Suppliers and packagers for ADCIRCA

ADCIRCA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332	NDA	United Therapeutics Corporation	66302-467-60	60 TABLET in 1 BOTTLE (66302-467-60)	2009-05-22

ADCirca (tadalafil) drug suppliers: API, finished-dose manufacturers, and key upstream sources

Last updated: June 1, 2026

Executive summary: ADCIRCA (tadalafil) is supplied in the US as a branded oral tablet (commonly 20 mg). Upstream supply is built around tadalafil API production and formulation/finished-dose manufacturing of the marketed tablets. Finished-dose supply for ADCIRCA in the US is tied to contract manufacturing arrangements supporting Eli Lilly’s US brand. For independent supplier due diligence, focus on (1) tadalafil API producers with FDA DMF status tied to the drug’s API use, (2) the CMO/batch-release sites listed on the US label and FDA inspection databases for tadalafil tablets, and (3) whether the supply chain uses direct Lilly manufacture versus contract packaging and release.

Who manufactures ADCIRCA tablets in the US, and what sites supply the market?

Direct supplier mapping for ADCIRCA finished dosage requires label- and FDA-registration-level site identifiers. Finished-dose tablets are typically manufactured in one or more NDA/label-registered sites, with batch release controlled by the applicant or its designated quality unit.

What does the ADCIRCA US prescribing information typically list as manufacturers?

US branded products typically name:

• Manufacturer / distributor (company label name)
• NDA holder (applicant)
• Local agent (if applicable)
• Sometimes manufacturing and packaging sites (varies by product, label format, and revision)

What supply-chain nodes are most relevant for licensing and litigation?

• API manufacturing site(s): tadalafil API producer(s) with Drug Master File (DMF) coverage for the API used in the marketed product.
• Finished-dose manufacturing site(s): tablet core and compression/excipients blending sites.
• Packaging and labeling sites: bottling, carton labeling, serialization.
• Batch release site: quality system release location.

Which companies supply tadalafil API for ADCIRCA (DMF-backed sources)?

High-confidence ADCIRCA API supplier identification depends on DMF-linked API use and the specific US reference listing for the API route and grade. For due diligence, the supplier list is built from:

• FDA DMF reference listings for tadalafil used in marketed tablets
• NDA manufacturing disclosures
• Inspection histories for DMF-linked API manufacturers and finished-dose sites

How do DMF listings connect to ADCIRCA supply?

A DMF-backed API supplier can support multiple brands. For ADCIRCA, the key question is which DMF is referenced in the ADCIRCA regulatory submissions for the specific dosage form and route (tadalafil tablet).

What API attributes affect supplier interchangeability?

• Tadalafil polymorph and physical properties control
• Particle size distribution and dissolution profile
• Impurity profile (including synthesis byproducts)
• Residual solvent levels and genotoxic impurity limits

What is the ADCIRCA manufacturing pathway (API to tablet) and what roles do suppliers play?

ADCirca’s upstream supply chain is a standard small-molecule workflow:

API synthesis to tadalafil bulk

Supplier role:

• Tadalafil synthesis, purification, crystallization/polymorph control
• API milling and dry blending to specifications
• QC release (assay, impurities, residuals)

Formulation to tablet

Supplier role:

• Powder blending of tadalafil with excipients
• Tablet compression and coating (if applicable)
• In-process controls for uniformity and hardness
• Finished product stability program

Packaging and distribution

Supplier role:

• Bottle filling, desiccant/closure configuration
• Label application and serialization compliance (if applicable)
• Warehouse distribution under temperature-controlled processes if required

How many ADCIRCA suppliers exist, and how concentrated is the upstream supply chain?

Small-molecule brands often use:

• One primary tadalafil API source plus secondary qualified sources
• One or a limited number of finished-dose manufacturing sites

Concentration is assessed using:

• NDA site registrations for tadalafil tablet manufacture
• Repeat historical inspection findings and consent decrees (if any)
• Supply interruptions reported through FDA, wholesalers, or market availability changes

What patent or regulatory status affects ADCIRCA supplier qualification and generic substitution?

Supplier decisions for brand products also track exclusivity and regulatory pathways that shape demand and bargaining power.

What is the FDA exclusivity and patent coverage that affects tadalafil tablet competition?

ADCirca’s regulatory landscape is driven by:

• Composition and use patents covering tadalafil formulations and indications
• Method-of-use patents tied to erectile dysfunction and pulmonary arterial hypertension (PAH)
• Manufacturing and formulation process patents that can constrain generic formulation adoption

How do Paragraph IV filings change supplier dynamics for tadalafil?

If and when a generic company files:

• It must justify bioequivalence and often uses different manufacturing sites
• It can create additional demand for tadalafil API and excipient sourcing
• It can trigger qualified generic supply chains, competing with brand purchasing volumes

What Orange Book status is associated with ADCIRCA, and how does it affect supplier strategy?

Orange Book coverage determines which changes are legally constrained for generics and authorized challengers.

Where supplier strategy intersects Orange Book listings

• If formulation or method-of-use patents are active, suppliers of alternative formulations may face launch barriers.
• If only limited patent families remain, supply diversification can accelerate for authorized generics or subsequent challengers.

Which distribution and logistics suppliers support ADCIRCA market availability?

Distribution for branded pharmaceuticals is typically handled by:

• Wholesalers and specialty pharma distribution partners
• Cold-chain is usually not central for tadalafil tablets unless label-stated (site and packaging requirements still apply)

Key logistics supply-chain parameters:

• Repackaging and commercialization compliance
• Lot traceability through serial and lot-based systems
• Time-temperature excursion management where applicable

What manufacturing/IP barriers can block new ADCIRCA supply entrants?

For upstream entrants attempting to qualify as an alternative supplier, the practical blockers are:

• NDA-level site qualification requirements
• Tight impurity specifications and control of genotoxic risk (process dependent)
• Patent and process IP coverage limiting “workaround” manufacturing routes
• Quality agreement complexity (audit acceptance, change control, comparability studies)

What are the typical qualification requirements for a new CMO in a brand supply chain?

• GMP and audit readiness
• Comparable process validation strategy (process capability, mixing uniformity, dissolution similarity)
• Analytical method transfer or method bridging
• Long-term stability comparability to label shelf life requirements

How does ADCIRCA compare with other tadalafil products (supplier implications)?

Tadalafil is also sold under other brands and generics. Supplier overlap can occur at:

• API supplier level (same DMF source)
• Finished-dose manufacturer level (if the CMO also makes other tadalafil strengths)

Key differences that change supplier mix:

• Strength and dosage form
• Excipients and release profile requirements
• Packaging formats and labeling requirements

Key takeaways

• ADCIRCA supply is governed by tadalafil API producers tied to FDA DMF-backed regulatory submissions and finished-dose tablet manufacturers at label-registered GMP sites.
• The most defensible supplier identification for business and litigation use is built from (1) FDA DMF references for tadalafil used in ADCIRCA, (2) NDA manufacturing site registrations, and (3) inspection and labeling disclosures.
• Supplier diversification is typically constrained by NDA site qualification, API impurity controls, and patent/process protections that limit manufacturing workarounds.

FAQs

1. Which FDA DMF(s) cover tadalafil API used in ADCIRCA tablets?
2. What GMP manufacturing sites are registered to produce ADCIRCA (tadalafil) tablets?
3. Can a tadalafil API supplier replace the ADCIRCA API source without NDA change?
4. Do patent-protected ADCIRCA formulation changes block generic tadalafil tablet manufacturing?
5. How do batch release and quality agreements typically work for ADCIRCA contract manufacturers?

References

No sources were provided in the prompt.