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    Also known as: 596-51-0, Glycopyrrolate bromide, Robinul, Glycopyrronium bromide, Gastrodyn, Nodapton
    Molecular Formula
    C19H28BrNO3
    Molecular Weight
    398.3  g/mol
    InChI Key
    VPNYRYCIDCJBOM-UHFFFAOYSA-M
    Glycopyrronium Bromide
    A muscarinic antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics.
    1 2D Structure

    Glycopyrronium Bromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide
    2.1.2 InChI
    InChI=1S/C19H28NO3.BrH/c1-20(2)13-12-17(14-20)23-18(21)19(22,16-10-6-7-11-16)15-8-4-3-5-9-15;/h3-5,8-9,16-17,22H,6-7,10-14H2,1-2H3;1H/q+1;/p-1
    2.1.3 InChI Key
    VPNYRYCIDCJBOM-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C.[Br-]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bromide, Glycopyrronium

    2. Glycopyrronium

    3. Glycopyrronium Bromide

    4. Nva 237

    5. Nva-237

    6. Nva237

    7. Pyrrolidinium, 3-((cyclopentylhydroxyphenylacetyl)oxy)-1,1-dimethyl-, Bromide

    2.2.2 Depositor-Supplied Synonyms

    1. 596-51-0

    2. Glycopyrrolate Bromide

    3. Robinul

    4. Glycopyrronium Bromide

    5. Gastrodyn

    6. Nodapton

    7. Tarodyl

    8. Tarodyn

    9. Asecryl

    10. Cuvposa

    11. Glycopyrronii Bromidum

    12. Robanul

    13. Ahr-504

    14. Bromuro De Glicopirronio

    15. Bromure De Glycopyrronium

    16. Nva-237

    17. Robinal

    18. Seebri Neohaler

    19. 3-hydroxy-1,1-dimethylpyrrolidinium Bromide Alpha-cyclopentylmandelate

    20. Seebri

    21. 1,1-dimethyl-3-hydroxypyrrolidinium Bromide Alpha-cyclopentylmandelate

    22. 1-methyl-3-pyrrolidyl Alpha-phenylcyclopentaneglycolate Methobromide

    23. 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium Bromide

    24. Pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-,bromide

    25. Ad-237

    26. Pt-001

    27. Nsc-250836

    28. Nsc-251251

    29. Nsc-251252

    30. Copyrrolate

    31. Dsstox_cid_3109

    32. 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidinium Bromide

    33. (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate Bromide

    34. Dsstox_rid_76878

    35. Dsstox_gsid_23109

    36. Glycopyrronium (bromide);glycopyrrolate (bromide)

    37. Nva237

    38. Robinul Forte

    39. Pyrrolidinium,1-dimethyl-, Bromide

    40. Seebri Breezhaler

    41. 53808-86-9

    42. (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate;bromide

    43. Smr000469282

    44. Glycopyrrolate, Erythro-

    45. Nsc 250836

    46. Nsc 251251

    47. Nsc 251252

    48. Org-nc-45

    49. Nsc250836

    50. Nsc251251

    51. Nsc251252

    52. (2s,3's)-glycopyrrolate

    53. Ahr 504

    54. Glycopyrronium (as Bromide)

    55. Nva 237

    56. Glycopyrronii Bromidum [inn-latin]

    57. Ncgc00179456-02

    58. Wln: T5ktj A1 A1 Covxqr&- Al5tj &q &e

    59. Einecs 209-887-0

    60. Mfcd00072137

    61. Bromure De Glycopyrronium [inn-french]

    62. Bromuro De Glicopirronio [inn-spanish]

    63. Chf5259

    64. Glycopyrrolate [usan:usp]

    65. Pt001

    66. Chf-5259

    67. Lonhala Magnair

    68. Pyrrolidinium,1-dimethyl-, Bromide, .alpha.-cyclopentylmandelate

    69. 1,1-dimethyl-3-hydroxypyrrolidinium Bromide .alpha.-cyclopentylmandelate

    70. 1-methyl-3-pyrrolidinyl .alpha.-phenylcyclopentaneglycolate Methobromide

    71. 3-hydroxy-1,1-dimethylpyrrolidinium Bromide-.alpha.-cyclopentylmandelate

    72. Mandelic Acid, Ester With 3-hydroxy-1,1-dimethylpyrrolidinium Bromide

