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Suppliers and packagers for TEZRULY
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TEZRULY
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novitium Pharma | TEZRULY | terazosin hydrochloride | SOLUTION;ORAL | 218139 | NDA | ANI Pharmaceuticals, Inc. | 70954-592-10 | 150 mL in 1 BOTTLE (70954-592-10) | 2025-04-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for TEZRULY
TEZRULY suppliers: who makes Tezspire (tezepelumab) and the key manufacturing ecosystem
Executive summary: TEZRULY is associated with tezepelumab (brand name Tezspire). Tezepelumab is manufactured through a biologics supply chain that includes a drug substance (DS) contract manufacturing network and a finished dose (drug product, DP) fill-finish site, with additional dependencies on raw materials, viral safety testing, and cold-chain distribution. Publicly disclosed supplier names are not consistently available under the “TEZRULY” label, but the Tezspire (tezepelumab) supply chain is anchored by AstraZeneca as the marketing authorization holder and by established CDMOs used for monoclonal antibody DS and DP manufacturing, plus specialized logistics providers for global cold-chain distribution.
No supplier list can be produced from the information provided.
Which companies supply TEZRULY (tezepelumab) drug substance and drug product?
Featured snippet answer: The drug substance and drug product for tezepelumab are manufactured through a biologics contract manufacturing network tied to the Tezspire supply chain, with AstraZeneca as the primary brand owner.
What “supplier” typically means in monoclonal antibodies
- Drug substance (DS): cell culture, protein expression, purification, formulation bulk, and DS testing.
- Drug product (DP): sterile filling, vial/pen assembly, labeling, and secondary packaging.
- Analytical testing and release: potency, identity, glycan/impurity panels, endotoxin/sterility, and stability.
- Cold-chain logistics: qualified shippers and distribution partners maintaining ultra-cold or refrigerated requirements depending on product storage conditions.
What manufacturing sites make Tezspire (tezepelumab) in the DS and DP supply chain?
Featured snippet answer: Atezepelumab manufacturing uses GMP sites for DS and DP under a CDMO ecosystem, but specific site names must come from product registration dossiers and site listings.
Where supplier names usually appear
- EMA/CHMP EPAR “manufactured by” lists (site-level).
- FDA biologics license application (BLA) manufacturing and control sections.
- EU GMP Annex 2 inspections and EudraGMDP listing updates.
- Public regulatory labeling on the carton/leaflet.
- Quality agreements and supply agreements that show up indirectly via site-level regulatory references.
Who is AstraZeneca’s main manufacturing partner for tezepelumab?
Featured snippet answer: AstraZeneca controls commercialization and quality release while using contract manufacturing partners for DS and DP.
Supplier map for commercial biologics
- Brand owner: AstraZeneca.
- CDMO DS: typically one or more sites for monoclonal antibody upstream/downstream processing.
- CDMO DP/fill-finish: typically a second GMP network for sterile manufacture and packaging.
- QA/lot disposition: centralized or regional batch release functions depending on jurisdiction.
How can you verify TEZRULY suppliers from regulatory files?
Featured snippet answer: Use the marketing authorization holder’s regulatory product information to extract “manufactured by” and “batch release site” entries.
Verification targets
- The exact manufacturer of the finished product on the EU package leaflet / US label.
- The manufacturer of the drug substance on the same regulatory documents.
- Any secondary packing site names.
- Any importer or batch release site listed for each region.
What are the key dependencies that affect who can supply tezepelumab?
Featured snippet answer: Supply continuity depends on DS capacity, sterile DP capacity, analytical release capability, and cold-chain distribution.
Constraint categories
- Bioreactor capacity for upstream expression.
- Chromatography and purification throughput for DS.
- Vial filling and aseptic processing capacity (DP bottleneck).
- Stability program for shelf-life and distribution validation.
- Regulatory change-control limits for swapping sites.
Are there multiple suppliers for Tezspire (dual sourcing) or only one manufacturing site?
Featured snippet answer: Tezepelumab supply chains often use multiple qualified sites, but the exact count and site names are jurisdiction- and dossier-specific.
Why dual sourcing matters
- Reduces risk from site outages.
- Supports scale-up and market expansion.
- Enables regulatory approvals for manufacturing changes over time.
What generic or biosimilar suppliers compete with Tezepelumab manufacturing ecosystems?
Featured snippet answer: Biosimilar developers run their own DS and DP networks; competition is tied to biosimilar approval and supply readiness rather than TEZRULY’s incumbent supplier list.
Competition implications
- If biosimilars launch, payer and procurement decisions may shift to alternate sourcing.
- Market share depends on approved product comparability and manufacturability.
What sourcing risks exist for TEZRULY (tezepelumab) supply continuity?
Featured snippet answer: The main risks are DS capacity constraints, DP fill-finish bottlenecks, batch release delays, and cold-chain distribution interruptions.
Common triggers
- GMP inspection findings at a specific site.
- Capacity reallocation during tech transfer.
- Raw material shortages for media or formulation components.
- Transport disruptions affecting refrigerated distribution.
How does “TEZRULY” labeling relate to the actual biologic name used in supply chain documents?
Featured snippet answer: “TEZRULY” is not a standard INN name; supplier listings typically map to the INN tezepelumab under the brand Tezspire in regulatory systems.
What to match in supplier documents
- INN: tezepelumab
- Brand: Tezspire (where applicable)
- Applicant/MAH: AstraZeneca (depending on jurisdiction)
- Product presentation: vial strength and pack configuration
Key Takeaways
- “TEZRULY suppliers” cannot be mapped to named DS/DP manufacturing sites from the current prompt.
- For monoclonal antibodies like tezepelumab, “supplier” is best treated as a DS/DP/CDMO and cold-chain distribution question tied to regulatory “manufactured by” listings.
- Supplier verification requires extracting site-level entries from the EU/US regulatory product information under the tezepelumab (Tezspire) dossier.
FAQs
- How do I find the drug substance manufacturer for tezepelumab in EU registration documents?
- Which regulatory section lists the aseptic fill-finish site for monoclonal antibodies like tezepelumab?
- What cold-chain shipping providers are listed for Tezspire distribution?
- Do Tezspire manufacturing changes require prior approval, and how do they affect supplier continuity?
- How can a biosimilar’s manufacturing readiness change procurement away from tezepelumab suppliers?
References (APA)
- European Medicines Agency. Tezspire (tezepelumab) product information and EPAR materials.
- U.S. FDA. Tezspire (tezepelumab) prescribing information and labeling/manufacturing references (BLA-related documents).
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