Suppliers and packagers for intrarosa

intrarosa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470	NDA	Millicent US, Inc.	72495-401-28	1 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK	2020-11-01
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470	NDA	Millicent US, Inc.	72495-501-14	1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK	2020-11-01

INTRAROSA (prasterone) Suppliers: Who Manufactures API, FDF, and Key Packaging for FDA-Approved Product

Last updated: May 30, 2026

INTRAROSA is an FDA-approved branded vaginal prasterone (prasterone / DHEA) product for moderate-to-severe dyspareunia due to menopause. The supplier set used for the U.S. market is determined by (1) the drug substance (API) and finished dosage form (FDF) manufacturers and (2) the product’s labeled packaging and distribution chain, as reflected on the U.S. product label and FDA’s drug listing systems.

Who supplies INTRAROSA (prasterone) in the US market?

Answer: INTRAROSA’s U.S. supply chain is identified on the FDA-approved label (manufacturing sites, packagers, and the NDA holder’s distribution chain).

Labeled manufacturing and distribution entities

• NDA holder / marketing authorization in the U.S.: AMAG Pharmaceuticals, Inc.
• Product manufacturing (FDF) and packaging: shown on the INTRAROSA U.S. prescribing information through “Manufactured for/Distributed by” and manufacturing facility statements.

API (drug substance) vs FDF (finished product)

• API supplier identity is not consistently visible from the label alone if only the FDF manufacturer is listed as “manufactured for/distributed by.”
• FDF manufacturer identity is the most reliably extractable supplier entity from the INTRAROSA label and FDA labeling.

Implication for procurement and licensing

• For procurement, the most defensible due diligence path is: label manufacturing language plus FDA listing records to separate API source from FDF and packaging.

What are the key INTRAROSA finished-dose suppliers (contract manufacturers) for vaginal inserts?

INTRAROSA is supplied as vaginal inserts. The supplier roles that matter for contracting and continuity planning are:

• Finished-dose (vaginal insert) manufacturer: produces the nal-delivered dosage form.
• Packaging site(s): primary and secondary packaging for sterility- and dosing-unit integrity.
• Quality release testing: often performed at the FDF site and/or contract QC labs listed in internal qualification documentation.

What to look for on the INTRAROSA label

• “Manufactured for” indicates the responsible manufacturer of record for the finished dosage form.
• “Packaged by” or facility line items identify packaging suppliers.
• Distribution language identifies the commercial logistics responsible entity, typically the NDA holder or its appointed distributor.

Who supplies the prasterone API used in INTRAROSA?

Answer: The API supplier is typically not fully enumerated in the patient-facing label unless AMAG or the FDA label explicitly names the drug substance manufacturer.

For API supply chain diligence, supplier discovery is done via:

• detailed FDA listing entries where available for drug substance/manufacturer fields,
• DMF-linked submissions (if the NDA references a controlled substance or DMF for prasterone manufacture),
• and contract/manufacturing disclosures in licensing and quality agreements.

Which companies are listed as manufacturers or packagers of INTRAROSA on FDA product labeling?

The INTRAROSA supplier set on U.S. labeling follows the standard FDA label structure:

• Manufactured for: finished dose manufacturer(s)
• Packaged by: packaging contractor(s), if shown
• Distributed by: U.S. commercial distributor, commonly the NDA holder or its authorized distributor

Bottom-line supplier map

• Marketing authorization and U.S. distribution entity: AMAG Pharmaceuticals, Inc.
• Finished-dose and packaging entities: defined by the manufacturer/packager facility names and addresses on the INTRAROSA prescribing information.

How does INTRAROSA supply chain change across package size, dosage unit, and NDC?

Answer: Supplier identity can stay constant while NDCs differ, or shift for packaging if packaging contractors change.

Key commercial effects:

• If AMAG changes the packaging contractor, the same finished-dose manufacturer may remain while packaging site names change across NDCs.
• If the formulation line changes (same active, different manufacturing process), the FDF manufacturer can change, which affects qualification requirements and may require bridge testing.

What supplier model does INTRAROSA use: vertical integration vs contract manufacturing?

Based on the typical branded vaginal insert model:

• Many branded products use contract manufacturing for FDF and specialty packaging for dosing-unit integrity.
• The NDA holder (AMAG) typically retains control of:
  • CMC package ownership,
  • specification and release strategy,
  • supplier qualification and audit rights.

INTRAROSA supplier risk: single-site manufacturing or dual-sourcing?

Supplier concentration risk for a vaginal insert typically turns on:

• whether there is a single FDF site for the insert,
• whether packaging is performed at one or multiple sites,
• and whether API supply is constrained by the prasterone chemical supply chain.

The risk controls that procurement teams typically require:

• change control and notification SLAs,
• batch rejection and deviation history by site,
• validation/tech transfer documentation for insert manufacturing.

What are the practical steps to identify INTRAROSA suppliers for procurement?

For supply chain procurement, the actionable workflow is:

1. Start from the INTRAROSA U.S. prescribing information and extract:
   • “Manufactured for” line item(s)
   • facility address(es) and packager language
2. Map the extracted manufacturers to their roles:
   • FDF manufacturer
   • packaging contractor
3. Validate against FDA product listing records by NDC:
   • confirm label-specified manufacturer facility for that NDC
4. Separate API and FDF supply in vendor onboarding:
   • request API CoA linkage, DMF references, and manufacturing site qualification packages as needed

Key Takeaways

• INTRAROSA’s supplier identity for the U.S. market is defined primarily by the manufacturer/packager entities named in the FDA-approved label and confirmed through FDA product listing records by NDC.
• The NDA holder for U.S. distribution is AMAG Pharmaceuticals, Inc.
• Finished-dose (vaginal insert) and packaging suppliers are the most defensible supplier targets from the label.
• API supplier names may not appear in the patient-facing label and usually require deeper FDA/CMC sourcing documents to confirm.

FAQs

1. Does INTRAROSA use the same supplier for all NDCs?
   Supplier identity can remain unchanged for FDF while packaging contractors differ by NDC.

2. Where on the INTRAROSA label are the manufacturing suppliers listed?
   In the “Manufactured for” / “Packaged by” / “Distributed by” sections of the prescribing information.

3. Is the prasterone API supplier shown on the INTRAROSA prescribing information?
   Often not in the label excerpted for patients; it depends on the specific labeling language.

4. What supplier changes typically trigger regulatory notification for INTRAROSA?
   Changes to FDF manufacturing site, packaging configuration that affects container closure integrity, or process changes that require CMC comparability.

5. What diligence is most important when qualifying a new packaging supplier for vaginal inserts?
   Line clearance, unit dosing integrity, stability bridging approach, and sterility assurance strategy tied to the packaging system.

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References

1. AMAG Pharmaceuticals, Inc. INTRAROSA (prasterone) Prescribing Information. U.S. FDA label.
2. U.S. Food and Drug Administration. Drug Approvals and Databases (NDC product listings and label repository).