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Chemistry

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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


Listed Suppliers

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01

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

Seqens

France
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  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Glycopyrronium Bromide

About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...

Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists in the development, scale-up and manufacturing of drug substances from pre-clinical to commercial stages. Seqens boasts a vast portfolio of APIs and proprietary products while also developing custom solutions and ingredients for the healthcare, electronics and cosmetics industries. It operates 16 industrial plants and 9 R&D centers worldwide. Seqens possesses technologies that enable it to produce complex molecules to meet both small- and large-scale demands.
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LGM Pharma

U.S.A
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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.
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04

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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.
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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.
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06

JPN Pharma

India
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Virtual BoothJPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry

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Glycopyrrolate

About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...

JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headquartered in Mumbai, we operate three state-of-the-art facilities in Tarapur, Maharashtra, complying with the highest international regulatory standards. With CEP and WC approvals, we excel in managing hazardous chemicals and executing complex reactions with precision. Backed by a robust R&D infrastructure and stringent QA/QC practices, we are committed to delivering high-quality, reliable solutions to the global pharmaceutical industry.
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07

Hikma Pharmaceuticals

United Kingdom
AMWC Asia-TDAC
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Hikma Pharmaceuticals

United Kingdom
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Glycopyrrolate

About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, ...

Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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08

Hovione

Portugal
AMWC Asia-TDAC
Not Confirmed
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Hovione

Portugal
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Glycopyrronium Bromide

About the Company : Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services fo...

Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices.
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AMWC Asia-TDAC
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Glycopyrronium Bromide

About the Company : Founded in 2007, Melody Healthcare is a rapidly growing, quality-oriented leading manufacturer of APIs, with a distinct emphasis on the development and production of technology-dri...

Founded in 2007, Melody Healthcare is a rapidly growing, quality-oriented leading manufacturer of APIs, with a distinct emphasis on the development and production of technology-driven products. Located in India, within a Government Approved industrial zone (MIDC) in Tarapur, Maharashtra, Melody Healthcare features advanced manufacturing facilities that comply with global regulatory standards and concentrate on specialized therapeutic areas, providing products in these segments: Respiratory, Hypertensive, Cardiovascular, Antibiotic
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10

AMWC Asia-TDAC
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AMWC Asia-TDAC
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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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API Reference Price

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MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"92893.3","totalValueFC":"1860.8","currency":"EUR","unitRateINR":"8091000","date":"03-Feb-2025","totalValueINR":"161820","totalValueInUsd":"1860.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8138821","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1, 08755 CASTELLBISBAL BARCELONA ES","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738521000,"product":"GLYCOPYRRONIUM BROMIDE NOT MICRONIZED (BATCH NO. P-16) (GLYCOPYRROLATE (GLYCOPYRRONIUM BROMIDE)GLYCOPYRRONIUM BROMIDE NOT MICRONIZED (BATCH NO. P-16) (GLYC","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"92893.2","totalValueFC":"930.4","currency":"EUR","unitRateINR":"8091000","date":"03-Feb-2025","totalValueINR":"80910","totalValueInUsd":"930.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8138821","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LLOBREGAT C\/ARGENT 1, 08755 CASTELLBISBAL BARCELONA ES","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
02-Jan-2021
07-Feb-2025
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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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ABOUT THIS PAGE

Looking for 596-51-0 / Glycopyrronium Bromide API manufacturers, exporters & distributors?

Glycopyrronium Bromide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Glycopyrronium Bromide 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 Glycopyrronium Bromide manufacturer or Glycopyrronium Bromide supplier for your needs.

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

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

API | Excipient name

Glycopyrronium Bromide

Synonyms

596-51-0, Glycopyrrolate bromide, Robinul, Gastrodyn, Nodapton, Tarodyl

Cas Number

596-51-0

About Glycopyrronium Bromide

A muscarinic antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics.

Glycopyrronium Manufacturers

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

Glycopyrronium Suppliers

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

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

Glycopyrronium USDMF

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

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

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

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

Glycopyrronium KDMF

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

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

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

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

Glycopyrronium CEP

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

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

Glycopyrronium WC

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

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

Glycopyrronium 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 Glycopyrronium as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Glycopyrronium GMP

Glycopyrronium 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 Glycopyrronium 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 Glycopyrronium GMP manufacturer or Glycopyrronium GMP API supplier for your needs.

Glycopyrronium CoA

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

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

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