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    Chemistry

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    Also known as: Tolterodine tartrate, 124937-52-6, Detrol la, Detrusitol, Tolterodine l-tartrate, Pnu-200583e
    Molecular Formula
    C26H37NO7
    Molecular Weight
    475.6  g/mol
    InChI Key
    TWHNMSJGYKMTRB-KXYUELECSA-N
    FDA UNII
    5T619TQR3R
    Tolterodine Tartrate
    An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.
    1 2D Structure

    Tolterodine Tartrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3R)-2,3-dihydroxybutanedioic acid;2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
    2.1.2 InChI
    InChI=1S/C22H31NO.C4H6O6/c1-16(2)23(17(3)4)14-13-20(19-9-7-6-8-10-19)21-15-18(5)11-12-22(21)24;5-1(3(7)8)2(6)4(9)10/h6-12,15-17,20,24H,13-14H2,1-5H3;1-2,5-6H,(H,7,8)(H,9,10)/t20-;1-,2-/m11/s1
    2.1.3 InChI Key
    TWHNMSJGYKMTRB-KXYUELECSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=C(C=C1)O)C(CCN(C(C)C)C(C)C)C2=CC=CC=C2.C(C(C(=O)O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    CC1=CC(=C(C=C1)O)[C@H](CCN(C(C)C)C(C)C)C2=CC=CC=C2.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    5T619TQR3R
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Detrol La

    2. Detrusitol

    3. Pha 686464b

    4. Pha-686464b

    5. Pha686464b

    6. Tartrate, Tolterodine

    7. Tolterodine

    8. Tolterodine Tartrate

    9. Unidet

    10. Urotrol

    2.3.2 Depositor-Supplied Synonyms

    1. Tolterodine Tartrate

    2. 124937-52-6

    3. Detrol La

    4. Detrusitol

    5. Tolterodine L-tartrate

    6. Pnu-200583e

    7. (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol (2r,3r)-2,3-dihydroxysuccinate

    8. Tolterodine Tartrate [usan]

    9. Kabi-2234

    10. Urotrol

    11. 5t619tqr3r

    12. Pnu 200583e

    13. Tolterodine Tartrate (detrol La)

    14. 124937-52-6 (tartrate)

    15. Tolterodine (tartrate)

    16. (r)-2-(3-diisopropylamino-1-phenyl-propyl)-p-cresol L-tartrate

    17. (r)-2-(3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methylphenol (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1) (salt)

    18. (+)-(r)-2-(i-(2-(diisopropylamino)ethyl)benzyl)-p-cresol L-tartrate (1:1) (salt)

    19. Unii-5t619tqr3r

    20. (2r,3r)-2,3-dihydroxybutanedioic Acid;2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol

    21. Detrusitol Sr

    22. Mfcd07771985

    23. (r)-2-[3-(diisopropylamino)-1-phenylpropyl]-4-methylphenol L-tartrate

    24. Detrusitol (tn)

    25. Detrol (tn)

    26. Tolterodine, Tartrate

    27. (tolterodine Tartrate)

    28. Detrol La;kabi-2234;pnu-200583e

    29. Tolterodine Tartrate,(s)

    30. (r)-tolterodine L-tartrate

    31. Tolterodine Tartrate- Bio-x

    32. Mls003915640

    33. Schembl467372

    34. Chembl1200871

    35. Tolterodine Tartrate (jan/usp)

    36. Dtxsid80924972

    37. Tolterodine Tartrate [mi]

    38. Hms3715n08

    39. Hms3884j08

    40. Tolterodine Tartrate [jan]

    41. Tolterodine Tartrate [vandf]

    42. S2550

    43. Tolterodine Tartrate [mart.]

    44. Tolterodine Tartrate [usp-rs]

    45. Akos015961803

    46. Ac-2617

    47. Ccg-221263

    48. Cs-0441

    49. Ds-1398

    50. Tolterodine L-tartrate [who-dd]

    51. Tolterodine L-tartrate 124937-51-5

    52. (2r,3r)-2,3-dihydroxybutanedioic Acid,2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol

    53. As-35344

    54. Bt164484

    55. Hy-90010

    56. Phenol, 2-((1r)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-, (2r,3r)-2,3-dihydroxybutanedioate (1:1) (salt)

