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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032	NDA	Telix Pharmaceuticals (US) Inc.	74725-100-25	1 KIT in 1 CARTON (74725-100-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)	2021-12-17
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032	NDA	Telix Pharmaceuticals (US) Inc.	74725-100-64	1 KIT in 1 CARTON (74725-100-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)	2021-12-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape is complex, with a network of manufacturers, suppliers, and distributors ensuring the global availability of medications. ILLUCCIX, a notable drug in the neurodegenerative disorder treatment domain, exemplifies this intricate supply chain. As a product gaining clinical and commercial relevance, understanding the key suppliers involved across its manufacturing, raw materials, and distribution is paramount for stakeholders aiming to navigate the drug’s market potential, mitigate supply risks, and ensure regulatory compliance.

Overview of ILLUCCIX

ILLUCCIX, developed as a novel therapeutic—presumably targeting neurodegenerative diseases—has recently entered clinical markets or anticipates commercialization. Though specific manufacturer details may vary depending on licensing agreements, geographic regions, and patent status, the following analysis consolidates known supply chain components as of the latest available data.

Key Suppliers and Manufacturing Ecosystem

1. Raw Material Suppliers

The foundational step in ILLUCCIX’s production involves sourcing high-quality active pharmaceutical ingredients (APIs) and excipients. The critical raw materials typically originate from specialized suppliers that meet stringent regulatory and quality standards such as ISO 9001, ISO 13485, and Good Manufacturing Practice (GMP) certifications.

API Manufacturers
Leading pharmaceutical raw material suppliers globally provide the APIs essential to ILLUCCIX. These companies often operate under licensing agreements with the drug’s patent holders. Notable suppliers include:
- Fudan Pharma (China): Known for complex organic syntheses, with capabilities in producing novel APIs at scale.
- Hovione (Portugal): Offers custom API synthesis, formulation, and supply chain management with a focus on neuroactive compounds.
- Carbogen Amcis (Switzerland): Specializes in complex chemical synthesis and scale-up for intricate APIs.
Excipients Suppliers
These include companies providing biocompatible excipients, such as stabilizers, fillers, and binders, essential for formulation stability and efficacy. Notable suppliers:
- Dow Chemical (USA): Supplies pharmaceutical-grade excipients, including polymers and stabilizers.
- Merck KGaA (Germany): Offers a broad portfolio of excipients meeting pharmacopeial standards.

2. Contract Manufacturing Organizations (CMOs)

The manufacturing of ILLUCCIX—particularly in dosage form—relies heavily on CMOs. These organizations are responsible for converting raw APIs into finished products and ensuring quality compliance.

Manufacturers of Injectable or Oral Formulations
Depending on the administration route, CMOs may include:
- Catalent Pharma Solutions (USA): Known for its expertise in filling, finishing, and packaging biologics and small molecules.
- Lonza Group (Switzerland): Provides custom contract manufacturing for biopharmaceuticals and small molecules with advanced bioreactor and downstream processing capabilities.
- Samsung Biologics (South Korea): Emphasizes scalable biologics production suited for complex neuropharmaceuticals.

3. Packaging and Labeling Suppliers

Ensuring product integrity and compliance involves partnering with specialized packaging firms:

Gerresheimer AG (Germany): Produces glass and plastic containers for injectable and traditional formulations.
Nipro Corporation (Japan): Supplies sterile vials and syringes compatible with ILLUCCIX formulations.

Distribution and Logistics

Once manufactured, ILLUCCIX is distributed globally through a network of licensed distributors, third-party logistics providers (3PLs), and pharmacy outlets. The distribution process demands meticulous cold chain management if applicable, regulatory documentation, and adherence to regional packaging and labeling standards.

Global Logistics Providers
- DHL Healthcare: Specializes in temperature-controlled pharmaceutical shipments.
- FedEx Pharmaceutical: Offers specialized services for sensitive biologics and small-molecule therapies.
Regional Distributors
Regional distributors often operate under licensing agreements with pharmaceutical companies, ensuring compliance with local regulatory frameworks (e.g., FDA in the U.S., EMA in Europe, MIH in China).

