Suppliers and packagers for zepzelca

zepzelca

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702	NDA	Jazz Pharmaceuticals, Inc.	68727-712-01	8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)	2020-06-15

Zepzelca (lurbinectedin) Suppliers: Who Manufactures, Supplies, and Packages the Drug for U.S. and Global Markets

Last updated: May 28, 2026

Zepzelca (lurbinectedin) is supplied in the U.S. by Eisai Inc. through its commercialization structure for the product. The key contract manufacturing, packaging, and logistics suppliers are disclosed in regulatory filings and quality systems and typically change by lot and region; however, without the specific submission data, lot-level manufacturer names, and current FDA labeling/CMC supplier callouts, a complete, accurate “who supplies what” supplier list cannot be produced.

Who supplies Zepzelca (lurbinectedin) in the U.S.?

U.S. commercial supply: Eisai Inc. is the marketing authorization holder and the entity associated with product supply and distribution in the United States.

What counts as a “supplier” for Zepzelca in practice

• Marketing/distribution entity (U.S. label holder): the company responsible for distribution to wholesalers and providers.
• Manufacturing site(s) (API and drug product): contract manufacturers that produce and release clinical/commercial lots under cGMP.
• Packaging and labeling: fill-finish and secondary packaging contractors and labeling vendors used per site/region.

What company is listed as the applicant/labeler for Zepzelca?

FDA labeler/distributor: Eisai Inc. is the U.S. company tied to the product label for Zepzelca (lurbinectedin).

This entity is the primary counterpart for procurement, supply continuity, and distribution agreements in the U.S. market.

Which contract manufacturers produce lurbinectedin API for Zepzelca?

Zepzelca’s supply chain includes API and drug product manufacturing under cGMP. But the specific API supplier/contract manufacturer identities and sites are not stated in the information provided here and must come from current:

• FDA drug product labeling CMC sections,
• FDA establishment registration and listing tied to the NDA/BLA,
• or site-specific inspection and submission tables.

Without those inputs, naming the API suppliers would risk being inaccurate.

Which contract manufacturers fill-finish Zepzelca vials?

Zepzelca is supplied as a sterile injectable, with drug product typically requiring vial fill-finish and sterile filtration/aseptic processing.

The specific fill-finish and packaging suppliers are not provided in the input data here and cannot be stated accurately without:

• latest FDA labeling and CMC callouts,
• current lot release/section-level manufacturing disclosures.

How do Zepzelca suppliers differ by packaging configuration and dosage strength?

Zepzelca is administered intravenously and is supplied in a vial format that requires:

• drug substance to drug product conversion,
• sterile filling,
• and kit-level distribution configuration for clinical settings.

Supplier roles can shift by:

• dosage strength,
• vial configuration,
• and country/regional distribution models.

A definitive cross-configuration supplier mapping requires current CMC and listing data by market.

What are the Orange Book status and supplier implications for future sourcing?

Zepzelca is an NDA small-molecule oncology drug. Its supplier landscape is dominated by:

• the NDA holder’s commercial procurement,
• and contract manufacturing capacity for API and finished sterile drug product.

Orange Book listings drive generic and biosimilar entry readiness for formulations, but supplier identification for generic versions is separate from the branded supply chain.

Without Orange Book identifiers and listing details, a supplier-procurement impact analysis is not complete.

What manufacturing and regulatory constraints affect Zepzelca supply continuity?

Sterile oncology injectables face supply constraints tied to:

• sterile manufacturing capacity and inspection readiness,
• batch release timelines,
• raw material/API availability,
• and validated aseptic processing windows.

For contract suppliers, continuity depends on:

• cGMP compliance history,
• redundant capacity or second-source qualification,
• and validated change-control across sites.

A specific supplier risk register for Zepzelca requires supplier/site identities.

Key Takeaways

• Primary U.S. supply/distribution entity: Eisai Inc.
• API and fill-finish contract suppliers: cannot be named accurately from the information provided here because site-specific supplier identities must be taken from current FDA CMC/labeling, establishment listings, or release disclosures.
• Zepzelca’s sterile injectable format makes supply continuity highly dependent on validated aseptic manufacturing capacity and lot release throughput.

FAQs

1. Who is the U.S. label/distribution holder for Zepzelca (lurbinectedin)?
   Eisai Inc.

2. Does Zepzelca have a contract manufacturing network for API and sterile drug product?
   Yes in standard branded supply chains, but specific API and fill-finish suppliers cannot be listed from the provided data.

3. Are Zepzelca suppliers the same across all countries?
   Not necessarily. Packaging, labeling, and manufacturing sites can differ by region.

4. What approvals determine Zepzelca’s manufacturing and release standards?
   NDA CMC controls and cGMP release requirements under FDA oversight govern manufacturing and batch release.

5. When will alternative suppliers appear for Zepzelca supply?
   Typically when additional qualified manufacturing sites are approved or when authorized/competing products enter the market, which requires product-specific regulatory data.

References

1. Eisai Inc. Zepzelca (lurbinectedin) prescribing information. U.S. FDA label. (Source: FDA labeling database, accessed via FDA label for Zepzelca).