ACTIQ: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-7866-65	30 BLISTER PACK in 1 CARTON (0093-7866-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7866-19)	2015-12-08
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-7868-65	30 BLISTER PACK in 1 CARTON (0093-7868-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7868-19)	2015-12-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 27, 2026

Executive summary

ACTIQ is an oral transmucosal fentanyl citrate product supplied under a single FDA-approved brand using specific manufacturing and testing sites tied to FDA-approved application filings and approvals (NDA/BLA does not apply; ACTIQ is an NDA product).
Supply is managed at the API-to-finished-dose level: fentanyl citrate synthesis and crystallization, controlled formulation of the transmucosal delivery unit, blister/packaging, and end-to-end QA release.
Availability risk concentrates in (1) limited fentanyl API and intermediate supply, (2) specialized manufacturing steps for transmucosal units, and (3) regulatory release timelines for finished goods.
The supplier landscape is best mapped through: (a) FDA labeling manufacturing sections, (b) FDA’s drug establishment registration (both API and finished dose), and (c) Orange Book product and listed manufacturing sites tied to the approved NDA.

Who supplies ACTIQ (fentanyl citrate) to the US market?

Direct answer: ACTIQ’s US supply comes from the manufacturer(s) listed in the product’s FDA labeling and current manufacturing/packaging sites associated with the approved application for ACTIQ.

What does “supplier” mean for ACTIQ supply chain?

For high-intent supply mapping, “supplier” typically breaks into three layers:

Finished-dose manufacturer: makes ACTIQ lozenges (including filling/blistering as applicable) and releases finished product.
Packaging and labeling supplier: blistering, unit packaging, and final labeling under GMP.
API and intermediate supplier: fentanyl citrate API (and relevant intermediates) used in the finished-dose formulation.

ACTIQ’s availability depends on continuity across all three.

What manufacturers are listed in ACTIQ’s FDA label for manufacturing and packaging?

Direct answer: The controlling source is ACTIQ’s current FDA-approved prescribing information, which lists:

manufacturing site(s) for the drug product
packaging site(s) and/or re-packaging configurations
distributor holder on US labels

Where to find the binding manufacturing details

Section on manufacturing/marketed by inside the current ACTIQ prescribing information (the “Manufactured for/Distributed by” and “Manufactured by” blocks).
FDA SPL (Structured Product Labeling) entries that reflect the label’s current marketed-by and manufacturing/packaging information.
FDA drug establishment registrations to identify whether those labeled sites are active for the specific product and category.

Which ACTIQ API suppliers produce fentanyl citrate?

Direct answer: Fentanyl citrate API supply in the US is typically limited to a narrow set of GMP-registered API manufacturers and contract manufacturers, but the specific named suppliers tied to ACTIQ are the ones that feed the approved finished-dose NDA manufacturing sites.

How to map ACTIQ’s API suppliers accurately

The most business-useful method is chain-of-custody:

Identify the approved finished-dose manufacturing site(s) listed in ACTIQ labeling.
Use FDA drug establishment registration and related FDA inspections data to determine which registered API manufacturers exist for fentanyl citrate.
Cross-check the API manufacturer linkage to the finished-dose NDA manufacturing site, which is often reflected in:
- supplier changes and site addenda over time,
- manufacturing transfer announcements,
- and the labeling’s listed manufacturing configuration.

How does ACTIQ distribution work: who is the marketed-by entity vs manufacturing sites?

Direct answer: The marketed-by/distributed-by company on the ACTIQ label is not always the same as the GMP manufacturing sites producing the product.

Common separation in controlled opioids

The entity appearing on the label can be a marketing and distribution arm.
The physical product can be manufactured and released by one or more contract facilities under GMP.
That separation matters for supply continuity planning and for substitution risk mitigation during manufacturing transfers.

What bottlenecks affect ACTIQ supply availability (and which supplier stage is most exposed)?

Direct answer: The most exposed stages for ACTIQ supply are typically fentanyl API availability, finished-dose transmucosal unit manufacturing capacity, and batch release/QA throughput at release sites.

Stage-by-stage risk

API stage
- limited qualified suppliers for fentanyl APIs
- volatility in GMP inspection outcomes and supply interruptions
Finished-dose formulation and unit build
- specialized formulation controls for transmucosal absorption
- capacity constraints for unit operations (mixing, unit formation, blistering)
Batch release
- testing and lot release queues
- regulatory documentation and deviation handling during QC release

What manufacturing and packaging sites are registered for ACTIQ under FDA establishment rules?

Direct answer: ACTIQ is produced and packaged at one or more sites registered in FDA drug establishment registration, aligned with the labeled manufacturing/packaging information.

How to use establishment data for supplier due diligence

Identify whether sites are registered for:
- human drug products
- relevant dosage form manufacturing categories
Check whether the manufacturing sites in labeling correspond to registered addresses.
Map changes across time to identify transitions in the supply chain.

Who are the contract manufacturers and logistics suppliers for ACTIQ (blistering, unit packaging, distribution)?

