Suppliers and packagers for generic pharmaceutical drug: OLICERIDINE

OLICERIDINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730	NDA	Trevena, Inc.	71308-011-10	10 VIAL, SINGLE-DOSE in 1 CARTON (71308-011-10) / 1 mL in 1 VIAL, SINGLE-DOSE (71308-011-01)	2020-08-07
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730	NDA	Trevena, Inc.	71308-021-10	10 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01)	2020-08-07

Suppliers and packagers for generic pharmaceutical drug: OLICERIDINE

Last updated: May 30, 2026

Oliceridine Suppliers 2025: Who Manufactures, Fills, and Supplies the Drug for US and Global Markets

Oliceridine is supplied through a tightly controlled, branded commercialization chain centered on its FDA approval in the US and its manufacturing network supporting commercial-scale supply. Publicly visible “supplier” data in the form of US FDA approvals (CDER drug listings), Orange Book marketing/holder entries, and CMC-driven contract manufacturing relationships is limited in the open record. What is available ties supply responsibility to the FDA-listed drug product and its application holder, then maps upstream CMO/CFF roles indirectly through manufacturing site references and corporate supply statements.

Practical supplier mapping for diligence and licensing work hinges on three data pillars:

1. FDA drug listing / application holder for the branded product entry and label supply responsibilities (US).
2. Orange Book listed patents to identify the branded sponsor and associated development organization for license and exclusivity timing.
3. Manufacturing site assignments reflected in FDA approvals and CMC submissions that link to packaging and drug substance/drug product supply, which is the basis for true “who supplies what” in regulatory terms.

Who is the application holder and branded “supplier” for oliceridine (Actiq? no) in the US?

Answer (featured snippet): Oliceridine’s US commercial sponsor and label/marketing responsibility are tied to the FDA-listed holder of the NDA for oliceridine (marketed as Oliceridine injection under the brand Olinvyk).

What this means for supplier selection: In US procurement and regulatory submissions, “supplier” for oliceridine is anchored to the NDA holder and the FDA-listed drug product manufacturer(s) for the commercial product, not to informal distributor networks.

Oliceridine branded product details that define the supplier chain

• Active ingredient: oliceridine
• Drug type: opioid analgesic (systemic)
• US brand: Olinvyk (liceridine injection; FDA-approved dosing forms include injection presentations used in clinical and hospital settings)

Why the NDA holder is the regulatory supplier-of-record

• FDA drug product listings and label controls tie the branded product’s regulatory obligations to the application holder.
• Any CMO acting on the label’s behalf is typically visible through manufacturing site and application references but the legal accountability remains with the NDA holder.

Which companies manufacture oliceridine drug product and packaging under contract?

Answer (featured snippet): Open-source “CMO-by-name” attribution for the full oliceridine commercial manufacturing and packaging chain is not consistently available in public records without relying on site-specific FDA CMC and inspection disclosure or paywalled label/manufacturing detail.

What can be stated from regulatory diligence practice (and how buyers confirm):

• Buyers confirm oliceridine supply chain through:
  • FDA label “Manufactured for / Distributed by” lines,
  • the US drug listing (NDC-linked) manufacturing sites,
  • and manufacturing agreement terms in GMP release documentation.

How to map the true oliceridine supplier for procurement

• Step 1: Start from the NDC for the commercial presentation.
• Step 2: Pull the FDA drug listing entry for that NDC to identify the manufacturer(s) listed as responsible for the drug product.
• Step 3: Verify packaging configuration using label statements and lot release documents (since injection products often have defined container closures and carton packaging suppliers).

What FDA sources list oliceridine manufacturers and distribution responsibility?

Answer (featured snippet): The primary public sources are FDA’s Drug Databases (drug listing and label distribution information) and the Orange Book record that identifies the marketed holder and exclusivity context.

Orange Book and exclusivity context (supplier relevance)

• Orange Book entries identify:
  • the patent-listed sponsor for the marketed product,
  • and patent exclusivity posture.
• While Orange Book does not always enumerate CMOs, it anchors the branded sponsor identity, which then drives who controls manufacturing tech transfers and approvals.

FDA drug listing record (supplier-of-record relevance)

• FDA listing includes the drug product manufacturer and marketing details tied to NDC.

Which contract manufacturing organizations (CMOs) support oliceridine supply?

Answer (featured snippet): A definitive, CMO-by-CMO roster for oliceridine requires site-level FDA and label manufacturing disclosures. The publicly accessible record does not reliably provide a single consolidated list of CMOs that can be quoted without introducing attribution errors.

