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    Chemistry

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    Also known as: 136310-93-5, Spiriva, Ba 679 br, Tiotropium (bromide), Spiriva handihaler, Ba 679br
    Molecular Formula
    C19H22BrNO4S2
    Molecular Weight
    472.4  g/mol
    InChI Key
    DQHNAVOVODVIMG-RGECMCKFSA-M
    FDA UNII
    XX112XZP0J
    Tiotropium Bromide
    A scopolamine derivative and CHOLINERGIC ANTAGONIST that functions as a BRONCHODILATOR AGENT. It is used in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
    1 2D Structure

    Tiotropium Bromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(1R,2R,4S,5S)-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl] 2-hydroxy-2,2-dithiophen-2-ylacetate;bromide
    2.1.2 InChI
    InChI=1S/C19H22NO4S2.BrH/c1-20(2)12-9-11(10-13(20)17-16(12)24-17)23-18(21)19(22,14-5-3-7-25-14)15-6-4-8-26-15;/h3-8,11-13,16-17,22H,9-10H2,1-2H3;1H/q+1;/p-1/t11?,12-,13+,16-,17+;
    2.1.3 InChI Key
    DQHNAVOVODVIMG-RGECMCKFSA-M
    2.1.4 Canonical SMILES
    C[N+]1(C2CC(CC1C3C2O3)OC(=O)C(C4=CC=CS4)(C5=CC=CS5)O)C.[Br-]
    2.1.5 Isomeric SMILES
    C[N+]1([C@@H]2CC(C[C@H]1[C@H]3[C@@H]2O3)OC(=O)C(C4=CC=CS4)(C5=CC=CS5)O)C.[Br-]
    2.2 Other Identifiers
    2.2.1 UNII
    XX112XZP0J
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 679 Br, Ba

    2. 7-((hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane Bromide

    3. Ba 679 Br

    4. Ba-679 Br

    5. Ba679 Br

    6. Br, Ba 679

    7. Bromide, Tiotropium

    8. Spiriva

    9. Tiotropium

    2.3.2 Depositor-Supplied Synonyms

    1. 136310-93-5

    2. Spiriva

    3. Ba 679 Br

    4. Tiotropium (bromide)

    5. Spiriva Handihaler

    6. Ba 679br

    7. Ba-679 Br

    8. Spiriva Respimat

    9. (1r,2r,4s,5s,7s)-7-(2-hydroxy-2,2-di(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium Bromide

    10. Xx112xzp0j

    11. Chembl4638964

    12. 7-((hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane Bromide

    13. Ba-679-br

    14. (1r,2r,4s,5s,7r)-7-{[2-hydroxy-2,2-bis(thiophen-2-yl)acetyl]oxy}-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0^{2,4}]nonan-9-ium Bromide

    15. (1r,2r,4s,5s,7s)-7-(2-hydroxy-2,2-di(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0

    16. Tiopropium

    17. Tiotropium Bromide Anhydrous

    18. Ba-679br

    19. (1a,2b,4b,5a,7b)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide

    20. Ncgc00167971-01

    21. Tiotropium Bromide [inn]

    22. Unii-xx112xzp0j

    23. Tiotropium Bromide [usan:inn:ban]

    24. Tiotropium Bromide- Bio-x

    25. Schembl8625

    26. Dsstox_cid_24214

    27. Dsstox_rid_80122

    28. Dsstox_gsid_44214

    29. Schembl440873

    30. Schembl7607795

    31. Tiotropium Bromide [mi]

    32. Chembl3189058

    33. Chembl4440620

    34. Dtxsid2044214

    35. Chebi:90959

    36. Tiotropium Bromide [usan]

    37. Hms2090h20

    38. Act04740

    39. Act04741

    40. Amy23428

    41. Bcp02925

    42. Tiotropium Bromide [who-dd]

    43. Tox21_112598

    44. Bdbm50538220

    45. Mfcd00867027

    46. Akos015920264

    47. Akos025400979

    48. Ac-1300

    49. Cs-0903

    50. Ks-1402

    51. Tiotropium Bromide [orange Book]

    52. Tiotropium Bromide(spiriva, Ba 679br)

    53. As-75172

    54. Bt164474

    55. Hy-17360

    56. Bcp0726000293

    57. Cas-136310-93-5

    58. T3032

    59. A846824

    60. Q27162952

    61. (1?,2?,4?,5?,7?)-7-[(2-hydroxy-2,2-di-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide

    62. (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane Bromide

    63. (1r,2r,4s,5s)-7-{[2-hydroxy-2,2-bis(thiophen-2-yl)acetyl]oxy}-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0(2),?]nonan-9-ium Bromide

