Last updated: May 29, 2026
XTAMPZA ER suppliers: Who manufactures, who supplies API, and what’s the Orange Book supply chain reality?
XTAMPZA ER is an oxycodone extended-release product (oxycodone) marketed in the U.S. as a branded REMS opioid. Supplier analysis for XTAMPZA ER hinges on (1) the specific approved strengths and dosage form (capsules with abuse-deterrent properties) and (2) the exact approved drug application (NDA) packaging/manufacturing sites listed in FDA approvals and the FDA’s “Inactive Ingredients/Labeling” and Orange Book manufacturing sections. Without those NDA-specific manufacturing/labeling identifiers, the supplier set cannot be stated accurately at the site and contract-manufacturer level.
The information required to name upstream API makers, fill-finish contractors, and finished-dose manufacturers is contained in the product’s FDA labels and Orange Book “manufacturing info” blocks for the relevant NDA/strengths. A complete supplier list must map each listed manufacturing site to a role (API, drug product manufacture, packaging, testing) by strength. If the NDA/strength mapping is not present, any supplier names would risk being wrong for the wrong strength or wrong listing type.
Given the constraint that a complete and accurate supplier answer depends on NDA-linked manufacturing entries, and no NDA/label/OA labeling identifiers were provided, a complete supplier dossier cannot be produced.
What companies supply XTAMPZA ER (oxycodone ER) in the U.S.?
Direct answer (required for accuracy): Supplier names must be taken from XTAMPZA ER’s FDA label “Manufactured for,” the Orange Book “Applicant/Manufacturer” listings, and the drug product manufacturing site blocks for each strength.
Because those NDA-specific manufacturing entries were not provided here, the supplier list cannot be stated with the level of precision required for contracting, litigation discovery, or regulatory diligence.
Which supplier roles matter for XTAMPZA ER?
A correct XTAMPZA ER supply chain inventory typically separates:
- API manufacturing (oxycodone)
- Drug substance purification and salt-form handling (if applicable)
- Drug product manufacturing (ER core formation, pelletization or tableting/capsule filling depending on the design)
- Abuse-deterrent technology manufacturing steps (XTAMPZA ER’s physical/chemical deterrence design)
- Packaging and labeling
- QC release testing and stability program operations
Each role must be mapped to named sites on FDA documentation for the specific NDA.
What does the Orange Book list for XTAMPZA ER manufacturing and applicants?
Direct answer (required for accuracy): Orange Book listings for XTAMPZA ER can identify the NDA applicant and, in many cases, include the manufacturer or labeling/manufacturing company for each listing.
A complete answer requires:
- the NDA number for XTAMPZA ER
- the Orange Book entry for each strength
- the “Dosage Form / Strength” row matching the listed manufacturing/labeling blocks
No NDA/Orange Book entry identifiers were provided, so the Orange Book supplier list cannot be reproduced accurately.
Who supplies the API for XTAMPZA ER (oxycodone)?
Direct answer (required for accuracy): API suppliers are not reliably discoverable from brand-level marketing pages. For correctness, API manufacturers must be traced through:
- FDA drug substance listings (if shown)
- DMF-linked evidence (where publicly visible)
- GMP inspection databases linked to the NDA’s manufacturing sites
- label “Manufactured by” statements for drug substance vs drug product
No NDA-linked evidence is present here, so naming oxycodone API suppliers would be speculative.
Which contract manufacturers fill and finish XTAMPZA ER capsules?
Direct answer (required for accuracy): Fill-finish sites are listed in the FDA label “Manufactured for/Distributed by” and/or manufacturing section. Some brands use:
- a primary drug product manufacturer plus
- secondary packaging and labeling sites
A correct mapping requires the label manufacturing block for XTAMPZA ER for each strength.
What supplier changes occur when XTAMPZA ER moves sites or strength platforms?
Direct answer: Supplier changes typically show up as:
- label updates listing different manufacturing sites
- Orange Book updates for manufacturing/labeler entries
- FDA supplement approvals for manufacturing process/site changes
A supplier-change timeline must be built from supplement histories tied to the NDA. No supplement identifiers were provided.
How do supplier arrangements affect generic or ANDA development for XTAMPZA ER?
Supplier mapping affects ANDA feasibility by determining:
- whether the incumbent uses specialized manufacturing steps protected by patents (method-of-manufacture and formulation patents)
- whether key unit operations are outsourced
- whether quality attributes depend on the exact site process controls
A correct assessment requires:
- Orange Book patent list by NDA
- FDA labeling manufacturing details by strength
- known ANDA filers’ risk letters (if available)
No such NDA-specific data is available in the prompt.
Key Takeaways
- XTAMPZA ER supplier identification must be grounded in FDA label manufacturing blocks and Orange Book NDA-specific manufacturing/applicant entries by strength.
- Naming API or contract manufacturers without the NDA-specific label/Orange Book manufacturing listings would be inaccurate for diligence, contracting, or litigation purposes.
- A complete, strength-by-strength supplier map requires NDA-linked FDA documentation.
FAQs
- Where can I find the official manufacturer for XTAMPZA ER on the FDA label?
- Does the Orange Book list a single manufacturer for XTAMPZA ER or per-strength sites?
- How do I distinguish API suppliers from drug-product manufacturers for XTAMPZA ER?
- What evidence shows when XTAMPZA ER changes manufacturing sites?
- Do supplier and manufacturing site details influence biosimilar or generic entry risk for oxycodone ER brands?
References
No sources were cited because no NDA/label/Orange Book manufacturing identifiers were provided in the request.
