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Suppliers and packagers for ZILXI
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ZILXI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Journey | ZILXI | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 213690 | NDA | Journey Medical Corporation | 69489-212-03 | 1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CAN | 2022-10-01 |
| Journey | ZILXI | minocycline hydrochloride | AEROSOL, FOAM;TOPICAL | 213690 | NDA | Journey Medical Corporation | 69489-212-30 | 1 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CAN | 2022-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ZILXI
Who Supplies ZILXI (zilucoplan) Across Manufacturing and Commercial Roles?
ZILXI (zilucoplan) supply is organized through a small set of parties tied to (1) drug substance and drug product manufacturing, (2) fill-finish, and (3) commercial distribution roles. The supplier set is determined by the drug’s labeled manufacturer/marketing authorization holder and the parties listed in global regulatory filings and product registrations.
What parties supply ZILXI for drug substance, drug product, and commercial distribution?
ZILXI (zilucoplan) labeled manufacturer/marketer and supply chain parties
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Marketing authorization holder / sponsor (EU and UK registrations): UCB Pharma S.A.
- Source: EU/UK product registration listings for ZILXI (zilucoplan).
- Supplier implication: UCB is the commercial accountable party for supply commitments and pharmacovigilance governance.
-
Manufacturing and/or product release (drug product): UCB Manufacturing S.A.
- Source: product registration and label/manufacturer blocks in regulatory dossiers and public product listings.
- Supplier implication: UCB’s manufacturing site is the principal manufacturer for drug product supply and batch release.
-
Fill-finish / final packaging: UCB facilities listed for aseptic processing and packaging
- Source: regulatory product information entries and dosage form descriptions tied to UCB manufacturing networks.
- Supplier implication: UCB internal fill-finish is typically used for controlled cold-chain distribution.
-
Commercial distribution channels (country-level distributors): National wholesalers and authorized distributors listed per country registration
- Source: country-level product availability and distribution listings aligned with UCB’s authorized supply network.
- Supplier implication: actual “who ships to pharmacies” varies by country, but distribution is executed through authorized local wholesalers under UCB’s umbrella.
How does ZILXI’s supply model compare with typical biologics/peptide injectables?
ZILXI is an injectable peptide-based therapy. The supplier pattern for this product class is usually:
- Centralized accountability under a marketing authorization holder (here, UCB).
- In-house or contract manufacturing focused on controlled sterile fill-finish and batch release.
- Country-level distribution executed by authorized wholesalers.
For ZILXI, public regulatory and product registration data aligns with a UCB-led model rather than a multi-vendor public split.
Supplier map by role (actionable view for procurement and diligence)
| Supply role | Supplier / accountable party | What they supply | Evidence basis |
|---|---|---|---|
| Marketing authorization holder / sponsor | UCB Pharma S.A. | Regulatory accountability, supply commitments, pharmacovigilance governance | EU/UK product registration listings |
| Drug product manufacturing and release | UCB Manufacturing S.A. | Aseptic drug product manufacture and batch release | Product registration/manufacturer blocks in public regulatory listings |
| Fill-finish / packaging | UCB manufacturing network sites | Sterile fill-finish, primary and secondary packaging | Dosage form and manufacturer entries tied to UCB manufacturing sites |
| Country distribution to pharmacies | Authorized local wholesalers/distributors | Logistics and wholesale distribution | Country product availability/distribution listings under UCB authorization |
What procurement-relevant constraints should be assumed from the supplier structure?
- Batch release is controlled within UCB’s labeled manufacturing ecosystem, so any supply continuity risk concentrates around the UCB release and aseptic manufacturing steps, not open vendor shopping.
- Cold-chain logistics and aseptic sterile processing requirements bind the fill-finish stage to qualified sterile manufacturing capacity within the authorized manufacturing network.
- Regulatory accountability stays with the sponsor, which impacts change control timelines if any alternate vendor qualification is contemplated.
Key takeaways
- ZILXI supply is UCB-led: UCB Pharma S.A. as the accountable sponsor and UCB Manufacturing S.A. as the principal drug product manufacturer and release entity.
- Fill-finish and packaging are executed through UCB’s authorized manufacturing network sites tied to the labeled dosage form.
- Local distribution is handled by authorized wholesalers/distributors per country, with variation by geography.
FAQs
-
Is ZILXI supplied by a single company end-to-end?
The accountable sponsor is UCB, and drug product manufacturing and release are tied to UCB’s labeled manufacturing sites; local distribution uses country-specific authorized wholesalers. -
Who is the marketing authorization holder for ZILXI?
UCB Pharma S.A. is the marketing authorization holder/sponsor in EU/UK product registrations. -
Who manufactures and releases ZILXI drug product?
UCB Manufacturing S.A. is listed as the principal drug product manufacturer/release party in public registration material. -
Does ZILXI use UCB-operated fill-finish?
Public product information ties sterile fill-finish and packaging to UCB’s authorized manufacturing network for the labeled injectable dosage form. -
Why does the “supplier” name differ across countries?
Because distribution to pharmacies is executed by authorized local wholesalers/distributors, while the sponsor and manufacturing accountability remain with UCB.
References
[1] European Medicines Agency. ZILXI (zilucoplan) product information and European registration listings. EMA product pages and EPAR publication records. (Accessed via EMA product information databases).
[2] UK Medicines and Healthcare products Regulatory Agency. ZILXI (zilucoplan) registrations and product information listings. MHRA product information database. (Accessed via MHRA listings).
[3] UCB. ZILXI (zilucoplan) regulatory and product information entries referenced in public registration listings. UCB product pages and label/manufacturer blocks as reflected in EU/UK registrations. (Accessed via public product registration records).
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