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    Chemistry

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    Also known as: Galanthamine hydrobromide, 1953-04-4, Reminyl, Nivalin, Nivaline, Razadyne
    Molecular Formula
    C17H22BrNO3
    Molecular Weight
    368.3  g/mol
    InChI Key
    QORVDGQLPPAFRS-XPSHAMGMSA-N
    FDA UNII
    MJ4PTD2VVW
    Galantamine Hydrobromide
    A benzazepine derived from norbelladine. It is found in GALANTHUS and other AMARYLLIDACEAE. It is a cholinesterase inhibitor that has been used to reverse the muscular effects of GALLAMINE TRIETHIODIDE and TUBOCURARINE and has been studied as a treatment for ALZHEIMER DISEASE and other central nervous system disorders.
    1 2D Structure

    Galantamine Hydrobromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,12S,14R)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol;hydrobromide
    2.1.2 InChI
    InChI=1S/C17H21NO3.BrH/c1-18-8-7-17-6-5-12(19)9-14(17)21-16-13(20-2)4-3-11(10-18)15(16)17;/h3-6,12,14,19H,7-10H2,1-2H3;1H/t12-,14-,17-;/m0./s1
    2.1.3 InChI Key
    QORVDGQLPPAFRS-XPSHAMGMSA-N
    2.1.4 Canonical SMILES
    CN1CCC23C=CC(CC2OC4=C(C=CC(=C34)C1)OC)O.Br
    2.1.5 Isomeric SMILES
    CN1CC[C@@]23C=C[C@@H](C[C@@H]2OC4=C(C=CC(=C34)C1)OC)O.Br
    2.2 Other Identifiers
    2.2.1 UNII
    MJ4PTD2VVW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Galantamin

    2. Galantamine

    3. Galanthamine

    4. Galanthamine Hydrobromide

    5. Lycoremine

    6. Nivalin

    7. Nivaline

    8. Razadyne

    9. Reminyl

    2.3.2 Depositor-Supplied Synonyms

    1. Galanthamine Hydrobromide

    2. 1953-04-4

    3. Reminyl

    4. Nivalin

    5. Nivaline

    6. Razadyne

    7. Lycoremine Hydrobromide

    8. Jilkon Hydrobromide

    9. Galanthamine (hydrobromide)

    10. Galanthamine Hbr

    11. Tamilin

    12. 193146-85-9

    13. Mj4ptd2vvw

    14. 5n4sa4kqx9

    15. (-)-galantamine Hydrobromide

    16. (+/-)-galantamine Hydrobromide

    17. (+/-)-galanthamine Hydrobromide

    18. Galantamine Hydrobromide (racemic)

    19. Galantamine Hydrobromide, (+/-)-

    20. (1s,12s,14r)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol;hydrobromide

    21. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide

    22. Razadyne Er

    23. Reminyl (tn)

    24. (1s,12s,14r)-9-methoxy-4-methyl-11-oxa-4-azoniatetracyclo[8.6.1.01,12.06,17]heptadeca-6(17),7,9,15-tetraen-14-ol;bromide

    25. (4as,6r,8as)-3-methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6h-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol Hydrobromide

    26. Galanthaminehydrobromide

    27. 1953-04-4 (hbr); 1953-04-4 (free Base).

    28. (1s,12s,14r)-9-methoxy-4-methyl-11-oxa-4-azatetracyclo[8.6.1.0^{1,12}.0^{6,17}]heptadeca-6(17),7,9,15-tetraen-14-ol Hydrobromide

    29. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol Hydrobromide

    30. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide (1:1), (4ar,6s,8ar)-rel-

