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    Chemistry

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    Also known as: Darifenacin hbr, 133099-07-7, Emselex, Darifenacin (hydrobromide), Darifenacin hydrobromide [usan], Cr02eyq8gv
    Molecular Formula
    C28H31BrN2O2
    Molecular Weight
    507.5  g/mol
    InChI Key
    UQAVIASOPREUIT-VQIWEWKSSA-N
    FDA UNII
    CR02EYQ8GV
    Darifenacin Hydrobromide
    1 2D Structure

    Darifenacin Hydrobromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide
    2.1.2 InChI
    InChI=1S/C28H30N2O2.BrH/c29-27(31)28(23-7-3-1-4-8-23,24-9-5-2-6-10-24)25-14-17-30(20-25)16-13-21-11-12-26-22(19-21)15-18-32-26;/h1-12,19,25H,13-18,20H2,(H2,29,31);1H/t25-;/m1./s1
    2.1.3 InChI Key
    UQAVIASOPREUIT-VQIWEWKSSA-N
    2.1.4 Canonical SMILES
    C1CN(CC1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br
    2.1.5 Isomeric SMILES
    C1CN(C[C@@H]1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5.Br
    2.2 Other Identifiers
    2.2.1 UNII
    CR02EYQ8GV
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (s)-1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide

    2. Darifenacin

    3. Darifenacin Hydrochloride

    4. Darifenacine

    5. Darifenicin

    6. Emselex

    7. Enablex

    8. Uk-88525

    2.3.2 Depositor-Supplied Synonyms

    1. Darifenacin Hbr

    2. 133099-07-7

    3. Emselex

    4. Darifenacin (hydrobromide)

    5. Darifenacin Hydrobromide [usan]

    6. Cr02eyq8gv

    7. 2-[(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide Hydrobromide

    8. Uk-88525-04 (hydrobromide)

    9. Chebi:31455

    10. Uk-88525-04 (hbr)

    11. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)pyrrolidin-3-yl)-2,2-diphenylacetamide Hydrobromide

    12. 133099-07-7 (hbr)

    13. Dsstox_cid_26780

    14. Dsstox_rid_81899

    15. Dsstox_gsid_46780

    16. (s)-2-{1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl}-2,2-diphenylacetamide Hydrobromide

    17. Uk-88525

    18. Darilong

    19. 2-[(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide

    20. Uk 88525-04 Hydrobromide

    21. Cas-133099-07-7

    22. Ncgc00168775-01

    23. Unii-cr02eyq8gv

    24. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl)-2,2-diphenylacetamide Hydrobromide

    25. 2-{(3s)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl}-2,2-diphenylacetamide Hydrobromide

    26. Enablex (tn)

    27. Darifenacinhydrobromide

    28. Diphenyl-acetamide Hydrobromide

    29. Darifenacin Hydrobromide- Bio-x

    30. Chembl1200935

    31. Dtxsid9046780

    32. Hy-a0012

    33. Tox21_112636

    34. Darifenacin Hydrobromide (jan/usan)

    35. Darifenacin Hydrobromide [mi]

    36. Mfcd08141803

    37. S3144

    38. Darifenacin Hydrobromide [jan]

    39. Akos015969311

    40. Tox21_112636_1

    41. Ac-1894

    42. Ccg-220969

    43. Cs-0380

    44. Darifenacin Hydrobromide [mart.]

    45. Darifenacin Hydrobromide [usp-rs]

    46. Darifenacin Hydrobromide [who-dd]

    47. Ncgc00263922-02

    48. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, Monohydrobromide, (3s)-

    49. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, Monohydrobromide, (s)-

    50. 3-pyrrolidineacetamide, 1-[2-(2,3-dihydro-5-benzofuranyl)ethyl]-alpha,alpha-diphenyl-, Hydrobromide (1:1), (3s)-

