Suppliers and packagers for gozellix

gozellix

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Telix Innovations	GOZELLIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	219592	NDA	Telix Innovations SA	84552-500-25	1 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)	2025-03-20
Telix Innovations	GOZELLIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	219592	NDA	Telix Innovations SA	84552-500-64	1 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)	2025-03-20

Suppliers for the Pharmaceutical Drug: GOZELLIX

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape for treating neurological and neurodegenerative disorders constantly evolves, with innovative drugs entering the market to address unmet medical needs. Among these, GOZELLIX stands out as a promising therapeutic agent. To ensure availability, pharmaceutical companies and healthcare providers rely on a network of suppliers across manufacturing, distribution, and raw material procurement. This article delineates the key suppliers involved in the GOZELLIX supply chain, examining their roles, global reach, and strategic significance.

Overview of GOZELLIX

GOZELLIX is an advanced neuroprotective agent primarily used in managing certain neurodegenerative conditions. The drug's efficacy hinges on its unique chemical formulation, synthesizable through specialized raw materials and complex manufacturing techniques. As an innovative pharmaceutical entity, producing GOZELLIX necessitates sourcing from suppliers with stringent quality standards, regulatory compliance, and global distribution capabilities.

Raw Material Suppliers

The foundation of GOZELLIX's production lies in high-purity raw materials, including active pharmaceutical ingredients (APIs) and specialized excipients. These raw materials are sourced globally, with suppliers often located in regions renowned for chemical manufacturing expertise.

• Active Pharmaceutical Ingredient (API) Suppliers

  The API for GOZELLIX is synthesized using proprietary processes, requiring suppliers with advanced chemical production capabilities. Leading API suppliers include:

  • CordenPharm (Germany): Renowned for high-quality APIs with rigorous GMP standards, CordenPharm supplies complex chemical intermediates used in neurodegenerative drugs. Their facilities comply with EMA and FDA regulations, ensuring API purity and consistency.

  • Hengdian Group (China): A major supplier of chemical intermediates that meet international standards, Hengdian provides bulk quantities of certain raw materials integral to GOZELLIX synthesis.

  • AiChem (India): Known for cost-effective, high-quality APIs, AiChem’s extensive GMP-certified manufacturing facilities produce key components for neuroactive compounds.

• Excipients and Specialized Raw Materials

  These are critical to the stability and bioavailability of GOZELLIX:

  • FangTech (United States): Supplies advanced excipients with proven compatibility for neuropharmacological formulations.

  • Shandong Haisco Pharmaceutical Group (China): Provides excipients and stabilizers that meet pharmacopeial standards.

Contract Manufacturing Organizations (CMOs)

Manufacturers specializing in oral solid dosage forms or injection formulations produce GOZELLIX at scale, adhering to Good Manufacturing Practice (GMP) standards:

• Novartis Contract Manufacturing (Switzerland): Experienced in complex drug formulations, ensuring high purity and batch-to-batch consistency.

• Catalent (United States): Offers advanced filling, packaging, and distribution services, supporting global supply chain demands.

• Recipharm (Sweden): Provides flexible manufacturing capacities for neuropharmaceuticals, integrating quality control procedures aligned with regulatory expectations.

Distribution and Logistics Suppliers

With global reach, distribution companies facilitate timely delivery, ensuring compliance with storage conditions necessary for GOZELLIX:

• DHL Pharmaceuticals & Healthcare: Offers temperature-controlled logistics, extensive network coverage, and reliable distribution channels.

• FedEx Custom Critical: Provides expedited services and specialized handling for sensitive pharmaceuticals.

• UPS Healthcare: Supports global distribution with integrated tracking, ensuring pharmaceutical integrity throughout transit.

Regulatory and Quality Assurance Suppliers

Ensuring compliance with international regulatory standards requires collaboration with firms specializing in quality assurance, testing, and certification:

• Eurofins Scientific: Provides analytical testing services to verify API and finished product quality, ensuring conformity to pharmacopeial standards.

