Suppliers and packagers for generic pharmaceutical drug: GANAXOLONE

GANAXOLONE

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: Ganaxolone

Last updated: July 28, 2025

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Introduction

Ganaxolone is a synthetic neuroactive steroid with anxiolytic, anticonvulsant, and neuroprotective properties. It is primarily developed for the treatment of epilepsy, especially refractory cases such as pediatric drug-resistant epilepsy, and possibly for other neuropsychiatric conditions. Since ganaxolone's development, securing reliable suppliers has become critical for pharmaceutical companies, researchers, and healthcare providers. This comprehensive overview examines the current landscape of ganaxolone manufacturing and supply chain dynamics, highlighting key suppliers, manufacturing partnerships, and market trends.

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Manufacturers and Development Stage

Ganaxolone was originally developed by Marinus Pharmaceuticals, which retains rights to the drug candidate. The manufacturing process of ganaxolone involves complex chemical synthesis, requiring specialized expertise and high-quality raw materials. Currently, ganaxolone is in Phase 3 clinical trials, with some formulations approaching regulatory submission. As of 2023, Marinus Pharmaceuticals is the principal company responsible for the production and commercial development [1].

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Key Suppliers and Licensing Agreements

Marinus Pharmaceuticals

Marinus Pharmaceuticals is the primary developer and manufacturer of ganaxolone. The company operates its own manufacturing facilities or contracts with third-party Contract Manufacturing Organizations (CMOs) to ensure supply consistency. Its manufacturing process involves high-purity chemical synthesis, purification, and rigorous quality control measures compliant with Good Manufacturing Practices (GMP).

Contract Manufacturing Organizations (CMOs)

Given the complexity of ganaxolone synthesis, Marinus relies on established CMOs with expertise in steroid chemistry and neuropharmacological agents. Notable CMOs involved in ganaxolone production include:

• Lonza: A leading global CMO specializing in complex chemical synthesis, including steroid compounds, with capabilities to produce pharmaceutical-grade APIs (Active Pharmaceutical Ingredients) at scale [2].

• Catalent: An international CMO known for advanced formulation and manufacturing services, possibly involved in formulation or final drug product assembly [3].

• Patheon (part of Thermo Fisher Scientific): Engages in API manufacturing and formulation services, providing scalable production solutions [4].

Availability of APIs from these CMOs depends on current capacity, project priorities, and regulatory compliance timelines.

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Raw Material Suppliers

The synthesis of ganaxolone involves the use of specialized raw materials, such as steroid precursors and other chemical reagents. Key raw material suppliers include:

• Sigma-Aldrich (Merck Group): Supplies high-purity chemical reagents used in steroid synthesis.

• Thermo Fisher Scientific: Offers organic intermediates compatible with ganaxolone synthesis.

• Chiron or Steroidsource: Smaller specialized suppliers, often contracted for high-value steroid intermediates.

Securing these materials requires qualification and validation to meet GMP standards, and interruptions in supply chains may impact production timelines.

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Market and Supply Chain Dynamics

The niche market for ganaxolone, primarily centered on epilepsy and neuropsychiatric indications, places supply chain considerations at the forefront. As it is still under regulatory review, commercial-scale production hinges on successful clinical outcomes and subsequent approval. The limited number of specialized manufacturers reinforces dependence on a few key suppliers, increasing supply chain vulnerability.

Furthermore, geopolitical factors, patent disputes, and raw material procurement challenges add layers of complexity. COVID-19 pandemic disruptions have exposed vulnerabilities in pharmaceutical supply chains, underscoring the importance of diversified supplier networks [5].

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Emerging Developments and Strategic Partnerships

To secure a stable supply, Marinus Pharmaceuticals has engaged in strategic licensing and manufacturing partnerships. In 2022, the company announced collaborations with CMOs in Europe and Asia to diversify production capabilities and mitigate supply risks [6].

Additionally, the advancement toward commercialization accelerates efforts to establish robust supply chains, including:

• Increasing API manufacturing capacity.

• Establishing long-term raw material supply agreements.

• Investing in process optimization for higher yields and lower production costs.

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Regulatory & Quality Considerations

Suppliers of ganaxolone-related materials must adhere to stringent GMP standards, as dictated by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The quality of raw materials and APIs directly impacts product safety and efficacy, thus supplier qualification processes involve:

• Audits of manufacturing facilities.

• Extensive testing for impurities.

• Certification of compliance with regulatory standards.

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Conclusion

The supply landscape for ganaxolone remains concentrated but strategically managed through collaborations with specialized CMOs and raw material suppliers. Primary manufacturing responsibilities reside with Marinus Pharmaceuticals, leveraging partnerships with industry leaders like Lonza. The future of ganaxolone supply hinges on successful clinical development, regulatory approval, and strategic scaling of production. Ensuring supply chain robustness is pivotal to meeting clinical and commercial demand, especially given the competitive and regulatory complexities inherent in neuropharmaceuticals.

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Key Takeaways

• Primary responsibility for ganaxolone manufacturing rests with Marinus Pharmaceuticals, utilizing CMOs such as Lonza.

• The supply chain depends heavily on specialized raw material suppliers and GMP-compliant CMOs.

• Strategic partnerships and capacity expansion initiatives aim to mitigate supply risks and support commercialization.

• Regulatory compliance and quality assurance are critical for maintaining supply chain integrity.

• Diversification of suppliers and geographic expansion are emerging strategies to enhance supply stability.

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FAQs

Q1: Who are the main manufacturers of ganaxolone?
A: Marinus Pharmaceuticals is the primary developer and manufacturer, utilizing partnerships with CMOs like Lonza for API production.

Q2: What raw materials are used in ganaxolone synthesis?
A: The synthesis involves high-purity steroid precursors and organic reagents supplied by companies like Sigma-Aldrich and Thermo Fisher Scientific.

Q3: Are there any alternative suppliers for ganaxolone?
A: Currently, ganaxolone production is concentrated among a few specialized CMOs, but strategic partnerships aim to diversify the supply chain.

Q4: How does regulatory compliance affect supply chain stability?
A: Strict GMP standards require rigorous audits and certifications, ensuring safe and consistent drug supply but potentially complicating supplier qualification.

Q5: What risks threaten the supply of ganaxolone?
A: Potential risks include raw material shortages, manufacturing bottlenecks, geopolitical disruptions, and unforeseen global events like pandemics.

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References

[1] Marinus Pharmaceuticals, Inc. (2023). Pipeline and Development Updates.
[2] Lonza Group AG. (2023). Pharmaceutical Manufacturing Capabilities.
[3] Catalent Pharma Solutions. (2023). Service Portfolio and Capabilities.
[4] Thermo Fisher Scientific. (2023). Contract Manufacturing and API Production.
[5] IHS Markit. (2022). Pharmaceutical Supply Chain Disruptions During COVID-19.
[6] Marinus Pharmaceuticals. (2022). Strategic Alliance Announcements.