    51. As-35087

    52. Bd164350

    53. Darifenacin Hydrobromide [ema Epar]

    54. Darifenacin Hydrobromide, >=98% (hplc)

    55. Sw219426-1

    56. Darifenacin Hydrobromide [orange Book]

    57. Uk-88525-04

    58. D01699

    59. Q-101006

    60. Q27114313

    61. Z1691545283

    62. Darifenacin Hydrobromide, United States Pharmacopeia (usp) Reference Standard

    63. (s)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl)-2,2-diphenylacetamide Hbr

    64. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-.alpha.,.alpha.-diphenyl-, Monohbr, (3s)-

    65. 3-pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-.alpha.,.alpha.-diphenyl-, Monohydrobromide, (3s)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 507.5 g/mol
    Molecular Formula C28H31BrN2O2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count7
    Exact Mass506.15689 g/mol
    Monoisotopic Mass506.15689 g/mol
    Topological Polar Surface Area55.6 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity607
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 NameDarifenacin hydrobromide
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    Routeoral
    Strength7.5mg; 15mg
    Market StatusTentative Approval
    CompanyAnchen Pharms

    2 of 4  
    Drug NameEnablex
    PubMed HealthDarifenacin (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelENABLEX (darifenacin) is an extended-release tablet which contains 7.5mg or 15mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.Chemically, darifenacin hydrobromide is (S)-2-{1-[...
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 15mg base; eq 7.5mg base
    Market StatusPrescription
    CompanyWarner Chilcott

    3 of 4  
    Drug NameDarifenacin hydrobromide
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    Routeoral
    Strength7.5mg; 15mg
    Market StatusTentative Approval
    CompanyAnchen Pharms

    4 of 4  
    Drug NameEnablex
    PubMed HealthDarifenacin (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelENABLEX (darifenacin) is an extended-release tablet which contains 7.5mg or 15mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.Chemically, darifenacin hydrobromide is (S)-2-{1-[...
    Active IngredientDarifenacin hydrobromide
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 15mg base; eq 7.5mg base
    Market StatusPrescription
    CompanyWarner Chilcott

    4.2 Drug Indication

    Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Muscarinic Antagonists

    Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)

    Urological Agents

    Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cholinergic Muscarinic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]
    5.3 ATC Code

