vivelle-dot: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7129-83	8 POUCH in 1 CARTON (0781-7129-83) / 1 PATCH in 1 POUCH (0781-7129-58) / 3.5 d in 1 PATCH	2014-12-22
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7138-83	8 POUCH in 1 CARTON (0781-7138-83) / 1 PATCH in 1 POUCH (0781-7138-58) / 3.5 d in 1 PATCH	2014-12-22
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7144-83	8 POUCH in 1 CARTON (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH	2014-12-22
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7156-83	8 POUCH in 1 CARTON (0781-7156-83) / 1 PATCH in 1 POUCH (0781-7156-58) / 3.5 d in 1 PATCH	2014-12-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

VIVELLE-DOT Suppliers: Who Manufactures Estradiol Transdermal Patches (VIVELLE-DOT) and Related Private-Label Sources

VIVELLE-DOT (estradiol transdermal system) is manufactured and supplied in the US through the commercial supply chain tied to the product’s NDA holder and patch manufacturing sites listed in FDA submissions and labeling. The key supplier identities for “VIVELLE-DOT” are the NDA holder/licensor and the contract/secondary manufacturers that produce the patch and package finished units for US distribution.

Actionable supplier map for procurement, sourcing, and IP/CMC due diligence:

Brand/NDA holder (marketing authorization and label responsibility): Antares Pharma, Inc.
Finished-dose supply chain: contract patch manufacturing and packaging performed at FDA-registered drug-product sites supporting the listed NDA/label configurations for VIVELLE-DOT transdermal systems.
Raw material ecosystem: estradiol drug substance suppliers and excipient providers support the patch formulation system, but specific drug-substance and excipient source names are not consistently disclosed in public-facing labeling.

Who is the manufacturer/supplier of VIVELLE-DOT (estradiol transdermal patch)?

Direct manufacturer identity for VIVELLE-DOT is determined by the NDA holder plus the finished dosage form site(s) used to produce and package the transdermal system for US release. In practice, procurement teams confirm supplier identity using:

FDA labeling “Manufactured for” / “Distributed by” lines on current package inserts
FDA’s Drugs@FDA and SPL (Structured Product Labeling) listings for firm names associated with the product label
NDC-to-firm mapping and FDA facility registration (drug product establishment list) for the finished-dose site(s)

What are the FDA-listed firms for VIVELLE-DOT label, NDC, and packaging?

For each strength and NDC package configuration, VIVELLE-DOT typically shows:

A label firm (marketing/distribution line)
A “manufactured for” or “manufactured by” line tied to a specific company and location
A packaging firm when packaging differs from manufacturing

Because VIVELLE-DOT is distributed in multiple strengths and NDC configurations (and firms can change with supply continuity), supplier verification must be done at the NDC level, not only the brand name.

Which companies supply estradiol transdermal patch systems like VIVELLE-DOT (CMO landscape)?

VIVELLE-DOT’s supply chain aligns to the CMO ecosystem that produces transdermal systems (matrix or reservoir-style patches) and completes packaging. In the US market, transdermal patch CMOs commonly provide:

Patch casting/coating and film lamination
Drug loading into adhesive layers
Controlled solvent processes (as relevant to the platform)
Barrier film and backing lamination
Unit packaging under serializable formats (where applicable)

Common CMO categories used for estradiol patch products include:

Transdermal system manufacturing specialists
Adhesive and laminate film processing vendors
Contract packaging and distribution firms

However, the exact CMO firms for VIVELLE-DOT must match the label’s “manufactured by/manufactured for” statements for the specific NDC. Public sources can differ between package configurations.

Which NDA holder controls VIVELLE-DOT supply and quality system?

VIVELLE-DOT’s NDA holder controls:

Quality agreements and release testing scope
Manufacturing site qualification and change control
Label and packaging specifications
Post-approval manufacturing changes (site transfers, scale changes, packaging configuration changes)

For VIVELLE-DOT, the NDA holder is Antares Pharma, Inc. (brand owner/marketer).

How do VIVELLE-DOT supplier changes affect NDCs and FDA registrations?

When the finished-dose manufacturing site changes:

The NDC may change (or the same NDC may stay while the underlying manufacturing site changes through the variation process).
The SPL and label typically update “manufactured for/by” text.
FDA facility registration lists may show updated manufacturing establishment participation.

Procurement and regulatory teams usually track:

NDC-level label firm names
FDA facility inspection and registration history
Change notice timelines in supplements (where available via FDA updates)

What private-label or authorized generic versions compete with VIVELLE-DOT supply?

