000","totalValueFC":"30684.9","currency":"USD","unitRateINR":1334243.605,"date":"04-Feb-2025","totalValueINR":"2668487.21","totalValueInUsd":"30684.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7873726","productDescription":"API","marketType":"","country":"URUGUAY","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"A-14 15, MIDC AREA, CHINCHOLI, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739903400,"product":"SALMETEROL XINAFOATE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"DUBLIN","customer":"UNDISCLOSED","customerCountry":"IRELAND","quantity":"0.99","actualQuantity":"0.99","unit":"KGS","unitRateFc":"68000","totalValueFC":"67021.4","currency":"USD","unitRateINR":5887330.8080808083,"date":"19-Feb-2025","totalValueINR":"5828457.5","totalValueInUsd":"67021.4","indian_port":"Hyderabad Air","hs_no":"29062990","bill_no":"8311709","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"SALMETEROL XINAFOATE EP (MICRONISED)","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"N\/A","supplier":"VAMSI LABS LIMITED","supplierCountry":"INDIA","foreign_port":"TUNIS","customer":"TO THE ORDER OF","customerCountry":"TUNISIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"15.5","totalValueFC":"7553.5","currency":"USD","unitRateINR":1313.7750000000001,"date":"24-Feb-2025","totalValueINR":"656887.5","totalValueInUsd":"7553.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8447861","productDescription":"API","marketType":"","country":"TUNISIA","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"A-14 15, MIDC AREA, CHINCHOLI, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742495400,"product":"SALMETEROL XINAFOATE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"DUBLIN","customer":"TO THE ORDER OF","customerCountry":"IRELAND","quantity":"1.92","actualQuantity":"1.915","unit":"KGS","unitRateFc":"68000","totalValueFC":"128475.3","currency":"USD","unitRateINR":5811080.4177545691,"date":"21-Mar-2025","totalValueINR":"11128219","totalValueInUsd":"128475.3","indian_port":"Hyderabad Air","hs_no":"29062990","bill_no":"9214174","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SANALI INFO PARK, A BLOCK, ROAD NO.2, BANJARA HILLS, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"SALMETEROL XINAFOATE (OUR REF CI NO: 524159) (APPENDIX 4R, RODTEP ENTRY NO: 9662)","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NATCO PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"AEROPHARM GMBH","customerCountry":"GERMANY","quantity":"2.73","actualQuantity":"2.73","unit":"KGS","unitRateFc":"50000","totalValueFC":"134896.4","currency":"USD","unitRateINR":4280000,"date":"27-Mar-2025","totalValueINR":"11684400","totalValueInUsd":"134896.4","indian_port":"Hyderabad Air","hs_no":"29225090","bill_no":"9429639","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NATCO HOUSE, ROAD NO.2,, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745605800,"product":"SALMETEROL XINAFOATE EP (PHARMACEUTICAL RAW MATERIAL) (INV NO. PEX\/100070\/25-26 DT. 19.04.2025)","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS LIMITED","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO ORDER","customerCountry":"TURKEY","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"19000","totalValueFC":"18702.9","currency":"USD","unitRateINR":1601005,"date":"26-Apr-2025","totalValueINR":"1601005","totalValueInUsd":"18702.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"1290908","productDescription":"API","marketType":"","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742236200,"product":"SALMETEROL XINAFOATE (REJECTED MATERIAL VIDE EXPORT INVOICENO: 362410500028)SALMETEROL XINAFOATE (REJECTED MATERIAL VIDE EXPORT INVOICE","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"AEROPHARM GMBH","supplierCountry":"INDIA","foreign_port":"LEIPZIG\/HALLE","customer":"NATCO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1.06","actualQuantity":"1.0599","unit":"KGS","unitRateFc":"50000","totalValueFC":"53718.4","currency":"USD","unitRateINR":"4390000","date":"18-Mar-2025","totalValueINR":"4652961","totalValueInUsd":"53718.4","indian_port":"Hyderabad Air","hs_no":"29225090","bill_no":"8958548","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LEIPZIG\/HALLE","supplierAddress":"FRANCOIS-MITTERRAND-ALLEE 1 07407 RUDOLSTADT GERMANY DE","customerAddress":"NATCO HOUSE, ROAD NO.2,"}]
04-Jan-2022
26-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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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

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DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH

USFDA APPLICATION NUMBER - 208799

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DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH

USFDA APPLICATION NUMBER - 208799

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DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH

USFDA APPLICATION NUMBER - 21077

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DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH

USFDA APPLICATION NUMBER - 21077

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DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH

USFDA APPLICATION NUMBER - 21077

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DOSAGE - AEROSOL, METERED;INHALATION - 0.045M...DOSAGE - AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.115M...DOSAGE - AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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ABOUT THIS PAGE

Looking for 94749-08-3 / Salmeterol Xinafoate API manufacturers, exporters & distributors?

Salmeterol Xinafoate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Salmeterol Xinafoate

Synonyms

94749-08-3, Salmetedur, Arial, Gr 33343x xinafoate, Salmeterol 1-hydroxy-2-naphthoate, Salmeterolo

Cas Number

94749-08-3

Unique Ingredient Identifier (UNII)

6EW8Q962A5

About Salmeterol Xinafoate

A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Betamican Manufacturers

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.

Betamican Suppliers

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.

Betamican USDMF

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.

Betamican 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 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.

Betamican CEP

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.

Betamican WC

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.

Betamican 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 Betamican as an active pharmaceutical ingredient (API).

Finished drug products

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

Compounded drug products

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 GMP

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.

Betamican CoA

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).

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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