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Suppliers and packagers for vagifem
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vagifem
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176-03 | 8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATOR | 2010-01-11 |
| Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176-04 | 18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATOR | 2010-01-11 |
| Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908 | NDA | Novo Nordisk | 0169-5176-99 | 6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATOR | 2010-01-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for vagifem
Vagifem Suppliers (Manufacturers), Contract Manufacturers, and API Sources: Who Makes It and What’s the Supply Chain?
Vagifem (estradiol vaginal tablets) is supplied through a defined manufacturing chain that typically includes (1) estradiol API, (2) formulation/tablet manufacturing, and (3) finished-dose packaging under the marketing authorization. The practical supplier set for “Vagifem” in commerce is best captured at the finished-dose level (marketing authorization holder and EU/Nordic/UK-manufacturing sites listed on product labels and regulatory files), with upstream API and excipients sourced through tiered procurement.
Bottom line for procurement and risk screening: treat “Vagifem suppliers” as two distinct layers. Finished-dose manufacturers and packagers are contractually and regulatory-bound to the marketing authorization product. Upstream API and key excipients are replaced more often, but they do not change which company legally supplies the finished product unless regulatory change orders are filed.
What companies supply Vagifem (estradiol vaginal tablets) in the EU/UK market?
Featured snippet answer: Vagifem’s supply is tied to the marketing authorization holder and the listed finished-product manufacturing and packaging sites on regulatory labeling (SmPC/package leaflet and product label). Those sites are the companies that function as “suppliers” for procurement of finished-dose Vagifem.
How to identify the “supplier” that matters for sourcing
- Marketing authorization holder (MAH) for the specific jurisdiction (EU member states and the UK can have different label/pack information).
- Finished-dose manufacturer(s) listed on the outer carton/leaflet as “manufactured by.”
- Packaging site(s) listed as “packaged by” where applicable.
- Import/distribution entities on local packs (sometimes distinct from the manufacturing site).
Supplier mapping by labeling role
| Procurement target | What to capture on the pack/leaflet | Typical role in supply |
|---|---|---|
| Finished-dose manufacturer | “Manufactured by” line | GMP manufacture of tablets |
| Primary packaging | “Packaged by” line | Filling, blistering, cartons |
| Secondary packaging/labeling | Local “distributed by” | Local compliance labeling and warehousing |
| API and excipients | Not always shown on retail pack | Tier-1 procurement and supply assurance |
Who manufactures estradiol vaginal tablets like Vagifem (tablet manufacturing sites and packaging)?
Finished-dose manufacturing is the supplier dimension with the highest regulatory lock-in.
Tablet GMP steps suppliers cover
- Mixing/granulation (if applicable)
- Compression tableting
- In-process controls (content uniformity, hardness, disintegration)
- Tablet coating (if any, depending on version)
- Blister formation and heat-seal controls
- Packaging and batch release
What “contract manufacturer” means for Vagifem
For legacy brands like Vagifem, finished-dose production can be performed by specialized GMP manufacturing sites under contract, even when the MAH is a separate company. The supplier list in practice is the set of GMP sites on the regulatory product information for each marketed presentation (strength and pack count).
Who supplies the estradiol API used in Vagifem?
Featured snippet answer: Estradiol API suppliers are identified through the drug substance section of the regulatory file (Drug Substance CEP/DMF route where used) and through batch release documentation. The retail pack rarely names API sources.
Typical API sourcing structure
- API made by an upstream estradiol manufacturer under GMP
- API delivered to the tablet manufacturer with CoA and full impurity profile controls
- Excipient suppliers provide binder/disintegrant/lubricant materials where the excipient specification is controlled
Procurement risk factors tied to API
- Estradiol impurity profile changes across suppliers can trigger formulation re-qualification.
- Regulatory constraints increase lead time for substitution.
- Supply continuity depends on API capacity and availability of qualified sources.
How do Vagifem suppliers differ by strength, pack size, and country labeling?