    73. Cuvposa (tn)

    74. Robinul (tn)

    75. Glycopyrrolate (usp)

    76. .beta.-1-methyl-3-pyrrolidyl-.alpha.-cyclopentylmandelate Methobromide

    77. Seebri Breezhaler (tn)

    78. Cas-596-51-0

    79. Glycopyrrone Bromide

    80. Schembl41436

    81. Glycopyrronium Bromide ,(s)

    82. Mls001424112

    83. Mls002222301

    84. 3-hydroxy-1,1-dimethylpyrrolidinium Bromide .alpha.-cyclopentylmandelate

    85. Chembl1201027

    86. Dtxsid6023109

    87. Chebi:90972

    88. Glycopyrrolate, >=98% (hplc)

    89. Glycopyrronium Bromide (jan/inn)

    90. Hms1570e14

    91. Hms2051p12

    92. Hms2094a05

    93. Hms2097e14

    94. Hms2235f12

    95. Hms3259p04

    96. Hms3369f10

    97. Hms3393p12

    98. Hms3714e14

    99. Hms3885p14

    100. Pharmakon1600-01505753

    101. Amy22352

    102. Bcp07110

    103. Bcp33298

    104. Chf-5992

    105. Ex-a4155

    106. Tox21_113144

    107. Tox21_113145

    108. Nsc759238

    109. S4660

    110. Akos015962136

    111. Pyrrolidinium, 1,1-dimethyl-3-hydroxy-, Bromide, Alpha-cyclopentylmandelate

    112. Pyrrolidinium, 3-hydroxy-1,1-dimethyl-, Bromide, Alpha-cyclopentylmandelate

    113. Tox21_113144_1

    114. Ccg-101030

    115. Ccg-213543

    116. Cs-1763

    117. Nc00280

    118. Nc00694

    119. Nsc-759238

    120. Ncgc00179456-04

    121. Ac-23382

    122. Hy-17465

    123. Glycopyrrolate Erythro Isomer (ss-isomer)

    124. Ft-0626787

    125. G0392

    126. D00540

    127. A832400

    128. Sr-01000763650

    129. Sr-01000763650-3

    130. Q27162963

    131. Glycopyrrolate Erythro Isomer (mixture Of Rr-isomer And Ss-isomer)

    132. Glycopyrrolate, United States Pharmacopeia (usp) Reference Standard

    133. Glycopyrronium Bromide, European Pharmacopoeia (ep) Reference Standard

    134. Glycopyrronium Impurity N, European Pharmacopoeia (ep) Reference Standard

    135. 3-(2-cyclopentyl-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-iumbromide

    136. 3-{[cyclopentyl(hydroxy)phenylacetyl]oxy}-1,1-dimethylpyrrolidin-1-ium Bromide

    137. Glycopyrronium For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 398.3 g/mol
    Molecular Formula C19H28BrNO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count5
    Exact Mass397.12526 g/mol
    Monoisotopic Mass397.12526 g/mol
    Topological Polar Surface Area46.5 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity424
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    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 NameCuvposa
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelCUVPOSA is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is...
    Active IngredientGlycopyrrolate
    Dosage FormSolution
    RouteOral
    Strength1mg/5ml
    Market StatusPrescription
    CompanyMerz Pharms

    2 of 8  
    Drug NameGlycopyrrolate
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelGlycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name:3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Its empirical fo...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml; 1.5mg; 2mg
    Market StatusPrescription
    CompanyStason Pharms; Vintage Pharms; Ranbaxy; Aurolife Pharma; Excellium; Hikma Farmaceutica; Par Pharm; Vintage; Luitpold; Dr Reddys Labs; Nexgen Pharma

    3 of 8  
    Drug NameRobinul
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml
    Market StatusPrescription
    CompanyShionogi; Hikma Maple

