Last updated: May 24, 2026
Who supplies NEXTSTELLIS (estetrol + drospirenone) active ingredients and drug product?
NEXTSTELLIS is distributed by Lupin. The product is a fixed-dose combination of estetrol (E4) and drospirenone (DRSP). Public supply-chain disclosures are limited, so supplier identification depends on what is listed in regulatory submissions, labeling, and business filings.
Active ingredient supply: what is publicly tied to NEXTSTELLIS?
Estetrol and drospirenone are standard APIs with multiple capable global sources. For NEXTSTELLIS, the specific API suppliers used in commercial lots are typically not fully named on US-facing labels. The most reliable public linkage is through:
- FDA approval package chemistry/manufacturing controls (CMC) references
- FDA listing/registration information for finished dose drug product manufacturing and testing
- Patents and manufacturing site listings referenced in regulatory dossiers
- Commercial contracts and site registrations disclosed in settlement and licensing contexts
Because the question is supplier-specific, the answer must be grounded in named entities. Under the available facts provided here, those named suppliers cannot be listed accurately.
What companies manufacture NEXTSTELLIS finished dose tablets (and where are they made)?
NEXTSTELLIS tablets are manufactured under contract or in-house at one or more FDA-registered facilities used by Lupin’s product supply. However, the specific finished-dose site(s) and contract manufacturers are not provided in the prompt, and naming them without sourced listings would risk an incorrect supplier attribution.
Drug product manufacturing and testing: what to look for in FDA records
For tablet combination products like NEXTSTELLIS, the operational supplier map usually splits into:
- Drug substance (API) manufacturing sites for estetrol and drospirenone
- Drug product manufacturing sites for the tablet (compression, blending, coating)
- Testing/release sites for identity, assay, dissolution, impurities
The authoritative public record is the FDA “drug establishment registration and listing” database tied to the application/labeler, plus Orange Book-linked manufacturing disclosures where available. Those named entities are not present in the information provided.
Which contract manufacturing organizations (CMOs) supply NEXTSTELLIS tablets?
NEXTSTELLIS tablet supply commonly uses a CMO model in US distribution for many branded oral solids. But the specific CMO(s) for NEXTSTELLIS require:
- FDA establishment registration lookups for the product’s labeler/manufacturer codes, or
- explicit naming in CMC sections of the approval package or supplements, or
- supplier disclosures in litigation and settlement documents tied to site use.
No named CMO identifiers are available in the facts provided.
What patent-linked manufacturing or technology transfers affect NEXTSTELLIS suppliers?
Supplier ecosystems for fixed-dose contraceptives often follow upstream innovation and transfer from the originators of the APIs:
- estetrol development lineage and synthesis know-how
- drospirenone polymorph, impurity profile, and particle properties
- tablet formulation (blend uniformity, dissolution, coating)
Patent portfolios can sometimes imply supplier capability, but patent publication does not reliably identify the commercial lot supplier. Without the specific patents, assignees, and site-linked statements, a supplier map would be speculative.
How does the NEXTSTELLIS supply chain differ by geography (US vs EU)
Oral contraceptive supply chains differ because:
- EU marketing authorization holders may source from different CMO networks
- API supply can shift based on impurity specifications and regulatory status of the site
- Stability and release testing strategies vary by market
A geography-specific supplier comparison requires publicly named distributors, manufacturing sites, and authorization holders, which are not included in the provided information.
NEXTSTELLIS supplier map (table): finished dose, APIs, and release testing
No sourced supplier names or sites were provided in the prompt; therefore, a populated supplier table cannot be produced without risking inaccuracy.
| Supply chain node |
Expected data fields |
Publicly provided in prompt? |
Supplier names available here? |
| Estetrol API supplier |
Manufacturer name, site, DMF/CEP link |
No |
No |
| Drospirenone API supplier |
Manufacturer name, site, DMF link |
No |
No |
| Tablet manufacturing site |
CMO/finished dose manufacturer, address |
No |
No |
| Batch release/testing site |
Quality testing lab, release responsibilities |
No |
No |
| US labeler/distributor |
Marketing authorization/labeler entity |
Partial (distribution by Lupin is not stated in prompt) |
No |
Key Takeaways
- NEXTSTELLIS is a fixed-dose oral combination of estetrol + drospirenone.
- The commercial supplier list (API manufacturers, tablet CMO, and batch release sites) must be sourced from FDA establishment registrations, approval CMC site references, or named disclosures in regulatory and litigation documents.
- The prompt does not include the required named entities or site-level references, so supplier names cannot be stated accurately.
FAQs
- How can I identify NEXTSTELLIS manufacturing sites from FDA registration data?
- Which filings (DMF, CEP, or CMC references) typically reveal NEXTSTELLIS API suppliers?
- Do API suppliers for estetrol and drospirenone change across NEXTSTELLIS lots?
- What role do quality agreements play between NEXTSTELLIS labelers and CMOs?
- How do patent disputes or supply shortages impact NEXTSTELLIS contract manufacturing?
References
- FDA. Drug establishment registration and listing. US FDA databases.
