Share This Page
Suppliers and packagers for triesence
✉ Email this page to a colleague
triesence
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048 | NDA | Novartis Pharmaceuticals Corporation | 0078-0897-78 | 1 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS | 2024-10-01 |
| Harrow Eye | TRIESENCE | triamcinolone acetonide | INJECTABLE;INTRAVITREAL | 022048 | NDA | Harrow Eye, LLC | 82667-800-01 | 1 BLISTER PACK in 1 CARTON (82667-800-01) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS | 2024-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for triesence
Suppliers for TRIESENCE (triamcinolone acetonide intravitreal) 40 mg/mL: key manufacturers, contract-fillers, and distribution footprint
Executive summary: TRIESENCE is supplied as a sterile intravitreal corticosteroid containing triamcinolone acetonide (40 mg/mL). The product is marketed in the US by Alcon. The supply chain typically involves a triad of roles: (1) drug-substance and sterile drug-product manufacturing, (2) sterile fill-finish under aseptic/terminal sterilization controls, and (3) nationwide distribution through wholesale and specialty channels. To identify specific “supplier” names at the component level (API source, fill-finish site, packaging/labeling), the relevant primary sources are the FDA Drug Establishment Registration and Listing (DE/RL) and the FDA Orange Book-linked drug application (NDA) and manufacturing site disclosures.
No complete, source-anchored supplier list can be produced here without access to the underlying FDA listing data and NDA manufacturing/supplier details for TRIESENCE.
Who manufactures TRIESENCE (triamcinolone acetonide intravitreal) and who is its marketing authorization holder?
Featured snippet answer: In the US, TRIESENCE is marketed by Alcon.
Marketing role vs. manufacturing role
- Marketing authorization holder (MAH)/NDA holder: the entity responsible for regulatory ownership and product labeling.
- Manufacturing sites: may be different legal entities and different facilities for:
- drug substance (API) manufacture,
- sterile drug product manufacture,
- fill-finish and primary packaging,
- secondary packaging and distribution release.
Common supplier categories for intravitreal sterile products
- API supply (triamcinolone acetonide)
- Sterile active drug product manufacture (formulation and aseptic processing)
- Aseptic fill-finish / terminal sterilization step (depending on validated process)
- Packaging, labeling, kit assembly (if applicable)
What is the Orange Book status of TRIESENCE and what does it imply for supplier transparency?
Featured snippet answer: Orange Book listings often link to the NDA and patent estate, not to the full supplier roster.
Orange Book-limited disclosure
- The Orange Book is designed to show:
- active ingredients,
- dosage forms,
- NDA numbers,
- listed patents,
- exclusivity (where applicable).
- It does not reliably enumerate every component supplier.
Where supplier names are typically found
- FDA DE/RL database (facility-level).
- NDA Chemistry, Manufacturing, and Controls (CMC) references (site-specific).
- Labeling and packaging insert (sometimes lists manufacturer/distributor).
Which FDA-registered facilities supply TRIESENCE drug product and sterile fill-finish?
Featured snippet answer: Supplier names at the facility level must be pulled from FDA Drug Establishment Registration and Listing (DE/RL) for the TRIESENCE product and dosage form.
Facility roles to match in DE/RL
- “Manufacturer” (including sterile manufacturing)
- “Repackager” (less common for brand drug product but possible for packaging/secondary distribution)
- “Initial importer” (if applicable)
- “Labeler” and “Distributor” roles
- “Sterile” indicator fields for fill-finish facilities
Why this matters commercially
- Intravitreal injectables are capacity-constrained because sterile fill-finish needs:
- validated aseptic controls or terminal sterilization,
- environmental monitoring,
- operator qualification and line clearance SOPs,
- container closure integrity testing and stability data.
Who supplies triamcinolone acetonide (API) for TRIESENCE?
Featured snippet answer: API suppliers for TRIESENCE are identified through FDA CMC disclosures and DE/RL site-level data tied to the NDA application.
API supply chain structure
- Many intravitreal brands use:
- centralized API manufacturing (specialty steroid capability),
- downstream sterile drug product manufacturing and fill-finish at separate sites.
- Supplier identity can change with:
- supply continuity needs,
- regulatory commitments,
- process validation updates,
- post-approval changes (CMC supplements).
What contract manufacturing and fill-finish suppliers are used for TRIESENCE?
Featured snippet answer: Specific contract manufacturers for TRIESENCE must be identified from FDA facility listings tied to the product’s NDA and dosage form.
Typical fill-finish bottlenecks for intravitreal injectables
- Prefilled syringe or vial container closure systems
- Sterile filtration vs. terminal sterilization (process dependent)
- Low bioburden and high assurance release testing
- Packaging line clearance to avoid cross-contamination
How does TRIESENCE distribution work: wholesale suppliers, specialty channels, and wholesalers?
Featured snippet answer: Distribution in the US is handled through licensed wholesalers and specialty distributors; the exact distributor roster is not a static “supplier list” in the way API/manufacturing sites are.
Practical distribution pattern for injectable brands
- Large wholesalers cover broad retail networks.
- Specialty channels cover ophthalmology and institutional purchase flows.
- Distribution may also include:
- hospital pharmacy channels,
- clinic procurement networks,
- group purchasing organizations (GPOs).
Why distributor names are not sufficient for IP or supply-risk analysis
- Distributor identities do not answer:
- manufacturing site capacity,
- sterile supply continuity,
- regulatory compliance risk,
- batch release constraints.
What changes supplier identity for TRIESENCE over time (line transfers, CMO switches, product relabeling)?
Featured snippet answer: Supplier identity changes are driven by regulatory CMC supplements and facility qualification updates.
Common trigger events
- New sterile fill-finish facility qualification
- Process change requiring comparability data and stability updates
- Expanded manufacturing capacity
- Regulatory enforcement actions or remediation affecting specific sites
- Packaging format changes (vial vs. syringe) if ever introduced
How strong is the supply-risk profile for TRIESENCE based on manufacturing topology?
Featured snippet answer: Supply-risk is usually more sensitive to the sterile fill-finish site than to the API supplier.
Supply-risk indicators to check in DE/RL and regulatory filings
- Number of registered sterile facilities for the product
- “Single-site” risk when only one facility is listed for sterile manufacture
- Recent facility additions or deletions
- Any “withdrawn” or “discontinued” manufacturing entries for the same dosage form
(A complete risk assessment requires facility-level data that cannot be enumerated here.)
Key Takeaways
- TRIESENCE is Alcon-marketed in the US as an intravitreal triamcinolone acetonide product.
- “Suppliers” split into roles: API source, sterile drug product manufacturer, fill-finish site, and distribution/wholesale network.
- The only defensible way to list the actual named supplier facilities and contract manufacturers is to extract the FDA DE/RL facility entries and NDA-linked manufacturing site disclosures for TRIESENCE.
FAQs
- Which FDA facilities are registered to manufacture TRIESENCE (triamcinolone acetonide intravitreal) drug product?
- Is TRIESENCE sterile filled at the same site that produces triamcinolone acetonide API?
- What does the TRIESENCE labeling list for manufacturer and distributor names in the US?
- How can I identify TRIESENCE’s contract fill-finish supplier without Orange Book patent data?
- Do triamcinolone acetonide intravitreal products share CMOs or sterile facilities across brands?
References
- FDA. (n.d.). Drug Establishment Registration and Listing (DE/RL). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishment-registration-and-listing-drug-product
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
More… ↓
