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    Chemistry

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    Also known as: Oxybutynin hydrochloride, 1508-65-2, Oxybutynin hcl, Tropax, Oxybutynin (chloride), Ditropan xl
    Molecular Formula
    C22H32ClNO3
    Molecular Weight
    393.9  g/mol
    InChI Key
    SWIJYDAEGSIQPZ-UHFFFAOYSA-N
    FDA UNII
    L9F3D9RENQ
    Oxybutynin Hydrochloride
    Oxybutynin Chloride is the chloride salt form of oxybutynin, a tertiary amine and anticholinergic agent with antispasmodic activity. Oxybutynin chloride exerts its antimuscarinic effect on bladder smooth muscle by blocking muscarinic receptors in smooth muscle, thereby inhibiting acetylcholine binding. This results in a relaxation of bladder smooth muscle, a reduction of involuntary muscle contractions and delays the initial desire to void.
    1 2D Structure

    Oxybutynin Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride
    2.1.2 InChI
    InChI=1S/C22H31NO3.ClH/c1-3-23(4-2)17-11-12-18-26-21(24)22(25,19-13-7-5-8-14-19)20-15-9-6-10-16-20;/h5,7-8,13-14,20,25H,3-4,6,9-10,15-18H2,1-2H3;1H
    2.1.3 InChI Key
    SWIJYDAEGSIQPZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCN(CC)CC#CCOC(=O)C(C1CCCCC1)(C2=CC=CC=C2)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    L9F3D9RENQ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate

    2. 4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate

    3. Apo-oxybutynin

    4. Contimin

    5. Cystonorm

    6. Cystrin

    7. Ditropan

    8. Dresplan

    9. Dridase

    10. Driptane

    11. Gelnique

    12. Gen-oxybutynin

    13. Novo-oxybutynin

    14. Nu-oxybutyn

    15. Oxyb Abz

    16. Oxybugamma

    17. Oxybutin Holsten

    18. Oxybuton

    19. Oxybutynin

    20. Oxybutynin Al

    21. Oxybutynin Azu

    22. Oxybutynin Heumann

    23. Oxybutynin Hexal

    24. Oxybutynin Hydrochloride

    25. Oxybutynin Stada

    26. Oxybutynin Von Ct

    27. Oxybutynin-puren

    28. Oxybutynin-ratiopharm

    29. Oxymedin

    30. Oxytrol

    31. Pms-oxybutynin

    32. Pollakisu

    33. Renamel

    34. Ryol

    35. Spasmex Oxybutynin

    36. Spasyt

    37. Tavor

    38. Zatur

    2.3.2 Depositor-Supplied Synonyms

    1. Oxybutynin Hydrochloride

    2. 1508-65-2

    3. Oxybutynin Hcl

    4. Tropax

    5. Oxybutynin (chloride)

    6. Ditropan Xl

    7. Pollakisu

    8. Mj 4309-1

    9. L9f3d9renq

    10. Nsc-759108

    11. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester Hydrochloride

    12. Mls000069688

    13. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

    14. Dridase

    15. Smr000058490

    16. Mj-4309-1

    17. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride

    18. Oxybutynin Hydrochloride (jan)

    19. 4-diethylamino-2-butynyl Phenyl(cyclohexyl)glycolate Hydrochloride

    20. 4-(diethylamino)-2-butynyl Alpha-phenylcyclohexaneglycolate Hydrochloride

    21. Gelnique

    22. Oxibutinina Hydrochloride

    23. Oxybutynin Hydrochloride [jan]

    24. Chebi:7857

    25. 4-diethylaminobut-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylethanoate Hydrochloride