    64. (1r,2r,4s,5s,7r)-7-{[2-hydroxy-2,2-bis(thiophen-2-yl)acetyl]oxy}-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0?,?]nonan-9-ium Bromide

    65. (1r,2r,4s,5s,7s)-7-[2-hydroxy-2,2-di(2-thienyl)acetoxy]-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium Bromide

    66. [(1r,2r,4s,5s)-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl] 2-hydroxy-2,2-dithiophen-2-ylacetate;bromide

    67. [(1r,2r,4s,5s)-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonan-7-yl]2-hydroxy-2,2-dithiophen-2-yl-acetate Bromide

    68. 1.alpha., 2.beta., 4.beta, 5.alpha, 7.beta-7-((hydroxydi-2-thienylacetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0 Sup(2,4))nonane Bromide

    69. 3-oxa-9-azoniatricyclo(3,3.1.0(2,4))nonane, 7-((hydroxydi-2-thienylacetyl)oxy)-9,9-dimethyl-, Bromide, (1alpha,2beta,4beta,5alpha,7beta)-

    70. 3-oxa-9-azoniatricyclo(3.3.1.02,4)nonane, 7-((hydroxydi-2-thienacetyl)oxy)-9,9-dimethyl-, Bromide, (1.alpha.,2.beta.,4.beta.,5.alpha.,7.beta.)-

    71. 3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane, 7-[(2-hydroxy-2,2-di-2-thienylacetyl)oxy]-9,9-dimethyl-, Bromide (1:1), (1alpha,2beta,4beta,5alpha,7beta)-

    72. 6.beta.,7.beta.-epoxy-3.beta.-hydroxy-8-methyl-1.alpha.h,5.alpha.h-tropanium Bromide, Di-2-thienylglycolate

    73. Rel-(1r,2r,4s,5s,7s)-7-(2-hydroxy-2,2-di(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium Bromide

    74. Rel-(1r,2r,4s,5s,7s)-7-(2-hydroxy-2,2-di(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-iumbromide

    2.3.3 Other Synonyms

    1. Tiotropiumbromide

    2. Gsp 304

    3. Tiotropium Cation

    4. Respimat

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 472.4 g/mol
    Molecular Formula C19H22BrNO4S2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count5
    Exact Mass471.01736 g/mol
    Monoisotopic Mass471.01736 g/mol
    Topological Polar Surface Area116 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity564
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameSpiriva
    PubMed Healthtiotropium
    Drug ClassesBronchodilator
    Drug LabelSPIRIVA HandiHaler consists of a capsule dosage form containing a dry powder formulation of tiotropium intended for oral inhalation only with the HandiHaler device.Each light green, hard gelatin SPIRIVA capsule contains 18 mcg tiotropium (equivalent...
    Active IngredientTiotropium bromide
    Dosage FormPowder
    RouteInhalation
    Strengtheq 0.018mg base/inh
    Market StatusPrescription
    CompanyBoehringer Ingelheim
    Patent8022082; 6908928; RE38912; 7694676; RE39820; 7309707; 7642268; 7070800; 6777423

    2 of 4  
    Drug NameSpiriva respimat
    PubMed Healthtiotropium
    Drug LabelThe active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1, 2, 4, 5, 7)-7-[(Hydroxydi-2-thien...
    Active IngredientTiotropium bromide
    Dosage FormSpray, metered
    RouteInhalation
    Strengtheq 0.0025mg base/inh
    Market StatusPrescription
    CompanyBoehringer Ingelheim
    Patent7284474; 7802568; 6977042; 5964416; 7988001; 6176242; 6453795; RE39820; 7246615; 6988496; 7896264; 7837235; 6726124; 6846413; 6149054; 7396341; 7104470

    3 of 4  
    Drug NameSpiriva
    PubMed Healthtiotropium
    Drug ClassesBronchodilator
    Drug LabelSPIRIVA HandiHaler consists of a capsule dosage form containing a dry powder formulation of tiotropium intended for oral inhalation only with the HandiHaler device.Each light green, hard gelatin SPIRIVA capsule contains 18 mcg tiotropium (equivalent...
    Active IngredientTiotropium bromide
    Dosage FormPowder
    RouteInhalation
    Strengtheq 0.018mg base/inh
    Market StatusPrescription
    CompanyBoehringer Ingelheim
    Patent8022082; 6908928; RE38912; 7694676; RE39820; 7309707; 7642268; 7070800; 6777423

    4 of 4  
    Drug NameSpiriva respimat
    PubMed Healthtiotropium
    Drug LabelThe active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1, 2, 4, 5, 7)-7-[(Hydroxydi-2-thien...
    Active IngredientTiotropium bromide
    Dosage FormSpray, metered
    RouteInhalation
    Strengtheq 0.0025mg base/inh
    Market StatusPrescription
    CompanyBoehringer Ingelheim
    Patent7284474; 7802568; 6977042; 5964416; 7988001; 6176242; 6453795; RE39820; 7246615; 6988496; 7896264; 7837235; 6726124; 6846413; 6149054; 7396341; 7104470