Direct answer: Contract packaging and distribution are typically handled by site-specific suppliers named in labeling or reflected in FDA registration and inspection databases, rather than in public “supplier lists” like those used for non-controlled OTC products.

What to look for

Packaging plant references in the label’s manufacturing/packaging blocks.
Batch labeling and distribution under GMP with recorded wholesalers/distributors.
Licensed handling and controlled substance transport requirements (opioid controls increase compliance overhead).

How does ACTIQ compare with other fentanyl oral transmucosal products on supplier concentration risk?

Direct answer: ACTIQ shares core supply-chain constraints with other oral transmucosal fentanyl products, with the highest concentration risk tied to:

fentanyl API supply
specialized transmucosal unit manufacturing
batch release capacity at qualified sites

What changes across products

Some products may have alternate manufacturing sites or distinct unit designs, affecting which facilities are qualified and the feasibility of rapid supply substitution.

What is the Orange Book status of ACTIQ and how does it relate to supply competition?

Direct answer: ACTIQ is an NDA brand with listed patents in the Orange Book only where applicable to the specific NDA and listed dosage forms. Generic entry and supply competition depend on ANDA status, patent status, and any exclusivity or litigation.

Why Orange Book status matters for suppliers

If generics exist and are approved, they add supply options and can reduce bottleneck risk.
If patents and litigation block ANDAs, supply remains dominated by the brand manufacturer’s supply chain.

What generic or biosimilar entry risks exist for ACTIQ that could change supplier landscape?

Direct answer: For small-molecule fentanyl citrate products like ACTIQ, the relevant entry route is ANDA (not biosimilar). Entry risk depends on:

patent expiration and listed patents in the Orange Book
FDA approval status of any ANDA filings
settlement outcomes and patent carve-outs

Why this affects “supplier” planning

If generics launch, brand supplier concentration risk drops.
If no ANDAs are approved or launches are blocked, the supplier base remains narrow.

Key timelines that drive ACTIQ supply and supplier transitions

Direct answer: Supplier transitions happen at specific inflection points:

manufacturing site additions/transfers
regulatory changes requiring new testing, packaging, or formulation control
controlled substance quota and procurement cycles impacting available inventories

How to model the timeline in practice

Map manufacturing site changes from FDA filings and labeling revisions.
Overlay batch release and shortage events if published.
Use regulatory and inspection histories to identify continuity risk points.

What supplier diligence artifacts matter most for ACTIQ procurement?

Direct answer: For controlled opioids, procurement and vendor qualification typically hinges on:

GMP status of manufacturing and packaging sites
FDA inspection history of the relevant sites
traceability artifacts (lot traceability, CoA availability)
controlled substance handling and distribution licenses
change control history (manufacturing transfers, formulation or packaging changes)

Procurement checklist (supplier-side)

Current CoA coverage per lot
Traceability from API to finished dose where available
Evidence of GMP release testing and validated methods
Evidence of packaging integrity controls
Evidence of compliance with controlled substance distribution requirements

Key Takeaways

ACTIQ’s supplier base is best identified from the product’s FDA label manufacturing and packaging sections plus FDA drug establishment registration for those specific sites.
Supply risk concentrates in fentanyl citrate API availability, specialized transmucosal finished-dose manufacturing capacity, and batch release/QC throughput at qualified sites.
Orange Book and any ANDA/generic activity determine whether the supplier landscape broadens beyond the brand’s manufacturing chain.
Supplier diligence should focus on site-level GMP validity, inspection history, and lot-level release and traceability.

FAQs

How do I identify the exact ACTIQ finished-dose manufacturing plant on FDA labeling?
Use the “Manufactured by/Manufactured for/Distributed by” blocks in the current ACTIQ prescribing information and match the registered site addresses in FDA establishment listings.
Can ACTIQ be sourced from multiple finished-dose manufacturers in the US?
It can if multiple GMP sites are approved for the same NDA configuration. Confirmation requires current labeling and FDA establishment registrations for the labeled dosage form.
Do ACTIQ packaging suppliers differ from manufacturing suppliers?
Yes, packaging and labeling are frequently performed at distinct GMP sites. The label’s packaging/manufacturing blocks indicate which sites do which operations.
What most often causes ACTIQ shortages: API, formulation, or QC release?
Most often it is upstream fentanyl API constraints, coupled with bottlenecks in specialized unit manufacturing and batch release timelines at finished-dose sites.
Does Orange Book status affect ACTIQ supplier availability?
Yes. When patents block ANDAs, supply stays concentrated in the brand’s approved manufacturing chain. If generic approvals occur, supply options expand and concentration risk declines.

References

FDA. “ACTIQ (fentanyl citrate) prescribing information.” FDA access data repository/SPL.
FDA. “Drug Establishment Registration and Drug Product Listing.” FDA Establishment Registration data.
FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” ACTIQ listing.

Suppliers and packagers for ACTIQ

ACTIQ

ACTIQ (fentanyl citrate) supply chain: who manufactures, how supply is controlled, and what bottlenecks drive availability