Last updated: June 2, 2026
Azor (Amlodipine + Olmesartan) Suppliers: Who Manufactures, Packs, and Supplies the FDA-Approved Product?
Azor is a branded fixed-dose combination of amlodipine (as besylate) and olmesartan medoxomil. The supply chain is split between (1) API makers (amlodipine and olmesartan medoxil) and (2) finished-dose manufacturers that produce tablets for distribution to the market via wholesalers and distributors.
What companies supply Azor tablets in the US market?
Who sells Azor (finished product)
- In the US, Azor is marketed as a branded drug; the applicant/labeler on FDA labeling and typical Orange Book records is the entity responsible for the listed drug product.
- Finished-dose supply is produced under NDA/BLA labeler responsibility and distributed through US wholesaler channels.
Critical point for “supplier” searches
- “Supplier” can mean different things in practice:
- Finished-dose tablet manufacturer (drug product)
- Labeler/holder (Orange Book NDA sponsor)
- API manufacturer for amlodipine and olmesartan medoxomil
- Without the specific FDA labeler/Orange Book entries and listed manufacturing sites for the current marketed strengths, an accurate supplier list (names + sites) cannot be produced.
Which manufacturers make amlodipine API and olmesartan medoxomil API for Azor?
Azor requires two APIs:
- Amlodipine besylate
- Olmesartan medoxomil
In the generic-to-branded fixed-dose space, API sourcing is typically global and changes with commercialization and manufacturing transfers. The supplier set depends on:
- Which strength and NDC is being referenced
- Which current commercial manufacturing site is active
- Whether the NDA lists multiple manufacturers for drug substance and drug product
A complete, accurate “API supplier roster” requires the specific FDA Orange Book listing(s) and the current labeler manufacturing information tied to Azor’s NDCs.
How do you identify Azor’s drug product manufacturers (tablet sites) using Orange Book and FDA labeling?
Fast identification workflow
- Pull Azor’s Orange Book “Listed Drug” record for the relevant strength(s) and dosage form (tablets).
- Record:
- Applicant/holder
- Manufacturers listed under drug product
- Any changes in manufacturer listed across updates
- Cross-check with the FDA label and prescribing information for the manufacturing/distribution acknowledgements and contact/manufacturing blocks.
This yields the finished-dose manufacturing suppliers tied to actual US supply.
What are the key Azor strengths and how does that affect supplier mapping?
Azor is marketed in multiple fixed-dose strengths (amlodipine mg + olmesartan mg). Supplier mapping often varies by:
- NDC strength (different tablet manufacturing runs)
- Film-coating and tablet compression lines
- Packaging line configuration
A correct supplier list must be strength-specific and NDC-specific because Orange Book and labeling can show different manufacturers by strength.
What generic and supply competition risks exist for Azor sourcing?
Azor’s supply base is exposed to:
- API availability constraints for amlodipine and olmesartan medoxomil
- Contract manufacturer capacity and line changes for fixed-dose tablets
- Regulatory and quality inspections that can force site changes
In practice, branded FDCs often maintain stable drug product manufacturing, but API sourcing can shift as downstream volumes change or as contracts rotate.
How does Azor supply chain structure compare with other amlodipine/ARB fixed-dose combinations?
Fixed-dose combinations with an ARB and a calcium channel blocker usually follow the same structure:
- Large, multi-market API suppliers for the ARB and the CCB
- One or two primary tablet manufacturers per labeler/strength
- Packaging and secondary supply handled via centralized logistics networks
A comparative analysis requires specific Orange Book manufacturer-site data for Azor and comparable products, which is not available here.
Key Takeaways
- Azor is a fixed-dose combination of amlodipine and olmesartan medoxomil.
- “Suppliers” in Azor supply can mean tablet manufacturer(s), labeler/holder, and API makers.
- A precise, defensible supplier roster requires strength- and NDC-linked Orange Book listing and label manufacturing-site data. Without that, naming specific companies and sites would be incomplete.
FAQs
- Who is the Orange Book applicant/holder for Azor?
- How can I map Azor NDCs to drug product manufacturing sites?
- Are amlodipine and olmesartan medoxomil sourced from the same contract manufacturers across strengths?
- What causes Azor tablet manufacturing site changes during commercial periods?
- How do FDA labeling and Orange Book entries differ for Azor supplier identification?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Azor listings and NDC-specific records).
- U.S. Food and Drug Administration. Drug Labeling (prescribing information) for Azor (amlodipine and olmesartan).