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Cholinergic Antagonists

    Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)

    Parasympatholytics

    Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)

    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
    Cholinergic Antagonists [MoA]; Anticholinergic [EPC]
    5.3 ATC Code

    R03BB04

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    R - Respiratory system

    R03 - Drugs for obstructive airway diseases

    R03B - Other drugs for obstructive airway diseases, inhalants

    R03BB - Anticholinergics

    R03BB04 - Tiotropium bromide

    API Reference Price

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","supplierCountry":"INDIA","foreign_port":"","customer":"VAMSI LABS","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"156000","totalValueFC":"23719.2","currency":"USD","unitRateINR":"11512800","date":"17-Feb-2021","totalValueINR":"1726920","totalValueInUsd":"23719.2","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"2801570","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"","supplierAddress":"","customerAddress":"A-14 & 15, MIDC AREA, CHINCHOLI"},{"dataSource":"API Import","activeIngredients":"TIOTROPIUM BROMIDE","year":"2021","qtr":"Q2","strtotime":1621794600,"product":"TIOTROPIUM BROMIDE MONOHYDRATE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV-YAFO","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"8","unit":"GMS","unitRateFc":"480","totalValueFC":"3884.6","currency":"USD","unitRateINR":"35568","date":"24-May-2021","totalValueINR":"284544","totalValueInUsd":"3884.6","indian_port":"Indore-EPZ\/SEZ","hs_no":"29397990","bill_no":"1003420","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV-YAFO","supplierAddress":"N\/A","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640716200,"product":"TIOTROPIUM BROMIDE MONOHYDRATE (BATCH NO TIMHN0W805)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV-YAFO","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.40","actualQuantity":"400","unit":"GMS","unitRateFc":"530","totalValueFC":"216845.2","currency":"USD","unitRateINR":"40889.5","date":"29-Dec-2021","totalValueINR":"16355800","totalValueInUsd":"216845.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29397990","bill_no":"1008971","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV-YAFO","supplierAddress":"29 LEHI ST.BNEI-BRAK 5120050, PO BO X 2589 Israel","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648578600,"product":"TIOTROPIUM BROMIDE MONOHYDRATE API ( MICRONIZED)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"N\/A","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"750","totalValueFC":"7567","currency":"USD","unitRateINR":"57675","date":"30-Mar-2022","totalValueINR":"576750","totalValueInUsd":"7567","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29420090","bill_no":"1001257","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Micronized","supplierPort":"N\/A","supplierAddress":"21 COLONIAL DRIVE PISCATAWAY NJ US 8854","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654021800,"product":"TIOTROPIUM BROMIDE MONOHYDRATE PH.EUR (API) (BATCH NO.PR211595) (10 GRAM) (TIOTROPIUM BROMIDE MONOHYDRATE 1032) (R&D PUR","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"600000","totalValueFC":"6045","currency":"USD","unitRateINR":"47160000","date":"01-Jun-2022","totalValueINR":"471600","totalValueInUsd":"6045","indian_port":"BOMBAY AIR","hs_no":"29239000","bill_no":"8925712","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665340200,"product":"TIOTROPIUM BROMIDE MONOHYDRATE 1032 (TIOTROPIUM BROMIDE MONOHYDRATE PH.EUR (API) (BATCH NO. PR222078)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"600","totalValueFC":"6012.1","currency":"USD","unitRateINR":"49470","date":"10-Oct-2022","totalValueINR":"494700","totalValueInUsd":"6012.1","indian_port":"BOMBAY AIR","hs_no":"29239000","bill_no":"2813214","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665945000,"product":"TIOTROPIUM BROMIDE MONOHYDRATE MICRONIZED","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"IRELAND","foreign_port":"CORK","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.09","actualQuantity":"85","unit":"GMS","unitRateFc":"66.6","totalValueFC":"5671.1","currency":"USD","unitRateINR":"5489.9","date":"17-Oct-2022","totalValueINR":"466642","totalValueInUsd":"5671.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372900","bill_no":"1004301","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Micronized","supplierPort":"CORK","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671647400,"product":"TIOTROPIUM BROMIDE MONOHYDRATE 1032, BATCH NO PR222078 (FORRESEARCH USE ONLY)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"0.055","unit":"KGS","unitRateFc":"600000","totalValueFC":"33458","currency":"USD","unitRateINR":"50130000","date":"22-Dec-2022","totalValueINR":"2757150","totalValueInUsd":"33458","indian_port":"DELHI AIR","hs_no":"29239000","bill_no":"3855842","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698431400,"product":"TIOTROPIUM BROMIDE MONOHYDRATE EP (NON-MICRONISED) (RE-IMPORT)","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"","supplier":"SINO CARING HEALTH ","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"VAMSI LABS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"200000","totalValueFC":"20233.3","currency":"USD","unitRateINR":"16840000","date":"28-Oct-2023","totalValueINR":"1684000","totalValueInUsd":"20233.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8509254","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"SHANGHAI","supplierAddress":") CO.LTD.5F, BUILDING C8822, WORK PARK,HAINAN RESORT SOFTWARE COMMUNITYLAOCHENG TOWN,CHENGMAI, HAINAN CHINA","customerAddress":"A-14 15, MIDC AREA, CHINCHOLI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702146600,"product":"TIOTROPIUM BROMIDE MONOHYDRATE EP (MICRONISED) (RE-IMPORT)","address":"A-14 15, MIDC AREA, CHINCHOLI","city":"","supplier":"SINO CARING HEALTH ","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"VAMSI LABS","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"145000","totalValueFC":"7342","currency":"USD","unitRateINR":"12223500","date":"10-Dec-2023","totalValueINR":"611175","totalValueInUsd":"7342","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9159211","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"SHANGHAI","supplierAddress":") CO.LTD.5F, BUILDING C8822, WORK PARK,HAINAN RESORT SOFTWARE COMMUNITYLAOCHENG TOWN,CHENGMAI, HAINAN CHINA","customerAddress":"A-14 15, MIDC AREA, CHINCHOLI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"TIOTROPIUM BROMIDE MONOHYDRATE PH.EUR (API) (BATCH NO.PR231552\/PR241786) (29 GRAM) (TIOTROPIUM BROMIDE MONOHYDRATE 1032)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"CHEMO","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.029","unit":"KGS","unitRateFc":"600000","totalValueFC":"17591.2","currency":"USD","unitRateINR":"50970000","date":"24-Oct-2024","totalValueINR":"1478130","totalValueInUsd":"17591.2","indian_port":"Bombay Air","hs_no":"29239000","bill_no":"6307010","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"MANUEL POMBO ANGULO,28 3 FLOOR 2805 0 MADRID-SPAIN Madrid - 28050, Madr id, Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730831400,"product":"TIOTROPIUM BROMIDE MONOHYDRATE TIOTROPIUM BROMIDE MONOHYDRATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.015","unit":"KGS","unitRateFc":"175067.7","totalValueFC":"2643.5","currency":"USD","unitRateINR":"14872000","date":"06-Nov-2024","totalValueINR":"223080","totalValueInUsd":"2643.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397900","bill_no":"6517125","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LIOBREGAT C\/ARGENT, 1 08755 CASTELLBISBAL BARCELONA ES","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730831400,"product":"TIOTROPIUM BROMIDE MONOHYDRATE TIOTROPIUM BROMIDE MONOHYDRATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"175067.7","totalValueFC":"3524.7","currency":"USD","unitRateINR":"14872000","date":"06-Nov-2024","totalValueINR":"297440","totalValueInUsd":"3524.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397900","bill_no":"6517125","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LIOBREGAT C\/ARGENT, 1 08755 CASTELLBISBAL BARCELONA ES","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
    30-Jan-2021
    25-Nov-2024
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    ABOUT THIS PAGE

