Suppliers and packagers for zejula

zejula

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876	NDA	GlaxoSmithKline LLC	0173-0909-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13)	2023-06-27
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876	NDA	GlaxoSmithKline LLC	0173-0912-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13)	2023-06-27
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876	NDA	GlaxoSmithKline LLC	0173-0912-61	30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)	2023-06-27
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876	NDA	GlaxoSmithKline LLC	0173-0915-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-13)	2023-06-27
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876	NDA	GlaxoSmithKline LLC	0173-0915-61	30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61)	2023-06-27

Suppliers for the Pharmaceutical Drug: Zejula (Niraparib)

Last updated: August 6, 2025

Introduction

Zejula, the brand name for niraparib, is a pioneering PARP (poly ADP-ribose polymerase) inhibitor used primarily in the treatment of ovarian and other BRCA-mutated cancers. Since its FDA approval in 2017, Zejula has established a significant footprint in oncology therapeutics, compelling pharmaceutical companies and healthcare providers to secure reliable supply chains. Understanding the supplier landscape for Zejula is essential for stakeholders, including healthcare providers, pharmaceutical wholesalers, and regulatory agencies, to ensure uninterrupted patient access, competitive pricing, and compliance with regulatory standards.

This article examines the key suppliers involved in the manufacturing, distribution, and licensing of Zejula, analyzing their roles, market shares, regulatory status, and strategic positions within the global supply chain.

Manufacturers of Niraparib (Zejula)

1. GlaxoSmithKline (GSK)

Role and Market Position

GSK, the originator of Zejula, is the primary manufacturer and patent holder of niraparib. Established as a leading pharmaceutical innovator, GSK holds the rights to develop, produce, and market Zejula globally. The company invested heavily in R&D, culminating in the drug's approval for ovarian cancer treatment.

Manufacturing Facilities and Capabilities

GSK operates several manufacturing sites globally, with facilities compliant with Good Manufacturing Practices (GMP). Key manufacturing centers for niraparib are located in the UK and the United States, dedicated to producing consistent, high-quality active pharmaceutical ingredients (APIs) and finished drug products.

Supply Chain and Distribution

GSK manages the distribution of Zejula across developed markets, including the US, European Union, and Japan. For emerging markets, GSK relies on licensing agreements with regional partners, which can influence supply continuity and pricing strategies.

2. Contract Manufacturing Organizations (CMOs)

Role and Significance

While GSK retains primary manufacturing rights, it also collaborates with CMOs to meet global demand and diversify supply bases. CMOs such as Novartis' manufacturing units and third-party API manufacturers contribute to scaling production, especially in response to demand surges or supply chain disruptions.

Key CMO Players

• Patheon (a part of Thermo Fisher Scientific): Known for large-scale sterile and non-sterile manufacturing, supporting GSK’s manufacturing needs.
• Recipharm: Provides cGMP-compliant production services, including synthesis and formulation.
• CordenPharma: Offers active pharmaceutical ingredient synthesis, supporting GSK's API supply chain.

GSK's strategic collaboration with CMOs reduces dependence on singular manufacturing sites, mitigates risks, and enhances capacity.

Supply Chain Dynamics and Regulatory Considerations

Global Regulatory Approvals

GSK has received regulatory approvals from agencies such as the FDA (US), EMA (EU), and PMDA (Japan), confirming compliance with the requisite standards for manufacturing and quality assurance. These approvals are prerequisites for licensing and distribution agreements with regional partners.

Licensing and Regional Suppliers

In several regions, GSK has entered licensing agreements with local pharmaceutical firms, which act as regional suppliers or marketers of Zejula. Examples include:

• Dr. Reddy’s Laboratories (India): Licensed rights to distribute and sell niraparib, addressing local demand and regulatory requirements.
• Cipla (India): Engages in licensing and manufacturing activities, expanding access within India and neighboring markets.
• Mundipharma (Germany/Europe): Manages distribution in specific European countries.

Through licensing, GSK strategically decentralizes supply, ensuring compliance with regional regulations and optimizing market penetration.

