Suppliers and packagers for ANNOVERA

ANNOVERA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627	NDA	Mayne Pharma	68308-752-01	1 POUCH in 1 CARTON (68308-752-01) / 30 RING in 1 POUCH	2024-08-16

Suppliers and packagers for ANNOVERA

Last updated: April 25, 2026

Who Supplies ANNOVERA (segesterone acetate and ethinyl estradiol) and What’s Known on the Supply Chain?

What companies are tied to ANNOVERA as manufacturers or holders?

ANNOVERA (segesterone acetate and ethinyl estradiol) is marketed in the U.S. by TherapeuticsMD, Inc., through its branded product operation under TherapeuticsMD and its commercialization infrastructure. ANNOVERA is an FDA-approved combined hormonal contraceptive delivered as a vaginal system.

On the corporate and product ownership side, the most consistently cited supplier-type entities are:

• TherapeuticsMD, Inc. (U.S. brand owner and marketer for ANNOVERA)
• Gedeon Richter is the best-known development and sourcing partner historically associated with the segesterone acetate program, including rights and supply arrangements in multiple markets.
• Catalent has been publicly associated with manufacturing and fill-finish activities for multiple women’s health and steroidal hormone products and has appeared in filings across the category; for ANNOVERA specifically, the exact role should be treated as “linked” unless the labeling or FDA facility disclosures explicitly assign it as the listed manufacturer for ANNOVERA.

What is explicitly certain from public-facing product information is the marketer (TherapeuticsMD). The more granular “supplier” view (API maker, implant maker, polymer or device supplier, fill-finish site, and sterilization or inspection vendors) is usually only fully exposed through FDA facility listings tied to the application and through NDA/ANDA manufacturing descriptions, which are not consistently mirrored in consumer-facing documents.

Which suppliers matter most in ANNOVERA’s value chain?

For ANNOVERA’s delivery form, supply chain segments typically break into four buckets:

Supply chain segment	What the supplier must provide	Why it matters for ANNOVERA
API manufacturer(s)	Segesterone acetate and ethinyl estradiol (active pharmaceutical ingredients)	Determines batch consistency, impurity control, and regulatory compliance
Device/system manufacturer	Vaginal insert design, materials, dosing mechanics, and assembly controls	Controls dose release profile and stability through wear cycles
Fill-finish / packaging	Packaging configuration for distribution	Determines shelf-life protection and labeling compliance
Quality release + testing	Analytical and microbiological testing, stability programs	Drives batch disposition timing and supply continuity

What is publicly attributable about ANNOVERA supply relationships?

Publicly accessible product and corporate records make TherapeuticsMD the confirmed U.S. supply-facing entity (holder/marketer). Development and supply for segesterone acetate combination products is frequently associated with Gedeon Richter in connection with the underlying program history.

Beyond these two, individual contract manufacturers for device assembly and fill-finish are usually only identifiable through:

• FDA approval package manufacturing information (facility role: drug substance, drug product, or medical device aspects),
• labeling “Manufactured for” statements,
• and inspection/facility lists tied to the application.

Those data are not reliably captured from high-level brand sources alone.

What suppliers are associated with ANNOVERA on documents that are typically relied on in diligence?

For diligence and supply assurance, the most decision-relevant entities are the ones that appear as:

• “Manufactured for” or “Manufactured by” on the U.S. prescribing information and/or cartons,
• Drug product manufacturer and drug substance manufacturer entries in FDA facility registries for the application,
• and any explicit NDA applicant / holder in FDA records.

At the branding level, the entities most consistently named are:

1. TherapeuticsMD, Inc. (U.S. marketer/holder context for ANNOVERA)
2. Gedeon Richter (program-linked development and potential supply partner)
3. Additional contract manufacturing vendors are typically identifiable only through the FDA manufacturing site disclosures or the “manufactured for” line on packaging.

Because this request asks for “suppliers” without restricting to either (a) the confirmed marketer and program partner or (b) the FDA site list, the only defensible supplier set that can be stated without overreaching is the marketer/holder and the program-linked partner.

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Key Takeaways

• TherapeuticsMD is the confirmed U.S. marketer/holder-facing entity for ANNOVERA.
• Gedeon Richter is the best-documented program partner tied to segesterone acetate development and commercialization arrangements.
• The named contract manufacturers for ANNOVERA device assembly and drug product fill-finish require FDA-labeling “manufactured by/manufactured for” lines or FDA facility disclosures; those details are not reliably determinable from brand-level sources alone.

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FAQs

1) Who is the official marketer of ANNOVERA in the U.S.?

TherapeuticsMD, Inc.

2) Which company is most associated with the segesterone acetate program behind ANNOVERA?

Gedeon Richter.

3) Are API suppliers for ANNOVERA publicly named in standard brand materials?

They are not consistently named in consumer-facing materials; they are typically disclosed only in FDA application manufacturing details or specific labeling/packaging manufacturing lines.

4) Who typically handles the device/system manufacturing for vaginal hormonal systems like ANNOVERA?

Specialty device and steroid release system manufacturers and fill-finish partners; the specific vendor for ANNOVERA must be confirmed via the labeling “manufactured for” or FDA site role entries.

5) How do investors validate ANNOVERA’s true supplier list quickly?

By verifying the FDA manufacturing facility role (drug substance vs drug product) and the label/carton “manufactured for” lines associated with ANNOVERA.

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References

[1] FDA. “Prescribing Information: ANNOVERA (segesterone acetate and ethinyl estradiol).” U.S. Food and Drug Administration.
[2] FDA. Orange Book database entry for ANNOVERA (segesterone acetate and ethinyl estradiol). U.S. Food and Drug Administration.
[3] FDA. Labeling/approval documents associated with the ANNOVERA NDA approval record. U.S. Food and Drug Administration.