Vagifem is marketed in multiple pack configurations (dose strength is the main differentiator). Supplier identity can shift between:
- blister/packaging line ownership (packagers can differ from tablet manufacturers)
- country-specific labeling/distribution channels
- subcontract manufacturing changes during lifecycle maintenance
What to check for each market
- Outer carton “manufactured by/packaged by”
- Package leaflet manufacturing section
- Batch number prefix mapping (sometimes aligns with manufacturer site)
Which companies are listed on Vagifem product labels as manufacturer or packager?
Featured snippet answer: The legally relevant suppliers for “Vagifem” are the companies printed under manufacturing and packaging lines on the medicine’s outer packaging and in the package leaflet for the specific jurisdiction.
Why this matters
In tenders and procurement, buyers should not rely on corporate parent names. Contracts are executed at the GMP site level. For logistics and recall management, batch traceability is maintained by manufacturer and packager site, not by brand owner alone.
What supplier changes happen over time for Vagifem, and how does that affect availability?
Supplier changes typically come from:
- capacity reallocation at GMP sites
- transfer of manufacturing/packaging between subcontractors
- regulatory updates requiring site change authorization
- lifecycle maintenance and batch release improvements
Availability impact pattern
- Supply interruptions are more likely when tablet manufacturing is concentrated in fewer sites.
- Packaging-only changes can be less disruptive, because finished tablets may already be produced and staged.
What is the Orange Book status of Vagifem (and why doesn’t it apply to suppliers)?
Featured snippet answer: Orange Book is a US-specific regulatory listing. Vagifem is primarily an EU/UK brand in many sourcing contexts, so Orange Book listing does not directly map to EU/UK supplier identification.
How US listings would affect supply decisions
If a product is listed in the US, the Orange Book helps identify listed patents and generic alternatives, not the physical manufacturer of Vagifem in EU/UK. Supplier sourcing still depends on label and regulatory manufacturing site disclosures.
What alternative supply routes exist for estradiol vaginal tablets if Vagifem supply is constrained?
Procurement substitutions typically fall into two lanes:
- Same active, alternative branded product (if marketed in the same jurisdiction)
- Generic/“essentially similar” estradiol vaginal tablet products (where authorized)
Supplier substitution reality
Even if the active ingredient is identical, supplier substitution changes:
- tablet formulation manufacturing method
- excipient sources
- impurity profile consistency
- packaging compatibility and batch traceability
Key Takeaways
- “Vagifem suppliers” should be interpreted as the finished-dose tablet manufacturing site(s) and packaging site(s) shown on the product label and package leaflet in the relevant country.
- Upstream estradiol API suppliers are usually not visible on retail packs and are identified in regulatory documentation and batch release records.
- Supplier identity can vary by market labeling, pack configuration, and subcontract manufacturing changes over time.
- For supply continuity and recall readiness, procurement should lock to GMP site and batch traceability, not just brand owner.
FAQs
1) Who is the marketing authorization holder for Vagifem in the EU vs the UK?
It is the entity named in the SmPC/package leaflet and on the product label for each jurisdiction.
2) Can the estradiol API supplier change without changing the Vagifem brand’s label supplier?
Yes, upstream API suppliers can change through regulatory-approved sourcing updates while the finished-dose manufacturing/packaging sites remain the same.
3) What determines which company is responsible in a Vagifem batch recall?
Recall responsibility is tied to the finished-dose manufacturer and batch release chain shown in regulatory and labeling documentation for that jurisdiction.
4) Are Vagifem manufacturing sites the same as the blister packaging sites?
Not necessarily. Tablet manufacture and packaging can be performed at different GMP sites.
5) How do I identify the correct Vagifem supplier for tender documents?
Use the “manufactured by” and “packaged by” lines on the specific market’s carton and package leaflet, matching batch traceability requirements.
References (APA)
- European Medicines Agency. (n.d.). Product information for vagifem (estradiol vaginal tablets). EMA. https://www.ema.europa.eu/
- UK Medicines and Healthcare products Regulatory Agency. (n.d.). Patient information and product details for Vagifem. GOV.UK. https://www.gov.uk/government/organisations/mhra
- European Commission. (n.d.). Union Register of medicinal products (marketing authorisation and product details). https://ec.europa.eu/health/documents/community-register/html/home.html
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