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Suppliers and packagers for cialis
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cialis
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4462-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30) | 2003-11-26 |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4463-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4463-30) | 2003-11-26 |
| Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368 | NDA | Eli Lilly and Company | 0002-4464-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0002-4464-30) | 2003-11-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
CIALIS (tadalafil): Who Supplies the Drug’s Key Inputs and Manufacturing Outsources
CIALIS is marketed as tadalafil for erectile dysfunction and related indications. The product’s supplier chain is organized around (1) active pharmaceutical ingredient (API) supply for tadalafil and (2) contract manufacturing and packaging of finished dosage forms (tablets). For investment and R&D diligence, the relevant “suppliers” are the API manufacturers named on regulatory filings and the finished-dose manufacturers that produce and release tablets under the marketing authorization.
What companies supply tadalafil (API) for CIALIS?
Tadalafil API suppliers vary by site and by market history because tadalafil is manufactured by multiple qualified plants over time. For diligence, the reliable source of truth is the marketing authorization dossier and regulatory listings that name specific API manufacturing sites and testing facilities.
API supply can include:
- API manufacturing sites (tadalafil synthesis and API bulk release)
- Intermediates and solid-state suppliers used for API crystallization, milling, and particle-size control
- API quality-control sites (testing and release)
Because supplier identity changes across manufacturing campaigns, site-level names should be taken from the most recent dossier/variation records for the specific jurisdiction and strength (most commonly 5 mg and 20 mg tablet presentations).
Who manufactures and packs CIALIS tablets?
Finished-dose “suppliers” are typically contract manufacturing organizations (CMOs) or the marketing authorization holder’s manufacturing network, with responsibility for:
- Tablet compression and coating
- Tablet splitting (if applicable by strength/format)
- Packaging (bottles, blister packs) and labeling
- Batch release testing and importation (for certain markets)
As with API, the finished-dose manufacturer and packaging site names are jurisdiction- and time-dependent and must be confirmed through the latest regulatory product listing.
How to identify the correct supplier list for due diligence
Use a two-layer approach that maps to how regulatory systems track manufacturing responsibility:
1) API sites
- Pull the tadalafil API manufacturer(s) listed in the marketing authorization dossier
- Confirm the control strategy dependencies (impurity profiles, polymorph control, residual solvent limits)
2) Finished-dose sites
- Pull the finished product manufacturer(s) and packaging sites
- Confirm which sites perform:
- manufacture
- packaging/labeling
- import release
- batch release testing
Why CIALIS supplier lists are not fixed
CIALIS supply is managed through a network model, so “suppliers for CIALIS” can mean different roles:
| Supplier role | What it supplies | Who appears as the “supplier” in records |
|---|---|---|
| API supplier | tadalafil bulk | API manufacturer site(s) and testing/release site(s) |
| CMO for tablets | tadalafil tablets | Finished-dose manufacturer site(s) |
| Packaging supplier | blisters/bottles and labeled units | Packaging/labeling site(s) |
| Release/import site | batch release services | National release/importer entity in that market |
This is why the same product name can show different manufacturing sites over time under regulatory variations.
Regulatory documentation that typically lists suppliers
For supplier identification, the most actionable filings usually include:
- The EPAR/SmPC dossier equivalents (EU)
- FDA Orange Book entries and labeling history (US)
- National formularies and product databases (EU member states and UK)
- DMF-linked API references (where applicable)
These documents typically identify:
- Manufacturing sites for API and finished product
- Specifications and control tests tied to those sites
- Variation history that flags site additions or removals
CIALIS formulation and strength context used in supplier mapping
Supplier listings should be tied to the exact finished strength and dosage format:
| Strength (typical) | Dosage form | Supplier mapping relevance |
|---|---|---|
| 5 mg | oral tablet | Most frequently produced strength for chronic dosing markets |
| 20 mg | oral tablet | Often has separate manufacturing runs and packaging formats |
| Other strengths historically used | oral tablet | May map to different campaigns or packaging suppliers |
Key due diligence checks for supplier risk (API + finished dose)
API
- Polymorph and particle-size control (tadalafil solid-state behavior)
- Impurity profile consistency across campaigns
- Residual solvents and elemental impurities compliance
Finished dose
- Tablet uniformity and dissolution specification alignment
- Coating and release performance consistency across packaging changes
- Deviations and corrective actions tied to specific sites
Supply continuity
- Track manufacturing site changes in regulatory variation logs
- Confirm whether the API plant and finished-dose plant are single-source or multi-source in each jurisdiction
Key Takeaways
- “Suppliers for CIALIS” should be interpreted as tadalafil API manufacturing sites plus finished-dose tablet manufacturing and packaging sites listed in regulatory dossiers for each market and strength.
- Supplier identities can change over time via regulatory variations, so the actionable list is the one tied to the most recent approved dossier for the jurisdiction in question.
- For risk and investment analysis, map each site to its responsibility: API manufacture, finished-dose manufacture, packaging/labeling, and batch release/import.
FAQs
1) What does “supplier for CIALIS” mean in regulatory terms?
It usually means the API manufacturer(s) of tadalafil and the finished product manufacturers/packagers responsible for tablet production, packaging, and batch release in the target market.
2) Are CIALIS suppliers the same worldwide?
No. Regulatory approvals and manufacturing networks change by jurisdiction and over time, so supplier lists differ across markets and product lifecycle events.
3) Does tadalafil API come from one manufacturer?
Not necessarily. Tadalafil API is typically supplied from multiple qualified sites across the product’s commercial history, depending on sourcing strategy and regulatory approvals.
4) How do I validate a specific supplier for a given CIALIS strength?
Use the latest regulatory dossier/listing for the market and strength to confirm the specific API and finished-dose sites assigned to that presentation.
5) What supplier-change signals matter most for CIALIS supply risk?
Regulatory variation entries that add or remove API sites, change finished-dose manufacturing sites, or alter packaging/labeling and release responsibilities are the most relevant signals.
References
[1] European Medicines Agency. EPAR product information and assessment reports for tadalafil-containing medicinal products (where available).
[2] U.S. FDA. Orange Book entries and labeling references for tadalafil products (where available).
[3] EMA and national competent authorities. Marketing authorization dossier content and variation documentation that lists manufacturing site responsibilities for API and finished product.
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