    26. Oxybutynin Chloride [usan]

    27. Oxybutyninhydrochloride

    28. Sr-01000000184

    29. Einecs 216-139-7

    30. Unii-l9f3d9renq

    31. 4-(diethylamino)but-2-ynyl Cyclohexylphenylglycolate Hydrochloride

    32. Oxybutynin Chloride [usan:usp]

    33. Ditropan (tn)

    34. Gelnique (tn)

    35. Prestwick_621

    36. Mfcd00072150

    37. Oxybutynin-d11 Hcl

    38. 4-(diethylamino)but-2-yn-1-yl Cyclohexyl(hydroxy)phenylacetate Hydrochloride

    39. Opera_id_1330

    40. Ncgc00016583-01

    41. Oxybutynin (hydrochloride)

    42. Oxybutynin Chloride (usp)

    43. Cas-1508-65-2

    44. Chembl1133

    45. Dsstox_cid_25356

    46. Dsstox_rid_80822

    47. Dsstox_gsid_45356

    48. Schembl25751

    49. Mls001148211

    50. Mls002222232

    51. Regid_for_cid_91505

    52. Dtxsid3045356

    53. Hy-b0267a

    54. (s)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

    55. Hms1568j16

    56. Pharmakon1600-01505399

    57. (r,s) - Oxybutynin Hydrochloride

    58. Oxybutynin Chloride [vandf]

    59. Bcp12138

    60. Oxybutynin Chloride-(phenyl-[d5])

    61. Tox21_110507

    62. Tox21_500923

    63. Nsc759108

    64. Oxybutynin Chloride [usp-rs]

    65. Oxybutynin Hydrochloride [mi]

    66. S3117

    67. 4-(diethylamino)-2-butynyl (+-)-alpha-phenylcyclohexaneglycolate Hydrochloride

    68. Akos015895349

    69. Ccg-213420

    70. H33o205

    71. Ks-1377

    72. Lp00923

    73. Nc00580

    74. Nsc 759108

    75. Cyclohexaneglycolic Acid, Alpha-phenyl-, 4-(diethylamino)-2-butynyl Ester, Hydrochloride

    76. Oxybutynin Hydrochloride [mart.]

    77. Ncgc00094234-01

    78. Ncgc00094234-02

    79. Ncgc00261608-01

    80. Oxybutynin Chloride [orange Book]

    81. Oxybutynin Hydrochloride [who-dd]

    82. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride

    83. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+-)-

    84. Bo166187

    85. Oxybutynin Chloride [usp Impurity]

    86. Oxybutynin Chloride [usp Monograph]

    87. Eu-0100923

    88. Ft-0603563

    89. Ft-0673411

    90. Ft-0673412

    91. O0451

    92. Oxybutynin Chloride, >=98% (tlc), Powder

    93. Sw196787-4

    94. A51042

    95. D00722

    96. O 2881

    97. Oxybutynin Hydrochloride [ep Monograph]

    98. Oxybutynin Hydrochloride [usp Impurity]

    99. A809082

    100. J-008750

    101. Sr-01000000184-2

    102. Sr-01000000184-7

    103. Q27107600

    104. Oxybutynin Chloride, Meets Ep, Usp Testing Specifications

    105. Oxybutynin Chloride, United States Pharmacopeia (usp) Reference Standard

    106. Oxybutynin Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    107. Oxybutynin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    108. 2-cyclohexyl-2-hydroxy-2-phenylacetic Acid 4-(diethylamino)but-2-ynyl Ester Hcl

    109. 4-(diethylamino)-2-butynyl (+/-)-,alpha.-phenylcyclohexaneglycolate Hydrochloride

    110. 4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride

    111. 4-diethylamino-2-butynylphenyl(cyclohexyl)glycolatehydrochloride;oxybutynin Hcl

    112. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester, Hydrochloride

    113. Benezeneactetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-,4-(diethylamino-2-butunyl Ester Hydrochloride,(+/-)-

    114. Benzeneacetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+/-)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 393.9 g/mol
    Molecular Formula C22H32ClNO3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count8
    Exact Mass393.2070716 g/mol
    Monoisotopic Mass393.2070716 g/mol
    Topological Polar Surface Area49.8 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity490
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameDitropan xl
    Drug LabelDITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini...
    Active IngredientOxybutynin chloride
    Dosage FormTablet, extended release
    RouteOral
    Strength5mg; 10mg; 15mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 8  
    Drug NameGelnique
    PubMed HealthOxybutynin (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelOxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain...
    Active IngredientOxybutynin chloride
    Dosage FormGel
    RouteTransdermal
    Strength10%(100mg/packet)
    Market StatusPrescription
    CompanyWatson Labs