Business consequence: For licensing, sourcing, or dispute avoidance:

• Counterparty qualification must be done against NDC-linked manufacturer-of-record and GMP release documentation for each lot.
• Contracting “the CMO you think makes it” is high risk unless it is cross-referenced to the specific FDA-listed manufacturing site for the NDC in question.

What patent estate is controlled by the oliceridine sponsor, and how does that affect sourcing from competitors?

Answer (featured snippet): Patent control impacts generic entry timing and can indirectly affect supplier availability, but it does not define the upstream CMO list. The supplier chain is controlled by manufacturing approvals and CMC ownership, while patent control defines who can introduce substitutes.

Orange Book-driven diligence checklist

• Identify:
  • active ingredient and drug product listing(s),
  • listed patents (composition, method-of-use, and formulation/delivery),
  • and exclusivity expiration windows.

How patent control affects “supplier switching”

• If a generic substitutes, the market shifts to an entrant’s manufacturing network.
• If no generic launches, supply stays with the branded manufacturing and any controlled lifecycle changes (supplements, tech transfer) managed by the sponsor.

Is oliceridine supplied as a hospital-only injectable, and who typically distributes it?

Answer (featured snippet): Oliceridine is supplied as an injectable opioid, with distribution managed through regulated pharmaceutical distribution channels that carry the brand NDA holder’s product.

Distribution versus manufacturing

• Manufacturing: GMP drug product release at one or more manufacturing sites.
• Distribution: wholesaler networks and specialty distribution for controlled substances handling.
• “Supplier” can mean either; procurement teams should distinguish:
  • drug product manufacturer-of-record for regulatory quality agreements,
  • wholesaler/distributor for logistics and invoicing.

How many oliceridine supplier sources exist for redundancy and continuity of supply?

Answer (featured snippet): The number of redundant supply sources is determined by:

• how many manufacturing sites are listed for the NDC(s),
• how many packaging lines are qualified,
• and the sponsor’s approved supplements. Public consolidated redundancy counts are not consistently available.

What procurement teams use to assess redundancy

• Manufacturing site count from FDA NDC listing.
• Sterility and container closure qualification scope.
• Lot release and allocation history.
• Controlled-substance logistics coverage.

What “supplier risk” matters most for oliceridine?

Answer (featured snippet): For oliceridine, supplier risk is dominated by:

• controlled-substance regulatory handling,
• sterile injectable manufacturing capacity constraints,
• and the sponsor’s ability to support GMP releases without a multi-site footprint.

Risk events that affect supply

• Site-specific GMP deviations.
• Container closure component shortages.
• Sterile manufacturing capacity interruptions.

Oliceridine supplier landscape comparison: branded supply vs generic entrant supply

Answer (featured snippet): Branded supply is sponsor-controlled; generic supply requires ANDA approval and manufacturing approvals tied to the entrant’s network. Until an approved generic enters for the US, supplier options remain limited to the branded supply chain.

How supplier options would expand if generics launch

• New manufacturing sites for the generic NDCs.
• New packaging suppliers for equivalent presentations.
• New distributors tied to generic wholesaler contracting.

Key Takeaways

• Oliceridine’s practical “supplier” in the US is the NDA holder’s branded product supply chain, anchored by FDA-listed manufacturer-of-record for the specific oliceridine NDC.
• Open public records do not provide a dependable, complete CMO roster in a single consolidated list suitable for quoting without site-by-site verification against FDA label/manufacturer-of-record entries.
• For procurement and licensing diligence, the actionable approach is NDC-linked confirmation of:
  1. drug product manufacturer(s),
  2. packaging configuration,
  3. and the NDA holder responsible for regulatory control.

FAQs

1. How do I identify the manufacturer-of-record for a specific oliceridine NDC?
   Use the FDA drug listing entry for the NDC and match the “Manufacturer” line to lot-release GMP documentation.

2. Does Orange Book list manufacturing sites for oliceridine?
   Orange Book lists patents and marketing exclusivity context; manufacturing sites are not reliably enumerated in Orange Book.

3. What is the difference between oliceridine “supplier” and “distributor”?
   Supplier-of-record is the GMP manufacturer tied to the NDC; distributor is the logistics/wholesaler channel handling controlled-substance distribution.

4. Can a CMO supply oliceridine without being visible by name in public records?
   Yes. CMO participation may be reflected only through FDA CMC references and label manufacturing statements, not always through widely published corporate names.

5. What supplier risks are most likely for sterile injectable opioids like oliceridine?
   Sterile manufacturing capacity, container closure/sterile component shortages, and site-specific GMP events.

References

1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. US Food and Drug Administration. Drugs@FDA: Drug Information.
3. US Food and Drug Administration. FDA Label information for oliceridine (Olinvyk).