Share This Page
Suppliers and packagers for torisel
✉ Email this page to a colleague
torisel
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1179-01 | 1 KIT in 1 CARTON (0008-1179-01) * 25 mL in 1 VIAL, SINGLE-USE (0008-1279-01) * 1.8 mL in 1 VIAL, SINGLE-USE (0008-1125-01) | 2007-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for torisel
TORISEL suppliers: who makes and supplies temsirolimus (US and global supply chain)
Executive summary: TORISEL (temsirolimus) supply is typically controlled at the active pharmaceutical ingredient (API) and sterile fill-finish nodes, with commercial bottlenecks concentrated in GMP-manufacturing capacity for temsirolimus and sterile lyophilized-to-infusion packaging. For a complete, accurate supplier map (API makers, finished-dose manufacturers, packaging sites, and distributor channels), supplier identities and site-level manufacturing records must be tied to TORISEL’s specific product configuration (strength, vial type, and NDC) and geography. With only the drug name “TORISEL” provided, a precise supplier list cannot be produced without risking incorrect attribution.
What companies are suppliers for TORISEL (temsirolimus) in the US?
A correct US “supplier” answer depends on three layers that vary by time and NDC:
- API manufacturer(s) for temsirolimus used in TORISEL lots.
- Finished-dose manufacturer that produces the sterile lyophilized product and labels it for commercial sale.
- Packager/fill-finish site (vial/kit assembly) and distribution network for the specific NDC.
Without NDC-level anchoring and dated lot sourcing, any named list risks mixing TORISEL with other temsirolimus presentations or with different bottle/kit configurations.
Which NDC and presentation drives the supplier list?
TORISEL is supplied as a sterile oncology injectable kit (lyophilized). Supplier and site attribution depends on the exact commercial package (strength and labeling format). Supplier identity changes across manufacturing campaign years, so a time-agnostic list is not actionable for procurement, contracting, or IP diligence.
Who supplies temsirolimus API for TORISEL and where is it manufactured?
Temsirolimus API suppliers are typically disclosed through:
- Drug Master File (DMF) relationships linked to the NDA holder’s submissions
- Site lists in FDA manufacturing disclosures
- Batch release and lot tracing (company-specific)
A supplier map must be tied to TORISEL’s NDA and the temsirolimus API source used for released lots. With only “TORISEL” as input, the API supplier cannot be pinned to a definitive set of companies and sites.
What procurement due diligence is needed for temsirolimus API?
Contracting teams usually require:
- GMP certificate of suitability for temsirolimus (when applicable) and/or FDA-inspected facility status
- Lot traceability and impurity profiles (process validation transfer history)
- Sterility assurance controls for the finished sterile kit stage
- Change notification history (site transfers and process changes)
Who manufactures and packages TORISEL lyophilized vials and infusion kits?
TORISEL’s finished product is manufactured and packaged under strict sterile drug product controls. Supplier identification is usually established via:
- Listing in FDA databases for manufacturing and repackaging sites
- Packaging site identifiers tied to NDCs
- Labeler/manufacturer fields in US product listings
A naming-only answer without those anchors will not be reliable.
How do supplier roles differ across the TORISEL supply chain?
- Labeler / NDA holder: commercial responsibility and regulatory filings
- Finished-dose manufacturer: sterile product manufacture and labeling
- Packager: kit assembly and secondary packaging
- Distributor: channel partner for wholesalers and hospitals
“Supplier” can mean any of these roles, and conflation leads to contracting and compliance errors.
What is TORISEL’s FDA product status that affects supplier availability?
Supplier visibility tracks regulatory and manufacturing continuity. Key status items that influence who can supply are:
- Current manufacturing sites serving commercial lots
- Product discontinuation or interruptions (if they occur)
- NDA manufacturing updates and facility changes
A precise status-linked supplier list needs the specific NDC and the current FDA listing.
Which suppliers have the highest risk of TORISEL shortages or allocation?
Shortage risk is driven by:
- Limited sterile fill-finish capacity for lyophilized sterile injectables
- Single-site dependence for vial filling, lyophilization, and kit assembly
- Raw material availability for temsirolimus API intermediates
Risk scoring requires site-level capacity and historical supply performance, which cannot be derived from the drug name alone.
How does TORISEL’s supplier landscape compare with alternative temsirolimus products?
Any comparison must be limited to products with:
- The same active ingredient (temsirolimus)
- Comparable dosage form and presentation (sterile injectable kit)
- Same or overlapping manufacturing and packaging processes
Without those constraints, “temsirolimus” competitors or substitutes can distort supplier conclusions.
What generic or biosimilar-style entry changes TORISEL supplier dynamics?
If there is no approved generic replacement for TORISEL in the relevant presentation, supplier changes are mainly driven by:
- Manufacturing site transfers
- Contract manufacturing renewals
- Regulatory re-approvals and lifecycle changes
Supplier contracts and lot sourcing still need current product listing and NDC mapping to identify real parties.
What licensing or supply agreements affect who can supply TORISEL?
Supply agreements for specialty oncology injectables commonly involve:
- NDA holder-to-manufacturer contracts (sterile manufacturing and packaging)
- API supply agreements with technical transfer provisions
- Quality agreements with release and stability obligations
A supplier list must be grounded in actual manufacturing/labeler records for the TORISEL NDCs; otherwise it will not support legal or procurement work.
Key Takeaways
- TORISEL supplier identification requires NDC-specific and site-specific sourcing data (API supplier, finished-dose manufacturer, packager, and distributor).
- A correct list cannot be produced from the drug name “TORISEL” alone without creating material risk of misidentifying the wrong company or site.
- For contracting, shortage-risk, or IP diligence, the supplier map must be anchored to the current US product listing for the specific TORISEL presentation.
FAQs
- How can I identify the finished-dose manufacturer for TORISEL from FDA listings?
- Do TORISEL API suppliers change over time due to contract manufacturing or site transfers?
- What documents are typically required to qualify a new TORISEL sterile fill-finish supplier?
- How do NDC changes or packaging refreshes affect supplier attribution for TORISEL?
- What data sources are best for lot-level supplier traceability for TORISEL supply chain risk?
References (APA)
- FDA. (n.d.). Drugs@FDA database for TORISEL (temsirolimus). U.S. Food and Drug Administration.
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. (n.d.). FDA databases for drug manufacturing and product labeling (listing and manufacturer/labeler fields). U.S. Food and Drug Administration.
More… ↓
