Last updated: May 27, 2026
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) is a fixed-dose combination where supply is dominated by the branded owner’s distribution network and a defined set of contract manufacturers that produce finished dosage forms and package product for the U.S. market. The observable supplier footprint depends on (1) whether the question targets U.S. branded distribution, (2) U.S. generic entry, or (3) API sourcing for olmesartan medoxomil and hydrochlorothiazide.
Who supplies Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) in the U.S.?
Answer: Benicar HCT sold in the U.S. is distributed through the branded product’s U.S. commercial channels and is manufactured/packaged by contract manufacturing partners under AstraZeneca’s (and its manufacturing supply chain) commercial stewardship. Generic supply chains add additional manufacturers for the same strength combinations.
Branded distribution vs. manufacturing responsibility
- Branded commercial owner (U.S. marketing): AstraZeneca for Benicar HCT.
- Actual finished-dose manufacturing/packaging: typically handled by contract manufacturers (CMOs) and secondary packagers assigned to the product’s approved label and current Good Manufacturing Practice (cGMP) supply plan.
- How “supplier” is operationally defined: buyer-facing “supplier” can mean either (a) wholesale distributor of record for finished drug, or (b) the manufacturer-of-record listed in FDA drug product submissions.
What to pull from FDA drug product listings for “supplier”
For each NDC and strength, the authoritative supplier list is derived from FDA drug product records (drug establishment registrations and application holders). Those sources also reveal:
- manufacturer-of-record (finished dosage)
- packager roles
- labeler and application holder relationships across dosage strengths
Which companies manufacture Benicar HCT tablets (NDC-level) and package them?
Answer: Finished-dose tablet manufacturing and packaging are performed by the company(ies) listed as manufacturing/packaging establishments for each NDC strength in the FDA product database. Without NDC-specific identification, the supplier set cannot be correctly enumerated because multiple NDCs exist for different strengths (20/12.5, 40/12.5, 40/25 mg) and different package configurations.
Strengths that drive different NDC supplier sets
Benicar HCT is commonly marketed in:
- 20 mg olmesartan medoxomil / 12.5 mg hydrochlorothiazide
- 40 mg olmesartan medoxomil / 12.5 mg hydrochlorothiazide
- 40 mg olmesartan medoxomil / 25 mg hydrochlorothiazide
Each strength can map to different batches, packaging sites, and NDCs, which changes the practical “supplier list” for procurement.
Who supplies olmesartan medoxomil API for Benicar HCT?
Answer: Olmesartan medoxomil API supply comes from API manufacturers qualified through submissions and used by the finished-dose supply chain. Multiple API sources can exist across markets and over time, so “the” API supplier is NDC- and batch-era-dependent.
API sourcing characteristics for olmesartan medoxomil
- API is typically supplied to CMO finished-dose plants under qualification and change control.
- API suppliers may differ by regulatory filing linkage and manufacturing window, even for the same branded product.
- Contract synthesis and repackaging can obscure procurement-level visibility unless you map the finished-dose manufacturer-of-record to its registered API sourcing in linked submissions.
Who supplies hydrochlorothiazide API for Benicar HCT?
Answer: Hydrochlorothiazide API supply is usually sourced from established HCT API manufacturers used across many combination diuretic products. As with olmesartan medoxomil, exact “supplier” identification is best tied to NDC manufacturing/packaging establishments and linked FDA registrations.
Why HCT supplier lists are broader than olmesartan medoxomil
- Hydrochlorothiazide is off-patent and widely manufactured.
- Finished-dose plants for branded and generic products often use multiple qualified suppliers for API continuity.
What finished-dose contract manufacturers produce Benicar HCT tablets?
Answer: Contract manufacturers for Benicar HCT are the manufacturers listed on FDA drug product listings for each NDC strength and packaging configuration. Contract manufacturing roles may include:
- tablet core manufacturing
- coating and compression
- primary packaging (blistering or bottles)
- secondary packaging and distribution labeling
How to identify CMO/packager accurately
A correct supplier map requires:
- specific NDC(s)
- mapping NDC to FDA establishment registrations (manufacturer/packager)
- linking those establishments to the label application holder
Without NDC-level selection, the list of CMOs cannot be stated without risking material error.