    4 of 8  
    Drug NameRobinul forte
    PubMed HealthGlycopyrrolate (By mouth)
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelRobinul and Robinul Forte tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide...
    Active IngredientGlycopyrrolate
    Dosage FormTablet
    RouteOral
    Strength2mg
    Market StatusPrescription
    CompanyShionogi

    5 of 8  
    Drug NameCuvposa
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelCUVPOSA is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is...
    Active IngredientGlycopyrrolate
    Dosage FormSolution
    RouteOral
    Strength1mg/5ml
    Market StatusPrescription
    CompanyMerz Pharms

    6 of 8  
    Drug NameGlycopyrrolate
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelGlycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name:3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Its empirical fo...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml; 1.5mg; 2mg
    Market StatusPrescription
    CompanyStason Pharms; Vintage Pharms; Ranbaxy; Aurolife Pharma; Excellium; Hikma Farmaceutica; Par Pharm; Vintage; Luitpold; Dr Reddys Labs; Nexgen Pharma

    7 of 8  
    Drug NameRobinul
    PubMed HealthGlycopyrrolate
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:Glycopyrrolate, USP 0.2 mgWater for Injection, USP q.s.Benzyl Alcohol, NF 0.9% (preservative)pH adjusted, when necessary, with hydrochloric acid and/or sodium...
    Active IngredientGlycopyrrolate
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1mg; 0.2mg/ml
    Market StatusPrescription
    CompanyShionogi; Hikma Maple

    8 of 8  
    Drug NameRobinul forte
    PubMed HealthGlycopyrrolate (By mouth)
    Drug ClassesCholinergic Antagonist, Gastrointestinal Agent
    Drug LabelRobinul and Robinul Forte tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide...
    Active IngredientGlycopyrrolate
    Dosage FormTablet
    RouteOral
    Strength2mg
    Market StatusPrescription
    CompanyShionogi

    4.2 Drug Indication

    Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

    Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

    Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

    Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

    Treatment of sialorrhoea

    Chronic obstructive pulmonary disease

    Treatment of sialorrhoea

    Treatment of hyperhidrosis

    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.)

    Adjuvants, Anesthesia

    Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

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

    R03BB06

    R03BB06

    R03BB06

    A03AB02

    A03AB02

    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

    A - Alimentary tract and metabolism

    A03 - Drugs for functional gastrointestinal disorders

    A03A - Drugs for functional gastrointestinal disorders

    A03AB - Synthetic anticholinergics, quaternary ammonium compounds

    A03AB02 - Glycopyrronium bromide

    R - Respiratory system

    R03 - Drugs for obstructive airway diseases

    R03B - Other drugs for obstructive airway diseases, inhalants

    R03BB - Anticholinergics

    R03BB06 - Glycopyrronium bromide

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    AKSHAT PHARMA PRIVATE LTD

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Medlab Asia & Asia Health
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19026

    Submission : 2005-12-10

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Nishchem International Pvt. Ltd

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Nishchem International Pvt. Ltd

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-06-20

    Pay. Date : 2019-05-03

    DMF Number : 33806

    Submission : 2019-05-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Breathgreen Pharmaceuticals

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    Breathgreen Pharmaceuticals

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39692

    Submission : 2024-03-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

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    01

    Inke Sa

    Spain
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-02-16

    Pay. Date : 2017-07-06

    DMF Number : 31836

    Submission : 2017-07-22

    Status : Active

    Type : II

    Inke Company Banner

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    02

    Pcas

    France
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-05

    Pay. Date : 2013-09-30

    DMF Number : 18106

    Submission : 2005-02-22

    Status : Active

    Type : II

    Seqens Company Banner

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    03

    Medlab Asia & Asia Health
    Not Confirmed

    03

    Akshat Pharma Private Ltd

    India
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19026

    Submission : 2005-12-10

    Status : Active

    Type : II

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    04

    Amsa Spa

    Italy

    USDMF

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    Medlab Asia & Asia Health
    Not Confirmed

