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Suppliers and packagers for TRYNGOLZA (AUTOINJECTOR)
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TRYNGOLZA (AUTOINJECTOR)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ionis Pharms Inc | TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614 | NDA | Ionis Pharmaceuticals, Inc. | 71860-101-01 | 1 SYRINGE, GLASS in 1 CARTON (71860-101-01) / .8 mL in 1 SYRINGE, GLASS | 2024-12-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for TRYNGOLZA (AUTOINJECTOR)
TRYNGOLZA (autoinjector): Who manufactures the drug product, device, and key components?
Tryngolza autoinjector is an injectable drug-device combination. Supplier sourcing spans (1) the small-molecule or biologic drug substance and drug product manufacturing chain, (2) the prefilled autoinjector delivery system including subassemblies (cartridge, syringe/barrel, needle, actuation spring/drive, dose selector, and housing), and (3) sterile filling and device integration under a combination-product quality system.
However, no supplier list, device bill of materials, or manufacturing allocation for Tryngolza autoinjector is provided in the information available here. Without identifiable FDA application references, Orange Book/NDC links, or publicly indexed agreements to anchor the named manufacturers, a supplier roster would be non-actionable.
What suppliers make TRYNGOLZA (autoinjector) drug substance and drug product?
Answer: Not determinable from the available input.
Drug substance (API) supply chain
- API manufacture is typically controlled via Drug Master File references in the New Drug Application (NDA/BLA) and cGMP chain-of-custody.
- For drug-device combinations, API and drug product often sit with different supply and fill/finish partners.
Sterile drug product and fill-finish
- Injectable combination products typically require:
- sterile filtration/aseptic handling (or terminal sterilization if compatible),
- sterile filling,
- container closure integrity testing,
- labeling, inspection, packaging.
- The actual fill-finish site and the named contract manufacturer are usually tied to the application manufacturing sites list.
Who supplies the autoinjector device for TRYNGOLZA (prefilled injection system)?
Answer: Not determinable from the available input.
Autoinjector subcomponents often sourced from specialists
- Prefilled syringe or cartridge manufacturing
- Needle assembly and coating/sterility validation
- Actuation mechanism (spring/drive system)
- Dose confirmation mechanisms (audible/tactile feedback, indicator window)
- Housing, overmold, and protective shield
- Device-level functional testing and QA release
Device integration model in combination products
- A common structure is:
- device manufacture by a device integrator (or component supplier),
- sterile drug filling into the primary container by a fill-finish site,
- final assembly of the filled primary container into the injector platform,
- finished-goods device testing under combination-product GMP.
What contract manufacturing organizations (CMOs) and partners support TRYNGOLZA autoinjector?
Answer: Not determinable from the available input.
Typical partner categories
- Sterile fill-finish CMO
- Device integrator/CMS (contract manufacturing support)
- Quality testing labs (sterility, particulate, extractables/leachables, mechanical actuation verification)
- Packaging and kitting supplier for autoinjector cartons and patient instructions
What is the Orange Book status of TRYNGOLZA and does it list manufacturers/suppliers?
Answer: Not determinable from the available input.
Why Orange Book matters for supply-chain visibility
- The Orange Book record can include product/labeler identifiers and application-level references that can lead to:
- NDA/BLA manufacturer site associations,
- product labeling/manufacturer names.
- It does not usually enumerate device suppliers directly.
Which companies supply the needle, syringe, and actuation mechanism for TRYNGOLZA?
Answer: Not determinable from the available input.
Needle and primary container supplier disclosure patterns
- Needle and primary container suppliers are frequently disclosed in:
- device regulatory filings,
- extractables/leachables reports,
- manufacturing site descriptions,
- procurement evidence from tenders and manufacturing listings.
- Those references are not present in the available input.
How do suppliers change across geographies for TRYNGOLZA autoinjector?
Answer: Not determinable from the available input.
Geographic sourcing
- Autoinjector supply often varies by:
- local sterile manufacturing capacity,
- device packaging and serialization rules,
- distribution center and cold-chain requirements.
What supplier risks exist if a key autoinjector component is constrained for TRYNGOLZA?
Answer: Not determinable from the available input.
Risk drivers that typically matter
- Needle supply continuity (specialty metallurgy/coatings)
- Spring mechanism sourcing (tolerance and fatigue validation)
- Primary container supply (glass/plunger/elastomer compatibility)
- Final assembly capacity (device integration and QA release throughput)
How does TRYNGOLZA’s supplier network compare with other autoinjector combination products?
Answer: Not determinable from the available input.
Benchmarking patterns used in autoinjector programs
- Common structures include a fill-finish CMO paired with a separate device integrator.
- Component-level specialization (needle/primary container) is typical.
Key Takeaways
- A supplier roster for TRYNGOLZA (autoinjector) cannot be produced from the information provided.
- Supplier identification for drug product vs device components usually requires NDA/BLA manufacturing site lists and device integration documentation that are not present here.
FAQs
-
What document lists the manufacturing sites for TRYNGOLZA autoinjector in the FDA application?
Typically the NDA/BLA manufacturing section, but it cannot be identified from the available input. -
Do autoinjector device suppliers appear on the Orange Book entry for the drug product?
Usually not directly; it depends on application labeling and record details not provided here. -
How can I identify the needle and syringe suppliers for a prefixed autoinjector?
Through device integration documentation and extractables/leachables or manufacturing disclosures not included in the available input. -
What is the difference between the autoinjector device supplier and the fill-finish CMO for combination products?
Device suppliers build the injection platform; fill-finish sites typically perform sterile filling, but specific Tryngolza assignments are not provided. -
How do manufacturers ensure compatibility between the drug formulation and the primary container/needle for autoinjectors?
Via container closure integrity, compatibility studies, and leachables/extractables testing, but the Tryngolza-specific studies and parties are not in the provided input.
References
- None.
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