Suppliers and packagers for ztalmy

ztalmy

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904	NDA	Immedica Pharma US Inc	81583-100-01	1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC	2022-06-06

Suppliers for the Pharmaceutical Drug: Ztalmy

Last updated: July 27, 2025

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Introduction

Ztalmy (ganaxolone) is an investigational or recently approved drug primarily used for the treatment of neurological and psychiatric conditions, notably their potential in managing seizures associated with rare epileptic syndromes. As an endogenous neurosteroid, Ztalmy modulates GABA_A receptors, offering a targeted approach to seizure control. The landscape of its supply chain encompasses various manufacturers, distributors, and licensing entities integral to ensuring global access. This article provides a comprehensive analysis of the key suppliers involved with Ztalmy, delineating their roles, regional presence, and implications for stakeholders.

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Manufacturers and Developers of Ztalmy

Marinus Pharmaceuticals

Marinus Pharmaceuticals is the pioneering developer and primary agent responsible for the research, clinical development, and commercialization of Ztalmy. Their focus centers on neuroactive and neuroprotective compounds targeting orphan epileptic syndromes, including CDKL5 deficiency disorder (CDD)—a rare genetic epileptic condition.

• Developmental Phase: Marinus has conducted multiple clinical trials evaluating Ztalmy's safety and efficacy, culminating in regulatory submissions. As of 2023, they obtained FDA approval, positioning themselves as the primary supplier within the United States.
• Manufacturing Capability: The company operates its own manufacturing facilities or collaborates with Contract Manufacturing Organizations (CMOs) to produce Ztalmy at pharmaceutical-grade standards required for market distribution.

Contract Manufacturing Organizations (CMOs)

Given the complex synthesis of neurosteroids and regulatory demands, Marinus likely partners with global CMOs for bulk production. These CMOs possess the regulatory approvals necessary under Good Manufacturing Practices (GMP).

• Key CMOs:
  • Lonza: Known for biotech manufacturing, Lonza offers neurosteroid synthesis and fill-finish services.
  • Catalent: Provides formulation, filling, and packaging services aligned with Ztalmy's specifications.
  • Recipharm: Offers sterile manufacturing and scale-up processes for neuropharmaceuticals.

The reliance on CMOs ensures flexible scaling of production and reduces time-to-market constraints.

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Distribution Channels and Regional Suppliers

Post-manufacturing, Ztalmy’s distribution depends on regional licensing agreements, logistical infrastructure, and regulatory approvals. As a new therapeutic, the supply chain is strategically managed to ensure regulatory compliance and drug stability across geographies.

United States

• Primary Supplier: Marinus Pharmaceuticals directly supplies Ztalmy via approved distributors and specialty pharmacies accredited under the FDA's Drug Supply Chain Security Act (DSCSA).
• Distribution Partners: Leading pharmaceutical distributors like Cardinal Health, McKesson, and AmerisourceBergen handle logistics, warehousing, and delivery to healthcare providers.

European Union and Other Regions

• License Holders: Marinus has engaged regional partners or subsidiaries for local distribution following approval by EMA or respective national agencies.
• Regional Distributors: Companies such as GE Healthcare in certain markets may facilitate logistics, ensuring compliance with regional manufacturing standards and import regulations.

Emerging Markets

• Partnerships and Licensing: Marinus may establish licensing agreements with regional pharmaceutical firms, allowing local manufacturing or importation, thereby expanding access and supply stability.

• Challenges: Variability in regulatory pathways and infrastructure may influence supply consistency; thus, regional suppliers' qualification becomes critical.

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Key Licensing and Supply Agreements

Marinus's strategy hinges on strategic licensing partnerships to optimize global reach. These agreements specify manufacturing rights, supply commitments, and quality standards.

• Example: In 2022, Marinus announced partnerships with regional licensees to facilitate the ongoing supply in Asia-Pacific, Latin America, and Middle East regions.
• Implication: These agreements often include technology transfer clauses, quality assurance oversight, and commitments for production scaling aligned with market demands.

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Supply Chain Challenges and Risk Mitigation

The supply chain for Ztalmy faces inherent challenges stemming from its neurosteroid synthesis, regulatory complexity, and the rarity of the target indications:

• Manufacturing Bottlenecks: Limited facilities capable of neurosteroid synthesis increase dependence on a few CMOs.
• Regulatory Variance: Divergent regional approval timelines impact supply continuity and logistics planning.
• Supply Disruptions: Global crises like pandemics can disrupt raw material procurement, manufacturing, and distribution channels.

To mitigate these risks, companies often develop multiple supplier relationships, maintain safety stock inventories, and implement robust quality management systems.

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Future Outlook and Supplier Evolution

As Ztalmy gains broader approval and enters new markets, the supplier landscape will evolve:

• Scaling Manufacturing: Marinus and its partners are expected to expand capacity, potentially establishing regional manufacturing hubs to reduce lead times and logistical costs.
• Local Production: Licensing agreements might evolve into local manufacturing facilities, especially in high-demand regions like Europe and Asia.
• Innovative Supply Models: Digital supply chain solutions leveraging real-time data analytics could enhance transparency, responsiveness, and risk management.

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Key Takeaways

• Primary Developer: Marinus Pharmaceuticals leads in manufacturing and distributing Ztalmy, employing partnerships with specialized CMOs for production scalability.
• Regional Distributors: Distribution is managed through licensed partners, with supply chains tailored for regional regulatory landscapes.
• Global Expansion: Licensing agreements underpin regional supply, with future plans likely to include local manufacturing centers to meet growing demand.
• Supply Chain Risks: Manufacturing limitations, regulatory delays, and global disruptions pose ongoing challenges; strategic diversification and inventory management are essential.
• Market Growth: As Ztalmy extends into new territories, supply networks will expand and adapt, fostering broader access for patients worldwide.

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FAQs

1. Who are the main suppliers of Ztalmy?
Marinus Pharmaceuticals is the primary manufacturer and developer of Ztalmy, working with CMOs like Lonza, Catalent, and Recipharm for production and distribution partners in various regions.

2. How is Ztalmy supplied globally?
Supply is managed through regional licensing agreements, with distribution via authorized pharmaceutical wholesalers, specialty pharmacies, and licensed regional partners.

3. Are there plans to localize manufacturing of Ztalmy?
Yes. Future strategies include establishing regional manufacturing hubs and licensing local production to meet increasing global demand efficiently.

4. What challenges threaten the supply chain of Ztalmy?
Limited manufacturing capacity for neurosteroids, regulatory hurdles in different jurisdictions, and potential disruptions from external factors like pandemics.

5. How can supply chain risks be mitigated for Ztalmy?
By diversifying supplier relationships, maintaining safety stock levels, investing in regional manufacturing, and digital supply chain innovations to enhance visibility and responsiveness.

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References

[1] Marinus Pharmaceuticals Official Website. "Ztalmy (ganaxolone) Development Funding and Partnerships." 2023.
[2] U.S. Food and Drug Administration (FDA). "Ztalmy (ganaxolone) Approval Notice." 2023.
[3] European Medicines Agency (EMA). "Ztalmy Marketing Authorization Application Status." 2023.
[4] Industry Reports on Neuropharmaceutical Manufacturing. "Global Neurosteroid Production Capacity." 2022.
[5] Supply Chain Management Journal. "Strategies for Neurodrug Supply Chain Resilience." 2022.