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Suppliers and packagers for generic pharmaceutical drug: ESTRADIOL; PROGESTERONE
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ESTRADIOL; PROGESTERONE
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 | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132 | NDA | Mayne Pharma LLC | 50261-211-05 | 1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK | 2019-04-03 |
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132 | NDA | Mayne Pharma LLC | 50261-251-05 | 1 BLISTER PACK in 1 CARTON (50261-251-05) / 5 CAPSULE in 1 BLISTER PACK | 2023-03-31 |
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132 | NDA | Mayne Pharma LLC | 50261-251-30 | 1 BLISTER PACK in 1 CARTON (50261-251-30) / 30 CAPSULE in 1 BLISTER PACK | 2023-03-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ESTRADIOL; PROGESTERONE
Who Supplies Estradiol and Progesterone for Pharmaceutical Drug Products?
What supplier segments cover estradiol and progesterone supply chains?
Suppliers for estradiol and progesterone typically come from three lanes:
- API manufacturers (active pharmaceutical ingredient) producing estradiol or progesterone (or both) as chemical APIs.
- Contract manufacturers (drug product/CDMO) formulating and packaging tablets, capsules, gels, creams, injectables, and other dosage forms using the API.
- API intermediates and chemical producers supplying key upstream building blocks used to make these steroids at scale.
Because estradiol and progesterone are commodity steroids with mature chemistry, the supply market is broad and tiered, with API availability often driving downstream production schedules.
Which API manufacturers supply estradiol?
The estradiol API market includes large-volume global suppliers and multiple regional producers. Commonly encountered API supplier categories in the public domain include:
- Steroid and hormone API specialists supplying estradiol (and often other hormones) under DMF and CEP/registration frameworks.
- Generic API producers in South Asia and parts of Eastern Europe supplying estradiol APIs for global generic and branded markets.
- China-based API manufacturers supplying estradiol APIs for export.
These suppliers distribute through direct sales, distributor networks, and CDMOs that qualify API vendors for commercial drug product production.
Which API manufacturers supply progesterone?
Progesterone API suppliers mirror the estradiol landscape:
- Steroid and hormone API specialists with capabilities for progesterone production and purification at scale.
- Commodity generic API producers supplying progesterone API to drug product manufacturers and CDMOs.
- Export-oriented API manufacturers providing progesterone API in multiple grades and packaging formats, typically aligned to regulatory filings and customer qualification requirements.
Progesterone demand is driven by multiple dosage forms in global markets, including injectables and oral formulations, which increases the number of qualified supply sources.
Where do estradiol and progesterone drug product manufacturers source from?
Drug product manufacturing (tablets, oral micronized products, transdermals, gels, creams, and injectables) generally sources from:
- Qualified API suppliers under quality agreements and audit packages.
- Distributors when a CDMO or local manufacturer needs an approved upstream chain for a specific regulatory market.
- Single-source qualification programs for injectables due to higher documentation and batch traceability requirements.
For both estradiol and progesterone, the practical procurement pattern is: API supplier qualification first, then formulation execution through CDMO manufacturing.
What dosage forms drive different supplier requirements?
Supplier selection changes based on dosage form because it changes the quality attributes that regulators and customers require:
| Dosage form | Typical supplier focus | Quality constraints that tighten |
|---|---|---|
| Oral tablets/capsules | API purity and particle/grade fit | Impurities, polymorph compatibility, dissolution performance |
| Micronized progesterone products | API particle size control | PSD specs, uniformity, stability profile |
| Vaginal products | API + excipient compatibility | Bioavailability, local tolerability, preservative compatibility |
| Transdermal gels/patches | API assay + formulation uniformity | Homogeneity, penetration performance, stability under storage |
| Injectables | API and sterile manufacturing readiness | Sterility assurance, endotoxin controls, container closure integrity |
What are the typical regulatory documentation touchpoints?
Estradiol and progesterone supply is commonly managed through:
- DMF (Drug Master File) submissions for API dossiers where applicable.
- CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) frameworks for EU-referenced products.
- Local marketing authorization drug product dossiers that incorporate API quality and manufacturing controls.
In practice, procurement teams and CDMOs require:
- Certificate of Analysis and batch traceability
- Impurity profiles and specification sheets
- Stability data aligned to customer storage and shelf-life requirements
- GMP compliance records and inspection history
How do suppliers differ for estradiol vs progesterone procurement?
Estradiol procurement often tracks dosage form demand (transdermals and oral regimens). Progesterone procurement often tracks injectable and oral demand patterns and the need for micronized grades in some markets.
Operationally:
- Both require strong impurity control because they are potent steroid APIs.
- Progesterone can require tighter control on particle size for micronized oral products.
- Estradiol often requires formulation compatibility support for transdermal and vaginal products.
What supplier strategy fits fast-moving commercial needs?
For commercial timelines, procurement typically favors:
- Multiple pre-qualified API sources
- CDMOs with established experience in hormone formulations
- Supplier diversification to avoid single-vendor batch availability constraints
This is especially relevant for injectables where lead times and quality documentation can extend onboarding.
Key Takeaways
- Estradiol and progesterone supply is dominated by API manufacturers, supported by CDMOs that package and formulate into oral, transdermal, and injectable dosage forms.
- Supplier selection depends on dosage form-driven quality constraints (micronization for progesterone, uniformity and penetration for estradiol transdermals, sterility for injectables).
- Regulatory readiness typically hinges on API dossier control (DMF/CEP-style documentation) plus GMP and batch traceability.
FAQs
1) Are estradiol and progesterone APIs treated like commodity chemicals in procurement?
No. They are chemically mature, but procurement still requires impurity control, dossier alignment, and GMP-compliant batch traceability, which limits interchangeability without qualification.
2) What matters most for progesterone sourcing?
For oral micronized products, particle size distribution and micronization consistency matter alongside standard impurity and stability requirements.
3) What matters most for estradiol sourcing?
For transdermal and vaginal products, API formulation compatibility, homogeneity, and stability matter as much as basic chemical specifications.
4) How do companies reduce supply risk for these hormones?
They qualify multiple API sources and rely on CDMOs with established hormone formulation experience and robust documentation workflows.
5) Do dosage forms change the supplier list?
Yes. Drug product requirements (sterile manufacturing, micronization, transdermal uniformity) can restrict which API suppliers and grades are acceptable.
References
[1] European Medicines Agency (EMA). European public assessment reports and product dossier frameworks. https://www.ema.europa.eu
[2] U.S. Food and Drug Administration (FDA). Drug Master File (DMF) program overview. https://www.fda.gov
[3] European Directorate for the Quality of Medicines (EDQM). Certificate of Suitability (CEP) framework. https://www.edqm.eu
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