Suppliers and packagers for DALIRESP

DALIRESP

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0088-28	1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK	2015-07-01
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0088-39	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) / 2 TABLET in 1 BLISTER PACK	2015-07-01
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0095-30	30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)	2015-07-01
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0095-90	90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)	2015-07-01

Daliresp (roflumilast) Drug Suppliers: API, Contract Manufacturers, and Distribution Network

Last updated: May 23, 2026

Daliresp is sold as roflumilast tablets (500 mcg) in the U.S. through Forest Laboratories (an Allergan affiliate), and globally under multiple brands. The supplier ecosystem splits into (1) roflumilast API and finished-dose manufacturers and (2) U.S. channel distribution and relabeling partners. Publicly available, decision-grade supplier identification depends on mapping the FDA “drug product” and “labeler” entities in the Orange Book/Drug Label to the registered manufacturing sites on file for the listed dosage form(s), then tying those to known API producers.

Who supplies Daliresp (roflumilast) in the U.S.?

Short answer: The U.S. “labeler” and distribution chain for Daliresp tablets is tied to Forest Laboratories’ U.S. marketing organization, while the underlying manufacturing is performed by FDA-registered facilities associated with the NDA’s approved drug product and strength (500 mcg tablet). Supplier identification at a site level is done through the Orange Book drug product listing and the FDA NDC directory, then validated against the label’s manufacturer of record and site registrations.

What entities are listed as the drug product “labeler” for Daliresp?

• The Orange Book listing for Daliresp tablets identifies the NDA holder/labeler that owns the approved dosage form and the NDC(s) tied to that product.
• The NDC directory indicates the “labeler” that markets the product under the NDC.
• The drug label typically names the manufacturer(s) for the finished dose and the packager/distributor entities.

How do you map the supplier list from Orange Book to manufacturing sites?

A defensible mapping workflow uses these exact linkages:

1. Orange Book: isolate the listed drug (Daliresp), strength (500 mcg), dosage form (tablet), and NDC(s).
2. FDA NDC Directory: confirm labeler and product identifiers tied to those NDCs.
3. FDA Facility Registrations (CDER registration datasets): map each manufacturer/packager to registered sites for oral solid dosage forms.
4. Label “Manufactured for/Distributed by” lines: confirm the manufacturer of record for the specific NDA and packaging configuration.

Which companies manufacture roflumilast API for Daliresp?

Short answer: Roflumilast API sourcing is typically handled by specialized small-molecule manufacturers that also supply multiple European and global partners. The decision-grade supplier list requires linking the NDA’s approved manufacturing route and intermediates to the API manufacturer(s) disclosed in regulatory submissions and facility registrations.

What does “API supplier” mean in this context?

• The API “supplier” is the entity that manufactures and controls the roflumilast active ingredient material used to produce the approved drug product.
• The finished-dose manufacturer may not be the API manufacturer; it may be a contract manufacturer using sourced API from one or more qualified suppliers.

How are API suppliers validated for small molecules like roflumilast?

• NDA chemistry/manufacturing disclosures are reflected indirectly via:
  • FDA drug product labeling (sometimes includes API supplier language, often does not in a buyer-friendly way)
  • FDA facility registration and manufacturing site association
  • Customs/import and distribution patterns (not always reliable without importer-of-record mapping)
  • Public procurement and quality agreements (rarely disclosed)

What finished-dose CDMO or contract manufacturers produce Daliresp tablets (500 mcg)?

Short answer: Finished-dose CDMOs are identified by the label’s “manufactured by”/“manufactured for” line and corroborated by FDA-registered oral solid dosage sites tied to the NDA product listing. Site-level identification is the actionable procurement step for licensing, formulation tech transfer, or generic manufacturing readiness.

What manufacturing steps affect Daliresp supplier eligibility?

• Tablet manufacturing for roflumilast includes blending, granulation (process-dependent), tableting, compression, coating (if applicable), and quality release.
• Supplier readiness requires:
  • validated assay and impurity control for roflumilast
  • polymorph/crystal habit control (where relevant to stability)
  • dissolution and impurity specifications matching NDA release criteria

How many tablet strengths are relevant to supplier selection?

• For Daliresp, the clinically marketed U.S. strength is 500 mcg in tablet form for COPD indication.
• Supplier selection should target oral solid dosage manufacturing for that specific strength, not only general “roflumilast tablets” capability.

What is the Orange Book status of Daliresp and how does it affect supplier mapping?

Short answer: Orange Book status determines who can legally market generic roflumilast tablets and how the NDA’s manufacturing and packaging entitlements shift over time. For supplier mapping, the Orange Book listing is the authoritative anchor for NDCs and product identifiers.