    31. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide (1:1), (4as,6r,8as)-

    32. Smr000449267

    33. Sr-01000597844

    34. Nivaline (pharmaceutical)

    35. C17h22brno3

    36. Anti-alzheimer

    37. Sr-05000001783

    38. Nivalin;razadyne

    39. Galantamine Hydrobromide [usan]

    40. Reminyl Xl

    41. Jilcon Hydrobromide

    42. Razadyne (tn)

    43. Prestwick_236

    44. Einecs 217-780-5

    45. Galanthamine Hydrobromide From Lycoris Sp.

    46. Mfcd00067672

    47. Unii-mj4ptd2vvw

    48. Unii-5n4sa4kqx9

    49. 1953-04-4 Unlabeled

    50. Chembl1555

    51. Galanthamine-d3 Hydrobromide

    52. Mls000758283

    53. Mls001401401

    54. Galanthamine Hydrobromide,(s)

    55. Schembl177993

    56. Spectrum1501202

    57. Hms1569f18

    58. Hms1921p21

    59. Hy-a0009

    60. Galantamine Hydrobromide (jan/usp)

    61. Ac-469

    62. Ccg-38829

    63. Galantamine Hydrobromide [mi]

    64. Galantamine Hydrobromide [usan:usp]

    65. S1339

    66. Galantamine Hydrobromide [jan]

    67. Galanthamine-o-methyl-d3 Hydrobromide

    68. Akos007930166

    69. Akos015960209

    70. Cs-0378

    71. Fd10095

    72. Galantamine Hydrobromide [hsdb]

    73. Nc00061

    74. Galantamine Hydrobromide [mart.]

    75. Galantamine Hydrobromide [vandf]

    76. Galantamine Hydrobromide [usp-rs]

    77. Galantamine Hydrobromide [who-dd]

    78. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide, (4as,6r,8as)-

    79. As-12155

    80. Gp-37267

    81. G0293

    82. Galantamine Hydrobromide [orange Book]

    83. D02173

    84. Galantamine Hydrobromide [ep Monograph]

    85. Galantamine Hydrobromide [usp Monograph]

    86. Galantamine Hydrobromide Racemic [usp-rs]

    87. 953g044

    88. A866857

    89. A903748

    90. R-113675

    91. Sr-01000597844-1

    92. Sr-01000597844-5

    93. Sr-05000001783-3

    94. Q47495772

    95. Z1558572528

    96. Galanthamine Hydrobromide From Lycoris Sp., >=94% (tlc)

    97. (4as,6r,8as)-3-methoxy-11-methyl-5,6,9,10,11,12-hexahydro-4ah-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol Hydrobromide

    98. (4as,6r,8as)-3-methoxy-11-methyl-5,6,9,10,11,12-hexahydro-4ah-benzo[2,3]benzofuro[4,3-cd]azepin-6-olhydrobromide

    99. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol, Hydrobromide

    100. (4as,6r,8as)-4a,5,9,10,11,12-hexahydro-3-methoxy-d3-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide

    101. 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6h-benzofuro[3a,3,2-ef][2]benzazepin-6-ol Hydrobromide

    102. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hbr (1:1), (4as,6r,8as)-

    103. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hbr, (4as,6r,8as)-

    104. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide, (4a.alpha.,6.beta.,8ar*)-

    105. 6h-benzofuro(3a,3,2-ef)(2)benzazepin-6-ol, 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, Hydrobromide, (4aalpha,6beta,8ar*)-

    2.3.3 Other Synonyms

    1. Galantamine

    2. Galanthamine Hydrobromide

    3. Lycoremin

    4. Lycoremine

    5. Nivalin

    6. Razadyne

    7. Reminyl

    8. Galanthamine

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 368.3 g/mol
    Molecular Formula C17H22BrNO3
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count1
    Exact Mass367.07831 g/mol
    Monoisotopic Mass367.07831 g/mol
    Topological Polar Surface Area41.9 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity440
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameGalantamine hydrobromide
    PubMed HealthGalantamine (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelGalantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide....
    Active IngredientGalantamine hydrobromide
    Dosage FormTablet; Capsule, extended release; Solution
    Routeoral; Oral
    Strengtheq 4mg base; 8mg; eq 12mg base; 4mg; 4mg/ml; 12mg; eq 16mg base; eq 24mg base; eq 8mg base
    Market StatusTentative Approval; Prescription
    CompanyRanbaxy; Apotex; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Sun Pharma Global; Roxane; Watson Labs; Teva Pharms; Zydus Pharms Usa; Dr Reddys Labs; Mylan; Impax Labs; Barr

