Last Updated: June 7, 2026

Suppliers and packagers for angeliq


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angeliq

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-482-03 3 BLISTER PACK in 1 CARTON (50419-482-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01) 2012-02-29
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-482-72 1 BLISTER PACK in 1 CARTON (50419-482-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71) 2012-02-29
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-483-03 3 BLISTER PACK in 1 CARTON (50419-483-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-01) 2005-11-28
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-483-72 1 BLISTER PACK in 1 CARTON (50419-483-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-483-71) 2005-11-28
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for angeliq

Last updated: April 25, 2026

What Companies Supply Angeliq (estradiol valerate + drospirenone)?

Angeliq (estradiol valerate and drospirenone) is supplied to the market through defined manufacturer and packaging chains for each marketed presentation (commonly 28-tablet calendars). The supplier lineup is anchored on the product’s original marketing authorization holder and the manufacturing sites listed in regulatory dossiers for EU/UK markets.

Who manufactures Angeliq tablets?

Angeliq is produced by contract manufacturing plants under the marketing authorization for specific regions. For EU/UK, manufacturing responsibility is reflected in the “Manufacturer” and “Batch release site” fields across the Summary of Product Characteristics (SmPC) and national product registers.

Commonly listed manufacturing sites across Angeliq presentations (EU/UK registrations):

  • Schering GmbH & Co. Productions KG (historical manufacturing entity associated with Bayer women’s health products; sites vary by dossier updates)
  • Bayer logistics and release entities tied to finished product batch release for the relevant country registrations
  • Secondary packaging sites that handle blister/carton packaging per national labeling requirements

Who supplies active ingredients (APIs) for Angeliq?

Angeliq uses two APIs:

  • Estradiol valerate
  • Drospirenone

API sourcing is handled via supplier qualification and GMP release under the marketing authorization. For Angeliq, API supply typically follows Bayer’s long-established procurement and qualified third-party manufacturing model used for steroid APIs (hormone compounds are generally produced at specialized GMP facilities, with multiple approved suppliers in master files).

Because API identities in public product pages are not consistently disclosed country-by-country, supplier lists must be taken from dossier-level references and batch-release declarations published in regulatory artifacts (SmPC/manufacturer sections do not always name API vendors).

Who handles packaging and labeling (blistering, cartons, and calendars)?

For Angeliq, finished product packaging is split into:

  • Primary packaging: blister formation and filling (28-tablet calendar format for common packs)
  • Secondary packaging: carton assembly, labeling, and inserts by country

Public regulatory records generally list:

  • Packager(s) / Manufacturer(s) responsible for batch release
  • Manufacturer(s) responsible for packaging operations

Supplier mapping by role (what to look for in filings)

Angeliq supplier discovery should be structured by function because public documents often list roles rather than commercial supplier brands.

Supply role What it controls What regulatory text usually says
Finished product manufacturer Tablet production, coating (if any), blending, compression/finishing “Manufactured by”
Batch release site QA release under GMP for distribution “Batch release by” / “Responsible for batch release”
Primary packager Blistering, strip/pack formation “Packaged by” (sometimes split from release)
Secondary packager Carton and labeling for each market “Packaged by” / “Market authorization holder” distribution mapping
API supplier Raw hormone manufacture and GMP compliance Often only visible in dossier-level sections (not always in SmPC)

How to verify suppliers for the exact Angeliq presentation in a given country?

Regulatory supply chains change by packaging lot, country label language, and batch-release routing. The reliable verification path uses:

  • The SmPC “Manufacturer” section for the specific country registration
  • The Patient information leaflet (PIL) packaging/manufacturer addresses
  • The national medicines agency register entries that mirror the SmPC (UK: MHRA; EU: national competent authorities)

For investors and R&D planners, supplier control impacts:

  • Supply continuity risk (batch release site changes)
  • Regulatory change management (site swaps for packaging and release)
  • Quality oversight (GMP inspection footprint)

What suppliers should your diligence target for Angeliq?

Finished product and release

Target these categories in diligence:

  • The finished product manufacturing site(s) for tablets
  • The batch release site(s) for finished product distribution
  • The primary and secondary packaging sites tied to the 28-tablet format

APIs

Target these categories in diligence:

  • Qualified estradiol valerate GMP supplier(s)
  • Qualified drospirenone GMP supplier(s)
  • The drug substance control strategy (specs, impurities, polymorph/particle control where relevant)

Key Takeaways

  • Angeliq supplier identification is driven by the SmPC “Manufacturer” and packaging/batch release fields for each market.
  • Finished product supply includes manufacturing, batch release, and packaging sites, which can differ across countries and over time.
  • API vendor names are not consistently disclosed in public SmPC text; supplier validation for estradiol valerate and drospirenone is typically dossier-level and quality-system based.

FAQs

1) Are Angeliq suppliers the same across all countries?

No. Batch release and packaging sites can change by country labeling needs and distribution logistics, even when the same SmPC dossier is used.

2) Where do I find the finished product manufacturer for Angeliq?

In the SmPC “Manufacturer” section and mirrored product-register entries in the relevant national regulator.

3) Are API suppliers (estradiol valerate, drospirenone) listed publicly for Angeliq?

Not consistently. Public SmPC/manufacturer sections usually focus on finished product sites, not the drug substance vendors.

4) What is the difference between a manufacturer and a batch release site in Angeliq records?

A manufacturer makes the product under GMP; a batch release site performs final QA release for distribution to the market.

5) Do packaging suppliers matter for Angeliq supply?

Yes. Packaging sites affect calendar blister configuration, labeling language, and carton-level compliance for each market.

References

[1] European Medicines Agency. Angeliq product information (SmPC). EMA product database.
[2] UK Medicines and Healthcare products Regulatory Agency (MHRA). Angeliq medicines information (SmPC/PIL entries). MHRA register.
[3] National competent authorities (EU). Angeliq summary of product characteristics and manufacturer/packager declarations for country-specific listings.

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