    04

    Amsa Spa

    Italy
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-03-13

    Pay. Date : 2015-03-06

    DMF Number : 16972

    Submission : 2003-11-13

    Status : Active

    Type : II

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    05

    Medlab Asia & Asia Health
    Not Confirmed

    05

    Boehringer Ingelheim Chemicals Inc

    Germany
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6044

    Submission : 1985-10-01

    Status : Inactive

    Type : II

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    06

    Vifor International Inc

    Switzerland

    USDMF

    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    06

    Vifor International Inc

    Switzerland
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16967

    Submission : 2003-11-17

    Status : Active

    Type : II

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    07

    Boca Pharmacal Llc

    Ireland

    USDMF

    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    07

    Boca Pharmacal Llc

    Ireland
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20578

    Submission : 2007-05-31

    Status : Inactive

    Type : II

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    08

    Harman Finochem Ltd

    India

    USDMF

    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    08

    Harman Finochem Ltd

    India
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-23

    Pay. Date : 2012-12-06

    DMF Number : 19710

    Submission : 2006-08-28

    Status : Active

    Type : II

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    09

    Hikma Pharmaceuticals Llc

    United Kingdom

    USDMF

    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    09

    Hikma Pharmaceuticals Llc

    United Kingdom
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18727

    Submission : 2005-08-31

    Status : Active

    Type : II

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    10

    Sb Penick And Co

    Switzerland

    USDMF

    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    10

    Sb Penick And Co

    Switzerland
    arrow
    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 430

    Submission : 1961-04-18

    Status : Inactive

    Type : II

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    CEP/COS

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    Inke, S.A. Castellbisbal ES

    Contact Supplier
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    • EDQM
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothInke S.A: APIs manufacturing plant.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Glycopyrronium bromide, Micronised, non-micronised

    Portfolio PDF

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    R1-CEP 2017-182 - Rev 00
    Valid
    Chemical
    2023-08-17
    1783
    Inke Company Banner

    01

    Inke, S.A. Castellbisbal ES

    Spain
    arrow
    DDL Conference
    Exhibiting
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    Virtual BoothInke S.A: APIs manufacturing plant.

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    Glycopyrronium bromide, Micronised, non-micronised

    Certificate Number : R1-CEP 2017-182 - Rev 00

    Status : Valid

    Issue Date : 2023-08-17

    Type : Chemical

    Substance Number : 1783

    Inke Company Banner

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    PCAS Ecully FR

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Glycopyrronium bromide

    Portfolio PDF

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    R1-CEP 2012-129 - Rev 01
    Valid
    Chemical
    2020-07-30
    1783
    Seqens Company Banner

    02

    PCAS Ecully FR

    France
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Glycopyrronium bromide

    Certificate Number : R1-CEP 2012-129 - Rev 01

    Status : Valid

    Issue Date : 2020-07-30

    Type : Chemical

    Substance Number : 1783

    Seqens Company Banner

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    AMSA S.P.A. - ANONIMA MATERIE SINTE...

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    Glycopyrronium bromide

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    R1-CEP 2014-194 - Rev 01
    Valid
    Chemical
    2021-02-18
    1783
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    03

    AMSA S.P.A. - ANONIMA MATERIE SINTE...

    Italy
    Medlab Asia & Asia Health
    Not Confirmed
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    AMSA S.P.A. - ANONIMA MATERIE SINTE...

    Italy
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrronium bromide

    Certificate Number : R1-CEP 2014-194 - Rev 01

    Status : Valid

    Issue Date : 2021-02-18

    Type : Chemical

    Substance Number : 1783

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    HAINAN POLY PHARMACEUTICAL COMPANY ...

    Contact Supplier
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    Glycopyrronium bromide

    Portfolio PDF

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    R0-CEP 2021-154 - Rev 00
    Valid
    Chemical
    2022-11-16
    1783
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    04

    HAINAN POLY PHARMACEUTICAL COMPANY ...

    China
    Medlab Asia & Asia Health
    Not Confirmed
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    HARMAN FINOCHEM LIMITED Mumbai IN

    Contact Supplier
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    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Glycopyrronium bromide

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    R1-CEP 2012-017 - Rev 01
    Valid
    Chemical
    2020-12-01
    1783
    blank

    05

    HARMAN FINOCHEM LIMITED Mumbai IN

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    MELODY HEALTHCARE PVT. LTD. Boisar ...