    2 of 4  
    Drug NameRazadyne
    Drug LabelRAZADYNE ER/RAZADYNE (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS ,6R,8aS )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H...
    Active IngredientGalantamine hydrobromide
    Dosage FormTablet; Solution
    RouteOral
    Strengtheq 4mg base; eq 12mg base; 4mg/ml; eq 8mg base
    Market StatusPrescription
    CompanyJanssen Pharms

    3 of 4  
    Drug NameGalantamine hydrobromide
    PubMed HealthGalantamine (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelGalantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide....
    Active IngredientGalantamine hydrobromide
    Dosage FormTablet; Capsule, extended release; Solution
    Routeoral; Oral
    Strengtheq 4mg base; 8mg; eq 12mg base; 4mg; 4mg/ml; 12mg; eq 16mg base; eq 24mg base; eq 8mg base
    Market StatusTentative Approval; Prescription
    CompanyRanbaxy; Apotex; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Sun Pharma Global; Roxane; Watson Labs; Teva Pharms; Zydus Pharms Usa; Dr Reddys Labs; Mylan; Impax Labs; Barr

    4 of 4  
    Drug NameRazadyne
    Drug LabelRAZADYNE ER/RAZADYNE (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS ,6R,8aS )-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H...
    Active IngredientGalantamine hydrobromide
    Dosage FormTablet; Solution
    RouteOral
    Strengtheq 4mg base; eq 12mg base; 4mg/ml; eq 8mg base
    Market StatusPrescription
    CompanyJanssen Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Nootropic Agents

    Drugs used to specifically facilitate learning or memory, particularly to prevent the cognitive deficits associated with dementias. These drugs act by a variety of mechanisms. (See all compounds classified as Nootropic Agents.)

    Cholinesterase Inhibitors

    Drugs that inhibit cholinesterases. The neurotransmitter ACETYLCHOLINE is rapidly hydrolyzed, and thereby inactivated, by cholinesterases. When cholinesterases are inhibited, the action of endogenously released acetylcholine at cholinergic synapses is potentiated. Cholinesterase inhibitors are widely used clinically for their potentiation of cholinergic inputs to the gastrointestinal tract and urinary bladder, the eye, and skeletal muscles; they are also used for their effects on the heart and the central nervous system. (See all compounds classified as Cholinesterase Inhibitors.)

    Parasympathomimetics

    Drugs that mimic the effects of parasympathetic nervous system activity. Included here are drugs that directly stimulate muscarinic receptors and drugs that potentiate cholinergic activity, usually by slowing the breakdown of acetylcholine (CHOLINESTERASE INHIBITORS). Drugs that stimulate both sympathetic and parasympathetic postganglionic neurons (GANGLIONIC STIMULANTS) are not included here. (See all compounds classified as Parasympathomimetics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cholinesterase Inhibitors [MoA]; Cholinesterase Inhibitor [EPC]

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    API Reference Price

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    05-Jan-2021
    29-Nov-2024
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    INTERMEDIATES SUPPLIERS

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    Aurore Life Sciences

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    Aurore Life Sciences

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    Narwedine

    CAS Number : 510-77-0

    End Use API : Galantamine Hydrobromide

    About The Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in...

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21169

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    DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21169

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    DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21169

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21615

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21615

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ ...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21615

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    ABOUT THIS PAGE

    Galantamine Hydrobromide Manufacturers

    A Galantamine Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galantamine Hydrobromide, including repackagers and relabelers. The FDA regulates Galantamine Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galantamine Hydrobromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Galantamine Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Galantamine Hydrobromide Suppliers

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

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

    Galantamine Hydrobromide USDMF

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

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

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

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

    Galantamine Hydrobromide KDMF

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

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

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

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

    Galantamine Hydrobromide CEP

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

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

    Galantamine Hydrobromide WC

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

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

    Galantamine Hydrobromide NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Galantamine Hydrobromide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Galantamine Hydrobromide API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Galantamine Hydrobromide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Galantamine Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galantamine Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.

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

    Galantamine Hydrobromide GMP

    Galantamine Hydrobromide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Galantamine Hydrobromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Galantamine Hydrobromide GMP manufacturer or Galantamine Hydrobromide GMP API supplier for your needs.

    Galantamine Hydrobromide CoA

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

    Galantamine Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Galantamine Hydrobromide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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