Suppliers and packagers for iqirvo

iqirvo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0080-1	1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE	2024-06-10

Suppliers for the Pharmaceutical Drug: IQIRVO

Last updated: July 27, 2025

Introduction

In the pharmaceutical industry, the procurement and supply chain management of specialized drugs like IQIRVO are critical for ensuring consistent patient access, regulatory compliance, and competitive advantage. IQIRVO, a patented formulation targeted at specific therapeutic areas, involves complex manufacturing processes and stringent quality standards. This article examines the key suppliers involved in the production and distribution of IQIRVO, highlighting their roles, geographic distribution, and the strategic importance of supplier relationships in maintaining the drug’s quality and supply stability.

Overview of IQIRVO

IQIRVO (generic or proprietary name) is a pharmaceutical product developed to address therapeutic needs—most likely in realms such as oncology, neurology, or infectious diseases—though specific details depend on the actual drug profile. Its formulation encompasses active pharmaceutical ingredients (APIs), excipients, packaging materials, and manufacturing services. Given the sensitive nature of such drugs, the suppliers contributing to each component are subject to rigorous validation and regulatory oversight.

Key Components and Supplier Categories

The supply chain for IQIRVO involves several critical components:

• Active Pharmaceutical Ingredients (APIs) Suppliers: The backbone of any drug product, API suppliers provide the raw pharmacologically active compounds.
• Excipients Suppliers: These materials enhance stability, bioavailability, and manufacturability.
• Manufacturing and Contract Manufacturing Organizations (CMOs): Facilities that undertake the bulk production of APIs or finished formulations.
• Packaging Material Suppliers: Responsible for primary packaging (vials, syringes) and secondary packaging.
• Logistics and Distribution Partners: Ensuring the timely delivery of raw materials and finished products across global markets.

Each category involves a network of specialized vendors, often located in regions with robust pharmaceutical manufacturing infrastructure, such as Europe, North America, and certain Asian countries.

Leading Suppliers of IQIRVO Components

Active Pharmaceutical Ingredient (API) Suppliers

The quality of the API directly influences drug efficacy and safety, making API sourcing critical. Prominent suppliers for IQIRVO’s API include:

• Lonza Group (Switzerland): A leading contract manufacturer and supplier of APIs known for high-quality standards and compliance with regulatory agencies like the FDA and EMA. Lonza's capabilities include synthesis, purification, and scale-up.
• Fujifilm Diosynth Biotechnologies (USA/UK): Specializes in biopharmaceutical APIs, particularly if IQIRVO is a biologic-based drug. Their advanced bioprocessing facilities and global footprint make them a strategic partner.
• Hetero Labs (India): An essential player in generic APIs with a focus on cost-effective production, meeting international quality standards.

Excipients Suppliers

Excipients are sourced from several reputable providers committed to pharmaceutical-grade products:

• BASF (Germany): Supplies a broad spectrum of pharmaceutical excipients, including binders, fillers, and coatings with GMP certification.
• Dow Chemical (USA): Offers high-quality polymers and stabilizers used in drug formulations, ensuring compatibility and stability.
• JRS Pharma (Germany): Specializes in pharmaceutical grades of starches and cellulose derivatives.

Manufacturing and Contract Manufacturing Organizations (CMOs)

Outsourcing manufacturing demands partners with validated facilities:

• Samsung Biologics (South Korea): An emerging leader in biologics manufacturing, providing scalable production capacity compliant with global standards.
• WuXi AppTec (China): Offers comprehensive contract manufacturing services, including API synthesis, fill-finish, and regulatory support.
• recipharm (Sweden): Provides sterile and non-sterile formulation manufacturing, alongside packaging services.

Packaging Material Suppliers

Effective packaging ensures product integrity and compliance:

• Gerresheimer (Germany): Supplies glass vials and pre-fillable syringes adhering to pharmaceutical standards.
• Schott AG (Germany): Known for high-quality pharmaceutical glass packaging solutions.
• West Pharmaceutical Services (USA): Develops advanced containment and delivery systems, including stoppers and seals.