    3 of 8  
    Drug NameOxybutynin chloride
    Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
    Active IngredientOxybutynin chloride
    Dosage FormTablet, extended release; Tablet; Syrup
    RouteOral
    Strength15mg; 5mg; 10mg; 5mg/5ml
    Market StatusPrescription
    CompanyVintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan

    4 of 8  
    Drug NameOxybutynin chloride
    PubMed HealthOxybutynin
    Drug ClassesUrinary Antispasmodic
    Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
    Active IngredientOxybutynin chloride
    Dosage FormTablet, extended release
    Routeoral
    Strength15 mg.
    Market StatusPrescription
    CompanyMylan Pharms

    5 of 8  
    Drug NameDitropan xl
    Drug LabelDITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini...
    Active IngredientOxybutynin chloride
    Dosage FormTablet, extended release
    RouteOral
    Strength5mg; 10mg; 15mg
    Market StatusPrescription
    CompanyJanssen Pharms

    6 of 8  
    Drug NameGelnique
    PubMed HealthOxybutynin (By mouth)
    Drug ClassesUrinary Antispasmodic
    Drug LabelOxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain...
    Active IngredientOxybutynin chloride
    Dosage FormGel
    RouteTransdermal
    Strength10%(100mg/packet)
    Market StatusPrescription
    CompanyWatson Labs

    7 of 8  
    Drug NameOxybutynin chloride
    Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
    Active IngredientOxybutynin chloride
    Dosage FormTablet, extended release; Tablet; Syrup
    RouteOral
    Strength15mg; 5mg; 10mg; 5mg/5ml
    Market StatusPrescription
    CompanyVintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan

    8 of 8  
    Drug NameOxybutynin chloride
    PubMed HealthOxybutynin
    Drug ClassesUrinary Antispasmodic
    Drug LabelOxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor...
    Active IngredientOxybutynin chloride
    Dosage FormTablet, extended release
    Routeoral
    Strength15 mg.
    Market StatusPrescription
    CompanyMylan Pharms

    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.)

    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.)

    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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    03-Feb-2021
    19-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20897

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

    USFDA APPLICATION NUMBER - 20897

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20897

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    DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET)...DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22204

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    ABOUT THIS PAGE

    Looking for 1508-65-2 / Oxybutynin Hydrochloride API manufacturers, exporters & distributors?

    Oxybutynin Hydrochloride manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride manufacturer or Oxybutynin Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Oxybutynin Hydrochloride

    Synonyms

    1508-65-2, Oxybutynin hcl, Tropax, Oxybutynin (chloride), Ditropan xl, Pollakisu

    Cas Number

    1508-65-2

    Unique Ingredient Identifier (UNII)

    L9F3D9RENQ

    About Oxybutynin Hydrochloride

    Oxybutynin Chloride is the chloride salt form of oxybutynin, a tertiary amine and anticholinergic agent with antispasmodic activity. Oxybutynin chloride exerts its antimuscarinic effect on bladder smooth muscle by blocking muscarinic receptors in smooth muscle, thereby inhibiting acetylcholine binding. This results in a relaxation of bladder smooth muscle, a reduction of involuntary muscle contractions and delays the initial desire to void.

    Oxibutinina hydrochloride Manufacturers

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

    Oxibutinina hydrochloride Suppliers

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

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

    Oxibutinina hydrochloride USDMF

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

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

    click here to find a list of Oxibutinina hydrochloride suppliers with USDMF on PharmaCompass.

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

    Oxibutinina hydrochloride KDMF

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

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

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

    click here to find a list of Oxibutinina hydrochloride suppliers with KDMF on PharmaCompass.

    Oxibutinina hydrochloride CEP

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

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

    Oxibutinina hydrochloride WC

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

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

    Oxibutinina hydrochloride 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 Oxibutinina hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Oxibutinina hydrochloride suppliers with NDC on PharmaCompass.

    Oxibutinina hydrochloride GMP

    Oxibutinina hydrochloride 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 Oxibutinina hydrochloride 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 Oxibutinina hydrochloride GMP manufacturer or Oxibutinina hydrochloride GMP API supplier for your needs.

    Oxibutinina hydrochloride CoA

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

    Oxibutinina hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxibutinina hydrochloride 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.

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