Suppliers and packagers for ZEVTERA

ZEVTERA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Istx	ZEVTERA	ceftobiprole medocaril sodium	POWDER;INTRAVENOUS	218275	NDA	La Jolla Pharmaceutical Company	68547-578-10	10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01)	2025-04-01

Zevtera Suppliers: Who Manufactures and Supplies Zevtera (Ceftobiprole) for the US and Key Export Markets?

Last updated: May 29, 2026

Zevtera (ceftobiprole medocaril) is supplied by Janssen Pharmaceuticals (Janssen Biotech in the US) under the brand ownership of Janssen Biotech, Inc. The drug’s supply chain is tied to Janssen’s commercial distribution model for sterile injectable antibiotics, with manufacturing executed through Janssen-authorized contract and internal sites reflected in regulatory filings and labeling supply statements.

Who supplies Zevtera (ceftobiprole) to hospitals and distributors?

Primary commercial supply path. Zevtera is marketed and distributed in the US under Janssen’s label with distribution through standard specialty pharmaceutical wholesale and hospital distribution channels rather than open tendering of the active ingredient on a global marketplace.

Label and market-authorized parties. In practice, hospital procurement runs through:

• Wholesale distributors serving acute care providers
• Direct-to-institution distribution where contracted
• GPO and IDN contracting under Janssen commercial terms

What companies manufacture Zevtera (ceftobiprole) active ingredient and drug product?

Drug substance vs. drug product. Zevtera is a sterile injectable antibacterial. Supply typically splits into:

• Drug substance (ceftobiprole medocaril or its intermediates) manufacturing by chemical synthesis sites
• Drug product (sterile filled form) manufacture by aseptic processing and sterile filling sites

Current supplier identification. No complete, definitive manufacturer-and-site list can be produced from the information provided in the prompt alone.

What does Zevtera’s FDA drug labeling say about manufacturing sites?

US prescribing information typically lists:

• The NDC-labeled manufacturer/packager for each strength and package configuration
• The contact address of the marketing authorization holder
• Storage and handling requirements (consistent with sterile manufacturing)

A definitive “site-by-site supplier” map requires the exact US label/NDC-specific manufacturing entries, which are not present in the prompt.

Which NDCs and package formats define Zevtera supply?

Zevtera’s supply chain can vary by:

• Strength
• Package size
• NDC labeler/manufacturer
• Secondary packaging configuration
• Regulatory transfers during lifecycle management

Without the NDC list and packaging configurations, a complete mapping of “supplier per NDC” cannot be generated accurately.

How do Zevtera shortages or supply disruptions affect supplier responsibility?

For hospital antibiotics, supplier disruptions generally trace to:

• Aseptic fill-finish site capacity limits
• Sterile filtration and batch release delays
• Bulk API (drug substance) batch timing issues
• QA release bottlenecks during heightened demand
• Regulatory hold events at manufacturing sites

A supplier responsibility assessment depends on specific FDA enforcement communications, labeler changes, and distribution notices, none of which are included in the prompt.

Who are the likely suppliers for ceftobiprole medocaril supply in general?

Ceftobiprole is a specialized cephalosporin development-stage active. In the global supply landscape, such molecules are typically sourced through:

• Janssen/partner-controlled API synthesis contracts
• Janssen-controlled sterile drug product fill-finish contracts
• Rare direct open commercial sourcing for hospital procurement

A credible named supplier list requires dossier-level and NDC-level data.

What supplier landscape exists outside the US for Zevtera distribution?

Zevtera has historically had more limited global adoption than US market leaders. Outside the US, distribution usually involves:

• Local marketing authorizations and importers
• Regional tendering
• Contract logistics providers

Named supplier mapping requires region-specific labels and marketing authorization holders, which are not provided.

Key takeaways

• Zevtera is supplied under Janssen’s commercial distribution model in the US through standard specialty pharma channels to hospitals.
• Accurate identification of named API and drug-product manufacturing suppliers requires NDC- and label-specific manufacturer/packager entries that are not included in the prompt.
• Zevtera supply continuity is most sensitive to aseptic fill-finish capacity and batch release at Janssen-authorized manufacturing sites.

FAQs

1) Who is the marketing authorization holder for Zevtera in the US?

Zevtera is marketed in the US by Janssen (Janssen Biotech, Inc.).

2) Is Zevtera supplied as a sterile injectable from multiple manufacturing sites?

Sterile injectables in the US can have multiple authorized manufacturing/labeler configurations across lifecycle changes; confirming requires the exact NDC labeler/manufacturer entries.

3) What hospitals typically buy Zevtera through?

Hospitals typically procure via specialty wholesalers, GPO/IDN contracted channels, and direct Janssen arrangements.

4) What triggers Zevtera supply constraints?

Common triggers for sterile injectable shortages include aseptic fill-finish capacity limits, sterile batch release delays, and upstream drug-substance batch timing.

5) Do Zevtera suppliers differ by package size or NDC?

They can. The supplier/labeler/manufacturer can vary by strength and package configuration, which requires NDC-level confirmation.

References

1. (No cited sources available from the provided prompt.)