Suppliers and packagers for ALYQ

ALYQ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Pharms Inc	ALYQ	tadalafil	TABLET;ORAL	216932	ANDA	Teva Pharmaceuticals, Inc.	0480-9277-06	60 TABLET, FILM COATED in 1 BOTTLE (0480-9277-06)	2024-02-20

ALYQ (tadalafil) Suppliers: How to Map API, Finished Dose, and Manufacturing Sources for US Supply

Last updated: May 29, 2026

ALYQ is a tadalafil brand used for pulmonary arterial hypertension (PAH). Suppliers fall into three practical buckets for diligence and sourcing: tadalafil API producers, finished-dose manufacturers that produce ALYQ tablets under FDA approvals, and contract manufacturers that support packaging, labeling, and distribution.

Which companies supply the tadalafil API used to make ALYQ?

Answer: ALYQ uses tadalafil as the active pharmaceutical ingredient (API). Identifying the exact API supplier list for ALYQ requires cross-referencing FDA manufacturing disclosures with the company’s labeled supply chain. The most reliable “supplier” sources in practice are (1) the API “manufacturer” entries tied to ALYQ’s FDA approval package and (2) the API facility disclosures in current CMC submissions for the listed dosage form(s).

What to check for API sourcing in ALYQ documentation

• API manufacturer name(s) tied to the ALYQ application and labeling package
• API site addresses that appear in FDA review materials and/or listing identifiers
• Control strategy and polymorph or particle size specifications that can limit supplier interchangeability

Do generic tadalafil API suppliers qualify for ALYQ?

For a brand product like ALYQ, “tadalafil API supplier” interchangeability depends on more than chemical identity:

• matching impurity profiles and residual solvent specifications
• polymorphic form and solid-state properties
• batch release testing and GMP status for the specific commercial scale

Who manufactures ALYQ tablets as the finished dose for the US market?

Answer: ALYQ’s finished-dose manufacturer is the entity that produces the tablets under the approved NDA/ANDA manufacturing authorization tied to the product’s FDA listing.

Where finished-dose “manufacturer” appears

• FDA drug listing records (product label “manufactured for” lines)
• NDA/CMC manufacturing site listings for tablet drug product
• Inspection histories that can be correlated to tablet manufacturing sites

How to interpret “manufactured for” vs “manufactured by”

For supply chain mapping:

• “Manufactured for” often points to the marketing authorization holder or brand owner.
• “Manufactured by” or labeled manufacturing responsibilities point to the contract manufacturer or site building the tablets.

Which contract manufacturers package and label ALYQ for distribution?

Answer: ALYQ distribution depends on packaging and labeling handlers that can include primary packaging (bottles/blisters), secondary packaging, and label/lot control. These are frequently different legal entities than tablet manufacturing.

Packaging and labeling roles to isolate

• bottle/blister primary packaging site
• secondary pack-out site
• labeling printing and application site
• distribution warehouse or 3PL that handles cold-chain is not typical for tablets, but temperature excursions still matter

What is the Orange Book status of ALYQ and how does that affect supplier risk?

Answer: ALYQ is tadalafil tablets. Orange Book status affects generic competition timing, which in turn impacts how many suppliers need to qualify for future demand surges. Patent and exclusivity status also determine how quickly manufacturers retool or add capacity.

Why Orange Book mapping matters for suppliers

• If patent barriers block generic entry, supplier substitution risk is lower in the near term.
• If exclusivity is near expiration or litigation is active, procurement plans tighten because demand can swing quickly.

What patent estate surrounds ALYQ that can constrain alternate manufacturing?

Answer: ALYQ is tadalafil; the competitive manufacturing landscape can still be constrained by:

• formulation patents (tablet composition, excipients)
• method-of-use patents (PAH dosing regimens)
• process/manufacturing method patents (granulation, compression, coating process steps)

How formulation and method patents affect suppliers

Even when API is available, a supplier may be blocked from producing a “commercially substitutable” product if:

• the generic’s formulation must be different
• bioequivalence is impacted by solid-state changes
• process steps are patented

Which generic tadalafil products compete with ALYQ and how does that change sourcing?

Answer: Multiple tadalafil generics exist in the US across indications. Competition affects:

• pricing pressure on tadalafil brands
• willingness of API suppliers to allocate capacity
• availability of qualified tablet CMOs that have already run tablet lines for PDE5 inhibitors

Supplier implications

• If competing products are already produced by the same CMO network, ALYQ’s manufacturing capacity may be easier to scale.
• If ALYQ’s exact formulation requires a specific manufacturing line or coating system, capacity expansion can be slower.

When does ALYQ lose exclusivity and what does that mean for suppliers?

Answer: Exclusivity and patent timelines determine when additional manufacturing entrants can pursue abbreviated pathways and commercial launch. The effect on suppliers is direct:

• increased demand for tablets and API around launch windows
• accelerated qualification of alternate CMO lines
• tighter API allocation and more frequent out-of-spec risk mitigation

What manufacturing/IP barriers can prevent swapping ALYQ suppliers?

Answer: The biggest barriers are typically:

• approved manufacturing site restrictions in the FDA filing
• validated process parameters tied to the brand’s CMC
• quality agreements and supply chain controls (change control, comparability)

Common swap blockers

• equipment design differences that shift dissolution or hardness profiles
• coating/sub-coating differences affecting dissolution rate
• testing methods that must be revalidated for the alternative site

Key takeaways

• ALYQ supply chain diligence should treat “supplier” as multiple entities: API producers, finished-dose tablet manufacturer, and packaging/labeling CMOs.
• The most defensible supplier mapping comes from FDA listing/manufacturing disclosures tied to the specific ALYQ dosage form.
• Patent and Orange Book status shape the generic entry calendar and therefore supplier capacity planning and procurement risk.
• Manufacturing swaps are constrained by validated CMC and approved site controls, not by tadalafil chemical availability alone.

FAQs

1. What does the ALYQ label list for manufacturing sites and how can that identify the tablet supplier?
2. How do tadalafil API quality attributes (impurities, polymorph) affect qualification for an ALYQ-compatible supply chain?
3. Can a CMO that makes generic tadalafil tablets switch to manufacturing ALYQ, and what FDA CMC controls govern that?
4. How do Paragraph IV challenges around tadalafil tablets typically impact supply and capacity allocation for brand products like ALYQ?
5. What documentation is most useful to map ALYQ’s API and drug product suppliers for regulatory or litigation due diligence?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration.
3. FDA. Drug Products, Current Approvals. U.S. Food and Drug Administration.