If an authorized generic exists, it is typically produced under the same commercial quality system and supplier network only if the license grants use of the brand manufacturing supply chain. For private-label transdermal estradiol patches:

Supplier selection often mirrors the platform CMO ecosystem
The product identity differs via NDC, label, and regulatory labeling

Procurement risk: “Same molecule, different patch platform” can affect clinical interchangeability and IP/CMC strategy.

What does FDA labeling say about who manufactured VIVELLE-DOT?

The fastest way to identify the active suppliers is:

The “Manufactured for” and “Manufactured by” lines in the current package insert or carton label
The SPL entry for the specific NDC and strength

These lines are the only consistently auditable, directly relevant sources for “who made the finished patch units” used for distribution under that exact labeled configuration.

What supplier due diligence should be performed for VIVELLE-DOT transdermal patches?

For sourcing, qualification, and supply continuity, teams typically verify:

GMP manufacturing site (FDA-registered establishment)
Drug product release testing scope (in-process and batch release)
Sterile status (transdermal estradiol patches are non-sterile, so the relevant controls focus on uniformity, content, and mechanical/adhesion properties)
Stability program and storage conditions
Packaging compatibility (shelf-life, desiccation control if relevant, and tamper-evidence)
Serialization status and data capture format (if mandated for the NDC)

How many manufacturing sites supply VIVELLE-DOT in the US?

Multiple sites can support commercial supply due to:

redundancy and surge capacity
changeover schedules
continuity after CMOs are replaced

Count by strength and NDC using the current SPL and label firm lines for each configuration.

What are the raw material supplier categories for estradiol patches (API and excipients)?

VIVELLE-DOT’s CMC bill of materials typically includes:

Estradiol drug substance
Patch formulation excipients: adhesives, polymers, enhancers/penetration modifiers as applicable to the platform
Backing and release liner films
Packaging components (pouch/overwrap, cartons, labels, and unit peel-back components)

Public disclosure of exact API and excipient suppliers is limited in label text; supplier names are usually available only through controlled supplier disclosure documents or regulatory submissions.

Supplier risks for VIVELLE-DOT continuity: what can disrupt supply?

Key disruption vectors:

Patch platform CMO capacity constraints
Solvent/adhesive film supply chain constraints
Packaging material lead-time issues
Drug substance lead-time constraints
GMP inspection outcomes affecting the release path

For procurement, mitigation includes:

NDC diversification across qualified manufacturing sources
safety stock planning aligned to supply chain lead times
contractual QC/release responsibility clarity

Key Takeaways

VIVELLE-DOT supply is governed by the NDA holder (Antares Pharma, Inc.) and implemented through finished-dose contract manufacturing and packaging sites that must be confirmed at the NDC/strength level using the product label and SPL entries.
For “who the supplier is,” the highest-integrity source is the current labeling “manufactured for/by” text for each NDC configuration.
Procurement and regulatory due diligence should verify FDA-registered drug product sites, stability and release controls, and packaging integrity at the exact labeled configuration.
Raw material suppliers (estradiol API and patch excipients) are generally not named in public-facing label text, so CMC diligence relies on regulatory submissions and supplier qualification packages.

FAQs

How can I identify the VIVELLE-DOT manufacturing site for a specific NDC?
Use the current VIVELLE-DOT label “manufactured for/manufactured by” lines and the corresponding SPL listing for that NDC and strength.
Does VIVELLE-DOT have different suppliers across strengths?
It can, because each strength/NDC configuration may be produced and packaged under different label and manufacturing arrangements.
Are there multiple FDA-registered manufacturing sites for VIVELLE-DOT transdermal systems?
Typically yes across time and configurations; confirm via FDA facility registration participation and the current SPL/label firm names for each NDC.
Who supplies the estradiol API used in VIVELLE-DOT?
The specific API supplier is usually not disclosed in labeling; confirm via supplier qualification dossiers or CMC regulatory documentation tied to the NDA.
What is the fastest way to qualify a new VIVELLE-DOT supplier for procurement?
Confirm the exact manufacturing and packaging firms listed on the NDC label/SPL, then validate GMP status, release testing scope, stability, and packaging controls for that configuration.

References

FDA. Drugs@FDA: VIVELLE-DOT (estradiol transdermal system) product information and labeling. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. SPL (Structured Product Labeling) data for VIVELLE-DOT by NDC. https://www.accessdata.fda.gov/scripts/cder/spl/
FDA. NDC Directory and label/SPL firm association via NDC. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

Suppliers and packagers for vivelle-dot

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