Last updated: June 16, 2026
Olmesartan Medoxomil and Hydrochlorothiazide Suppliers: API, Intermediates, and Finished-Dose Market Source Map (US/Global)
The commercial supply chain for olmesartan medoxomil + hydrochlorothiazide (HCTZ) breaks into three tiers: API manufacturers, intermediate and salt-form suppliers, and finished-dose (FDF) contract manufacturers and packagers. For sourcing, regulatory risk, and substitution planning, the practical focus is on (1) whether a supplier is listed as an Orange Book source for approved combination products, and (2) whether they hold cGMP capability for olmesartan medoxomil and HCTZ plus robust controlled substance and nitrosamine controls where applicable.
Supplier universe at a glance
| Supply tier |
What to source |
Typical supplier roles |
What matters for procurement |
| API |
Olmesartan medoxomil API; HCTZ API |
API manufacturers, large chemical houses |
DMF/CEP availability, quality history, polymorph control, impurity profile |
| Intermediates |
Key olmesartan medoxomil intermediates; HCTZ synthetic inputs |
Intermediate producers |
Route control, impurity linkage, patent-safe sourcing |
| FDF |
Combination tablet manufacturing (fixed dose) |
CMO/CDMO (tablets, blending, compression, coating), packaging |
Batch size, scale-up track record, regulatory filings and inspection history |
Note: A complete and accurate supplier list must be anchored to specific registrations (DMF/CEP, Orange Book “listed drug” and “applicant” entities, and approved ANDA sources). Without those anchored identifiers, supplier claims risk being wrong or incomplete.
Which companies supply olmesartan medoxomil and hydrochlorothiazide APIs?
Featured snippet answer: Suppliers are found via FDA DMF holders (olmesartan medoxomil and HCTZ), CEP manufacturers (if used), and Orange Book-linked ANDA applicants that disclose manufacturing arrangements. The API supplier set is stable across multiple generic and branded combination SKUs, but naming differs by jurisdiction and label.
API sourcing: how procurement maps to regulatory listings
-
Olmesartan medoxomil API
- Typically manufactured under a DMF or CEP framework in markets where generics rely on cross-referenced quality dossiers.
- The supplier identity is often revealed through ANDA applicants and their contract manufacturing network.
-
Hydrochlorothiazide API
- Often supplied by multiple global chemical producers with widespread generic adoption.
- HCTZ impurity profiles and residual solvents are key selection criteria.
Fast screening criteria used by buyers
- DMF status coverage for both APIs
- Batch release and inspection readiness (FDA and MHRA equivalence)
- Impurity controls consistent with monographs and application specs
- Ability to support combination tablet requirements (blend uniformity, tablet hardness, coating specs)
Which finished-dose (FDF) contract manufacturers make olmesartan medoxomil/HCTZ tablets?
Featured snippet answer: FDF manufacturers are identified by ANDA labeling and FDA inspection records tied to the manufacturing sites for tablet compression, coating, and packaging. The same CDMO frequently serves both brand and multiple generic applicants, but the legal entity named on the label can differ from the plant operator.
Where supply chain bottlenecks typically occur
- Tablet blending and homogeneity (fixed-dose combination)
- Film coating line capacity and validated weight control
- Packaging formats (bottles vs unit-dose) depending on commercial channel
What buyers should verify in audits
- Compression and coating validation packages for the exact strength (example: 20/12.5 mg, 40/12.5 mg, 40/25 mg depending on market)
- Data integrity controls for batch records
- Stability program compatibility with the assigned shelf-life claims
What patents or IP barriers affect sourcing of olmesartan medoxomil/HCTZ combinations?
Featured snippet answer: The sourcing constraint is usually not “the APIs are patented,” but rather the combination product and certain formulations, processes, or polymorph-related improvements can be protected in some jurisdictions. Generic or biosimilar entry risk is tied to whether a given applicant can reference a non-infringing pathway.
How IP affects procurement strategy
- Patent estate mapping dictates whether a supplier can legally support a specific tablet composition or process variant in a target market.
- Process-specific IP can restrict certain intermediate syntheses or crystal forms used in particular API routes.
When can generic olmesartan medoxomil/HCTZ launch without Orange Book risk?
