Last updated: May 29, 2026
IMVEXXY is manufactured for marketing by Theramex (branded product in the US). Publicly available supplier visibility for upstream estradiol drug substance and key excipient components is limited; the strongest, decision-grade supplier determination is the finish-product manufacturer and labeler assignment tied to US FDA listings.
Who is the manufacturer of IMVEXXY in the US?
IMVEXXY’s US “labeler” and the accountable manufacturing entities are disclosed through the FDA’s drug listing records for NDC activity. The labeler responsible for the branded product is Theramex.
What does FDA “labeler” mean for supplier due diligence?
For supplier mapping, the FDA labeler indicates the party linked to the branded product’s regulatory submissions and distribution chain in the US. It does not by itself reveal the upstream API supplier.
How to identify the finished-product manufacturing site(s)?
The finished-product “manufacturer” (not just labeler) is typically captured on the FDA listing for the corresponding NDC strength and dosage form. Supplier diligence should target:
- finished dosage manufacturer(s) for estradiol vaginal insert (sterile, applicator-associated manufacturing chain)
- packaging site(s) for the insert and applicator kit components
- any contract-manufacturing arrangements shown in FDA listing fields
Which NDC strengths exist for IMVEXXY and how does that affect supplier mapping?
IMVEXXY is sold in multiple strengths. Each strength can have different NDCs, and each NDC can point to different manufacturing/packaging records in FDA databases.
Why NDC-specific mapping matters for supplier selection
- Different strengths can be produced on different lines or sites.
- Packaging and applicator configurations can change across strengths.
- Change control history is usually NDC-specific, affecting qualification and regulatory submissions.
What upstream supplies are typically required for an estradiol vaginal insert?
IMVEXXY is an estradiol local therapy delivered via a vaginal insert. Upstream sourcing for such products generally includes:
- estradiol drug substance (API supplier)
- polymer or matrix components used to form the insert
- mucoadhesive or release-modulating excipients
- applicator assembly materials (if supplied in-kit)
- primary packaging (insert contact materials, seals)
- sterilization or bioburden control systems (depending on product design and FDA classification)
Which supplier categories usually have the highest IP and compliance risk?
- API source control for estradiol (DMF-based submissions often constrain qualified sources)
- excipient or polymer components that impact release profile and stability
- applicator components that affect patient usability and dose delivery reproducibility
Are there multiple manufacturers for IMVEXXY or is it a single-source supply chain?
Public supplier intelligence for IMVEXXY is usually driven by:
- FDA drug listing manufacturer fields tied to NDCs
- quality agreements disclosed via regulatory filings
- logistics continuity across strengths
A single listed manufacturer is common for branded vaginal inserts, but supply continuity can still involve multiple contract manufacturers or packaging sites.
What supplier information is most relevant for licensing, litigation, or CMC planning?
For business-critical decisions, supplier due diligence should center on:
- finished-product manufacturer (FDA listing)
- packager and kit assembly site(s)
- API and DMF linkage strength-specific (if DMF-driven controls apply)
- quality documentation availability for transfer and validation planning
Key Takeaways
- IMVEXXY is a branded estradiol vaginal insert whose US labeler is Theramex, and supplier mapping should be anchored to FDA NDC drug listing records for the finished-product manufacturer and packaging/assembly sites.
- Upstream estradiol API and key excipient suppliers are not reliably confirmable from high-level public materials; defensible supplier identification must come from FDA listing manufacturing fields and any DMF-linked submissions tied to the specific NDCs.
FAQs
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How do I find IMVEXXY’s finished-product manufacturer by NDC?
Use the FDA drug listing for the exact NDC and read the “manufacturer” field for that strength/dosage form.
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Does IMVEXXY’s packaging manufacturer differ from the insert manufacturer?
It can. FDA listing records for NDCs often separate manufacturing from packaging.
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Are there supplier controls (DMF) for estradiol API for IMVEXXY?
Estradiol products frequently use DMF-linked controls; the definitive answer is tied to the dossier/DMF references for the specific NDC.
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How does strength (NDC) change IMVEXXY supplier mapping?
Different strengths can map to different manufacturer/packaging records due to production-line and configuration differences.
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What supplier categories are most important for IMVEXXY CMC transfers?
Finished dosage manufacturer, kit/application assembly site(s), and any DMF-constrained API and critical excipient sourcing.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drug Listing (NDC directories) for IMVEXXY (estradiol vaginal insert). FDA.
