LISINOPRIL AND HYDROCHLOROTHIAZIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-00	100 TABLET in 1 BOTTLE (65862-043-00)	2006-03-14
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-01	100 TABLET in 1 BOTTLE (65862-043-01)	2006-03-14
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-05	500 TABLET in 1 BOTTLE (65862-043-05)	2006-03-14
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606	ANDA	Aurobindo Pharma Limited	65862-043-30	30 TABLET in 1 BOTTLE (65862-043-30)	2006-03-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Lisinopril and Hydrochlorothiazide Drug Suppliers: API, Finished Dosage Manufacturers, and Key Supply-Chain Sources

Executive summary

Lisinopril (API) is supplied globally by multiple established manufacturers, with common sourcing from China and India plus availability from US/EU-aligned suppliers through contracted distributors.
Hydrochlorothiazide (API) has a similarly broad supplier base, including specialty chemical/API plants that produce thiazide intermediates and HCTZ API.
Fixed-dose combination (FDC) tablets (lisinopril + hydrochlorothiazide) are produced by numerous generic manufacturers across NDA/ANDAs, often under contract manufacturing agreements (CMOs) and through multiple API-to-tablet supply paths.
For business decisions (licensing, procurement, litigation risk, or regulatory planning), the actionable approach is to map (1) Orange Book-listed FDC products, (2) USP/NDC distributors, and (3) API DMFs/letter-of-authorization holders that those products rely on.

Which companies supply lisinopril and hydrochlorothiazide APIs?

A practical way to identify true upstream suppliers is to link FDC tablet sponsors and their DMF/LOA references for the component APIs. In the absence of product-specific DMF-to-API attribution in your input, the supplier landscape is best handled at the industry-standard supplier roster level: major global API producers that consistently appear in ANDA supply chains for these actives.

Typical global API suppliers for lisinopril

Commonly used API sources for lisinopril include manufacturers located in:

India (generic API manufacturing and ANDA supply support)
China (large-scale ACE inhibitor API production)
Selected EU/US-aligned suppliers providing commercial or DMF-referenced API for certain markets via distribution or toll manufacturing

Typical global API suppliers for hydrochlorothiazide

Commonly used API sources for hydrochlorothiazide include manufacturers located in:

China and India, including companies with thiazide chemistry and intermediate capacity
Occasional specialty API suppliers that provide higher compliance packages for specific regulatory regimes

How to verify the exact supplier that feeds an FDC

For each lisinopril/hydrochlorothiazide tablet product you care about, you verify:

the ANDA/Labeler and its listed API source(s) through DMF reference in the application dossier
the DMF holder name (or LOA holder) that authorizes use of the API in that application
distribution via the labeled NDC manufacturer chain

This is the only path that converts “industry suppliers” into case-specific sourcing facts.

Who manufactures lisinopril and hydrochlorothiazide combination tablets (FDC)?

The market includes multiple branded (historical) and generic FDC tablet products. The manufacturing chain is frequently:

API supplier → tablet CMO or finished-goods manufacturer → NDA/ANDA labeler → NDC distribution network.

Common category of tablet manufacturers

Generic FDC manufacturers commonly include:

Large multinational generics
Mid-tier generic firms with established cardiovascular portfolios
Contract manufacturers producing multiple labelers’ products

Key operational reality

FDC tablet supply often depends on:

formulation and tablet press capability
validated blending and dissolution performance
packaging line availability (bottle/blister, child-resistant where required)
stability program constraints

For procurement and licensing, the most actionable view is not “which firms exist,” but which firms currently supply the NDCs you buy, then trace their API DMFs.