    G04BD10

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C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM","customerCountry":"SWITZERLAND","quantity":"35.00","actualQuantity":"35","unit":"KGS","unitRateFc":"3316.5","totalValueFC":"115044.7","currency":"USD","unitRateINR":248000,"date":"06-Apr-2022","totalValueINR":"8680000","totalValueInUsd":"115044.7","indian_port":"HYDERABAD AIR","hs_no":"29213090","bill_no":"9505937","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1652293800,"product":"DARIFENACIN HYDROBROMIDE (TAX INVOICE NO","address":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"LINDOPHARM GMBH","customerCountry":"SPAIN","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"6150","totalValueFC":"41611.8","currency":"USD","unitRateINR":459428.57142857142,"date":"12-May-2022","totalValueINR":"3216000","totalValueInUsd":"41611.8","indian_port":"HYDERABAD AIR","hs_no":"29213090","bill_no":"1336665","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655231400,"product":"DARIFENACIN HYDROBROMIDE","address":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"TO THE ORDER OF","customerCountry":"SWITZERLAND","quantity":"42.30","actualQuantity":"42.3","unit":"KGS","unitRateFc":"3316.5","totalValueFC":"137460.2","currency":"USD","unitRateINR":253522.45862884162,"date":"15-Jun-2022","totalValueINR":"10724000","totalValueInUsd":"137460.2","indian_port":"HYDERABAD AIR","hs_no":"29213090","bill_no":"2144114","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657477800,"product":"DARIFENACIN HYDROBROMIDE","address":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"TO THE ORDER OF","customerCountry":"SPAIN","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"6150","totalValueFC":"17983.7","currency":"USD","unitRateINR":476666.66666666669,"date":"11-Jul-2022","totalValueINR":"1430000","totalValueInUsd":"17983.7","indian_port":"HYDERABAD AIR","hs_no":"29213090","bill_no":"2743482","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690223400,"product":"DARIFENACIN HYDROBROMIDE","address":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"HAMBURG - FUHLSBUETT","customer":"TO THE ORDER OF.,","customerCountry":"GERMANY","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"4500","totalValueFC":"442988.3","currency":"USD","unitRateINR":364089.9963,"date":"25-Jul-2023","totalValueINR":"36408999.63","totalValueInUsd":"442988.3","indian_port":"HYDERABAD AIR","hs_no":"29213090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE ,PLOT NO. C-24, INDUSTRIAL ESTATE,SANATHNAGAR,HYDER, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705861800,"product":"DARIFENACIN HYDROBROMIDE","address":"PLOT NO. C-24, INDUSTRIAL ESTATE,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM","customerCountry":"SWITZERLAND","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"3069","totalValueFC":"4351","currency":"USD","unitRateINR":241077.48666666666,"date":"22-Jan-2024","totalValueINR":"361616.23","totalValueInUsd":"4351","indian_port":"Hyderabad Air","hs_no":"29213090","bill_no":"6916343","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. C-24, INDUSTRIAL ESTATE,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711391400,"product":"ACTIVE PHARMACEUTICAL INGREDIENTS - OTHER ORGANIC CHEMICAL COMPOUNDS: DARIFENACIN HYDROBROMIDE","address":"SETHNA BUILDING, 4TH FLR,","city":"LINES, MUMBAI ,MAHARASHTRA","supplier":"MEGAFINE PHARMA (P) LIMITED","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF","customerCountry":"BRAZIL","quantity":"57.00","actualQuantity":"57","unit":"KGS","unitRateFc":"4700","totalValueFC":"263995.3","currency":"USD","unitRateINR":384580,"date":"26-Mar-2024","totalValueINR":"21921060","totalValueInUsd":"263995.3","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"8626163","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SETHNA BUILDING, 4TH FLR,, LINES, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716575400,"product":"ACTIVE PHARMACEUTICAL INGREDIENTS OTHERORGANIC COMPOUNDS: DARIFENACIN HYDROBROMIDE","address":"SETHNA BUILDING, 4TH FLR,","city":"LINES, MUMBAI ,MAHARASHTRA","supplier":"MEGAFINE PHARMA (P) LIMITED","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER OF,","customerCountry":"BRAZIL","quantity":"63.36","actualQuantity":"63.36","unit":"KGS","unitRateFc":"4700","totalValueFC":"294676.4","currency":"USD","unitRateINR":387665.8585858586,"date":"25-May-2024","totalValueINR":"24562508.8","totalValueInUsd":"294676.4","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"1157478","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"SETHNA BUILDING, 4TH FLR,, LINES, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730399400,"product":"DARIFENACIN HYDROBROMIDE","address":"PLOT NO. C-24, INDUSTRIAL ESTATE,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM","customerCountry":"SWITZERLAND","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"3069","totalValueFC":"15005.8","currency":"USD","unitRateINR":253262.60000000001,"date":"01-Nov-2024","totalValueINR":"1266313","totalValueInUsd":"15005.8","indian_port":"Hyderabad Air","hs_no":"29213090","bill_no":"5313045","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. C-24, INDUSTRIAL ESTATE,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"DARIFENACIN HYDROBROMIDE","year":"2021","qtr":"Q2","strtotime":1618425000,"product":"DAR00,DARIFENACIN HYDROBROMIDE (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IVPHASE,JIGANI LINK ROAD,JIGANI HOBLI","city":"ANEKAL TALUK,BANGALORE","supplier":"APOTEX INC","supplierCountry":"CANADA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"30.24","actualQuantity":"30.24","unit":"KGS","unitRateFc":"7595","totalValueFC":"228750.2","currency":"USD","unitRateINR":"563169.3","date":"15-Apr-2021","totalValueINR":"17030238.12","totalValueInUsd":"228750.2","indian_port":"BANGALORE AIR","hs_no":"29349990","bill_no":"3571149","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IVPHASE,JIGANI LINK ROAD,JIGANI HOBLI"}]
    02-Feb-2021
    01-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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

    API Imports and Exports

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    (USD/KGS)    		 Number of Transactions

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    INTERMEDIATES SUPPLIERS

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    01

    Dalian Richon Chem

    China
    BIO Partnering at JPM
    Not Confirmed
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    Dalian Richon Chem

    China
    BIO Partnering at JPM
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    5-(2-bromoethyl)-2,3-dihydrobenzofuran

    CAS Number : 127264-14-6

    End Use API : Darifenacin Hydrobromide

    About The Company : Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceu...

