Suppliers and packagers for VTAMA

VTAMA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272	NDA	Organon LLC	81672-5051-1	1 TUBE in 1 PACKAGE (81672-5051-1) / 60 g in 1 TUBE	2025-05-28

Suppliers and packagers for VTAMA

Last updated: May 26, 2026

VTAMA (tapinarof) suppliers: contract manufacturers, API and fill-finish vendors, and supply-chain constraints

Executive summary: Publicly disclosed supplier detail for VTAMA (tapinarof) cream, 1% is limited. What can be stated from nonconfidential, FDA-linked, and commercial disclosure patterns is that VTAMA supply typically involves (1) tapinarof API sourcing from established chemical manufacturers, (2) finished-dose manufacturing under US and/or global contract manufacturing organizations (CMOs), and (3) specialty dermal product fill-finish appropriate for topical creams in US-labeled packaging. Without specific, citable manufacturer and site-of-manufacture listings for VTAMA in the public record used here, a complete supplier roster cannot be produced without risking fabrication.

Who manufactures VTAMA (tapinarof) and which companies supply the cream?

Direct answer: A verified list of VTAMA cream manufacturers and named suppliers is not available in the public record content used for this response.

What counts as “supplier” for VTAMA sourcing

• API supplier: tapinarof active ingredient manufacturer.
• Drug product CMO: formulation, bulk manufacture, emulsification/cream processing, and packaging.
• Fill-finish: filling tubes/jars, sealing, labeling, and secondary packaging.
• Packaging supplier: compliant containers/tubes and closures for dermal use.

How VTAMA supply is typically structured

• Tapinarof is a small-molecule dermatology active, usually produced through multi-step organic synthesis and then formulated into a topical cream matrix under controlled GMP.
• Finished-dose production for topical creams often requires thermally managed blending, controlled rheology/emulsion stability, and package compatibility validation (tube liner and closure behavior can matter for stability).

What suppliers provide tapinarof API for VTAMA?

Direct answer: A verified vendor list for tapinarof API cannot be produced from citable public sources in the dataset used here.

API sourcing risks for tapinarof

• Multi-step synthesis can concentrate risk in a small number of capable chemistries.
• If a supplier is licensed primarily for commercial volumes, ramps for generics or additional dermatology indications can be constrained.

Which contract manufacturers make VTAMA 1% cream (fill-finish and packaging)?

Direct answer: A verified list of CMOs or fill-finish sites for VTAMA 1% cream cannot be produced from citable public sources in the dataset used here.

What to look for in supplier validation

• FDA establishment inspection records (site addresses tied to finished product and/or API).
• Drug master file (DMF) cross-references where publicly indexed.
• Orange Book “Manufacturer” vs “Applicant” vs “Distributor” distinctions for drug product labeling.
• Site-specific GMP for topical semisolids, including container closure integrity testing.

What is the Orange Book status of VTAMA and how does that tie to suppliers?

Direct answer: The Orange Book entry for VTAMA establishes applicant/holder and patent/exclusivity context, but it does not reliably provide a complete supplier roster (API, CMOs, packaging) without additional establishment-level references.

Orange Book fields that can help

• Applicant/Oral holder: ties to rights and regulatory ownership.
• Dosage form: cream 1%.
• Patents: formulation, method of use, or packaging-specific claims can drive CMO process constraints.
• Exclusivity: can limit direct generic supply without challenge and/or licensure.

When do VTAMA exclusivity and patents expire, and do that affect supplier switching?

Direct answer: This response cannot provide a correct expiration timeline for VTAMA patents or exclusivity without citable patent-by-patent data for VTAMA.

How exclusivity changes the supplier landscape

• As exclusivity approaches, sponsors and potential entrants prequalify additional CMOs to reduce launch risk.
• Even when exclusivity blocks generic approval, upstream CMOs may prepare for scale.

Which companies are challenging VTAMA with generics or Paragraph IV?

Direct answer: A verified list of Paragraph IV filers and their associated applicants cannot be produced from citable content here.

What supplier implications follow Paragraph IV

• Challengers often dual-source API and secure at least two independent fill-finish lines to mitigate supply delays.
• Litigation and settlement can bind manufacturing choices, including which sites can make a commercial product under licenses.

Does biosimilar-style manufacturing risk apply to VTAMA?

Direct answer: No. VTAMA is a small-molecule topical drug (tapinarof), so biosimilar frameworks do not apply.

What risks do apply

• Generic topical products face bioequivalence/liquid diffusion and local performance considerations, plus formulation comparability and stability.
• CMO capabilities for dermal cream manufacturability are a gating factor.

How strong is the patent estate for VTAMA formulations and does it constrain CMO processes?

Direct answer: A patent-strength assessment for VTAMA requires specific, citable patent numbers and claim scopes. That is not available in the dataset used here.

Common VTAMA-relevant IP buckets for topical products

• Formulation composition and concentrations.
• Penetration/permeation enhancement elements.
• Manufacturing methods (process parameters for semisolids).
• Method-of-use claims (indications and dosing regimens).
• Packaging and stability-related claims (less common).

What generic entry risks exist for VTAMA creams and how could that affect suppliers?

Direct answer: Generic entry risks depend on the VTAMA patent and exclusivity landscape, which cannot be stated accurately here without citable patent/exclusivity data.

Supplier risk pathways in topical generics

• If process or formulation patents are broad, generic formulations may need litigation-free design changes.
• Even if legally allowed, stability and product appearance can be hard to replicate, limiting CMO shortlist.

Competitive landscape: are there alternative tapinarof suppliers outside VTAMA’s direct supply chain?

Direct answer: A verified map of alternative tapinarof supply chains cannot be provided from citable sources used here.

How to think about “alternative suppliers” in practice

• Alternate API sources can exist but may not be qualified for the specific formulation and analytical method set used by VTAMA’s finished product sponsor.
• Alternative CMOs can exist but may lack topical semisolid expertise or packaging compatibility certification.

Key Takeaways

• A complete, verified list of VTAMA (tapinarof) suppliers (API vendors, CMOs, and fill-finish/package vendors) cannot be produced from the citable public source set used for this response.
• VTAMA supply chain decisions hinge on Orange Book/applicant context, patent/process constraints, and site-level GMP qualification, none of which can be tied to specific named supplier entities here without risking incorrect attribution.
• The most actionable supplier due-diligence in practice is establishment- and site-based: identify the manufacturing establishments tied to VTAMA drug product and API and then map capable CMOs/fill-finish partners to those validated capabilities.

FAQs

1. How can I verify VTAMA manufacturing sites from FDA records?
   Use FDA establishment listing and inspection-linked establishment identifiers tied to the VTAMA drug product.

2. Does VTAMA require specialized CMO capabilities for topical cream stability?
   Yes. Topical semisolids need controlled emulsification, rheology control, and packaging compatibility testing.

3. What is the main difference between VTAMA supply for branded product versus generic launches?
   Generic launches usually require separate qualification of the formulation and may require alternative sites to meet scale and regulatory readiness.

4. How do formulation patents typically affect sourcing for topical small molecules like tapinarof?
   They can constrain permissible excipients and process parameters, which can limit which CMOs can make a legally compliant product.

5. Can API sourcing from multiple tapinarof manufacturers reduce VTAMA supply disruption risk?
   In principle yes, but only after qualification for the sponsor’s quality system, impurity profile, and analytical method equivalence.

References

1. U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Drug establishment registration and listing (facility and product establishment identifiers).