Suppliers and packagers for ZESTRIL

ZESTRIL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-238-07	90 TABLET in 1 BOTTLE (24979-238-07)	2024-04-25
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-239-07	90 TABLET in 1 BOTTLE (24979-239-07)	2024-04-25
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-240-07	90 TABLET in 1 BOTTLE (24979-240-07)	2024-04-25
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-241-07	90 TABLET in 1 BOTTLE (24979-241-07)	2024-04-25
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777	NDA	Upsher-Smith Laboratories, LLC	24979-242-07	90 TABLET in 1 BOTTLE (24979-242-07)	2024-04-25

Suppliers and packagers for ZESTRIL

Last updated: June 2, 2026

Zestril suppliers (lisinopril): API manufacturers, finished-dose contractors, and key ingredient sourcing channels

Zestril is the brand name for lisinopril, an oral ACE inhibitor. Core suppliers are split across (1) lisinopril API producers and (2) finished-dose manufacturers that produce Zestril tablets under licensing and supply agreements. Because “Zestril suppliers” can mean different points in the value chain (API, tablet manufacturing, packaging, or distribution), the supplier set that matters commercially is the one that is tied to FDA product listings and Orange Book-referenced manufacturing sites and to the labeler of record for each strength.

How to interpret “suppliers” for Zestril

• API suppliers: companies that manufacture lisinopril active pharmaceutical ingredient (API) for downstream tablet manufacturers.
• Finished-dose suppliers: contract manufacturers and sites that produce and package lisinopril tablets labeled as Zestril.
• Distribution suppliers: wholesalers and specialty distributors are typically secondary to the manufacturing/IP supply chain and are not usually determinative for IP or regulatory risk.

Bottom line: Zestril’s supplier landscape is not a single list. It is a shifting network tied to labeler-of-record, site-specific manufacturing, and contract packaging, with API sourcing often multiple-sourced to manage supply risk.

Which companies supply Zestril (lisinopril) tablets in the US?

Zestril is marketed in the US by AstraZeneca (labeler-of-record for the brand in most periods). The manufacturing and packaging operations for tablets are performed at one or more FDA-listed sites that appear in the NDA/ANDA listing for the product and/or in FDA drug registration databases.

What is the labeler-of-record for Zestril?

• Zestril US brand activity is typically tied to AstraZeneca Pharmaceuticals LP as the sponsor/brand owner. (The manufacturing sites are often different from the labeler.)

What factories manufacture and package the tablet strengths?

To identify “which companies” manufacture Zestril tablet strengths, the authoritative sources are:

• FDA Orange Book product listing (brand NDA) for Zestril, which links to manufacturing/marketing information.
• FDA product listing and registration databases that list the manufacturing/packaging sites associated with the drug product.

Answer format used in supplier workstreams: you build a site-level map (company + address + role: manufacturer, packager, tester) for each strength (for example 2.5 mg, 5 mg, 10 mg, 20 mg) and each dosage form (tablet), then overlay API sourcing.

Who makes Zestril API (lisinopril) and what are the typical API supplier tiers?

Lisinopril API supplier networks typically include:

• End-to-end API producers (complete synthesis and crystallization)
• Intermediate manufacturers (supply of key intermediates to API producers)
• Contract API sites registered for lisinopril manufacture

How do analysts identify lisinopril API suppliers for a branded product?

Common approaches include:

• Cross-referencing DMF holders and API manufacturer names used in submissions
• Tracing cGMP manufacturing site registrations connected to the API
• Reviewing manufacturer-of-record details that surface in regulatory filings and inspection histories

Operational note: For business decisions, the supplier identity is strongest when it is tied to a specific FDA-listed manufacturing site or to an identified DMF-to-product referencing pathway.

What does the Orange Book say about Zestril suppliers and manufacturing sites?

For branded drugs, the Orange Book entry points to:

• NDA number
• Applicant
• Dosage form
• Route of administration
• Key patents (not “suppliers” per se)
• Sometimes product manufacturing information depending on how the listing is surfaced and linked to FDA product data.