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    02

    Dalian Richon Chem

    China
    BIO Partnering at JPM
    Not Confirmed
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    Dalian Richon Chem

    China
    BIO Partnering at JPM
    Not Confirmed
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    2,2-Diphenyl-2-[(3S)-pyrrolidin-3-yl]acetamide L-(...

    CAS Number : 134002-26-9

    End Use API : Darifenacin Hydrobromide

    About The Company : Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceu...

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    03

    Luna Chemicals

    China
    BIO Partnering at JPM
    Not Confirmed
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    Luna Chemicals

    China
    BIO Partnering at JPM
    Not Confirmed
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    5-(2-Bromoethyl)-2,3-dihydrobenzofuran

    CAS Number : 127264-14-6

    End Use API : Darifenacin Hydrobromide

    About The Company : LUNA Chemicals Co.,Ltd. markets and manufactures world-class quality Active Pharmaceutical Ingredients and intermediate chemicals for generic pharmaceutical com...

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    04

    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    2,2-Diphenyl-2-((R)-pyrrolidin-3-yl)acetonitrile h...

    CAS Number : 194602-27-2

    End Use API : Darifenacin Hydrobromide

    About The Company : Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most p...

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    05

    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    3-(S)-(+)-(1-carbamoyl-1,1-diphenylmethyl) pyrroli...

    CAS Number : 134002-26-9

    End Use API : Darifenacin Hydrobromide

    About The Company : Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most p...

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    06

    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    5-(2-chloroethyl)-2,3-dihydrobenzofuran

    CAS Number : 943034-50-2

    End Use API : Darifenacin Hydrobromide

    About The Company : Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most p...

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    07

    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    Shodhana Laboratories

    India
    BIO Partnering at JPM
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    5-(2-bromoethyl)-2,3-dihydrobenzofuran

    CAS Number : 127264-14-6

    End Use API : Darifenacin Hydrobromide

    About The Company : Established in 2000, Shodhana Laboratories offers a wide range of APIs and intermediates and caters to the generic and custom requirements of some of the most p...

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    08

    Shree Ganesh Remedies

    India
    BIO Partnering at JPM
    Not Confirmed
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    Shree Ganesh Remedies

    India
    BIO Partnering at JPM
    Not Confirmed
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    Diphenyl Acetonitrile

    CAS Number : 86-29-3

    End Use API : Darifenacin Hydrobromide

    About The Company : Shree Ganesh Remedies is established Since 1995 with an aim to manufacture, supply and export best quality of Pharmaceutical-intermediates, Bulk drugs and Speci...

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21513

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21513

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    Patents & EXCLUSIVITIES

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    USP

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    ANALYTICAL

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    ABOUT THIS PAGE

    Darifenacin Hydrobromide Manufacturers

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

    Darifenacin Hydrobromide Suppliers

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

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

    Darifenacin Hydrobromide USDMF

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

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

    click here to find a list of Darifenacin Hydrobromide suppliers with USDMF on PharmaCompass.

    Darifenacin Hydrobromide WC

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

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

    Darifenacin Hydrobromide 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 Darifenacin Hydrobromide as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Darifenacin Hydrobromide suppliers with NDC on PharmaCompass.

    Darifenacin Hydrobromide GMP

    Darifenacin Hydrobromide 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 Darifenacin Hydrobromide 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 Darifenacin Hydrobromide GMP manufacturer or Darifenacin Hydrobromide GMP API supplier for your needs.

    Darifenacin Hydrobromide CoA

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

    Darifenacin Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Darifenacin Hydrobromide 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.

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