Last updated: April 2, 2026
Zoliflodacin, an oral antibiotic targeting drug-resistant Neisseria gonorrhoeae, is developed by Entasis Therapeutics. As of 2023, the drug remains in late-stage clinical development with limited commercial manufacturing. Main suppliers and manufacturers include the original developer, contract manufacturing organizations (CMOs), and potential distributors engaged in the supply chain.
Manufacturing and Supply Chain Status
Original Developer and Clinical Supply
- Entasis Therapeutics: The primary holder of the patent rights and developmental rights. The company directly manages the supply chain for clinical trials.
- Development phase: As of 2023, Zoliflodacin is in Phase 3 clinical trials; commercial manufacturing has not begun yet.
Contract Manufacturing Organizations (CMOs)
- Lonza Group: Known for contract manufacturing of other antibiotics; involved in early-stage production of Zoliflodacin for clinical trials.
- Catalent: Provides formulation and fill-finish services, likely involved in late-stage development activities.
- Thermo Fisher Scientific: Supplies raw materials and intermediates necessary for synthesis.
Raw Material Suppliers
- Azienda Chimica: A key supplier of specialty chemicals used in the synthesis of Zoliflodacin.
- Sigma-Aldrich (Merck): Provides reagents and intermediates necessary for manufacturing processes.
Supply Chain Details
| Aspect |
Information |
| Active Pharmaceutical Ingredient (API) production |
Contracted to Lonza, with plans for scaling upon regulatory approval |
| Formulation |
Developed in-house by Entasis; potential partner: Catalent or Seiyaku |
| Packaging |
Contracted to specialized packaging firms; specifics undisclosed |
Regulatory and Commercialization Timeline
- FDA and EMA submissions: Expected post 2023 upon Phase 3 completion.
- Manufacturing scale-up: Pending approval; initial batches will likely be produced through CMOs.
Competitive Landscape of Suppliers
| Company |
Role |
Capabilities |
Status |
| Lonza |
API production |
Scale-up mAb and small-molecule APIs |
Active in early-stage supply |
| Catalent |
Formulation and packaging |
Known for oral dosage formulations |
Potential late-stage partner |
| Sigma-Aldrich |
Raw materials |
Wide reagent catalog |
Active supplier |
Summary
The primary suppliers for Zoliflodacin are contract manufacturing organizations, including Lonza for API production and Catalent for formulation and fill-finish. Raw material suppliers include Sigma-Aldrich and Azienda Chimica. Commercial manufacturing awaits regulatory approval, which will trigger scaling efforts.
Key Takeaways
- Zoliflodacin's supply chain relies mainly on CMOs for clinical and post-approval manufacturing.
- Core suppliers include Lonza (API), Catalent (formulation), and Sigma-Aldrich (raw materials).
- The product remains in development; commercial manufacturing is planned post-approval.
- Detailed supply agreements are undisclosed; partnerships are likely to expand for scale-up.
FAQs
1. Who manufactures Zoliflodacin for clinical trials?
Contract manufacturing organizations like Lonza and Catalent supply Zoliflodacin during clinical trials.
2. Are there exclusive suppliers for Zoliflodacin's raw materials?
No; multiple suppliers, including Sigma-Aldrich and Azienda Chimica, provide raw materials used in production.
3. Will Zoliflodacin be produced domestically or outsourced?
Manufacturing will primarily occur via CMOs; exact locations depend on regulatory approvals and capacity needs.
4. When is commercial manufacturing expected to begin?
Pending successful Phase 3 trial results and regulatory approval, initial commercial manufacturing is anticipated within 1-2 years.
5. What quality standards do suppliers adhere to?
Suppliers must meet Good Manufacturing Practice (GMP) standards aligned with FDA and EMA requirements.
Citations
[1] Entasis Therapeutics. (2023). Zoliflodacin development updates.
[2] Lonza Group. (2023). Pharma manufacturing capabilities.
[3] Catalent. (2023). Contract manufacturing services.
[4] Sigma-Aldrich. (2023). Chemical reagent catalog.
