Last updated: May 31, 2026
Executive summary. CADUET is a fixed-dose combination tablet that pairs generic-equivalent active ingredients in a single dosage form: amlodipine (as besylate) and atorvastatin (as calcium salt). The supply chain is therefore split into (1) amlodipine API and key intermediates and (2) atorvastatin API and key intermediates, followed by (3) tablet formulation, blending, compression, coating, and packaging. CADUET sourcing is typically handled through branded and generic manufacturers that procure APIs from specialized API suppliers, then run finished-dose manufacturing (FDF) at contract manufacturers under quality agreements and change-control approvals aligned with FDA cGMP.
Who supplies CADUET active pharmaceutical ingredients (APIs): amlodipine and atorvastatin
CADUET’s API suppliers are the upstream vendors for amlodipine besylate and atorvastatin calcium (and intermediates used to make them). In most markets, APIs for these well-established molecules come from multiple manufacturers across China and India, plus a smaller set in Europe and the US.
What API salt forms are in CADUET
- Amlodipine in CADUET is typically amlodipine besylate.
- Atorvastatin in CADUET is typically atorvastatin calcium.
How CADUET API sourcing is structured
- API and intermediate manufacturers (often located in India/China) supply:
- amlodipine core intermediates and final API
- atorvastatin acid/intermediate chemistry and final API
- Finished-dose (FDF) manufacturers (tablet makers) source:
- APIs per approved DMF/CEP registrations and/or approved supplier lists
- excipients and packaging components
- then produce CADUET tablets under cGMP with validated blending/compression and stability controls
Which companies supply amlodipine besylate for combination products like CADUET
Amlodipine besylate is a mature generic API with broad vendor coverage. Suppliers commonly include international and large Indian/Chinese API firms that regularly support combination products in the US/EU via DMFs.
Amlodipine API supply categories
- Multi-product API plants producing:
- amlodipine besylate API
- homologs and related intermediates
- Contract organizations that handle:
- analytical testing and stability monitoring
- batch release under QMS and change-control systems
Common manufacturing geographies for amlodipine APIs
- India and China dominate global small-molecule API capacity for mature statins/calcium channel blockers.
- Europe and US have smaller volumes for widely sourced, off-patent APIs.
Which companies supply atorvastatin calcium for combination products like CADUET
Atorvastatin calcium is also mature and heavily supplied worldwide. Most CADUET-relevant sourcing flows through API houses and intermediate manufacturers with established compliance frameworks for FDA filings.
Atorvastatin API supply categories
- Producers of:
- atorvastatin calcium API
- key intermediates used in atorvastatin synthesis
- Analytical-release and stability vendors that support:
- shelf-life justification
- ongoing comparability
Common manufacturing geographies for atorvastatin APIs
- India and China supply much of the global atorvastatin API market.
- Europe/US are present but typically less dominant for mature statin APIs, where multiple qualified suppliers exist.
Who manufactures CADUET tablets (finished-dose manufacturing and outsourcing partners)
CADUET’s visible supplier set in practice is the finished-dose tablet manufacturer plus packaging and distribution partners. FDF responsibility is tied to:
- FDA application labeling and manufacturing site disclosures
- DMF-linked API sourcing
- PAT and validated process controls for dose uniformity and dissolution
What FDF suppliers typically do
- Formulation development and scale-up for fixed-dose combinations
- Tablet core manufacturing:
- blending and granulation (direct compression or wet/dry granulation depending on formulation)
- tablet compression
- Coating (if applicable), polishing, debossing/printing
- In-process controls:
- blend uniformity
- content uniformity
- dissolution and disintegration
- Packaging and labeling:
- bottle filling or blister packing
- child-resistant packaging where required
- lot traceability and serialized distribution systems where used
How do you identify the actual CADUET suppliers for a specific strength and lot
In the US, supplier accountability is usually traceable to:
- FDA label and manufacturing description
- Orange Book listing for the reference listed drug (RLD)
- For generics: the abbreviated new drug application (ANDA) labeling and manufacturing information
- DMFs for API and intermediates (used by FDFs to source compliant API)
What to look for on FDA submissions
- Strength-specific listing of manufacturing sites
- Facilities for:
- drug substance
- drug product
- Cross-references to DMFs or supplier codes used by the applicant
What supplier switching risks exist for CADUET (API and FDF change-control)
Because CADUET is a fixed-dose combination, supplier changes are managed through comparability and regulatory reporting.
API supplier switching risk drivers
- Salt form consistency:
- amlodipine besylate polymorph and particle size control
- atorvastatin calcium polymorph and crystal form control
- Impurity profile alignment:
- process-related impurities and elemental impurities
- Stability and dissolution impact on the combination tablet
FDF supplier switching risk drivers
- Blend and compression effect on dose uniformity across two APIs
- Dissolution behavior and rate limits per specification
- Coating and surface-related stability changes
- Packaging and humidity control affecting statin stability
CADUET supply chain by function: API, intermediates, and excipients
Even without naming every single vendor per market/strength, the functional supply map for CADUET typically includes:
1) Amlodipine API function
- Amlodipine besylate API production
- Intermediate production (upstream)
- Analytical release and stability reporting
2) Atorvastatin API function
- Atorvastatin calcium API production
- Intermediate production (upstream)
- Analytical release and stability reporting
3) Tablet manufacturing function
- Blending and compression
- Coating (if included in the approved formulation)
- Labeling and packaging
4) Excipients and packaging
- Common excipient classes:
- binders/disintegrants/fillers/lubricants
- coating components if used
- Packaging:
- bottles/blisters, desiccant where needed, printed packaging components
Key Takeaways
- CADUET’s supplier ecosystem is a two-API chain: amlodipine (besylate) and atorvastatin (calcium), then tablet finished-dose manufacturing under cGMP.
- Upstream supplier identification is typically done via FDA labeling/manufacturing site disclosures and DMF cross-references, not by brand-level marketing materials.
- Switching either API or the tablet manufacturing site for CADUET triggers strict comparability controls because the combination’s stability and dissolution depend on both APIs and the final dosage form process.
FAQs
- How can I identify the API manufacturer for CADUET amlodipine besylate? Look to FDA drug substance manufacturing information tied to the product’s approved DMFs and manufacturing sites for the specific strength.
- How can I identify the finished-dose manufacturer for CADUET tablets? Use the product label and FDA listing that identifies drug product manufacturing facilities for that strength.
- Do CADUET generics use the same suppliers as the branded product? They may use different qualified API and FDF suppliers, provided submissions support same or approved equivalence and quality requirements.
- What are the main quality risks when changing atorvastatin API supplier? Impurity profile, crystal form/polymorph behavior, and stability-linked dissolution performance in the finished combination tablet.
- Which filings typically disclose CADUET manufacturing and supplier details? Orange Book RLD/ANDA records for manufacturing site details, plus DMF references for the drug substance chain.
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-01).
- FDA Drug Label (CADUET prescribing information). (Accessed 2026-06-01).
- FDA eCTD/ANDA and DMF records referenced through FDA listings and cross-references. (Accessed 2026-06-01).
