Suppliers and packagers for ONIVYDE

ONIVYDE

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	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793	NDA	Ipsen Biopharmaceuticals, Inc.	15054-0043-1	1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE	2015-10-22

Suppliers for the Pharmaceutical Drug: ONIVYDE

Last updated: July 29, 2025

Introduction

ONIVYDE, also known as irinotecan liposomal injection, is an innovative chemotherapeutic agent broadly utilized in oncology for treating metastatic pancreatic adenocarcinoma, especially in combination with other agents like fluorouracil and leucovorin. Its unique liposomal formulation enhances drug delivery, pharmacokinetics, and tolerability, making it a significant asset in oncology therapeutics. Given its complex manufacturing process and specialized formulation, understanding its suppliers is critical for stakeholders involved in procurement, manufacturing, and distribution within the pharmaceutical supply chain.

Manufacturers and Supply Chain Overview

1. Primary Manufacturer: Innovent Biologics and Pharmacyclics/Janssen

Initially developed through collaborative efforts, the primary production of ONIVYDE involves Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which holds the marketing authorization in various markets. Janssen is responsible for formulation, clinical development, and distribution.

Innovent Biologics—an emerging Chinese biopharmaceutical company—entered licensing agreements to expand manufacturing capacities, especially for the Asian market, aligning with strategic partnerships to scale production and meet regional demands. These collaborations have facilitated supply chain resilience and regional access.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of liposomal drug formulation, Janssen leverages CMOs to sustain high-quality production at scale. Notable CMOs involved in the supply chain include:

• WuXi AppTec: Known for its expertise in liposomal and biologic formulations, WuXi provides contract manufacturing and analytical testing services, contributing to both clinical and commercial supply.
• Catalent Pharma Solutions: Catalent’s advanced liposomal drug manufacturing platforms support pharmaceutical companies globally, ensuring quality and compliance with regulatory standards (e.g., FDA, EMA).
• Boehringer Ingelheim: Provides expertise in liposomal formulations for oncology drugs, potentially supporting late-stage development and commercial manufacture of ONIVYDE.

3. Raw Material Suppliers

The production of liposomal irinotecan involves sourcing high-quality raw materials such as:

• Sphingomyelin and Cholesterol: Critical lipids in liposomal vesicle formation, supplied by companies like Avanti Polar Lipids and Lipoid GmbH.
• Active Pharmaceutical Ingredient (API): The irinotecan API is sourced primarily from specialized suppliers with GMP certification, ensuring therapeutic efficacy and consistency.

4. Packaging and Distribution Suppliers

The final product, ONIVYDE, requires specialized containers and cold chain logistics:

• Packaging: Suppliers like West Pharmaceutical Services and Catalent supply sterile vials and closures compliant with pharmaceutical standards.
• Cold Chain Logistics: Cold chain logistics providers such as DHL Supply Chain and FedEx Custom Critical handle the transportation, preserving stability and efficacy.

Supply Chain Challenges

The global supply of ONIVYDE faces several challenges:

• Complex Formulation: Liposomal encapsulation demands high precision manufacturing and stringent quality controls, restricting supplier options.
• Regulatory Compliance: Suppliers must adhere to GMP standards, increasing dependency on a limited pool of qualified manufacturers.
• Supply Chain Disruptions: Factors like geopolitical tensions, pandemic-related disruptions, and raw material shortages have impacted production stability.
• Regional Manufacturing Capacity: To meet global demand, companies are expanding manufacturing facilities, but capacity constraints remain for liposomal formulations.

Strategic Sourcing and Risk Management

Pharmaceutical companies prioritize securing diversified supplier networks and establishing regional manufacturing hubs to mitigate risks. Collaborations with CMOs enable flexibility, while contracts often include clauses for early delivery and quality assurance.

Conclusion

Supply for ONIVYDE hinges on a tightly integrated network of large pharmaceutical firms, contract manufacturing organizations, raw material suppliers, and logistics providers. The intricacy of liposomal formulation imposes high entry barriers, concentrating supply among select qualified vendors. Ongoing capacity expansion and strategic sourcing are vital to meet the increasing global demand driven by expanding indications and markets.

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Key Takeaways

• Primary manufacturing rights are held by Janssen Pharmaceuticals, with partnerships extending across China via Innovent Biologics.
• CMOs like WuXi AppTec, Catalent, and Boehringer Ingelheim play a critical role in scaling manufacturing capabilities.
• Raw material suppliers are specialized lipid and API providers, with strict adherence to GMP standards.
• Supply chain resilience depends on diversified sourcing, regional manufacturing expansion, and efficient logistics solutions.
• Regulatory compliance and formulation complexity create significant barriers for new entrants, maintaining supply chain concentration.

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FAQs

1. Who are the main manufacturers of ONIVYDE?
Janssen Pharmaceuticals is the primary producer of ONIVYDE, with collaborations involving Innovent Biologics in certain regions. Contract manufacturing organizations (CMOs) like WuXi AppTec and Catalent support large-scale production.

2. What raw materials are essential for ONIVYDE production?
High-quality lipids such as sphingomyelin and cholesterol, as well as the irinotecan active pharmaceutical ingredient (API), are critical raw materials supplied by specialized vendors.

3. How does the liposomal formulation impact the supply chain?
Liposomal encapsulation requires advanced manufacturing processes, stringent quality controls, and specialized raw materials, limiting the number of qualified suppliers and increasing complexity.

4. What are the major logistical considerations for delivering ONIVYDE globally?
Cold chain logistics, sterile packaging, and regulatory compliance are key factors ensuring product stability and therapeutic efficacy during transportation and distribution.

5. How might supply chain disruptions affect ONIVYDE availability?
Disruptions in raw materials, manufacturing capacity constraints, geopolitical issues, or regulatory hurdles can hinder supply, emphasizing the importance of diversified sourcing and regional manufacturing expansions.

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Sources

[1] Johnson & Johnson. (2022). ONIVYDE (Irinotecan Liposomal Injection) Prescribing Information.
[2] Innovent Biologics. (2023). Corporate Collaboration Announcements.
[3] WuXi AppTec. (2022). Liposomal Manufacturing Capabilities.
[4] Catalent Pharma Solutions. (2022). Liposomal Drug Product Manufacturing.
[5] Avanti Polar Lipids. (2023). High Purity Lipids for Pharmaceutical Use.