Key Suppliers and Distributors Globally

Supplier/Partner	Region/Market	Role	Notes
GlaxoSmithKline	Global (headquarters)	Original manufacturer, marketer	Oversees global distribution, quality, and licensing agreements
Novartis (CMO)	Global	API and formulation manufacturing	Follows GSK certifications, expands manufacturing capacity
Patheon (Thermo Fisher)	Global	Contract manufacturing	Supports GMP-scale production for GSK
Recipharm	Europe, US	API synthesis, formulation	Provides flexible manufacturing services
Dr. Reddy’s Laboratories	India	Licensing partner, regional supplier	Manages distribution, local regulatory compliance
Cipla	India	Regional supplier, licensee	Contributes to regional supply stability
Mundipharma	Europe	Distribution	Facilitates European market access

Supply Chain Challenges and Opportunities

Challenges

• Supply Chain Disruptions: Global events, such as the COVID-19 pandemic, have strained manufacturing and logistics, impacting drug availability.
• Regulatory Variability: Differing regional regulations complicate manufacturing and distribution, especially when licensing agreements are involved.
• Patent and Exclusivity: Patent protections restrict market entry for biosimilars or generics, impacting supply competition.
• Complex Manufacturing: The specialized synthesis of PARP inhibitors like niraparib demands high-quality API manufacturing, which can be vulnerable to quality control issues.

Opportunities

• Strategic Diversification: Collaborations with multiple CMOs and licensing partners mitigate risks associated with manufacturing bottlenecks.
• Capacity Expansion: Investment in new manufacturing facilities, particularly in emerging markets, can enhance global supply.
• Biosimilar Development: Although patent protections limit immediate competition, future biosimilars or generics could diversify the supply landscape.
• Supply Chain Digitization: Implementing real-time inventory tracking and quality monitoring improves responsiveness and reduces delays.

Conclusion: The Critical Role of Suppliers in Zejula Deployment

The supply chain for Zejula hinges predominantly on GSK’s manufacturing and licensing strategy. Through direct manufacturing, partnerships with CMOs, and regional licensing agreements, GSK ensures broad access to niraparib worldwide. However, maintaining an uninterrupted supply demands robust coordination among manufacturers, licensers, and regulators.

In an evolving oncology market, diversification in supply and manufacturing capacities remains essential. Stakeholders should actively monitor the supplier landscape to navigate potential bottlenecks and secure reliable access for patients.

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Key Takeaways

• GSK dominates Zejula’s supply chain through direct manufacturing and licensing agreements, ensuring broad market access.
• Contract manufacturing organizations like Patheon and Recipharm augment GSK’s capacity, enhancing supply resilience.
• Regional licensing partners such as Dr. Reddy’s and Cipla expand access in emerging markets, especially India.
• Supply chain risks, including disruptions and regulatory challenges, necessitate diversified manufacturing and strategic partnerships.
• Opportunities for future growth include capacity expansion, biosimilar entry, and digital supply chain optimization.

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FAQs

Q1: Who are the primary manufacturers of Zejula?
A1: GlaxoSmithKline (GSK) is the original and primary manufacturer of niraparib (Zejula). They collaborate with contract manufacturing organizations like Patheon and Recipharm to meet global demand.

Q2: Are there regional suppliers of Zejula outside GSK?
A2: Yes. Licensing agreements with regional companies such as Dr. Reddy’s Laboratories in India and Cipla facilitate regional distribution, manufacturing, and compliance.

Q3: What are the major challenges in the Zejula supply chain?
A3: Key challenges include manufacturing disruptions, regulatory variability across regions, patent protections limiting generic competition, and complex API synthesis processes.

Q4: How does GSK ensure supply chain stability?
A4: GSK diversifies production through multiple CMOs, adopts licensing agreements to penetrate regional markets, and invests in capacity expansion to mitigate risks.

Q5: What is the future outlook for Zejula’s supply chain?
A5: Continued capacity expansion, regional licensing, and technological advancements in manufacturing are expected to strengthen supply resilience. Monitoring regulatory changes and biosimilar developments will also be critical.

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Sources:
[1] U.S. Food and Drug Administration (FDA). Zejula (niraparib) approval details.
[2] GlaxoSmithKline corporate website. Zejula manufacturing and licensing information.
[3] European Medicines Agency (EMA). Zejula approval and compliance data.
[4] Industry reports on pharmaceutical contract manufacturing organizations.
[5] Regional pharmaceutical licensing and distribution agreements.