What suppliers are used for FDA-approved fixed-dose combinations? (Orange Book-based mapping)

To map “supplier” precisely, you must map by FDA product listing (Orange Book):

Identify the lisinopril/hydrochlorothiazide FDC products (by NDC and labeler)
Extract the listed patents and the application sponsor
Use the application to identify the API DMF reference(s) and corresponding LOA holders
Confirm whether the product is produced in-house or by a CMO

What the supply chain typically looks like

API DMF/LOA: controls “who makes the API”
ANDA labeler: controls “who markets the finished drug”
Manufacturing site: controls “where finished tablets are made”
NDC: controls “what you actually buy”

How many API DMFs and supplier options exist for lisinopril?

For lisinopril, the supplier count is usually high because:

multiple ANDAs rely on different DMFs
some DMFs are associated with specific impurity controls and polymorph specs
supplier substitution is possible when quality agreements and validations exist

Business impact:

procurement resiliency is typically good for lisinopril API, assuming qualified supplier onboarding
litigation and recall risk are product line-specific, not only active-specific

How many API DMFs and supplier options exist for hydrochlorothiazide?

Hydrochlorothiazide usually has:

multiple DMF holders reflecting different manufacturing routes and impurity profiles
supplier continuity driven by chemical intermediate availability

Business impact:

supply redundancy can be higher for thiazides than for smaller-demand APIs
quality and regulatory compliance differ across DMFs, so substitution requires documentation and testing

What formulation patents affect supply contracts for lisinopril/HCTZ tablets?

Generic FDC manufacturing can be constrained by:

formulation patents (composition, ratios, excipients, stability)
process patents (granulation, blending, drying, compression)
method-of-use patents (less common for classic antihypertensive FDCs, but possible)

Typical patent categories that affect manufacturing

Specific tablet compositions with controlled release or improved dissolution
Process patents for granulation and drying parameters
Packaging/system patents are less common for classic generics but can exist

For supply planning, you need to map each product to:

active patent landscape (Orange Book)
exclusivity windows (if any)
any ongoing Hatch-Waxman litigation

When do lisinopril/HCTZ exclusivity or key patents expire?

For generic FDC products, most exclusivity/patent restrictions vary by:

which branded reference product is used historically
which ANDA filing date and 505(b)(2) routes are involved
whether any newer patents (formulation or method) extend the effective “no-generic” zone

Actionable procurement impact:

products under active pediatric exclusivity or patent stay can delay generic manufacturing or enforce supply restrictions through litigation settlements.

Which generic entries are most likely under Paragraph IV?

Paragraph IV challenges commonly occur when:

a generic applicant seeks FDA approval referencing patents listed in the Orange Book
the applicant asserts non-infringement, invalidity, or lack of enforceability

Supply-chain impact:

Paragraph IV-triggered litigation can produce temporary market exclusivity for the first challenger
settlements can impose launch delays or negotiated licensing for specific strengths

To evaluate this for lisinopril/HCTZ, map:

Orange Book patent families for the relevant FDC
ANDA first-filer and subsequent certifications
settlement dates and terms (when publicly documented)

What patent litigation affects lisinopril/HCTZ suppliers and licensing?

For these actives, litigation typically clusters around:

combination product patents
formulation/polymorph or processing improvements
secondary patents (labeling, stability, manufacturing methods)

Business impact:

licensing terms and allowed launch dates affect “who can supply” and “when”
settlement agreements can shift sourcing decisions among manufacturers

A company’s practical exposure comes from:

whether its product is directly implicated
whether it sources via a labeler that is under a settlement restriction

What is the Orange Book status of lisinopril/HCTZ products?

Orange Book status is product-specific:

each NDC strength and dosage form can map to different patent sets
the same actives can have different patent estates depending on the reference and filing

Actionable step for procurement:

build an NDC-by-NDC Orange Book watchlist for the specific strengths and packaging formats you buy.

Which CMOs commonly produce lisinopril/HCTZ tablets?

FDC manufacturing is frequently performed by:

established tablet CMOs with high-throughput compression lines
facilities experienced in cardiovascular solids dosage forms
plants qualified under multiple regulatory regimes

Because finished-goods CMOs vary by region and labeler, the only reliable method to identify a specific CMO is to connect:

the finished product’s manufacturing site in labeling
the ANDA site and manufacturing statement
any disclosed contract manufacturing arrangements

Which markets have the highest supplier availability for lisinopril/HCTZ?

