VIREAD: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577	NDA	Gilead Sciences, Inc.	61958-0403-1	1 BOTTLE, PLASTIC in 1 CARTON (61958-0403-1) / 60 g in 1 BOTTLE, PLASTIC	2012-01-18
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0401-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1)	2001-10-26
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0404-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1)	2012-01-18
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0405-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0405-1)	2012-01-18
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0406-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0406-1)	2012-01-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 30, 2026

Viread (tenofovir disoproxil fumarate) Suppliers: API, Finished Dosage Manufacturers, and Key Upstream Players

Viread is a brand of tenofovir disoproxil fumarate (TDF) in the antiviral class. Market supply is split between (1) upstream API manufacture of tenofovir disoproxil fumarate and (2) downstream finished-dose tablet production under Gilead’s commercialization. The practical supplier set for “Viread” in commerce is therefore the companies producing TDF API and the contract manufacturers (CMOs) that make and package Viread tablets for Gilead.

Who supplies Viread (tenofovir disoproxil fumarate) in the US market?

What “supplier” means for Viread

API suppliers: manufacture tenofovir disoproxil fumarate (TDF) active pharmaceutical ingredient.
Finished-dose suppliers: manufacture and package tenofovir disoproxil fumarate tablets labeled as Viread.
Specialty logistics suppliers: support distribution and secondary distribution, typically through Gilead or its distribution partners.

Brand holder and commercial controller

Brand owner/commercial controller: Gilead Sciences (Viread).

Common commercial supply pattern

Viread supply typically uses a small set of qualified API sources plus one or more tablet CMOs with validated manufacturing slots across dosage-line capacity. When outages occur, Gilead can re-allocate supply among approved manufacturing sites.

Which companies make tenofovir disoproxil fumarate (TDF) API used for Viread?

API scope

TDF API suppliers vary by site and year. For “supplier” diligence, you track:

API manufacturing sites qualified for Gilead’s NDA/ANDA supply chain
inspection history for TDF manufacturing
whether API sites are also used by generic TDF players (signals capability redundancy)

API supplier mapping approach used in licensing and litigation

Businesses typically cross-check:

FDA facility registrations and listings for API
import records and commercial availability signals
CMC disclosures in branded and generic applications referencing TDF API sourcing
supplier qualification lists in quality agreements (where accessible)

Commercial reality

TDF is a mature generic API, so multiple global producers exist. What matters for Viread-specific supply is not “all producers,” but which are approved/used in Gilead’s controlled supply chain and labeled quality system.

Which contract manufacturers produce Viread tablets (finished-dose suppliers)?

Finished-dose manufacturing scope

Tablet CMO responsibility typically includes:

tablet compression/granulation process
blending and milling
coating (if applicable for that formulation)
packaging (bottles, blister where used)
lot release and stability management under the license holder’s quality system

How to identify Viread tablet CMOs

Operationally, Viread CMO names surface through:

FDA establishment registrations tied to “tenofovir disoproxil fumarate” tablet manufacturing
packaging/manufacturing site identifiers on labels or regulatory submissions
supplier disclosure in filings where Gilead lists manufacturing sites
importation patterns for branded product

What does the US FDA facility registration data show for Viread suppliers?

Establishment registration is a proxy

FDA establishment registration identifies manufacturing/processing roles by site. In practice:

“Manufacturing” and “packaging” roles identify likely finished-dose suppliers
“API manufacturing” listings identify likely upstream suppliers

How companies use this in procurement

Pharma buyers and litigators treat site registration as a high-signal starting point, then validate with:

inspection outcomes
historical lots and shipment records
NDA/label references that connect site to product

How do Viread supply chains differ from generic tenofovir supply?

Generic manufacturers often buy from overlapping API networks

TDF is widely generic. As a result:

Many API suppliers support both branded and generic production.
The differentiator is the finished-dose manufacturing and packaging capacity.

Procurement implications

Branded supply is constrained by Gilead’s site qualification and release specs.
Generic supply can be broader, but quality consistency affects launch and ongoing supply stability.

What are the main risks in Viread supplier continuity (API and tablet manufacturing)?

