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

Zejula (niraparib) Suppliers and Upstream Manufacturing: Who Makes the Drug, Key API/Intermediate Sources, and How Supply Ties to IP and Launch Risk

Last updated: June 2, 2026

Executive summary: Zejula (niraparib) supply is concentrated in a small number of large-scale manufacturers for the active pharmaceutical ingredient (API) and finished dosage form. For commercial sourcing and risk planning, the practical supplier map is: (1) original and contract API manufacturers listed on regulatory filings and quality documentation tied to worldwide registrations, (2) contract manufacturing organizations (CMOs) for capsules/tablets packaging under Zai/GlaxoSmithKline’s distribution structure in the US, and (3) secondary sources that qualify to meet stability, cold-chain (where applicable), and packaging specs. In parallel, patent and exclusivity timelines shape whether alternative suppliers can legally enter via authorized distribution or generic manufacturing.

Who supplies Zejula (niraparib) API and finished capsules?

Featured snippet answer: Zejula’s drug supply chain is led by manufacturers that produce niraparib API and then package niraparib capsules for the branded label. The dominant model in oncology small molecules is: one or two API makers plus multiple CMOs for finished dosage forms, with each finished-goods site listed via FDA drug application and related registrations/labeling.

API supply: what to map for supplier due diligence

For niraparib, upstream supplier qualification typically hinges on:

• API synthesis route control: impurity profile and polymorph/crystal form consistency for niraparib API
• Residual solvents and elemental impurities: meeting ICH Q3D limits
• Particle size and flow: relevant for encapsulation uniformity
• Analytical method transfer: stability-indicating HPLC/LC-MS methods
• Batch traceability: DMF/CEP linkage and audit history

Finished dosage form suppliers: how to identify capsule makers

Finished-goods supply is usually mapped through:

• NDA/label manufacturing sites for Zejula capsules
• Commercial batch labeling (manufacturer and packager on packaging)
• Regulatory product registration listings in major jurisdictions
• GMP inspection outcomes at capsule sites for contamination controls

Which companies manufacture niraparib (Zejula) API for branded supply?

Featured snippet answer: The niraparib API supplier set is narrower than the finished-goods supplier set, with API production concentrated among large oncology intermediates and API platforms. Supplier names for niraparib must be verified against regulatory listings and DMF references tied to the Zejula marketing authorization.

Upstream supplier categories you should screen

• API manufacturers with DMFs supporting niraparib registration
• CMOs capable of high-potency handling (occupational exposure controls, dedicated areas, validated cleaning)
• Contract packagers with oncology packaging spec compliance (desiccant, tight-lot serialization, tamper evidence)

What “supplier” means for sourcing

In procurement terms, Zejula supply can be sourced as:

• API only (for internal formulation or contract formulation)
• Intermediates to API (more common in complex heterocycles, but less accessible)
• Finished capsules (most common for brand continuity and for distributors)
• Packaged commercial units (includes labeling and secondary packaging)

What patents protect Zejula supply chain, and how do they affect alternative suppliers?

Featured snippet answer: Zejula’s supplier landscape is constrained by the patent estate covering niraparib composition, crystal/polymorph forms (where claimed), formulations, and method-of-use. These patents do not typically prevent API manufacturing alone for non-US markets, but they do block US commercial manufacture/sale and can trigger litigation for generic or “authorized” entrants.

Patent estate components relevant to supplier entry

Supplier entry barriers generally fall into these buckets:

• Composition of matter: claims on niraparib itself
• Formulation: claims on capsule composition, excipients, or dissolution/processing parameters
• Polymorph/crystal form: if specific solid-state forms are claimed
• Method-of-use: claims tied to HRD-positive/BRCA-mutated ovarian cancer lines and combinations
• Manufacturing method: if specific synthetic steps or impurity controls are claimed

How IP drives supplier qualification

Even if a supplier can make niraparib API in principle, commercial entry depends on:

• Jurisdiction-specific patent coverage
• Patent challenge status (e.g., Paragraph IV for generics, where applicable)
• Settlement terms that restrict launch dates, volumes, or distribution channels
• Quality system readiness to meet FDA/EMA specs

When does Zejula lose exclusivity, and when can suppliers scale generic capacity?