Supplier availability tracks regulatory and commercial patterns:

US: multi-sponsor generic competition with broad NDC coverage; DMF-to-finished mapping is dense
EU: centralized and national differences; availability depends on local licensing and batch release systems
Emerging markets: often higher dependence on China/India API and local finished-goods plants

Business implication:

for continuity of supply, US and EU labelers typically maintain more formal supplier qualification processes, but this can increase lead times.

How does lisinopril/HCTZ supplier risk compare with other antihypertensive FDCs?

Compared with:

rare-disease drugs, supplier risk is usually lower due to high demand and many generic entrants
complex biologics, supplier risk is structurally lower since it is a controlled small-molecule manufacturing chain

Key residual risks:

API quality drift by DMF holder
batch-to-batch impurity differences
compression/film-coating line constraints if products share facilities

Key supplier-selection criteria for lisinopril and hydrochlorothiazide procurement

When evaluating suppliers (API or finished tablets), the decision inputs typically include:

DMF holder quality history and inspection outcomes
impurity and residual solvent control capability
polymorph/form stability evidence (as relevant to the API)
right-first-time manufacturing yield for tablets
regulatory filing alignment for the target market (US DMF/ANDA linkage, EU dossier readiness)

What does a defensible supply strategy for lisinopril/HCTZ look like?

A workable strategy for procurement and product management is:

Choose target strengths and NDCs.
Map each NDC to its ANDA sponsor and manufacturing sites (finished-goods).
Trace each product to the API DMF/LOA holder(s).
Qualify at least two API sources and two finished-goods sources where feasible.
Maintain a rolling view of:
- Orange Book listing status for launch constraints
- any known litigation-linked launch delays that affect supply continuity

Key Takeaways

Lisinopril and hydrochlorothiazide have broad API supplier coverage, concentrated in China and India with additional DMF/LOA-backed suppliers feeding US and global FDC markets.
The actionable “who supplies what” answer is NDC-specific: Orange Book and ANDA dossiers link labelers to manufacturing sites and API DMFs.
Procurement resilience is best built by qualifying multiple DMF holders for each API and multiple finished-goods manufacturers for each strength and packaging configuration.
Patent and litigation effects are product- and strength-specific, so supplier planning should use an NDC-by-NDC Orange Book and ANDA watchlist.

FAQs

1) Which NDCs have the highest generic competition for lisinopril/hydrochlorothiazide?

Generic competition is strongest where multiple ANDAs with overlapping strengths exist and where recent patent stays or exclusivities have lapsed. Build the answer by NDC mapping in the Orange Book for your specific strengths.

2) Do lisinopril and hydrochlorothiazide tablets share API suppliers across brands?

Often yes at the API DMF level, but finished-goods manufacturing sites and packaging configurations differ by labeler. DMF-to-ANDA mapping confirms this.

3) What are the most common quality failure modes for thiazide tablet supply?

In solids manufacturing, the recurring risk areas are content uniformity (blend/compression), impurity control from API quality drift, and dissolution variability tied to process parameters.

4) Can suppliers switch API DMF holders without FDA notification?

Not without regulatory impact. Any change in the API source for an ANDA product can require prior approval or supplemental change reporting depending on the change type and regulatory pathway.

5) What factors determine whether a generic launch is delayed for lisinopril/HCTZ?

Launch delays are driven by Orange Book-listed patents, exclusivity periods, and Hatch-Waxman litigation or settlement terms tied to specific NDA/ANDA references and strengths.

References (APA)

U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/
U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (n.d.). Hatch-Waxman Patent Certifications and Related Information (FDA resources). https://www.fda.gov/

Suppliers and packagers for LISINOPRIL AND HYDROCHLOROTHIAZIDE