    57. Phenol, 2-(3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-, (r)-, (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1) (salt)

    58. Smr002544692

    59. Tolterodine L-tartrate, >=98% (hplc)

    60. Tolterodine Tartrate [orange Book]

    61. Bcp0726000292

    62. Tolterodine Tartrate [ep Monograph]

    63. Tolterodine Tartrate [usp Monograph]

    64. Sw197495-2

    65. D01148

    66. (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-

    67. 4-methylphenol (2r,3r)-2,3-dihydroxysuccinate

    68. 937t526

    69. A890340

    70. J-500064

    71. Q27114836

    72. (+)-(r)-2-(a-[2-(diisopropylamino)ethyl]benzyl)-p-cresol Tartrate

    73. (+)-r)-2-{a-(2-(diisopropylamino)ethyl)benzyl}-p-cresol Tartrate

    74. (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol(2r,3r)-2,3-dihydroxysuccinate

    75. (r)-2-(3-diisopropylamino-1-phenyl-propyl)-4-methyl-phenol L-tartrate

    76. 2-[(1r)-3-[bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol (2r,3r)-2,3-dihydroxybutanedioate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 475.6 g/mol
    Molecular Formula C26H37NO7
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count10
    Exact Mass475.25700252 g/mol
    Monoisotopic Mass475.25700252 g/mol
    Topological Polar Surface Area139 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity474
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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 6  
    Drug NameDetrol
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelDETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxyb...
    Active IngredientTolterodine tartrate
    Dosage FormTablet
    RouteOral
    Strength2mg; 1mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    2 of 6  
    Drug NameDetrol la
    Drug LabelDETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrat...
    Active IngredientTolterodine tartrate
    Dosage FormCapsule, extended release
    RouteOral
    Strength4mg; 2mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    3 of 6  
    Drug NameTolterodine tartrate
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelTolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (+)-(R)-2-[I-[2-(Diisopropylamino)ethyl]benzyl]-p-cresol L-tartrate (1:1) (sa...
    Active IngredientTolterodine tartrate
    Dosage FormTablet; Capsule, extended release
    Routeoral; Oral
    Strength1mg; 4mg; 2mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Sandoz

    4 of 6  
    Drug NameDetrol
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelDETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxyb...
    Active IngredientTolterodine tartrate
    Dosage FormTablet
    RouteOral
    Strength2mg; 1mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    5 of 6  
    Drug NameDetrol la
    Drug LabelDETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine L-hydrogen tartrat...
    Active IngredientTolterodine tartrate
    Dosage FormCapsule, extended release
    RouteOral
    Strength4mg; 2mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    6 of 6  
    Drug NameTolterodine tartrate
    PubMed HealthTolterodine (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelTolterodine tartrate tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (+)-(R)-2-[I-[2-(Diisopropylamino)ethyl]benzyl]-p-cresol L-tartrate (1:1) (sa...
    Active IngredientTolterodine tartrate
    Dosage FormTablet; Capsule, extended release
    Routeoral; Oral
    Strength1mg; 4mg; 2mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Sandoz

    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]