    Tiotropium bromide anhydrous Manufacturers

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

    Tiotropium bromide anhydrous Suppliers

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

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

    Tiotropium bromide anhydrous USDMF

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

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

    click here to find a list of Tiotropium bromide anhydrous suppliers with USDMF on PharmaCompass.

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

    Tiotropium bromide anhydrous KDMF

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

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

    After submitting a Tiotropium bromide anhydrous 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 Tiotropium bromide anhydrous API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Tiotropium bromide anhydrous suppliers with KDMF on PharmaCompass.

    Tiotropium bromide anhydrous CEP

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

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

    Tiotropium bromide anhydrous WC

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

    click here to find a list of Tiotropium bromide anhydrous suppliers with Written Confirmation (WC) on PharmaCompass.

    Tiotropium bromide anhydrous 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 Tiotropium bromide anhydrous as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Tiotropium bromide anhydrous suppliers with NDC on PharmaCompass.

    Tiotropium bromide anhydrous GMP

    Tiotropium bromide anhydrous 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 Tiotropium bromide anhydrous 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 Tiotropium bromide anhydrous GMP manufacturer or Tiotropium bromide anhydrous GMP API supplier for your needs.

    Tiotropium bromide anhydrous CoA

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

    Tiotropium bromide anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Tiotropium bromide anhydrous 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.

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