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EU WC
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EDQM
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USP
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JP
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Europe
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DRUG PRODUCT COMPOSITIONS
US Medicaid
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FDF
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Data Compilation #PharmaFlow
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1. Memogain Gluconate
2. Ln7pmj4p57
3. Galantamine Benzoate Gluconate
4. Gln-1062 Gluconate
5. Unii-ln7pmj4p57
6. 1542321-58-3
7. Zunveyl (tn)
8. Benzgalantamine Gluconate (usan)
9. D12931
| Molecular Weight | 587.6 g/mol |
|---|---|
| Molecular Formula | C30H37NO11 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 9 |
| Exact Mass | Da |
| Monoisotopic Mass | Da |
| Topological Polar Surface Area | 186 |
| Heavy Atom Count | 42 |
| Formal Charge | 0 |
| Complexity | 815 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 7 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43827
Submission : 2026-03-30
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43333
Submission : 2025-12-26
Status : Active
Type : II

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Details:
The Company plans to allocate the net proceeds for the acceleration of commercial launch of Zunveyl (benzgalantamine), a prodrug of galantamine, an acetylcholinesterase inhibitor.
Lead Product(s): Benzgalantamine gluconate,Inapplicable
Therapeutic Area: Neurology Brand Name: Zunveyl
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Titan Partners Group
Deal Size: Undisclosed Upfront Cash: $35.0 million
Deal Type: Public Offering September 30, 2025

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Lead Product(s) : Benzgalantamine gluconate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Titan Partners Group
Deal Size : Undisclosed
Deal Type : Public Offering
Alpha Cognition Inc. Announces Pricing of $35 Million Oversubscribed Public Offering
Details : The Company plans to allocate the net proceeds for the acceleration of commercial launch of Zunveyl (benzgalantamine), a prodrug of galantamine, an acetylcholinesterase inhibitor.
Product Name : Zunveyl
Product Type : Miscellaneous
Upfront Cash : $35.0 million
September 30, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
The Company plans to allocate the net proceeds for the acceleration of commercial launch of Zunveyl (benzgalantamine), a prodrug of galantamine, an acetylcholinesterase inhibitor.
Lead Product(s): Benzgalantamine gluconate,Inapplicable
Therapeutic Area: Neurology Brand Name: Zunveyl
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Titan Partners Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering September 30, 2025

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Lead Product(s) : Benzgalantamine gluconate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Titan Partners Group
Deal Size : Undisclosed
Deal Type : Public Offering
Alpha Cognition Inc. Announces Proposed Public Offering of Common Shares
Details : The Company plans to allocate the net proceeds for the acceleration of commercial launch of Zunveyl (benzgalantamine), a prodrug of galantamine, an acetylcholinesterase inhibitor.
Product Name : Zunveyl
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 30, 2025

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RLD : Yes
TE Code :
Brand Name : ZUNVEYL
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 5MG BASE
Approval Date : 2024-07-26
Application Number : 218549
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ZUNVEYL
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2024-07-26
Application Number : 218549
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ZUNVEYL
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 15MG BASE
Approval Date : 2024-07-26
Application Number : 218549
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Patents & EXCLUSIVITIES
Patent Expiration Date : 2042-01-13
US Patent Number : 11795176
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2042-01-13

Patent Expiration Date : 2042-01-13
US Patent Number : 11795176
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2042-01-13

Patent Expiration Date : 2045-07-23
US Patent Number : 12551491
Drug Substance Claim :
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2045-07-23

Patent Expiration Date : 2026-12-01
US Patent Number : 9763953
Drug Substance Claim :
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2026-12-01

Patent Expiration Date : 2045-07-23
US Patent Number : 12551491
Drug Substance Claim :
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2045-07-23

Patent Expiration Date : 2026-12-01
US Patent Number : 9763953
Drug Substance Claim :
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2026-12-01

Patent Expiration Date : 2045-07-23
US Patent Number : 12551491
Drug Substance Claim :
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2045-07-23

Patent Expiration Date : 2026-12-01
US Patent Number : 9763953
Drug Substance Claim :
Drug Product Claim :
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2026-12-01

Patent Expiration Date : 2044-02-26
US Patent Number : 12208167
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2044-02-26

Patent Expiration Date : 2044-02-26
US Patent Number : 12208167
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 218549
Patent Use Code : U-713
Delist Requested :
Patent Use Description : TREATMENT OF MILD TO M...
Patent Expiration Date : 2044-02-26

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Benzgalantamine gluconate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Benzgalantamine gluconate manufacturer or Benzgalantamine gluconate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzgalantamine gluconate manufacturer or Benzgalantamine gluconate supplier.
A Galantamine benzoate gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Galantamine benzoate gluconate, including repackagers and relabelers. The FDA regulates Galantamine benzoate gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Galantamine benzoate gluconate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Galantamine benzoate gluconate supplier is an individual or a company that provides Galantamine benzoate gluconate active pharmaceutical ingredient (API) or Galantamine benzoate gluconate finished formulations upon request. The Galantamine benzoate gluconate suppliers may include Galantamine benzoate gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Galantamine benzoate gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Galantamine benzoate gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Galantamine benzoate gluconate active pharmaceutical ingredient (API) in detail. Different forms of Galantamine benzoate gluconate DMFs exist exist since differing nations have different regulations, such as Galantamine benzoate gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Galantamine benzoate gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Galantamine benzoate gluconate USDMF includes data on Galantamine benzoate gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Galantamine benzoate gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Galantamine benzoate gluconate suppliers with USDMF on PharmaCompass.
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 benzoate gluconate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Galantamine benzoate gluconate API and other APIs are published in this directory by the FDA.
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 benzoate gluconate 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.
The NDC directory also contains data on finished compounded human drug products that contain Galantamine benzoate gluconate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Galantamine benzoate gluconate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Galantamine benzoate gluconate suppliers with NDC on PharmaCompass.
Galantamine benzoate gluconate 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 benzoate gluconate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Galantamine benzoate gluconate GMP manufacturer or Galantamine benzoate gluconate GMP API supplier for your needs.
A Galantamine benzoate gluconate CoA (Certificate of Analysis) is a formal document that attests to Galantamine benzoate gluconate's compliance with Galantamine benzoate gluconate specifications and serves as a tool for batch-level quality control.
Galantamine benzoate gluconate CoA mostly includes findings from lab analyses of a specific batch. For each Galantamine benzoate gluconate 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 benzoate gluconate may be tested according to a variety of international standards, such as European Pharmacopoeia (Galantamine benzoate gluconate EP), Galantamine benzoate gluconate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Galantamine benzoate gluconate USP).