Featured snippet answer: Zejula’s exclusivity and patent expirations determine when generic suppliers can legally sell in the US and other jurisdictions. The practical supplier scaling window begins after the earliest allowable date for “commercial manufacture/sale” under US patent status and any exclusivity restorations.

Timing signals procurement teams track

• US patent expiries (composition, formulation, method)
• Regulatory exclusivities (data exclusivity, pediatric exclusivity where relevant)
• Orange Book listing status (patent listed vs. expired vs. removed)
• Settlement agreements that extend effective exclusivity

What is the Orange Book status of niraparib for Zejula?

Featured snippet answer: The Orange Book lists the approved drug (NDC), active ingredient, dosage form, and associated patents (with expiration dates) for Zejula. Those listed patents are the ones that can be challenged via Paragraph IV and that control generic launch timing.

How Orange Book status maps to supplier risk

• If a patent is listed and unexpired, a supplier planning generic finished goods must clear infringement risk or litigate.
• If patents have expired or are delisted, suppliers can use that to support legal “at-risk” or non-infringing positioning.

Which generic entrants could compete with Zejula, and what does that mean for suppliers?

Featured snippet answer: Generic competition is driven by Paragraph IV filings and final court outcomes, which determine market entry dates. Supplier networks for generics then reallocate capacity toward niraparib once legal barriers drop.

Supplier implications of generic entry

• Capacity ramp: additional API lots, finished capsules manufacturing slots, and packaging lines
• Price pressure: margin compression forces tighter COGS and higher utilization
• Quality harmonization: method equivalency and dissolution performance verification
• Regulatory batch acceptance: tighter release timelines and more frequent deviation reporting risk

What manufacturing bottlenecks affect Zejula supply (API, encapsulation, packaging)?

Featured snippet answer: For small-molecule oncology drugs like niraparib, bottlenecks are typically API impurity control, potency handling readiness, and capsule encapsulation performance.

Where supply breaks most often

• API batch failures due to impurity excursions or out-of-spec residual solvent
• Solid-state inconsistencies affecting dissolution or bioavailability
• Encapsulation variability affecting content uniformity and dissolution profiles
• Packaging component shortages (capsule bands, desiccant, bottles, labels, serialization)

How does Zejula’s supply chain differ across geographies?

Featured snippet answer: Supply splits by jurisdiction because of different marketing authorizations, labeled manufacturing sites, and patent status. A supplier that is qualified for US release may be different from the one qualified for EU/UK or other markets.

Geographic screening checklist

• US: NDA/Orange Book-linked sites and FDA inspection outcomes
• EU/UK: EMA dossier manufacturing sites and GMP certificates
• Canada/other: local drug establishment licensing and importer-of-record constraints

Who are the key distributors for Zejula, and how do they affect “supplier” procurement?

Featured snippet answer: “Supplier” can mean either manufacturer or distributor. For procurement, distribution affects service levels, allocation, and lead times, while manufacturer affects COGS and IP/legal compliance.

Distributor role in allocation and continuity

• Allocation during supply constraints
• Lot-by-lot traceability
• Cold-chain needs (if any are specified by product handling instructions)
• Regulatory-compliant returns and reverse logistics

Key Takeaways

• Zejula supply is structured around niraparib API manufacturing plus finished capsule production and packaging, with a small API supplier set and multiple finished-goods sites.
• Supplier eligibility for non-branded supply is constrained by Orange Book-listed patents and exclusivity, plus any Paragraph IV and settlement-driven launch calendars.
• Procurement risk concentrates in API impurity control, solid-state consistency, high-potency manufacturing readiness, and capsule encapsulation performance.
• Market entry by generics changes supplier economics quickly through capacity ramp and price compression, driven by patent status and litigation outcomes.

FAQs

1. How do I identify niraparib API manufacturers for procurement from Zejula regulatory filings?
2. What manufacturing sites are typically listed for Zejula capsules in US FDA applications?
3. Which Zejula patents most commonly block generic niraparib capsule launches?
4. What quality attributes (impurities, polymorphs) drive API batch acceptance for niraparib?
5. How do settlement agreements and Paragraph IV outcomes change the timeline for supplier substitution to generics?

References

1. FDA Orange Book. “Zejula (niraparib)”. U.S. FDA.
2. FDA. “NDA Application and Labeling Information for Zejula (niraparib)”. U.S. FDA.