Why Orange Book listings matter to suppliers

• Each listed drug entry ties to:
  • NDCs
  • dosage form and strength
  • patent and exclusivity entries
  • application/holder identity
• Supplier identity is then derived from those NDCs and the associated FDA facility registrations.

Do Daliresp suppliers differ by geography (U.S. vs EU vs other markets)?

Short answer: Yes. Roflumilast is distributed across multiple regions via different market authorization holders, and manufacturing sites can vary by regulatory market.

What typically changes by region

• The marketing authorization holder (MAH) and packager/distributor
• Licensed manufacturing sites for tablets and packaging
• API supply chains and importers-of-record

How do you build a procurement-grade supplier list for Daliresp (roflumilast) procurement?

Short answer: Use a three-layer verification stack: Orange Book and NDC identifiers to lock the exact labeled product, then FDA facility registration to identify the actual manufacturing sites, then label/packaging inserts to confirm manufacturer-of-record.

Procurement-grade data stack (actionable fields)

• Product identifiers: NDC, strength, dosage form
• Regulatory identifiers: NDA number, application type
• Facility identifiers: FDA registration number, site address, dosage form capability
• Quality and compliance artifacts:
  • GMP status and inspection outcomes (site level)
  • impurity profile capability for roflumilast
  • stability and dissolution test execution matching the NDA standard

What to request from a qualified CDMO for Daliresp tablets

• Analytical method capability for roflumilast release and stability testing
• Process validation package for tablet strength homogeneity and impurity control
• Facility oral solid track record and capacity confirmation
• Traceability and change-control governance aligned to NDA requirements

What supplier risks exist for roflumilast tablets (single-source and tech transfer)?

Short answer: Small-molecule COPD assets can face supply risk from API bottlenecks, crystallization control, and constrained oral solid capacity at qualified facilities. For licensing or generic development, the principal risks are tech-transfer failure and failure to meet impurity and dissolution targets.

Common points of failure in tech transfer for roflumilast

• API lot-to-lot impurity variability and clearance controls
• Dissolution drift due to formulation/process differences
• Coating or tableting performance instability (if applicable)

How does Daliresp supply connect to generic entry and Paragraph IV challenges?

Short answer: When generics enter, manufacturing shifts to additional contract facilities, and API sourcing broadens. The competitive landscape is shaped by patent/exclusivity status and by readiness to meet NDA-quality specifications for oral solid roflumilast.

What to monitor

• Orange Book patent expirations and exclusivity windows
• Generic ANDA approvals for roflumilast 500 mcg tablets
• Settlements that can delay launch and preserve Daliresp supply economics

Key Takeaways

• Identify Daliresp suppliers by anchoring on Orange Book NDCs and labeler, then mapping to FDA-registered manufacturing sites and the label’s manufacturer-of-record.
• For API, roflumilast sourcing is typically handled by specialized small-molecule manufacturers; API supplier identification must be validated via facility registrations and NDA-associated manufacturing disclosures rather than assumptions.
• Supplier risk for roflumilast tablets centers on API quality consistency and oral solid process validation for impurity and dissolution targets.
• Geography can change both marketing entities and manufacturing/packaging sites, so supplier lists should be built per market authorization environment.

FAQs

1) What are the key manufacturing sites for roflumilast 500 mcg tablets in the U.S.?
U.S. sites are identified by Orange Book NDC mapping to FDA oral solid dosage form facility registrations and confirmed by the Daliresp label’s manufacturer/packager-of-record.

2) Who is the Daliresp labeler on the FDA NDC directory?
The labeler is the marketing entity tied to the Orange Book listed drug entry for Daliresp tablets; it should be read directly from the matching NDC product record.

3) Can a CDMO manufacture roflumilast tablets without roflumilast API ownership?
Yes, finished-dose manufacturing is often performed using sourced API, but the CDMO must qualify the API supplier chain and meet the NDA’s impurity/dissolution specifications.

4) Are roflumilast API and tablet manufacturing requirements different?
Yes. API controls focus on synthesis impurities and polymorph/crystal behavior; tablet manufacturing focuses on blend uniformity, compression/coating behavior, dissolution, and stability.

5) How do exclusivity and Orange Book patents affect supplier strategy for entrants?
They govern launch timing and commercialization risk; incumbents maintain demand while entrants must plan manufacturing readiness to support an at-risk or post-expiry launch schedule.

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. (n.d.). NDC Directory. FDA.
3. U.S. Food and Drug Administration. (n.d.). Drug Registration and Listing System (DRLS) and facility registration information. FDA.