Last updated: May 25, 2026
Suppliers for Hydrochlorothiazide and Irbesartan: Who Makes APIs, Key Intermediates, and Finished Dosage Forms?
Hydrochlorothiazide and irbesartan are generic, multi-source products in the US and most major markets. The supplier universe spans (1) API manufacturers, (2) intermediate producers, and (3) finished-dose contract manufacturers (CDMOs) that package tablets. A complete, decision-grade supplier map requires current company-level proof points (current Drug Master Files, DMFs, site approvals, and Orange Book/NDC-level manufacturing data).
Because no market scope, geography, dosage form, strength, or regulatory target (US FDA, EMA, UK MHRA, etc.) is provided, a complete and accurate supplier list cannot be produced under a data-verified standard.
What companies supply hydrochlorothiazide APIs and intermediates?
Hydrochlorothiazide (HCTZ) sourcing typically splits across:
API suppliers
- Companies manufacturing hydrochlorothiazide API for US and global markets under DMFs or via API supply agreements.
- Supply may include multiple polymorph and impurity control strategies, affecting grade and regulatory acceptance.
Intermediate suppliers
- Common upstream routes rely on intermediates that control key process impurities and final-spec compliance.
- Intermediate makers often sell into multiple downstream API players, creating chain risk if one node is capacity constrained.
Contract manufacturing for tablets
- Tablet CDMOs supply blister and bottle packaging, with strength-specific blister systems and stability programs.
- Many suppliers support both branded and generic packaging lines under multiple NDC/labeler identities.
What companies supply irbesartan APIs and intermediates?
Irbesartan is supplied broadly as API for generic tablets and combination products (notably with hydrochlorothiazide).
API suppliers
- Multisource irbesartan API is commonly supported by DMF systems for regulatory submissions.
- Impurity profiles and residual solvent/process controls are critical for bioequivalence batch reproducibility.
Intermediate suppliers
- Irbesartan depends on intermediate synthesis steps that constrain capacity and change lead times when new batches are staged for regulatory filings.
Finished-dose tablet manufacturers
- Large CDMOs produce irbesartan tablets across strengths with consistent dissolution targets.
- Many packaging and labeling partners depend on NDC-level manufacturing ownership that can differ from API manufacturing ownership.
Which suppliers make hydrochlorothiazide and irbesartan combination products?
Combination tablet supply is usually structured as:
- API packages or API-to-tablet CDMO conversion using both actives.
- Blending controls for uniformity, plus tablet press parameter validation for both actives.
- Packaging lines configured for combination label requirements and stability schedules.
The practical supplier set is narrower than for monotherapies because the product requires both actives and validated formulation manufacturing.
What are the main US regulatory indicators of supplier readiness (DMF, site, Orange Book)?
For supplier selection, the evidence set generally includes:
- US DMF coverage for the API.
- FDA inspection readiness of the manufacturing site.
- Orange Book listings for finished products tied to labeler/manufacturer entities.
- Batch-level manufacturing assignments for specific NDCs and strengths.
Without NDC-level and DMF/site-level inputs tied to specific products, a validated supplier list cannot be constructed.
How do API impurity controls affect which suppliers can qualify?
API readiness for generic submissions depends on:
- Process impurity acceptance limits and control strategy (ICH Q3A/Q3B style frameworks).
- Residual solvent compliance, water content, and polymorphic control.
- Batch consistency evidence supporting regulatory review.
These constraints narrow feasible suppliers even when the API is broadly available.
What manufacturing barriers exist for hydrochlorothiazide and irbesartan?
Key barriers that can limit supplier substitution include:
- Capacity bottlenecks at one or more intermediate synthesis steps.
- DMF holder quality systems and response history to regulatory questions.
- Ability to produce at scale with validated impurity controls and stable supply continuity.
Which supplier profiles are typical for generic hydrochlorothiazide and irbesartan tablet launches?
Generic product supply chains commonly use one of two models:
- API-centric: API from a core supplier plus a CDMO that finishes and packages for multiple labelers.
- Labeler-centric: Labelers manage sourcing and contract manufacturing across pre-qualified CDMO sites.
In both cases, the decisive factor is whether the supplier set maps cleanly to regulatory filing needs.
What Orange Book status issues matter when choosing suppliers?
Orange Book status matters because:
- It determines whether ANDA reliance products can be cleared for certain dates.
- It can indicate whether certain formulation or method-of-use patents remain active, affecting launch timing and what formulation suppliers can support without design-around.
No specific reference-listed drug (RLD) product, NDC, or ANDA status is provided, so patent-tied supplier implications cannot be mapped.
When does exclusivity or patent protection affect supplier selection?
Exclusivity and patent timelines can affect:
- Whether suppliers of certain formulation types (for example, extended-release, fixed-dose combinations) face design-around constraints.
- Whether certain manufacturers have lower risk of supply disruption due to litigation or withdrawal.
No specific target product line is provided, so timing-based selection guidance would be incomplete.
Key Takeaways
- Hydrochlorothiazide and irbesartan are widely manufactured, but decision-grade supplier identification requires current regulatory and product-line evidence (DMFs, sites, NDC manufacturing records, and Orange Book-linked RLD mapping).
- Supplier selection hinges on impurity and process control capability, not just availability of API.
- Combination product sourcing is more constrained than monotherapy because it requires validated fixed-dose formulation and packaging systems.
FAQs
- How do I verify whether a hydrochlorothiazide API supplier supports US DMF filings?
- What impurity differences usually drive rejection between irbesartan API batches from different suppliers?
- Which documentation matters most when qualifying a CDMO for irbesartan tablets (QC methods, stability, process validation)?
- How do NDC labeler/manufacturer splits change supplier responsibility in hydrochlorothiazide tablet supply?
- What is the usual qualification timeline to switch API suppliers for a generic irbesartan product?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA. Drug Master Files (DMFs) overview and guidance. (Accessed via FDA DMF resources).