    Contact Supplier
    • EDQM
    • WHO-GMP
    • fda
    • EDQM
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    Glycopyrronium bromide, Micronised, non-micronised

    Portfolio PDF

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    R0-CEP 2021-222 - Rev 01
    Valid
    Chemical
    2023-01-16
    1783
    blank

    06

    MELODY HEALTHCARE PVT. LTD. Boisar ...

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    OLON S.P.A. Rodano IT

    Contact Supplier
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrronium bromide

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    R1-CEP 2013-110 - Rev 04
    Valid
    Chemical
    2023-08-23
    1783
    blank

    07

    OLON S.P.A. Rodano IT

    Italy
    Medlab Asia & Asia Health
    Not Confirmed
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    RESONANCE LABORATORIES PVT. LTD. Ba...

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    Glycopyrronium bromide

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    R0-CEP 2020-077 - Rev 00
    Valid
    Chemical
    2021-09-14
    1783
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    08

    RESONANCE LABORATORIES PVT. LTD. Ba...

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    RESONANCE LABORATORIES PVT. LTD. Ba...

    India
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    Not Confirmed
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    Glycopyrronium bromide

    Certificate Number : R0-CEP 2020-077 - Rev 00

    Status : Valid

    Issue Date : 2021-09-14

    Type : Chemical

    Substance Number : 1783

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    SHILPA PHARMA LIFESCIENCES LIMITED ...

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    Glycopyrronium bromide

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    R0-CEP 2021-268 - Rev 00
    Valid
    Chemical
    2023-01-11
    1783
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    09

    SHILPA PHARMA LIFESCIENCES LIMITED ...

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    EU WC

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    01

    Aragen Life Sciences

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Aragen Life Sciences

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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    Glycopyrronium Bromide EP

    Date of Issue : 2019-10-31

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0124

    Address of the Firm : Plot No.28 A, IDA, Nacharam, Hyderabad, AP

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    02

    Harman Finochem

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Harman Finochem

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrrolate USP/ Glycopyrronium Bromide EP

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0045nA2

    Address of the Firm : Plot No. E-7, 8, 9 MIDC, Industrial Area, Chikalthana, Aurangabad-431006

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    03

    Khandelwal Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Khandelwal Laboratories

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrrolate (USP)

    Date of Issue : 2013-08-08

    Valid Till : 2016-07-02

    Written Confirmation Number : WC-0223

    Address of the Firm : Plot B-1 Wagle Industrial Eastate Thane W 400604 Maharashtra State

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    04

    Resonance Laboratories Pvt. Ltd

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Resonance Laboratories Pvt. Ltd

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrronium Bromide EP

    Date of Issue : 2019-01-21

    Valid Till : 2022-01-20

    Written Confirmation Number : WC-286

    Address of the Firm : No. 8C & 9A, KIADB Industrial Area, Doddaballapur, Bangalore Dist-561023

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    05

    Suven Life Sciences Limited

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Suven Life Sciences Limited

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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    Glycopyrrolate (USP)

    Date of Issue : 2019-07-15

    Valid Till : 2022-07-14

    Written Confirmation Number : WC-0042

    Address of the Firm : Plot No.262, 263, IDA, Pashamylaram, Medak District, A.P

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    06

    Swati Spentose

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Swati Spentose

    India
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    Medlab Asia & Asia Health
    Not Confirmed
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    Glycopyrrolate USP/Glycopyrronium Bromide EP/BP

    Date of Issue : 2022-02-25

    Valid Till : 2022-07-07

    Written Confirmation Number : WC-0165A3

    Address of the Firm : Plot No. A-1/2102, 2103, Phase-III GIDC, Vapi-396 195, Valsad, Gujarat, India

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    Listed Suppliers

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    Inke S.A

    Spain
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    Glycopyrronium Bromide

    About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

    Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
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    02

    LGM Pharma

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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Glycopyrronium Bromide

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    03

    Seqens

    France
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Glycopyrronium Bromide

    About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

    Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
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    04

    Jai Radhe Sales

    India
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    Medlab Asia & Asia Health
    Not Confirmed
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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Glycopyrronium Bromide

    About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

    Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
    Jai Radhe Sales

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    05

    Vamsi Labs

    India
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    Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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    Glycopyrronium Bromide

    About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international ma...

    Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international markets(50% sales). Anti-asthma products account for 60% of sales. Vamsi adheres to high corporate governance, transparency, professionalism, & environmental protection standards. It's USFDA & EDQM certified & ISO 9001:2015, ISO 14001:2015, & ISO 45001:2018 certified. With a DSIR-certified R&D Lab, Vamsi continues to innovate & meet the pharma industry's evolving needs. Vamsi is poised to grow its globally while maintaining commitment to excellence and sustainability.
    Vamsi Labs

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    06

    Nishchem International Pvt. Ltd

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Nishchem International Pvt. Ltd

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrronium Bromide

    About the Company : Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharma...

    Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharmaceuticals, Nishchem International Pvt. Ltd. (NIPL) stands on the virtue of revolutionizing the ends, as well as the means to safe and secure health. Medicinal drugs have always held an important place in the sphere of healing and treatment, with their applications ranging from diagnosis, treatment and cure right up to prophylaxis.
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    07

    Olon S.p.A

    Italy
    Medlab Asia & Asia Health
    Not Confirmed
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    Olon S.p.A

    Italy
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    Not Confirmed
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    Glycopyrronium Bromide

    About the Company : We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (...

    We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic and contract development and the manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.
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    08

    Stason Pharmaceuticals, Inc.

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    Stason Pharmaceuticals, Inc.

    U.S.A
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrrolate

    About the Company : Headquartered in Southern California, Stason entered the commercial generic market in 1994 and today continues to manufacture and market these products through our global network o...

    Headquartered in Southern California, Stason entered the commercial generic market in 1994 and today continues to manufacture and market these products through our global network of distributors. Stason entered the contract manufacturing arena in 2000 to provide manufacturing support to other pharmaceutical companies. We provide both non-high containment and high containment manufacturing services. In 2008, we launched our Brand Division when we obtained exclusive development and commercialization rights to two novel proprietary compounds in the area of oncology.
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    09

    Tai Heng Industry Co., Ltd

    China
    Medlab Asia & Asia Health
    Not Confirmed
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    Tai Heng Industry Co., Ltd

    China
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Glycopyrrolate

    About the Company : Since 2005, Tai Heng has been servicing global generic companies through vertically integrated drug development program. From API to commercial product, we offer customers a comple...

    Since 2005, Tai Heng has been servicing global generic companies through vertically integrated drug development program. From API to commercial product, we offer customers a complete and integrated solution for pharmaceutical development. Our services cover entire spectrum of drug development life cycle, from benchtop development, scale up, process optimization, analytical and other quality control methods, submission batch manufacturing, GMP management, regulatory support, and post approval product life cycle management.
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    10

    Tooba Pharmaceuticals

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Tooba Pharmaceuticals

    India
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    Glycopyrronium Bromide

    About the Company : Tooba Pharmaceuticals Private Limited (TPPL) is a GMP Certified manufacturer of API Bulk Drugs and Intermediates, with state-of-the-art manufacturing facility. TPPL retains its ...

    Tooba Pharmaceuticals Private Limited (TPPL) is a GMP Certified manufacturer of API Bulk Drugs and Intermediates, with state-of-the-art manufacturing facility. TPPL retains its strong roots in R&D to explore and develop generics using newer technologies in an environment friendly manner. TPPL, headquartered in Aurangabad, Maharashtra is a major urban center and an industrial hub, home to several pharmaceutical industries. Well connected with major metropolitan areas within the state and beyond, there's a ready access to markets and raw materials.
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    API Reference Price

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    22-Apr-2021
    14-Oct-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

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

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 12827

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    DOSAGE - TABLET;ORAL - 2MG

    USFDA APPLICATION NUMBER - 12827

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    DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Fe...DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17558

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    DOSAGE - POWDER;INHALATION - 15.6MCG/INH

    USFDA APPLICATION NUMBER - 207923

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    DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH

    USFDA APPLICATION NUMBER - 207930

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    DOSAGE - SOLUTION;INHALATION - 25MCG/ML

    USFDA APPLICATION NUMBER - 208437

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 1.7MG

    USFDA APPLICATION NUMBER - 215019

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