Last updated: June 12, 2026
EXFORGE HCT is a fixed-dose combination of amlodipine (as besylate), valsartan, and hydrochlorothiazide (HCTZ). On the market, “supplier” typically maps to (1) FDA-labeled manufacturer(s) of the finished dosage form and (2) upstream API and key intermediate sources. The most defensible, decision-grade supplier list is the FDA-labeled drug-product manufacturer(s) appearing on the product’s labeling and the corresponding facilities associated with the finished dosage form.
This response contains only supplier identifications that are directly supportable from FDA product labeling and related official records.
Who supplies Exforge HCT (amlodipine/valsartan/HCTZ) finished drug product to wholesalers?
The finished-dosage supplier for Exforge HCT is the company that appears as the manufacturer, repackager, or distributor on the U.S. FDA label for the specific Exforge HCT presentation (strength and dosage form). These labeled entities are the primary “suppliers” used in procurement, channel partner onboarding, and accountability for CGMP performance.
What are the labeled Exforge HCT manufacturing/release entities?
A complete supplier list depends on the exact package presentation (e.g., tablet strength) and the specific label version in force at time of procurement. Without the exact strength/package identifier and label revision, it is not possible to provide a complete and accurate supplier roster.
Which company manufactures the Exforge HCT tablets in the U.S.?
Exforge HCT is an oral tablet fixed-dose combination. The U.S. manufacturer of record can be the marketing authorization holder and may differ from the manufacturing sites listed under CGMP responsibility.
How to identify the correct manufacturer of record for sourcing
For procurement and supply chain diligence, the authoritative identifier is:
- The “Manufactured for” / “Manufactured by” language on the prescribing information (PI) label
- The labeled site name(s) and address(es)
Who supplies the APIs for Exforge HCT: amlodipine besylate, valsartan, and hydrochlorothiazide?
API supply is more fragmented than finished drug supply. Upstream suppliers can include multiple vendors for different steps (API, salts, intermediates, drying, milling, blending, and tablet compression/granulation).
Common API-supply structure for fixed-dose antihypertensives
- Amlodipine besylate: salt formation and polymorph control often drives vendor qualification
- Valsartan: typically sourced through established synthetic routes with impurity and solvent controls
- Hydrochlorothiazide: less complex chemistry but still requires tight impurity spec compliance
Why an exact API supplier list is procurement-critical
API supplier attribution must be traced to:
- DMF/EDMF entries and referenced manufacturing sites
- the ANDA/505(b)(2) or listed drug’s commercial supply chain disclosure (often limited in public documents)
Without the exact regulatory file mapping for Exforge HCT and the cited DMF/EDMF linkages, a definitive vendor table of API suppliers cannot be produced.
Do generic Exforge HCT versions use the same suppliers as the brand?
In practice, generics can source from:
- the same API vendors and CMO tablet facilities as the brand
- different API sources with different impurity profiles
- different compression/blending and coating sites
Procurement implication
If you are selecting a contract manufacturer for a “drop-in” or “bridge” supply, you need:
- DMF linkage verification for each API vendor
- facility-level CGMP and inspection history for each site in the chain
What is the most reliable supplier list source for Exforge HCT?
For supplier due diligence, the most reliable starting points are:
- FDA label (prescribing information) for the specific strength presentation
- Orange Book listing for the referenced listed drug (RLD), which anchors the regulatory identity
- FDA drug establishment and facility registration entries for manufacturing sites (where available for the specific firm)
These are the sources that withstand litigation and audit scrutiny.
Key Takeaways
- The only procurement-grade “supplier” entities for Exforge HCT are the FDA-labeled finished drug product manufacturers/release sites for the exact tablet strength presentation.
- A complete and accurate upstream API supplier list cannot be stated without mapping the specific regulatory dossier linkages and DMF/EDMF referenced sites to vendor names.
- For supply chain decisions, supplier identification should be anchored to the current U.S. FDA label and the labeled manufacturing/release language, then reconciled to facilities registered with FDA.
FAQs
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How do I find the labeled manufacturer of Exforge HCT for a specific tablet strength?
Use the prescribing information “Manufactured for/Manufactured by” section on the exact strength’s FDA label package insert.
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Where can I verify Exforge HCT manufacturing facilities for regulatory due diligence?
Cross-check the label’s site address with FDA drug establishment/facility registration records for the firm.
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Do ex-factory distributors count as suppliers for CGMP responsibility?
No. Distributors are channel actors; CGMP responsibility rests with the labeled manufacturer/release facility.
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Can I source the same APIs from the brand vendor for Exforge HCT generics?
Not reliably. Generics may use different DMFs and different suppliers for amlodipine, valsartan, or HCTZ.
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What documents are used to qualify API suppliers for amlodipine/valsartan/HCTZ combinations?
DMF/EDMF linkages, CoA/CoC specifications, impurity profiles, and inspection history tied to the referenced manufacturing sites.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-12).
- U.S. Food and Drug Administration. Prescribing Information (FDA label) for EXFORGE HCT (amlodipine/valsartan/hydrochlorothiazide). (Accessed 2026-06-12).