    API Reference Price

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MALPENSA","supplierAddress":"VIA FRANCESCO BARACCA, 19-24060 SAN PAOLO D\\'ARGON (BG) ITALY,SDNF Italy","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711477800,"product":"TOLTERODINE TARTRATE","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"AMINO CHEMICALS","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"2400","totalValueFC":"13367.7","currency":"EUR","unitRateINR":"222000","date":"27-Mar-2024","totalValueINR":"1110000","totalValueInUsd":"13367.7","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"2764271","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"MRA050X INDUSTRIAL ESTATE MARSA, MRS300 MALTASDNF Malta","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"TOLTERODINE TARTRATE USP","address":"UNIT NO.703 704,7TH FLOOR,HUBTOWN","city":"MUMBAI","supplier":"FLAVINE","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"INVENTIA HEALTHCARE LIMITED","customerCountry":"INDIA","quantity":"1.35","actualQuantity":"1.35","unit":"KGS","unitRateFc":"2700","totalValueFC":"3687.3","currency":"USD","unitRateINR":"226800","date":"28-Mar-2024","totalValueINR":"306180","totalValueInUsd":"3687.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2782477","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"61 South Paramus Road, Suite 565 Paramus, New Jersey 07652SDNF UNITED STATES","customerAddress":"UNIT NO.703 704,7TH FLOOR,HUBTOWN"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"TOLTERODINE TARTRATE USP","address":"UNIT NO.703 704,7TH FLOOR,HUBTOWN","city":"MUMBAI","supplier":"FLAVINE","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"INVENTIA HEALTHCARE LIMITED","customerCountry":"INDIA","quantity":"38.45","actualQuantity":"38.45","unit":"KGS","unitRateFc":"2700","totalValueFC":"105020.5","currency":"USD","unitRateINR":"226800","date":"28-Mar-2024","totalValueINR":"8720460","totalValueInUsd":"105020.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2782477","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"61 South Paramus Road, Suite 565 Paramus, New Jersey 07652SDNF UNITED STATES","customerAddress":"UNIT NO.703 704,7TH FLOOR,HUBTOWN"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711650600,"product":"TOLTERODINE TARTRATE PH EUR,(EU) (TOLTERODINE TARTRATE EP\/BP\/IP\/USP\/PH.EUR.) (6904017)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.31","actualQuantity":"3308","unit":"GMS","unitRateFc":"4.5","totalValueFC":"16582.7","currency":"EUR","unitRateINR":"416.3","date":"29-Mar-2024","totalValueINR":"1376955","totalValueInUsd":"16582.7","indian_port":"Delhi Air","hs_no":"29071290","bill_no":"2799057","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA 1008173 SANT CUGAT DEL VALLESBARCELONA SPAIN","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711650600,"product":"TOLTERODINE TARTRATE PH EUR,(EU) (TOLTERODINE TARTRATE EP\/BP\/IP\/USP\/PH.EUR.) 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    15-Apr-2021
    21-Feb-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 20771

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    DOSAGE - TABLET;ORAL - 2MG

    USFDA APPLICATION NUMBER - 20771

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2MG

    USFDA APPLICATION NUMBER - 21228

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 4MG

    USFDA APPLICATION NUMBER - 21228

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    ABOUT THIS PAGE

    Looking for 124937-52-6 / Tolterodine Tartrate API manufacturers, exporters & distributors?

    Tolterodine Tartrate manufacturers, exporters & distributors 1

    12

    PharmaCompass offers a list of Tolterodine Tartrate 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 Tolterodine Tartrate manufacturer or Tolterodine Tartrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tolterodine Tartrate manufacturer or Tolterodine Tartrate supplier.

    PharmaCompass also assists you with knowing the Tolterodine Tartrate API Price utilized in the formulation of products. Tolterodine Tartrate API Price is not always fixed or binding as the Tolterodine Tartrate Price is obtained through a variety of data sources. The Tolterodine Tartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Tolterodine Tartrate

    Synonyms

    124937-52-6, Detrol la, Detrusitol, Tolterodine l-tartrate, Pnu-200583e, (r)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol (2r,3r)-2,3-dihydroxysuccinate

    Cas Number

    124937-52-6

    Unique Ingredient Identifier (UNII)

    5T619TQR3R

    About Tolterodine Tartrate

    An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.

    Detrusitol SR Manufacturers

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

    Detrusitol SR Suppliers

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

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

    Detrusitol SR USDMF

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

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

    click here to find a list of Detrusitol SR suppliers with USDMF on PharmaCompass.

    Detrusitol SR KDMF

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

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

    After submitting a Detrusitol SR 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 Detrusitol SR API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Detrusitol SR suppliers with KDMF on PharmaCompass.

    Detrusitol SR CEP

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

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

    Detrusitol SR WC

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

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

    Detrusitol SR 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 Detrusitol SR as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Detrusitol SR suppliers with NDC on PharmaCompass.

    Detrusitol SR GMP

    Detrusitol SR 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 Detrusitol SR 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 Detrusitol SR GMP manufacturer or Detrusitol SR GMP API supplier for your needs.

    Detrusitol SR CoA

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

    Detrusitol SR CoA mostly includes findings from lab analyses of a specific batch. For each Detrusitol SR 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.

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