Last updated: May 27, 2026
LUMRYZ is a once-nightly oral formulation of sodium oxybate (central nervous system depressant; GABA-B receptor agonist). The drug’s commercial supply chain is built around (1) API manufacture for sodium oxybate and (2) drug-product manufacturing for the modified-release oral formulation. Publicly documented supplier detail is often limited; the most decision-useful supplier-identification is driven by FDA manufacturing site listings (NDC labeler/manufacturer), Orange Book application/manufacturer references, and cGMP inspection records.
What companies supply LUMRYZ (sodium oxybate) drug product for US distribution?
Answer: LUMRYZ is marketed under an FDA NDA and is distributed via the company that holds the NDA and labeler/manufacturer role on the US label/NDC listing, with drug-product manufacturing performed at specific cGMP sites. Those site-specific manufacturers are typically the controlling “supplier” entities for procurement and contract manufacturing risk in the US.
Who is the labeler and NDA holder for LUMRYZ?
Answer: Jazz Pharmaceuticals is the NDA holder/brand owner for LUMRYZ.
Which contract manufacturing organizations build the LUMRYZ tablets/capsules?
Answer: Drug product is manufactured at named cGMP facilities shown on the FDA NDC labeler/manufacturer and submission manufacturing site records for LUMRYZ. This determines the immediate supplier pool for:
- Finished dosage form supply (modified release)
- Packaging (bottles, cartons, labeling)
- Stability and release testing workflows
(A complete, accurate list of named drug-product and API sites requires pulling the current FDA NDC labeler/manufacturer and Orange Book manufacturing site entries for LUMRYZ.)
Who supplies the sodium oxybate active pharmaceutical ingredient (API) for LUMRYZ?
Answer: Sodium oxybate API supply typically comes from one or more specialized chemical manufacturers with the ability to meet the cGMP and analytical specifications used in the LUMRYZ NDA. In practice, the API supplier set is constrained by:
- consistent impurity profile
- salt form control for sodium oxybate
- scale-up capability
- qualified analytical method performance
How to identify sodium oxybate API suppliers for LUMRYZ
The supplier-identification chain for API is usually:
- US FDA drug listing for LUMRYZ (NDC labeler/manufacturer)
- FDA application manufacturing information (site role: API vs drug product)
- Orange Book entry details for the NDA and listed manufacturing/release sites
- cGMP inspection records linked to the site
What manufacturing sites appear on the LUMRYZ FDA label and NDC listing?
Answer: The FDA NDC labeler/manufacturer field identifies the site-level “manufacturer of record” for distribution. For supplier procurement and production continuity planning, the site roles matter:
- Drug product manufacturer (finished LUMRYZ)
- Secondary packer / labeler
- Batch release testing role (often inside drug product facilities)
Supplier risk factors tied to the manufacturing site list
- Single-site dependence for modified-release product manufacture
- Change control exposure for formulation scale-up
- Packaging line constraints for labeler/secondary packaging
Which contract manufacturers (CDMOs) can produce a modified-release sodium oxybate product?
Answer: The modified-release oral format and dosing design (nightly regimen) require formulation expertise and process know-how. The supplier pool for “drop-in” CDMO replacement is typically limited to CDMOs with:
- modified-release solid oral dosage line qualification
- experience with pharmaceutical salts and controlled release polymers/technologies
- validated analytical release for modified-release performance
What qualifies a CDMO as a realistic LUMRYZ alternative supplier?
- Approved or demonstrated experience with central nervous system controlled substances supply chains
- Proven handling of sodium oxybate under cGMP
- Capability to support comparability protocol and regulatory supplements if manufacturing changes occur
How does LUMRYZ’s supply chain compare with Xyrem and generic sodium oxybate launches?
Answer: Compared with Xyrem (sodium oxybate immediate-release), LUMRYZ’s supplier set is usually more constrained because modified-release manufacture has additional unit operations and stability requirements.
What changes supply risk between Xyrem and LUMRYZ?
- Different formulation and manufacturing process controls
- Different packaging and release testing specifications
- Different NDA manufacturing site configurations
What supplier lists matter for procurement, licensing, and litigation?
For business decisions, “suppliers” should be treated as three distinct categories:
- NDA/brand owner (commercial control)
- Drug-product manufacturing site (batch supply continuity)
- API manufacturing sites (cost and continuity for starting material)
Licensing and tech-transfer implications
If a prospective partner is assessing supply availability for:
- contract manufacturing,
- development of next-gen formulations,
- or authorized generics,
the controlling supplier contracts are typically the drug-product facility and API supply qualification packages.
Key Takeaways
- LUMRYZ is marketed by Jazz Pharmaceuticals, which controls NDA-related supply and labeling.
- “Supplier” for operations planning is primarily the drug-product manufacturing site(s) identified on FDA NDC and application manufacturing records.
- Sodium oxybate API suppliers are determined by the API manufacturing site(s) qualified to the LUMRYZ NDA and reflected in FDA manufacturing information.
- For procurement and continuity risk, focus on site-level drug-product manufacturing and packaging/labeling responsibilities, not only brand ownership.
FAQs
- Which manufacturing sites are listed for LUMRYZ in the FDA NDC database?
- Who holds the LUMRYZ NDA and controls supply chain qualification in the US?
- How can I identify the sodium oxybate API manufacturer for LUMRYZ from FDA public records?
- What are the main CDMO capabilities required to manufacture a modified-release sodium oxybate product?
- How does the manufacturing complexity of LUMRYZ affect supply continuity versus immediate-release sodium oxybate products?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
- FDA NDC Directory. US Food and Drug Administration.
- FDA Drug Listing Files and labeler/manufacturer information for LUMRYZ. US Food and Drug Administration.
