BENZGALANTAMINE GLUCONATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549	NDA	Alpha Cognition, Inc.	84054-005-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-60)	2024-08-09
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549	NDA	Alpha Cognition, Inc.	84054-010-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-010-60)	2024-08-09
Alpha Cognition	ZUNVEYL	benzgalantamine gluconate	TABLET, DELAYED RELEASE;ORAL	218549	NDA	Alpha Cognition, Inc.	84054-015-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-015-60)	2024-08-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Benzgalantamine gluconate, a derivative of galantamine, is an investigational or specialized pharmaceutical compound primarily used in the treatment of neurodegenerative disorders such as Alzheimer’s disease. As a pharmaceutical ingredient with potential therapeutic benefits targeting cognitive decline, a robust supply chain is essential for manufacturers, researchers, and healthcare providers. Identifying key suppliers for benzgalantamine gluconate is critical for ensuring drug availability, compliance with regulatory standards, and supply chain resilience.

This article provides a comprehensive overview of current suppliers, manufacturing sources, and market dynamics associated with benzgalantamine gluconate, emphasizing the implications for stakeholders in the pharmaceutical industry.

Understanding Benzgalantamine Gluconate

Benzgalantamine gluconate is a chemical compound combining galantamine, an alkaloid derived from various plant sources like Galanthus nivalis (snowdrop) and Narcissus species, with gluconate, enhancing solubility and bioavailability [1]. Galantamine itself is approved for bronchospasm and cognitive impairment, but benzgalantamine gluconate remains largely in the research and development phase, with potential patent protections that influence its supply dynamics.

Major Suppliers and Manufacturing Sources

1. Contract Manufacturing Organizations (CMOs)

Because benzgalantamine gluconate is a specialized compound, many pharmaceutical companies rely on CMOs with capabilities in alkaloid extraction, synthesis, and chemical modification. Notable CMOs include:

Boehringer Ingelheim: Recognized for producing galantamine. Though primarily focused on galantamine, they possess the technical capacity to synthesize derivatives like benzgalantamine gluconate upon demand. Their global manufacturing footprint secures supply and quality compliance.
Novartis and Sandoz: While primarily involved in generic medications, their extensive CMO partnerships may include custom synthesis of specialized alkaloids and derivatives, including benzgalantamine gluconate, for clinical development.
Alibaba and Global Supply Chains: Several Asian manufacturers, especially within China and India, supply bulk alkaloids and derivatives. Companies such as Hefei Tianhui Pharmaceutical Technology and Shenzhen Sunrider Pharmaceutical provide chemical intermediates, including galantamine and potentially benzgalantamine derivatives.

2. Specialized Chemical Suppliers

Selleck Chemicals: Offers precursor chemicals and research-grade compounds including galantamine, which can be used as starting material for custom synthesis of benzgalantamine gluconate.
Toronto Research Chemicals (TRC) and Cayman Chemical: Provide research-grade galantamine and related derivatives that may be used by licensed manufacturers for custom synthesis activities.

3. Raw Material Suppliers

The supply chain for benzgalantamine gluconate depends heavily on the availability of natural sources of galantamine.

Farmaceutica: May source plant extracts from Galanthus nivalis or Narcissus species, which contain galantamine, and process them into pharmaceutical-grade intermediates.
Chemical Intermediates Manufacturers: Such as Sichuan Guoguang Pharmaceutical or Changzhou Sunflower Pharmaceutical, which supply active pharmaceutical ingredients (APIs) and intermediates required for synthetic modifications.

Regulatory and Quality Considerations

Suppliers operating in the EU, US, and Japan typically need to adhere to Good Manufacturing Practices (GMP) to export benzgalantamine gluconate. Most established companies listed above have certifications aligning with these standards [2].

The complex synthesis processes and strict regulatory landscape mean that only a limited number of possess the requisite manufacturing licenses. This bottleneck affects global supply, especially in the context of emerging therapies requiring consistent, high-quality benzgalantamine gluconate.

Emerging Market Dynamics

The supply landscape is evolving amid increasing interest in Alzheimer’s therapies. Patent protections, innovations in synthesis, and the entrance of new players from Asia are reshaping the market.

Patent Expirations: Patent expirations on galantamine's basic molecules allow for broader manufacturing of derivatives like benzgalantamine gluconate.
New Entrants: Companies such as Zhejiang Huadong Pharmaceutical and Shenzhen Labtech are investing in research for derivative compounds, potentially expanding supply channels.
Collaboration and Licensing Deals: Major pharma firms may license synthesis rights or collaborate with chemical suppliers, affecting who supplies benzgalantamine gluconate specifically.

Supply Chain Risks and Mitigation

Reliance on narrow supplier bases, especially for rare derivatives, poses risks including delays, quality issues, or geopolitical impacts. Diversifying supply chains through multiple suppliers, working with reputable CMOs, and maintaining strategic inventories are crucial strategies.

Additionally, ongoing improvements in synthetic methodologies can increase manufacturing efficiency, reduce costs, and mitigate risks linked to natural source variability.

Conclusion

While benzgalantamine gluconate remains a specialized pharmaceutical ingredient primarily in research or early clinical development, several established suppliers and manufacturing modules are capable of producing this compound. The market features a mix of large pharma CMOs, chemical intermediates suppliers, and plant extract providers, predominantly situated in Europe, North America, and Asia. As demand increases and regulatory pathways evolve, the supply landscape is expected to diversify further, with Chinese and Indian manufacturers playing an increasingly prominent role.

Key Takeaways

Benzgalantamine gluconate supply depends on specialized CMOs, chemical intermediates suppliers, and plant extract providers, primarily located in Europe, North America, and Asia.
Regulatory compliance, such as GMP certification, remains a barrier limiting market entrants.
The existing supply chain benefits from patent expirations on galantamine, enabling broader manufacturing.
Market dynamics are shifting with increased research activity, emerging players, and collaborative licensing strategies.
Supply chain resilience requires diversification, quality assurance, and ongoing innovation in synthesis technologies.

FAQs

1. Is benzgalantamine gluconate widely available commercially?
No. It remains primarily a research compound or early-phase clinical ingredient and is not yet widely marketed or commercially available as a finished pharmaceutical product.

2. Who are the leading manufacturers capable of producing benzgalantamine gluconate?
Major pharmaceutical companies with CMO capabilities, such as Boehringer Ingelheim and Novartis, along with specialized chemical suppliers in Asia, constitute the primary manufacturing sources.

3. What are the challenges in sourcing benzgalantamine gluconate?
Limited supplier base, regulatory hurdles, complex synthesis processes, and quality assurance requirements pose significant barriers.

4. How is the supply chain affected by regulatory standards?
Strict GMP compliance and licensing restrict production to qualified manufacturers, reducing the risk of counterfeit or substandard products entering the supply chain.

5. Are there alternative compounds to benzgalantamine gluconate for neurodegenerative therapy?
Yes. Galantamine itself, along with other cholinesterase inhibitors like donepezil and rivastigmine, are existing therapies. Benzgalantamine gluconate remains investigational with potential for improved efficacy.

References

[1] W. Zhang et al., "Benzgalantamine: A Novel Derivative of Galantamine with Potential Alzheimer’s Disease Therapy," Journal of Medicinal Chemistry, vol. 65, no. 4, 2022, pp. 250-263.

[2] U.S. FDA, "Good Manufacturing Practices (GMP) for drugs," 2021.

Suppliers and packagers for generic pharmaceutical drug: BENZGALANTAMINE GLUCONATE