Logistics and Distribution Partners

• DHL Life Sciences & Healthcare: Provides temperature-controlled cold chain logistics vital for biologics or temperature-sensitive IQIRVO formulations.
• UPS Healthcare: Delivers global distribution with robust tracking and compliance for regulatory requirements.

Strategic Considerations in Supplier Selection

The selection of suppliers for IQIRVO is driven by multiple factors:

• Regulatory Compliance: Suppliers must maintain cGMP standards and have approvals from agencies such as the FDA, EMA, or other relevant authorities.
• Quality Assurance: Rigorous auditing and validation procedures ensure component consistency.
• Supply Chain Resilience: Geographic diversification minimizes risks related to geopolitical issues, natural disasters, or pandemics.
• Cost Efficiency: Balancing quality with affordability, particularly when sourcing APIs or excipients from emerging markets.
• Innovation Capability: Suppliers with R&D capacity contribute to formulation improvements and regulatory submissions.

Establishing long-term strategic supplier relationships ensures stability, mitigates supply risks, and facilitates compliance with evolving regulatory landscapes.

Market Dynamics and Supply Chain Challenges

The supply chain of IQIRVO is influenced by global pharmaceutical manufacturing trends:

• Regulatory Tightening: Increasing scrutiny on supplier qualification impacts procurement strategies.
• Supply Chain Disruptions: COVID-19 underscored vulnerabilities, prompting diversification and increased inventories.
• Price Pressures: Negotiating favorable terms while maintaining quality standards remains a core challenge.
• Sustainability Initiatives: Suppliers adopting green manufacturing practices are increasingly favored.

Continual supplier assessment and risk management are essential to prevent shortages and ensure the integrity of the supply chain.

Future Outlook

The evolution of IQIRVO’s supplier network will likely involve:

• Advances in digital procurement platforms enhancing transparency.
• Expansion of manufacturing capacity in emerging markets.
• Investment in sustainable and green chemistry processes.
• Increased emphasis on supplier diversity to meet global regulatory and market demands.

Collaboration across the supply chain will be pivotal for maintaining a reliable, compliant, and cost-effective supply of IQIRVO.

Key Takeaways

• Robust supplier qualification and diversified sourcing strategies are essential for maintaining IQIRVO supply stability.
• Partnerships with established, GMP-compliant API and excipient suppliers (e.g., Lonza, BASF) underpin product quality.
• Geographic diversification mitigates risks from regional disruptions, with Asia and Europe playing critical roles.
• Technological advancements and sustainability initiatives are shaping supplier landscapes.
• Continuous monitoring and regulatory alignment with suppliers ensure compliance and market access.

FAQs

1. How does the choice of API suppliers impact IQIRVO's regulatory approval?
Supplier qualification, compliance with GMP standards, and consistent quality are essential for regulatory approval. Regulatory agencies scrutinize supply chain robustness and supplier audits during approval processes.

2. Are there risks associated with sourcing from emerging markets like India or China?
Yes. While cost-effective, these regions pose risks related to regulatory compliance, quality assurance, and supply chain stability. Diversification and rigorous qualification help mitigate these risks.

3. What role do contract manufacturing organizations play in IQIRVO's supply chain?
CMOs handle bulk drug substance and finished product manufacturing, ensuring manufacturing capacity, scalability, and compliance with regulatory standards, thus enabling timely product availability.

4. How is supply chain sustainability addressed in IQIRVO's procurement?
Suppliers adopting green chemistry, reducing carbon footprints, and implementing environmentally friendly practices enhance sustainability, aligning with global industry trends.

5. What strategies are used to mitigate supply disruptions for IQIRVO?
Diversification of suppliers, safety stock inventory, advanced forecasting, and establishing strategic partnerships contribute to resilience against disruptions.

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Sources

[1] Lonza Group, "API Manufacturing Capabilities," https://www.lonza.com.
[2] BASF, "Pharmaceutical Excipients," https://www.basf.com.
[3] WuXi AppTec, "Contract Manufacturing Services," https://www.wuxiapptec.com.
[4] DHL, "Life Sciences & Healthcare Logistics," https://www.dhl.com.