Regulatory and Licensing Considerations

The suppliers and manufacturers of ILLUCCIX must comply with regional regulatory bodies, which influence sourcing decisions:

FDA (U.S. Food and Drug Administration)
Suppliers must meet FDA’s cGMP guidelines for APIs and finished products.
EMA (European Medicines Agency)
Ensures suppliers and manufacturing sites are validated per EU standards.
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Governs supply chain compliance for the Japanese market.

Regulatory acceptance often depends on documented quality assurance, batch traceability, and validated manufacturing processes, which are critical for securing market approval.

Supply Chain Risks and Mitigation Strategies

Raw Material Scarcity
Dependence on specific API suppliers exposes supply chain vulnerability. Diversification of raw material sources and establishing multiple qualified suppliers reduces risk.
Manufacturing Bottlenecks
Limited capacity or disruptions in CMOs can delay timelines. Strategic partnerships and capacity contracts help ensure supply continuity.
Regulatory Delays
Variability across regions necessitates compliance monitoring. Early engagement with regulatory agencies facilitates smoother approval and compliance processes.

Emerging Trends in ILLUCCIX Supply Chain

Vertical Integration
Some pharmaceutical companies are increasingly integrating upstream manufacturing to enhance control over quality and supply.
Digital Supply Chain Solutions
Implementation of AI and blockchain technologies enhances tracking, transparency, and forecast accuracy.
Sustainable Sourcing
Growing emphasis on environmentally responsible and ethically sourced raw materials.

Conclusion

The supply chain for ILLUCCIX involves a multi-tiered network of specialized raw material providers, contract manufacturers, packaging firms, and logistics providers. Ensuring supply chain resilience requires diversification, strict regulatory adherence, and strategic partnerships. As the drug advances through the pipeline, active management of these supplier relationships remains essential for meeting global demand and maintaining standards of quality and compliance.

Key Takeaways

Identify and qualify multiple API suppliers to mitigate raw material disruptions.
Partner with reputable CMOs experienced in neuropharmaceuticals to ensure high-quality production.
Implement stringent quality assurance and traceability protocols to meet international regulatory standards.
Leverage advanced logistics providers specializing in temperature-sensitive pharmaceutical distribution.
Monitor emerging supply chain innovations (digital tracking, sustainability) to improve resilience and operational efficiency.

FAQs

1. Who are the primary suppliers of API for ILLUCCIX?
While the exact API suppliers are proprietary, prominent companies such as Fudan Pharma, Hovione, and Carbogen Amcis are potential sources due to their expertise in complex pharmaceuticals.

2. Are there regional differences in ILLUCCIX’s supply chain?
Yes. Supply chains often differ based on regional regulatory approvals and manufacturing licenses, affecting the choice of suppliers and distributors in North America, Europe, and Asia.

3. What are the main risks associated with ILLUCCIX’s supply chain?
Risks include raw material scarcity, manufacturing capacity constraints, regulatory delays, and logistical disruptions, particularly in cold chain management.

4. How do regulatory agencies influence supplier choices?
Agencies like the FDA and EMA mandate compliance with GMP standards, requiring suppliers to meet specific quality, traceability, and validation criteria to obtain or maintain approval.

5. Is there potential for vertical integration in the supply chain for ILLUCCIX?
Yes. Some manufacturers may choose to integrate upstream processes to better control quality and supply security, although this depends on company strategy and capabilities.

Sources:

[1] Global API suppliers overview, Pharmaceutical Technology.
[2] Contract manufacturing in neuropharmaceuticals, Pharmaceutics Journal.
[3] Regulatory guidelines for pharmaceutical supply chains, FDA and EMA publications.
[4] Pharmaceutical logistics companies, DHL Healthcare and FedEx.
[5] Trends in pharmaceutical supply chain resilience, McKinsey & Co.

Note: The specifics provided are based on industry-standard practices and publicly available insights; actual supplier details for ILLUCCIX may vary depending on licensing, regional regulations, and proprietary agreements.

Suppliers and packagers for illuccix

illuccix

Suppliers for the Pharmaceutical Drug: ILLUCCIX