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Suppliers and packagers for generic pharmaceutical drug: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
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HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-139-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-139-01) | 2021-06-01 |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-139-02 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-139-02) | 2021-06-01 |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-140-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-140-01) | 2021-06-01 |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387 | NDA | Organon LLC | 78206-140-02 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-140-02) | 2021-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Suppliers for Hydrochlorothiazide and Losartan Potassium: What to Source, Who Provides It, and What to Watch
Executive summary: Hydrochlorothiazide and losartan potassium are commodity generics with a broad supplier base across API, intermediates, and finished-dose (FDF) manufacturing. Supply risk clusters around API quality systems, DMF/CEP coverage, impurity control for losartan, and finished-dose capacity for combination products (notably losartan/hydrochlorothiazide). For sourcing, buyers typically qualify vendors by cGMP status, DMF/EDMF alignment, stability/packaging compliance, and analytical method transfer readiness.
Which companies supply hydrochlorothiazide API and intermediates?
Hydrochlorothiazide (HCTZ) API suppliers generally cover both:
- Direct API manufacture (HCTZ active ingredient), and
- Intermediate supply chains used to synthesize the thiazide core.
What API manufacturing footprints exist for hydrochlorothiazide?
HCTZ is widely produced in India, China, and parts of Europe for global export. Buyer qualification usually focuses on:
- consistent impurity profiles across batches,
- control of residual solvents and process-related impurities, and
- traceability for starting materials and reactive intermediates.
Which supplier categories matter for procurement?
- API manufacturers with cGMP compliance and batch release documentation.
- API traders/brokers that aggregate compliant lots from multiple sites.
- Contract manufacturers for solid oral dosage (tablets) using third-party API.
- Intermediate manufacturers when buyers require cost-down or supply redundancy.
Who supplies losartan potassium API and where are the supply chokepoints?
Losartan potassium is a “complexity step-up” versus many simple antihypertensives because impurity control and synthetic route discipline matter at scale.
How does losartan potassium impurity risk affect supplier selection?
Losartan supply qualification prioritizes:
- control of process impurities (route-dependent),
- stability of polymorphic/physical form (powder behavior affects blending and compression),
- reproducible particle-size distributions for consistent dissolution and tablet performance.
Where are most losartan API sources located?
Losartan API is commonly supplied from China and India, with select producers in Europe. Procurement teams typically build a dual-source model because losartan manufacturing schedules and impurity excursions can tighten availability.
Are there fewer qualified suppliers for losartan because of DMF/filing requirements?
DMF/EDMF coverage is a key gating item for losartan-related supply because many buyers want:
- an active DMF (Type II/III depending on the filing),
- a consistent manufacturing site history, and
- an ability to support regulatory audits and method transfers for QC release.
For HCTZ, DMF coverage is usually more widely available given broader commoditization. For losartan, the supplier pool is still large but qualification effort is higher.
Which suppliers support the finished dosage form: hydrochlorothiazide tablets and losartan tablets?
Finished-dose (FDF) supply is split between:
- generics manufacturers (tablet/capsule scale),
- combination product plants (notably losartan/HCTZ),
- contract packagers handling labeling, packaging, and secondary distribution.
What matters in FDF supplier selection for buyers?
- GMP certificate for the exact dosage form and strength
- validated blend and compression process controls
- packaging compliance (CTD labeling alignment, child-resistant packaging where required)
Who supplies the combination product losartan potassium + hydrochlorothiazide (FDC)?
The combination losartan/HCTZ tends to concentrate procurement into fewer plants because it requires:
- both APIs (or pre-approved API sources),
- synchronized batch scheduling, and
- validated fixed-dose ratio performance.
What supply chain risk is most common for FDC?
- API schedule mismatch between the two actives
- one API’s impurity/out-of-spec incident delaying the complete lot
- packaging lead times that become the gating item once APIs clear QC
What procurement KPIs separate “approved” from “approved-but-risky” API suppliers?
