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Suppliers and packagers for yaz
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yaz
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 | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-405-03 | 3 BLISTER PACK in 1 PACKAGE (50419-405-03) / 1 KIT in 1 BLISTER PACK | 2006-03-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for yaz
Yaz (drospirenone/ethinyl estradiol) Suppliers: API, CDMO, and Packager Landscape for Generic and Brand Manufacturing
Who supplies the API and drug product components for Yaz (drospirenone/ethinyl estradiol)?
Yaz is a fixed-dose combined oral contraceptive (COC) containing drospirenone and ethinyl estradiol. Supplier sourcing typically splits into: (1) API manufacturers for each active ingredient, (2) finished-dose drug product (tablet) CDMOs, and (3) packaging suppliers (blister and carton systems).
Key supply-chain components
- Drospirenone API (steroid progestin)
- Ethinyl estradiol API (synthetic estrogen)
- Tablet formulation package (excipients, blending, compression, coating, quality control)
- Blister packaging and secondary packaging (aluminum-PVC or PVC-PE blisters, cartons, leaflets)
Practical sourcing implication for diligence
- If you are underwriting a generic or “authorized generic” strategy for Yaz, the highest controllability risk is usually the drospirenone and ethinyl estradiol API supply and the tablet manufacturing know-how (including particle size control, coating uniformity, and stability management). Packaging risk is usually lower but can affect launch timing.
What companies manufacture Yaz tablets for retail supply, hospital formularies, and wholesale distribution?
Yaz commercial manufacturing is handled by branded and contract manufacturing networks that are not consistently published at the same granularity as API sourcing. For supply-chain work, the most actionable path is to map:
- Finished dosage manufacturer (tablet plant)
- Testing and release sites
- Packaging sites
- Labeling and distribution logistics
This mapping is normally derived from FDA inspection histories, CDMO marketing claims, and emerging details in ANDA related documents when generics are litigated or settled.
Because the request is specifically “suppliers,” the analysis is incomplete without tying Yaz’s exact marketed tablet to a specific finished-dose manufacturer and packaging plant. Without reliable, attributable manufacturer identities for the specific product configuration sold in the US, a supplier list risks being inaccurate.
Which CDMOs can produce drospirenone/ethinyl estradiol tablets and support US FDA commercial launch?
The generic-entry and lifecycle market for COCs is mature, and many tablet CDMOs support hormone-based solid oral dose manufacturing. In practice, shortlist screening targets CDMOs that can demonstrate:
- experience with steroidal APIs
- validated tablet manufacturing including film coating and hardness/weight control
- stability capability for estrogen/progestin systems
- regulatory track record supporting ANDA or 505(b)(2) submissions
High-value diligence artifacts typically requested
- facility OOS/OOT trends
- batch history for estrogen/progestin products
- cleaning validation approach
- coating uniformity and dissolution control strategies
A credible supplier list requires linking to actual Yaz manufacturing or ANDA/CDMO participation for drospirenone/ethinyl estradiol tablets.
What packaging suppliers support Yaz (blister, cartons, patient information inserts)?
COCs in the US are commonly blister-packaged. Supplier categories include:
- Blister film and forming lines (PVC/PE-based and aluminum components)
- Heat-seal and thermoforming equipment providers (facility capability)
- Carton and leaflet packaging vendors
Packaging suppliers become relevant in:
- launch readiness (lead times for blister materials and cartons)
- labeling compliance (lot/expiry printing, NDC formatting)
- supply continuity (secondary packaging shortages)
As with API/CDMO, a precise supplier list depends on identifying the actual US product packaging plants for the marketed Yaz presentations.
How do API supplier choices affect ANDA supply timing and risk for Yaz generics?
For Yaz competitors, the supply-chain gating items are usually:
- availability and batch reliability of drospirenone and ethinyl estradiol API
- regulatory acceptability of the DMF route (if used)
- control of polymorph/particle properties for bioequivalence
If API sourcing is constrained, launch can slip even with patent clearance, because tablet manufacturing needs stable API lots for BE batches and later commercial validation.
What patent or regulatory factors change the supplier landscape for Yaz?
Supplier strategy for Yaz is shaped more by regulatory and lifecycle controls than by manufacturing complexity:
- Orange Book exclusivity/patents affect generic entry timing and can shift who supplies finished dose manufacturing for ANDA candidates.
- If a generic is blocked by patents, CDMO and packaging selections may differ for early-stage clinical BE vs. post-approval commercial runs.
- For COCs, changes in formulation or coating can trigger additional controls even when bioequivalence is the stated target.
Which jurisdictions matter most for sourcing drospirenone and ethinyl estradiol APIs for Yaz?
For supply due diligence, jurisdictional relevance usually tracks:
- DMF filing locations
- GMP inspection regimes and inspection outcomes
- export logistics for controlled supply chains and documentation
A defensible supplier map requires specific API manufacturer identification and their current regulatory posture.
Key Takeaways
- Yaz is supplied through an end-to-end chain: drospirenone API, ethinyl estradiol API, tablet manufacturing (tablet/CDMO), and blister/secondary packaging.
- The most decision-relevant supplier risk for Yaz competitors is typically API lot reliability (drospirenone and ethinyl estradiol) and tablet manufacturing controls rather than packaging logistics.
- A precise, named “supplier list” for Yaz requires manufacturer attribution to the marketed US product configuration. Without that, any company names presented would be speculative.
FAQs
- How can I identify the finished-dose manufacturer of Yaz sold in the US?
- What documents are most useful to map Yaz API suppliers (DMF, inspections, submissions)?
- What are the typical tablet manufacturing controls required for drospirenone/ethinyl estradiol bioequivalence?
- How do API lead times for drospirenone and ethinyl estradiol impact generic COC launch timelines?
- What packaging formats are most common for US combined oral contraceptives like Yaz, and what supplier capabilities matter?
References
- FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). US Food and Drug Administration.
- FDA. Drug Master Files (DMF) and drug application submission resources. US Food and Drug Administration.
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