Featured snippet answer: Timing depends on the Orange Book-listed patents and exclusivities for the specific “listed drug” combination strengths and dosage forms. For combination products, multiple patent categories can apply (composition, formulation, method of use, and manufacturing).
Key timing drivers
- Patent expiration dates for the listed drug’s patents
- Any pediatric exclusivity or market exclusivity affecting the combination
- Orange Book “listed” blocking patents that must be cleared via Paragraph IV or settlement
What generic entry risks exist for olmesartan medoxomil/HCTZ tablets?
Featured snippet answer: The risk set includes:
- Remaining blocking Orange Book patents for the specific strengths
- Manufacturing process and impurity spec mismatches that trigger quality disputes
- Settlement-driven “design-around” that limits certain ANDA filers in a subset of strengths
Supply chain impacts of litigation/settlement
- Some ANDA applicants rely on specific API suppliers because a settlement or court outcome narrows formulation/process freedom.
- Buyers can face constrained supplier choices if a validated ANDA’s API route is tied to a particular intermediate vendor.
What is the Orange Book status of olmesartan medoxomil/HCTZ?
Featured snippet answer: Status is strength- and applicant-specific, driven by Orange Book “listed drugs” and patent line items. A definitive answer requires exact product identifiers (NDA number(s), strength(s), dosage form) to enumerate the listed patents and expirations.
How to interpret Orange Book for sourcing decisions
- Map patents by type (composition vs formulation vs process)
- Identify which patents are “blocking” for the specific dosage strength
- Track which ANDA applicants entered via Paragraph IV and whether a settlement limits launch
How does the supplier landscape differ by geography (US, EU, India, China)?
Featured snippet answer: The core API chemistry supply base overlaps globally, but the workable commercial suppliers for FDF depend on:
- local regulatory filing systems (DMF in US; CEP in EU; ANDA/DMF in India)
- inspection outcomes that grant market access
- contract packaging and labeling standards required by wholesalers
Global sourcing patterns
- US/EU markets: buyers typically prefer suppliers tied to DMF/CEP ecosystems and with a demonstrated inspection history
- India/China markets: larger share of intermediate and bulk chemical procurement, with FDF sourcing shifting to India/CDMO hubs if validated for export
Which companies are challenging branded or pioneer combinations of olmesartan medoxomil/HCTZ?
Featured snippet answer: ANDA challengers are identified by Paragraph IV filings and FDA acceptance/approval records, which then tie to specific manufacturing sites and API/CMO partners. A list must reference ANDA/applicant entities and filings by NDA.
Why challenger identification matters for procurement
- Challenger ANDAs can create supply volume stability if multiple applicants validate the same API suppliers.
- Challenger litigation outcomes can freeze or redirect supply chain choices for a subset of strengths.
Which suppliers are best for risk-managed procurement (API + FDF integration)?
Featured snippet answer: Best-fit suppliers are those that (1) support both API quality dossiers and (2) provide an audit-ready interface to the FDF CMO or contract packaging site. Integration reduces rework from spec deviations and shortens tech transfer.
Selection checklist used in sourcing projects
- Regulatory dossier linkage for each API (DMF/CEP)
- Proven impurity profile and control strategy
- Validated tablet formulation transfer capability
- Stability and packaging compatibility
- Quality agreement readiness and batch record data integrity commitments
Key Takeaways
- Supply for olmesartan medoxomil/HCTZ is best analyzed as an API + intermediate + FDF network, with regulatory linkage as the primary filter.
- Definitive supplier names require anchoring to Orange Book (NDA/patent line items and applicants) and FDA DMF/CEP holders tied to approved ANDA/FDF manufacturing sites.
- Procurement risk is driven by Orange Book patent clearing, strength-specific product approvals, and tablet manufacturing validation constraints more than by API availability alone.
FAQs
- How do I identify reliable olmesartan medoxomil API suppliers for US filings?
- Do olmesartan medoxomil/HCTZ tablets use the same API supplier across strengths (20/12.5 vs 40/25 mg)?
- What documentation do contract manufacturers provide for tablet coat and packaging validation for olmesartan medoxomil/HCTZ?
- How does Paragraph IV litigation affect which API suppliers a generic applicant can use?
- What Orange Book patent categories most commonly block generic olmesartan medoxomil/HCTZ entry?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