High-velocity buyers typically gate suppliers on:
- cGMP audit outcomes (no critical deficiencies)
- annual production volume and on-time delivery rate
- batch deviation history frequency and severity
- ability to provide COA, impurity profile, and stability protocol execution
- analytical capability for release testing and stability program timepoints
Do suppliers need to offer DMF support for both APIs?
For most regulated markets, yes:
- buyers seek suppliers with regulatory-ready documentation (DMF/CEP or equivalent).
- method transfer capability is often more decisive than price.
How should buyers qualify API suppliers for hydrochlorothiazide vs losartan potassium?
Hydrochlorothiazide qualification focus
- impurity control aligned to compendial/specification limits
- solvent and residual contaminant control
- physical properties suitable for tableting
Losartan potassium qualification focus
- impurity control tied to route-specific impurities
- particle size and flow properties for uniform blending
- stability performance at packaging-relevant conditions
- capability to support regulator-facing comparability if the route or site changes
What generic entry risks exist if a supplier loses regulatory approval for losartan or HCTZ?
When an API supplier is removed from a buyer’s approved vendor list, buyers face:
- requalification time for the alternative site
- DMF updates and regulatory response timelines
- risk of slower launch if the new supplier’s impurity profile drives reformulation or QC method updates
In losartan, impurity profile sensitivity tends to create longer requalification cycles than for HCTZ.
Which manufacturing and compliance factors drive pricing differences among suppliers?
Price dispersion for both actives typically comes from:
- quality system maturity (deviation management, change control discipline)
- yield and solvent usage per batch
- cost of compliance documentation (DMF updates, stability programs)
- batch size utilization and availability of the supply chain
For losartan, route discipline and impurity control costs can dominate.
How does the supplier landscape differ by geography: US, EU, and key emerging markets?
US market
- Buyers often require DMF alignment and stable cGMP inspection readiness.
- Combination products face added scrutiny around formulation and dissolution.
EU market
- CEP pathways often influence supplier qualification.
- Finished-dose manufacturers emphasize dossier consistency and validated stability.
India/China export markets
- Supplier density is high.
- Buyer qualification focuses on consistent impurity and batch release reporting.
Key Takeaways
- Hydrochlorothiazide and losartan potassium have broad supply bases, but supplier qualification effort is meaningfully higher for losartan due to impurity and route control.
- For finished dosing, the biggest operational risk is API schedule mismatch in losartan/HCTZ fixed-dose combinations.
- Buyers should score vendors using DMF/CEP support, impurity profile reproducibility, QC release capability, and stability program readiness rather than relying on price alone.
- The supplier “winning” strategy is dual sourcing with regulatory-ready documentation and a validated change-control path.
FAQs
1) Which suppliers are best for dual sourcing hydrochlorothiazide API and losartan potassium API?
Dual sourcing should target suppliers with demonstrated cGMP performance and regulatory documentation support (DMF/EDMF or equivalent), not just price competitiveness.
2) What documentation should an API supplier provide for losartan potassium?
Typically a full QC package: COA, impurity profile, residual solvent data, and stability protocol support aligned to buyer specs and filings.
3) What is the main bottleneck in scaling losartan/HCTZ fixed-dose combinations?
Most frequently it is batch scheduling and QC alignment across both APIs, then downstream compression and packaging timing.
4) Can suppliers switch manufacturing sites for HCTZ or losartan without risking regulatory delays?
Site changes are often manageable only with strict change control, comparability evidence, and timely regulatory dossier updates.
5) What supplier attributes reduce the risk of supply interruption for commodity antihypertensives?
High-performing suppliers show production continuity, low deviation frequency, strong deviation/CAPA discipline, and inventory/lead-time resilience for both APIs and packaging materials.
References (APA)
No sources were provided in the prompt, and no supplier list or regulatory database citations were included.
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