Last updated: June 11, 2026
Otrexup (otrexup is a methotrexate injection using an auto-injector pen) is sourced through a managed supply chain that typically splits across (1) active pharmaceutical ingredient manufacturing, (2) sterile drug product fill-finish, and (3) delivery-system (auto-injector) supply. However, no complete, reliable supplier-identification set (API maker, sterile fill-finish site(s), and device manufacturer) is available from the information provided in this prompt.
What companies supply Otrexup (methotrexate injection) API, sterile fill-finish, and the auto-injector?
No complete supplier mapping can be produced without the underlying source documents (e.g., FDA Drug Approval Package listings, Orange Book/Labeler details, device constituent filings, or inspection-site assignments for manufacturing).
What supplier types exist in Otrexup’s manufacturing stack?
- API manufacturing (methotrexate)
- Sterile fill-finish (aseptic filling, sterilization, packaging under GMP)
- Auto-injector pen components and final assembly (device engineering and sterile-ready integration)
- Labeling/secondary packaging and distribution
What does the Otrexup label reveal about manufacturers and license holders?
The label and FDA review package usually contain different entities for:
- Marketer/holder (NDA holder)
- Manufacturer of drug product (GMP release site)
- Manufacturer of packaged unit
- Potential device-related manufacturer information
No label text or FDA package data is present in the prompt, so supplier entities cannot be enumerated.
Which sites manufacture Otrexup: how many fill-finish locations are listed?
A site-level count requires the FDA manufacturing section of the approval package or current GMP listing tied to the marketed NDCs. Those inputs are not included here, so a quantified list cannot be compiled.
How do Otrexup suppliers compare with other methotrexate auto-injectors?
Comparison requires:
- Identifying the closest competitor products and their listed labeler/manufacturer identities
- Mapping shared device or fill-finish providers across brands
No competitor product list or NDC/labeler data is provided.
What are the main Otrexup procurement risk points in the supply chain?
Risk points in injectable, device-integrated combination products typically include:
- Aseptic sterile capacity and sterility assurance
- Component availability for the auto-injector mechanism (springs, plungers, springs force consistency, sealing)
- Device qualification and change control affecting compatibility with the drug formulation
A defensible, product-specific risk assessment requires specific supplier and site identification, which is not available.
What does FDA manufacturing oversight say about Otrexup suppliers (inspections, warning letters)?
Inspection outcomes and observations are supplier- and site-specific. Without named manufacturing sites and referenced inspection histories, no credible supplier oversight narrative can be produced.
Key Takeaways
- Otrexup’s supply chain spans API production, sterile fill-finish, and auto-injector device supply.
- Supplier identification requires FDA labeler/manufacturer and device constituent information that is not present in the prompt.
- No authoritative list of Otrexup suppliers (API, fill-finish, or device) can be produced from the provided inputs.
FAQs
- Who is the NDA holder for Otrexup and does the holder also manufacture the product?
- Which auto-injector pen manufacturer supplies Otrexup’s delivery device?
- Where is Otrexup aseptically filled and finished for release?
- Are Otrexup suppliers shared with other methotrexate injection brands using similar pens?
- What supply constraints are most likely to impact Otrexup availability (sterile capacity vs device components)?
References
No sources were provided in the prompt.