API risks

API batch failures (impurity profile deviations)
raw-material sourcing constraints (key intermediates)
inspection outcomes at API sites

Finished-dose risks

tablet manufacturing capability limitations
coating/packaging line downtime
recall events that force requalification and lot scrapping

Business impact

Supplier concentration can lead to allocation if an approved site loses capacity. Mature APIs like TDF reduce the risk of complete supply collapse but do not eliminate site-specific disruption.

Which suppliers support other tenofovir disoproxil fumarate brands and generics (competitive landscape)?

Competitive adjacency

TDF products in the same therapeutic space are often supplied through the same API and sometimes overlapping CMOs. This increases:

interchangeability risk (same API network)
leverage for generic entrants in contracting
opportunities for backward integration in litigation

Why this matters for licensing

Licensors and generic challengers assess:

whether Gilead’s suppliers are also used by ANDA filers
whether the manufacturing process is protected via method or formulation patents that constrain certain suppliers

What patent barriers affect who can supply Viread (manufacturing/IP barriers)?

How patents intersect with supply

For a commodity-like molecule such as TDF, IP barriers typically shift from composition-of-matter to:

method-of-use claims (indication-specific)
formulation/process patents (e.g., granulation, coating, dissolution profiles)
manufacturing control/process claims (less common for older TDF supply chains)

Supplier practicalities

Even if patents are not stringent, supply can remain constrained by:

CMC tech transfer capability
validated dissolution and impurity specifications
regulatory release history

Key timelines: when does Viread exclusivity end and how does that change suppliers?

Practical market outcome

As Viread aged out of initial exclusivity, supply expanded through:

more CMO participation
more API supply sources
broader generic market uptake

Supplier consequence

When exclusivity ends, the set of competitive producers grows, but branded procurement stays with qualified sites. The difference shows up as:

increased total market supply
reduced branded allocation pressure over time
greater interchangeability at the API tier, less at finished-dose tier

What is the Orange Book status of Viread and how does it affect supplier entry?

Brand-to-generic status is the driver

Orange Book listings track:

patents submitted for FDA approval (listed patents)
exclusivity codes (when applicable)
patent expiry and litigation posture

Supplier entry implication

Patent lists shape:

whether ANDAs can file Paragraph IV certifications
the time window for a generic to begin commercial supply
the negotiation leverage for licensing or settlement

What generic entry risks exist for tenofovir disoproxil fumarate (TDF), and do they affect Viread suppliers?

Risks

regulatory delays (CMC issues, stability, impurity specifications)
patent litigation stay periods after Paragraph IV filings
manufacturing quality incidents

Effect on branded suppliers

Increased generic availability can reduce Viread pricing power, affecting volume allocations and procurement planning.
Shortages in generic supply can increase reliance on branded product and vice versa.

Key Takeaways

“Viread suppliers” are best treated as a two-tier system: TDF API producers plus tablet manufacturing/packaging CMOs qualified for Gilead’s quality system.
TDF is mature and widely manufactured, so the API tier typically has multiple global suppliers; the finished-dose tier remains more constrained by qualification, capacity, and packaging line availability.
The commercial supplier set for Viread is determined less by “who can make TDF” and more by “who is qualified and released for branded Viread tablet lots.”
Patent and Orange Book status determine generic commercial timing, which indirectly changes brand volume needs and branded procurement allocation decisions.

FAQs

How can I identify the tablet manufacturing site that produced specific lots of Viread?
Use lot labeling and match to FDA establishment registrations for “drug product” manufacturing/packaging sites.
Are Viread and generic tenofovir disoproxil fumarate made with the same API suppliers?
Often the API tier overlaps in a mature molecule environment; branded qualification is the constraint.
Do Viread packaging formats (bottles vs unit-dose) come from different suppliers?
Packaging typically uses different packaging-line qualified sites; tablet core manufacturing can be separate from packaging.
What inspection outcomes matter most for supplier risk in TDF manufacturing?
API sites and final product tablet sites both matter, but API impurity control and drug product batch release drive continuity.
How does Paragraph IV litigation timing affect Viread procurement?
It changes market supply expectations for generics, which can shift branded volume plans and allocation among qualified suppliers.

References (APA)

No sources were provided in the prompt and no cited FDA/Orange Book or facility-registration documents were included. Therefore, no references can be listed without fabricating citations.