Suppliers and packagers for generic pharmaceutical drug: PRASTERONE

PRASTERONE

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

Prasterone (Dehydroepiandrosterone, DHEA): Supplier Landscape for API and Key Intermediates

Last updated: April 23, 2026

Who supplies prasterone API?

Prasterone (also called DHEA, dehydroepiandrosterone; CAS 53-43-0) is commercially supplied as a regulated steroid active ingredient via global chemical-pharma manufacturers and specialty steroid API vendors. In practice, prasterone procurement is sourced through:

• API producers supplying “prasterone” (DHEA) directly under pharma-grade documentation.
• Contract manufacturers and traders who package the API with documentation (CoA, EDQM-style/EMA-relevant paperwork, GMP statements where applicable).

Core procurement reality: buyers typically qualify prasterone suppliers based on GMP status, DMF/CEP support (where available), and impurity profiles (not generic catalog price).

API procurement checklist used to qualify prasterone sources

• Specification set: identity, assay, impurities (including steroid-related related substances), residual solvents, water/LOD (as applicable)
• Regulatory support: GMP certificate of suitability references (if held), or DMF pathway documentation where used in registration
• Supply format: micronization grade or dissolution grade if used for specific dosage forms
• Analytical package: CoA trend capability and validated methods (HPLC/GC, steroid impurities panel)
• Quality system: batch traceability and deviation/CAPA reporting for steroid impurities
• Controlled substance handling: prasterone itself is not universally controlled like certain opioids, but steroid supply still triggers compliance checks and customer audits

Which major API manufacturers historically supply DHEA/prasterone?

Prasterone is stocked by multiple global steroid and chemical-pharma producers. The suppliers below are commonly associated with DHEA/prasterone API availability and/or steroid intermediate capabilities used to produce DHEA. (Final qualification requires buyer-side documentation review.)

Commonly listed DHEA/prasterone API source types (global)

• Specialty steroid manufacturers (steroid chemistry, GMP steroid API)
• Bulk chemicals-to-pharma converters (convert commodity steroid inputs into pharma-grade API)
• Intermediates-to-API vertically integrated producers (produce upstream steroids and finalize DHEA under GMP)

Practical supplier sourcing routes used by buyers

• Direct tender to GMP API producer (preferred for long-term supply and regulatory support)
• Dual sourcing through two GMP-certified vendors plus a qualified backup (common for steroid API continuity)
• Use of a compliant distributor for initial qualification batches, followed by switch to direct supply

Who supplies prasterone intermediates that feed DHEA production?

Most prasterone supply chains depend on steroid feedstocks and intermediates that can be produced from steroid precursors through oxidation/reduction steps and purification. Typical intermediate categories used in commercial DHEA production include:

• Steroid ketones/ols used for ring functionalization
• Androstane skeleton intermediates with staged oxidation states before final DHEA release
• Protected or partially reduced steroid intermediates that require finishing steps under GMP

In buyer terms, intermediate suppliers matter because they determine:

• impurity spectrum (steroid relatives)
• batch-to-batch variability
• ability to meet pharmacopeial-style impurity limits

What documentation and quality items should be requested from any prasterone supplier?

Steroid APIs succeed or fail on analytical control. Requests typically include:

• CoA for each lot: assay and all listed impurities with limits and method references
• GMP certificate for the manufacturing site
• DMF or CEP pathway documentation (if used in regulatory submissions)
• Impurity panel details: steroid-related substances (process impurities) and residual solvents
• Stability data: at least accelerated and long-term where required by the dosage form developer
• Change control history: site/process/equipment changes and impact assessment

How to compare suppliers: what matters in prasterone pricing and availability

Prasterone pricing varies with:

• grade (pharma-grade vs technical)
• packaging (bulk vs drum vs smaller retail packs)
• impurity compliance and analytical package strength
• lead time and allocation during steroid market tightness

Buyers typically compare by:

• delivered unit cost + lead time
• documentation completeness (GMP, CoA format, impurity method)
• ability to pass incoming QC (impurity profile and assay acceptance)

Where is prasterone used, and why it shapes supplier requirements?

Prasterone is used for hormone replacement and urology-related indications depending on formulation and regulatory labeling in each market. The end-use affects supplier requirements:

• oral vs topical vs intravaginal products impose different impurity and residual solvent constraints
• clinical vs commercial sourcing routes differ (clinical batches often prioritize documentation and analytical rigor over absolute lowest unit price)

Key Takeaways

• Prasterone API supply is global but procurement depends on GMP documentation, impurity control, and regulatory support rather than catalog listings alone.
• Supplier qualification should be spec- and impurity-driven: steroid-related impurities and analytical method alignment are decisive.
• Intermediate supply capability influences API impurity spectrum, batch consistency, and long-term supply stability.
• Best practice is dual sourcing for steroid APIs due to lead-time and batch allocation risks.

FAQs

1. Is prasterone widely available as an API?
   Yes, it is commercially available from multiple global steroid API supply channels, but pharma-grade qualification requirements limit which vendors can pass buyer QA.

2. What specs are most important for incoming QC of prasterone?
   Identity confirmation, assay, steroid-related related substances/impurities, residual solvents, and water/LOD (as applicable) dominate acceptance outcomes.

3. Do buyers need DMF or CEP support for prasterone?
   Many registrations rely on a regulatory filing pathway; whether a DMF or CEP exists depends on the manufacturing site and submission strategy.

4. Does prasterone sourcing require particular compliance handling?
   It typically requires controlled documentation, traceability, and GMP compliance; handling constraints can vary by region and customer quality system.

5. How do intermediate suppliers affect final prasterone quality?
   They influence the impurity profile carried through purification steps and can drive batch-to-batch variability if intermediate control is weak.

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References

[1] PubChem. Prasterone (DHEA). https://pubchem.ncbi.nlm.nih.gov/compound/Prasterone
[2] FDA. Drugs@FDA: Prasterone-related products (example references by brand). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] EMA. European public assessment reports and product information (search portal for prasterone-containing medicines). https://www.ema.europa.eu/