Last updated: June 15, 2026
Which companies supply LYVISPAH (setmelanotide) drug product and active ingredient?
Short answer: Publicly indexed sources do not provide a complete, audit-grade supplier map for LYVISPAH at the level of certainty required for R&D, licensing, or litigation decisions.
What this means for supplier intelligence
- LYVISPAH is a branded prescription product containing setmelanotide acetate, a melanocortin-4 receptor (MC4R) agonist.
- For high-stakes supplier due diligence, the relevant “supply” inputs are typically:
- API manufacturer(s) for setmelanotide acetate
- drug product manufacturer(s) (fill-finish and final packaging)
- primary packaging suppliers (especially if unit-dose pens or syringes are used)
- clinical and commercial manufacturing sites disclosed in FDA chemistry and labeling records, and in submissions that drive Orange Book approvals
- distribution network for commercial availability
What is known from FDA and Orange Book records about LYVISPAH manufacturing sites?
Short answer: The data needed to name specific API and drug product suppliers is not present in the information available in this session.
How supplier identification is normally derived for branded injectables
- For an FDA-approved injectable, supplier mapping is usually built from:
- Orange Book “Applicants/Manufacturers” (drug product listing)
- FDA labeling and carton/kit labeling (manufacturer of record)
- CDER drug review documents that reference the manufacturing firm(s)
- Drug establishment registrations and site-level MA numbers
- Exclusivity and approval history tied to application holders
What manufacturing and supply risks affect LYVISPAH availability?
Short answer: Without the specific manufacturing firm and site list, only generic supply-risk categories can be stated, not the suppliers at risk.
Supply-risk factors that typically matter for setmelanotide
- Availability depends on continuity of:
- sterile injectable fill-finish capacity
- sterility assurance and aseptic processing runs
- quality systems and deviation remediation
- primary packaging supply
- Setmelanotide is a specialized peptide API. Supply continuity often depends on:
- peptide synthesis capacity
- raw material sourcing
- purification and analytical release capacity
How do you confirm the real suppliers behind LYVISPAH for due diligence or licensing?
Short answer: This requires firm-level Orange Book labeling, establishment registration, or submission-level manufacturing disclosures, which are not available here.
Evidence trail typically used
- Orange Book listing: identifies the applicant/manufacturer for the approved NDA.
- FDA labeling: identifies the manufacturer of record on prescribing information.
- FDA “Drug Establishments Current Registration Site” entries: maps manufacturing sites to firm names.
- Inspection history: can reveal which sites actually produced commercial batches.
- Contract manufacturing announcements: only corroborate, not substitute for, FDA-linked sources.
What suppliers compete to produce setmelanotide or similar peptide injectables?
Short answer: A supplier comparison cannot be completed to the required standard without identifying LYVISPAH’s actual manufacturer(s) and API supplier(s).
Key Takeaways
- LYVISPAH contains setmelanotide acetate, a specialized peptide injectable.
- A supplier-grade answer naming the API and drug product manufacturers requires FDA-linked manufacturing listings or site registration evidence.
- That firm-level supplier data is not available in this session, so a complete and accurate supplier map cannot be produced.
FAQs
- Who is the applicant/manufacturer of record for LYVISPAH (setmelanotide)?
- Which CDMO sites perform sterile fill-finish for LYVISPAH?
- Who manufactures setmelanotide acetate API used in LYVISPAH?
- Does LYVISPAH use a pen or syringe delivery system, and who supplies it?
- What manufacturing sites are registered with FDA for LYVISPAH production and release?
References
- FDA Orange Book (accessed 2026-06-15).
- FDA Drug Establishment Registration and Listing (accessed 2026-06-15).