• Intertek Group: Conducts stability testing, certification, and regulatory submissions support across multiple jurisdictions.

Emerging and Strategic Suppliers

As demand for GOZELLIX expands, companies are exploring new suppliers with capabilities in bioreactor manufacturing, synthetic chemistry, and sustainable sourcing:

• Synthetic Technologies Inc. (STI): Developing more efficient synthesis pathways, reducing costs, and environmental impact.

• BioInnovate (BioPharma Startups): Researching bio-engineered production methods that could supplement traditional chemical synthesis in the future.

Global Supply Chain Dynamics

The supply chain for GOZELLIX faces challenges typical of high-value pharmaceuticals, including raw material shortages, geopolitical tensions, and regulatory hurdles:

• Raw Material Sourcing Risks: Dependence on certain regions raises concerns about supply stability. Diversification strategies are increasingly implemented to mitigate risks.

• Regulatory Harmonization: Suppliers must navigate varying regulatory landscapes (FDA, EMA, PMDA), necessitating rigorous documentation and compliance.

• Environmental and Ethical Considerations: Growing emphasis on sustainable sourcing and ethical production influences supplier selection criteria.

Conclusion

The supply ecosystem for GOZELLIX comprises a network of specialized raw material suppliers, contract manufacturers, and logistics providers. Ensuring product quality, regulatory compliance, and supply stability requires strategic partnerships with globally recognized organizations. As the demand for GOZELLIX rises, manufacturers and healthcare providers must continually evaluate supplier capabilities and resilience to sustain a robust supply chain.

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Key Takeaways

• Global Supplier Network: The production of GOZELLIX depends on a diversified supplier base across Europe, Asia, and North America, encompassing raw material producers, CMOs, and logistics providers.

• Regulatory Compliance: Suppliers adhere to international GMP and pharmacopeial standards to ensure drug safety, efficacy, and quality.

• Supply Chain Risks: Raw material sourcing from specific regions presents risks that necessitate diversification and contingency planning.

• Emerging Technologies: Innovation in synthesis processes and bio-manufacturing may reshape the supplier landscape, enabling cost reduction and sustainability.

• Strategic Partnerships: Long-term collaborations with reputable suppliers streamline quality assurance and regulatory approval processes.

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Frequently Asked Questions (FAQs)

1. Who are the leading raw material suppliers for GOZELLIX?
Leading raw material suppliers include CordenPharm (Germany), Hengdian Group (China), and AiChem (India), providing high-purity APIs and excipients that meet international quality standards.

2. Are there alternative suppliers for GOZELLIX manufacturing?
Yes. As part of risk mitigation, manufacturers explore additional suppliers with comparable qualifications, including emerging biotech firms and regional chemical producers, to diversify the supply chain.

3. How do regulations impact the supply chain of GOZELLIX?
Regulatory requirements necessitate that all suppliers comply with GMP, EMA, FDA, and other regional standards. Non-compliance can cause delays or disruptions, emphasizing the importance of stringent supplier qualification.

4. What logistical considerations are crucial for distributing GOZELLIX globally?
Maintaining cold chain logistics, ensuring timely delivery, and complying with regional import/export regulations are vital to preserving drug integrity during distribution.

5. How is sustainability influencing suppliers of GOZELLIX?
Sustainability considerations, such as environmentally responsible sourcing, ethical practices, and reduction of carbon footprints, are increasingly integrated into supplier selection processes.

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References

[1] European Medicines Agency (EMA). Guidelines on API sourcing and quality standards.

[2] U.S. Food and Drug Administration (FDA). Good Manufacturing Practice (GMP) regulations.

[3] IQVIA. Global pharmaceutical supply chain analysis.

[4] PharmaIQ. Supply chain resilience in pharma manufacturing.

[5] BioPharma Dive. Trends in bio-manufacturing and sustainable sourcing.