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    Synopsis

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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]

    API Reference Price

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ORDER","customerCountry":"RUSSIA","quantity":"0.04","actualQuantity":"0.039","unit":"KGS","unitRateFc":"2024000","totalValueFC":"892.5","currency":"INR","unitRateINR":1922846.1538461538,"date":"25-Oct-2024","totalValueINR":"74991","totalValueInUsd":"892.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5110421","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"SALMETEROL XINAFOATE EP (MICRONISED)","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"N\/A","supplier":"VAMSI LABS","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"TO THE ORDER OF....","customerCountry":"PAKISTAN","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"8.5","totalValueFC":"811.8","currency":"USD","unitRateINR":682.11800000000005,"date":"26-Oct-2024","totalValueINR":"68211.8","totalValueInUsd":"811.8","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5160386","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"A-14 15, MIDC AREA, CHINCHOLI, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"SALMETEROL XINAFOATE","address":"SANALI INFO PARK, A BLOCK","city":"ROAD NO.2, BANJARA HILLS, HYDERABAD","supplier":"NEULAND LABORATORIES","supplierCountry":"INDIA","foreign_port":"DUBLIN","customer":"TO THE ORDER OF","customerCountry":"IRELAND","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"68000","totalValueFC":"60588.7","currency":"USD","unitRateINR":5681079.0222222218,"date":"19-Nov-2024","totalValueINR":"5112971.12","totalValueInUsd":"60588.7","indian_port":"Hyderabad Air","hs_no":"29062990","bill_no":"5735816","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":"2024","qtr":"Q4","strtotime":1732732200,"product":"SALMETEROL XINAFOATE EP (MICRONISED) (PSD-D99 BELOW 5 MICRONS)","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"N\/A","supplier":"VAMSI LABS","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF....","customerCountry":"BANGLADESH","quantity":"1.00","actualQuantity":"1000","unit":"GMS","unitRateFc":"10.5","totalValueFC":"10393.7","currency":"USD","unitRateINR":877.10748999999998,"date":"28-Nov-2024","totalValueINR":"877107.49","totalValueInUsd":"10393.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5973829","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"A-14 15, MIDC AREA, CHINCHOLI, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"SALMETEROL XINAFOATE EP (PHARMACEUTICALRAW MATERIALS) (PEX\/0961\/24-25 DT: 29.11.2024)","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"MINSK","customer":"TO ORDER","customerCountry":"BELARUS","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1553120","totalValueFC":"17845.9","currency":"INR","unitRateINR":1516350,"date":"05-Dec-2024","totalValueINR":"1516350","totalValueInUsd":"17845.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6196797","productDescription":"API","marketType":"REGULATED MARKET","country":"BELARUS","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733509800,"product":"SALMETEROL XINAFOATE (PHARMACEUTICAL RAWMATERIALS) (PEX\/0962\/24-25 DT: 29.11.2024)","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"AARTI PHARMALABS","supplierCountry":"INDIA","foreign_port":"SHANGHAI - PU DONG","customer":"TO ORDER","customerCountry":"CHINA","quantity":"0.27","actualQuantity":"0.27","unit":"KGS","unitRateFc":"35000","totalValueFC":"9294.4","currency":"USD","unitRateINR":2924933.333333333,"date":"07-Dec-2024","totalValueINR":"789732","totalValueInUsd":"9294.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6253886","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"2ND FLOOR, GODOWN No. 204, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1625077800,"product":"SALMETEROL XINAFOATE","address":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"135000","totalValueFC":"4075.7","currency":"EUR","unitRateINR":"12150000","date":"01-Jul-2021","totalValueINR":"303750","totalValueInUsd":"4075.7","indian_port":"HYDERABAD AIR","hs_no":"29225090","bill_no":"4528310","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728671400,"product":"(RE- IMPORT) (SB NO. 7765224 DT. 23.02.2024)SALMETEROL XINAFOATE PH.EUR","address":"2ND FLOOR, GODOWN No. 204","city":"MUMBAI","supplier":"GENETIC S.P.A.","supplierCountry":"INDIA","foreign_port":"MILAN - MALPENSA","customer":"AARTI PHARMALABS","customerCountry":"INDIA","quantity":"1.94","actualQuantity":"1.94","unit":"KGS","unitRateFc":"13500","totalValueFC":"29376.5","currency":"EUR","unitRateINR":"1272375","date":"12-Oct-2024","totalValueINR":"2468407.5","totalValueInUsd":"29376.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6084384","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"CONTRADA CONFORA SNC ZONA INDUSTRIALE 84084 FISCIANO (SALERNO) - ITALY SDNF","customerAddress":"2ND FLOOR, GODOWN No. 204"}]
    13-Jan-2021
    07-Dec-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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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

    Salmeterol Xinafoate Manufacturers

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

    Salmeterol Xinafoate Suppliers

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

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

    Salmeterol Xinafoate USDMF

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

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

    click here to find a list of Salmeterol Xinafoate suppliers with USDMF on PharmaCompass.

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

    Salmeterol Xinafoate CEP

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

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

    Salmeterol Xinafoate WC

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

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

    Salmeterol Xinafoate 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 Salmeterol Xinafoate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Salmeterol Xinafoate 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 Salmeterol Xinafoate 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 Salmeterol Xinafoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Salmeterol Xinafoate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Salmeterol Xinafoate suppliers with NDC on PharmaCompass.

    Salmeterol Xinafoate GMP

    Salmeterol Xinafoate 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 Salmeterol Xinafoate 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 Salmeterol Xinafoate GMP manufacturer or Salmeterol Xinafoate GMP API supplier for your needs.

    Salmeterol Xinafoate CoA

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

    Salmeterol Xinafoate CoA mostly includes findings from lab analyses of a specific batch. For each Salmeterol Xinafoate 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.

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