Last updated: May 29, 2026
ULTIVA (remifentanil) Suppliers and Contract Manufacturers: Who Provides Drug Substance and Finished Dosage in Key Markets
ULTIVA is a brand of remifentanil hydrochloride, an opioid used for anesthesia. Supply for ULTIVA is driven by upstream active pharmaceutical ingredient (API) manufacturers and downstream finished-dose manufacturers for injectable strengths. The supplier landscape is determined by (1) FDA drug listing and labeling, (2) Orange Book patent ownership and manufacturer listings, (3) distribution/sourcing disclosures in regulatory submissions, and (4) global supply continuity for controlled-substance opioids.
Because supplier identity is highly specific to NDC/strength, manufacturing site, and market, a complete supplier map requires tying ULTIVA’s exact NDC configurations to their listed finished drug manufacturers and to the relevant API sites. If the underlying NDC-to-manufacturer records are not provided, a supplier list cannot be produced without risking material inaccuracies.
Which companies supply ULTIVA remifentanil injection in the US market?
Answer (direct): A supplier list must be built from FDA records linking ULTIVA NDCs to the corresponding applicant/labeler and finished dosage manufacturing site(s). Without those NDC identifiers and their FDA-linked manufacturing entries, no definitive supplier roster can be stated.
What Orange Book fields identify ULTIVA manufacturers
When ULTIVA has an Orange Book listing (controlled-substance product notwithstanding), the Orange Book entry can include:
- Applicant holder / marketing authorization holder
- Dosage form and strength
- Patent-protected claims (used to anchor product identity to a specific listing)
- Listed drug and NDC mapping (when present)
Supplier names that matter for sourcing diligence are typically those tied to:
- The finished drug manufacturer listed for the NDC/strength
- The applicant/holder that owns the FDA NDA/labeling
What to pull for supplier diligence
For operational sourcing, diligence targets:
- Manufacturing sites for lyophilized powder for injection or solution forms (remifentanil is commonly supplied as powder/vial)
- Labeler and distributor consistency by strength
- Any site transfers caused by validation, capacity, or regulatory actions
How do ULTIVA suppliers differ by NDC strength and dosage form?
Answer (direct): Supplier identity can differ across NDC strengths and package configurations even when the brand and active ingredient are the same.
For remifentanil, supply differentiation often tracks:
- Different vial sizes and strengths
- Different labeling configurations by market
- Different manufacturing lines or contract sterilization/fill-finish vendors
Without an NDC-to-strength mapping for ULTIVA, a “one company supplies all strengths” statement is not defensible.
Which supply roles should be separated
A correct supplier map separates:
- API manufacturer (remifentanil hydrochloride)
- Drug product manufacturer (fill-finish/sterile manufacture)
- Labeler/holder (FDA applicant)
- Distribution network (GPO and wholesaler paths)
What patents or regulatory listings constrain who can supply ULTIVA?
ULTIVA’s supply is not constrained primarily by formulation patents in the way standard generics are. The dominant constraints are:
- FDA NDA ownership and manufacturing authorization
- Controlled-substance supply controls and DEA requirements
- Sterile manufacturing and aseptic validation
- Labeling and labeling change control
That said, Orange Book listings can be used to confirm product identity and tie NDCs to the correct NDA entry, which in turn ties to manufacturer listings.
Do remifentanil generics compete with ULTIVA supply?
Yes, but procurement and sourcing risk depend on whether the competitor product is:
- Approved ANDA with its own manufacturing sites, or
- A re-labeled product sourcing from shared contract manufacturing
This affects supplier diversification and continuity planning.
What contract manufacturing and fill-finish models are typical for remifentanil injection?
Answer (direct): For injectable opioids like remifentanil, supply typically uses one or more of the following:
- API-to-finished transfer to a specialized sterile injectables fill-finish site
- Dedicated aseptic processing and terminal sterilization controls
- Lyophilization and sterile reconstitution processes if the commercial form is powder
A supplier list still requires site-specific regulatory mapping to avoid conflating entities with different roles.
Which countries supply remifentanil injection for ULTIVA and how does this impact procurement?
Answer (direct): Cross-border sourcing is common for sterile injectables. For controlled substances, procurement risk increases when:
- Manufacturing sites are geographically concentrated
- Regulatory inspection outcomes impact release timelines
- Political and logistics risk delays controlled inventory flows
A country-level supplier map requires the manufacturing country/site for each ULTIVA NDC/strength.
What generic or biosimilar entry risks affect ULTIVA supply and pricing?
Remifentanil is a small-molecule opioid; the direct comparator risk is generic competition rather than biosimilars.
Key supply and pricing dynamics:
- Generic manufacturers reduce unit pricing once approvals and launches occur
- Shortages can still occur across multiple products if upstream API supply or sterile capacity is constrained
- Controlled substance quotas and procurement allocations affect availability more than IP alone
A supplier risk assessment requires the competitor launch and manufacturer site landscape, which again requires NDC-linked product mapping and approval histories.
Key Takeaways
- ULTIVA supply is determined by NDC-level mapping to the FDA-listed applicant and finished dosage manufacturing sites, plus any API source tied to regulatory submissions.
- Without NDC-to-manufacturer records, a definitive list of “ULTIVA suppliers” cannot be provided without risking incorrect company attribution.
- The correct procurement view requires separating API suppliers, sterile fill-finish manufacturers, labeler/holder, and distribution channels.
FAQs
- How can I identify the FDA-listed manufacturer for ULTIVA by NDC?
- Do ULTIVA strengths have different manufacturing sites?
- What upstream API supply risks affect remifentanil injection availability?
- How do generic remifentanil approvals change supplier options for ULTIVA procurement?
- What regulatory records confirm finished drug manufacturing sites for controlled-substance injectables like remifentanil?
References
- FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). ULTIVA (remifentanil hydrochloride) listings.
- FDA. NDC Directory. ULTIVA labeler and NDC mapping (remifentanil hydrochloride products).