How do generic Benicar HCT suppliers differ from the branded product?
Answer: Generic versions of olmesartan medoxomil/hydrochlorothiazide can be manufactured and packaged by multiple firms under ANDA approvals. Supplier diversity is higher because generics can use different manufacturing sites and sometimes different API suppliers, provided bioequivalence and chemistry/manufacturing controls meet FDA requirements.
Key supplier drivers in generic entry
- ANDA applicant changes (different labeler)
- manufacturing site and packaging site differences
- API supplier qualification differences (even when finished dosage manufacturer is constant)
What is the Orange Book status of Benicar HCT, and does it affect sourcing?
Answer: Benicar HCT’s patent and exclusivity landscape affects generic entry and timing, not the day-to-day supplier list for branded product manufacturing. However, it changes the set of ANDA-approved generics that may be available as procurement alternatives.
Patent estate vs. supplier availability
- A constrained generic universe tightens supply competition.
- When multiple ANDAs are approved, procurement choices expand across manufacturers-of-record and packaging sites.
Which ANDA products compete with Benicar HCT and who are their suppliers?
Answer: The competing ANDA products and their manufacturers-of-record are enumerated at the NDC level within FDA’s drug listing and ANDA mappings. Without NDCs, you cannot reliably name the exact generic suppliers because:
- multiple ANDA applicants exist per strength
- NDCs vary by package and labeler
What manufacturing/IP barriers affect Benicar HCT supply (authorization, changes, and site transfers)?
Answer: Benicar HCT supply is constrained by cGMP site authorization, validated manufacturing processes, and any ongoing patent restrictions that block generic substitution until expiration or settlement.
Where supply breaks in practice
- changes in manufacturing site require FDA review of CMC supplements
- API sourcing changes require regulatory support for equivalency and control strategy
- packaging and labeling changes can trigger additional compliance steps
Benicar HCT supplier map by procurement scenario (what to ask internally)
Answer: Supplier selection depends on procurement objective:
| Procurement objective |
What to treat as “supplier” |
Best source to map suppliers |
What changes supplier list |
| Buy branded product |
distributor-of-record and manufacturer-of-record for each NDC |
FDA drug product listing by NDC |
NDC strength and package configuration |
| Source finished-dose manufacturing |
CMO/packager on each NDC |
FDA establishment registrations tied to NDC |
site changes across batch eras |
| Source API |
API supplier supplying the qualified finished-dose plant |
linkage via FDA filings and registered suppliers |
qualifying new API source and batch-era changes |
| Plan substitution (generic) |
ANDA labeler/manufacturer-of-record per NDC |
FDA ANDA drug listings |
ANDA holder and NDC differences |
Key Takeaways
- “Suppliers for Benicar HCT” is not a single fixed list; it is NDC- and strength-dependent across finished-dose manufacturing, packaging, and distribution.
- Branded Benicar HCT supply is tied to AstraZeneca’s commercial stewardship, with finished-dose manufacturing and packaging performed by FDA-registered manufacturer/packager establishments for each NDC.
- For API sourcing, olmesartan medoxomil and hydrochlorothiazide come from qualified API vendors into the finished-dose cGMP supply chain; exact names require NDC-level linkage to FDA registrations and (where available) submission-level sourcing.
- Generic competition increases supplier diversity through multiple ANDA manufacturers-of-record; exact supplier names again require NDC mapping.
FAQs
- Which NDCs correspond to Benicar HCT 20/12.5, 40/12.5, and 40/25 mg?
- How do I identify the manufacturer and packager for a specific Benicar HCT NDC?
- Do branded and generic olmesartan medoxomil/hydrochlorothiazide use the same API suppliers?
- What FDA records show changes in manufacturing sites for Benicar HCT?
- How does ANDA approval status affect available suppliers for Benicar HCT strengths?
References
- U.S. Food and Drug Administration (FDA). Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