Which Orange Book fields are used in supplier mapping?

• NDA identifier for Zestril
• Applicant/holder (brand owner)
• Drug product characteristics that map to FDA product listing and manufacturing site data

Supplier workstream: Orange Book tells you where to anchor the product record; FDA manufacturing site data tells you who actually makes the tablet.

What generic-entry risks change supplier decisions for lisinopril (Zestril) tablets?

Supplier selection for a branded ACE inhibitor like lisinopril is impacted by:

• Short generics lifecycle risks after exclusivity/patent expiry (influence on demand forecasting)
• Sourcing redundancy requirements (API and finished-dose multi-sourcing)
• Regulatory inspection history and batch release reliability

Do Zestril patent expirations affect sourcing?

• When branded IP weakens, demand can shift quickly to generics, which pressures branded suppliers on capacity, pricing, and long-term supply commitments.

How many suppliers does Zestril typically use for API and finished tablets?

Most mature small-molecule products rely on:

• Multiple API sites for continuity of supply and price leverage
• Multiple finished-dose sites or packaging lines to manage volume and distribution lanes

Why do the supplier counts vary by strength and time?

• Tablet strengths often have separate manufacturing campaigns.
• Packaging and imprint variations can trigger different packing lines.
• Regulatory site history can change over the product lifecycle.

Which companies are competing with Zestril as lisinopril generics?

Competitors are not “Zestril suppliers,” but they shape supplier negotiations by determining:

• Market pricing
• Contract manufacturing utilization
• API cost dynamics

Who typically competes in US lisinopril markets?

Generic ACE inhibitor tablet competition in the US is broad, with multiple manufacturers and multiple ANDAs per strength. The relevant competitive set for procurement and supply risk is the group that:

• holds ANDAs for the same strengths,
• has higher FDA inspection pass rates,
• and supplies through major distributors.

What manufacturing/IP barriers matter when qualifying a new Zestril tablet supplier?

Qualifying a new supplier for a branded tablet can face barriers tied to:

• cGMP validation
• comparability of dissolution, particle size, and tablet quality attributes
• controlled formulation elements (for fixed-dose brands, usually excipient and process controls)
• regulatory and audit readiness of new facilities

Is lisinopril formulation heavily protected?

For widely used small-molecule APIs like lisinopril, the IP and regulatory focus is usually:

• Brand patents on specific claims (process, polymorph, salts, method of use, or formulation variants)
• Generic bioequivalence rather than radical reformulation.

Zestril supplier map: what procurement teams should compile

A defensible supplier map for Zestril should include:

• API supplier name(s) and manufacturing site addresses
• Finished-dose manufacturer(s) and packaging sites
• Labeler-of-record and NDA anchor (for the product record)
• Strength-level manufacturing attribution (if it differs)
• Quality agreements, change control scope, and audit cadence

Deliverable format used in licensing and litigation prep: a matrix by strength with (company, site, role, product line, regulatory source).

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Key Takeaways

• Zestril is lisinopril tablets. “Suppliers” breaks into API producers and finished-dose tablet manufacturers/packagers tied to FDA-listed product records.
• The authoritative way to identify supplier companies is to anchor on the Zestril NDA product record and then extract the manufacturing and packaging sites from FDA listings and drug registration data.
• Competitive generic pressure affects supplier strategies, but supplier identification for Zestril must be anchored to regulatory product listings rather than market assumptions.
• A practical supplier map for business decisions should be built at site level and strength level, then used for supply continuity, quality risk, and contracting.

FAQs

1. How do you identify the manufacturing site for each strength of Zestril tablets in FDA records?
2. Which drug registration databases list lisinopril tablet manufacturers and packagers for Zestril?
3. How can DMF references help trace lisinopril API suppliers used in branded products?
4. What cGMP comparability attributes matter most when switching tablet contract manufacturing for lisinopril?
5. How do generic lisinopril ANDA approvals affect procurement and multi-sourcing decisions for branded supply?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
2. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. (n.d.). NDC Directory. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory