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Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; ETONOGESTREL
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ETHINYL ESTRADIOL; ETONOGESTREL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal | ELURYNG | ethinyl estradiol; etonogestrel | RING;VAGINAL | 210830 | ANDA | Amneal Pharmaceuticals LLC | 65162-469-35 | 3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) | 2019-12-16 |
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157 | ANDA | Northstar Rx LLC | 16714-029-03 | 3 POUCH in 1 CARTON (16714-029-03) / 21 d in 1 POUCH (16714-029-01) | 2023-11-01 |
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157 | ANDA | AvKARE | 42291-478-03 | 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11) | 2023-09-21 |
| Xiromed | ENILLORING | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211157 | ANDA | Xiromed, LLC | 70700-156-91 | 3 POUCH in 1 CARTON (70700-156-91) / 21 d in 1 POUCH (70700-156-11) | 2023-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; ETONOGESTREL
Etinyl Estradiol and Etonogestrel Drug Suppliers: Who Makes the Actives, Intermediates, and Finished Dosage Forms?
Executive summary: Etinyl estradiol (EE) and etonogestrel (ETO) are widely sourced active pharmaceutical ingredients (APIs) with mature global supplier bases for both APIs and key intermediates. In the US, the most commercially relevant EE + ETO combination is typically tied to long-acting contraception delivery systems. Finished-dose supply is concentrated among a smaller set of branded manufacturers and their contract manufacturers, while API supply is broadly distributed across China, India, and EU/US GMP sites.
Who supplies ethinyl estradiol API and what are the key intermediate supply chains?
Featured answer: Etinyl estradiol API and related intermediates are supplied by multiple global GMP manufacturers, with common sourcing hubs in China and India for bulk EE API and in EU/US for higher-spec products tied to controlled submissions and pharmacopoeial conformity.
Etinyl estradiol API: sourcing patterns
- API market structure: EE is an established steroidal estrogen, so the API tier is deep and competitive.
- Typical intermediate build: EE is produced through a multi-step steroid synthesis and aromatization/functional group tailoring depending on the route (commonly involving estrone/estradiol derivatives and subsequent modifications).
- Quality signals buyers screen:
- DMF/CEP footprint for regulatory readiness
- GMP batch history (site qualification and comparability package readiness)
- Residual solvents and genotox risk controls aligned to EU/ICH expectations
What customers usually dual-source
- Core API supplier for commercial batches
- Alternate site for supply continuity and regulatory fallback
- Intermediate supplier for lead-time and price stabilization
Who supplies etonogestrel API and what intermediate chemistry is most used?
Featured answer: Etonogestrel API is produced by fewer qualified suppliers than EE but still has robust global capacity, concentrated in companies with steroid synthesis expertise and extensive regulatory documentation for gestagen APIs.
Etonogestrel API: supply chain constraints
- Steroid synthesis complexity: requires specialized hydrogenation, oxidation, and stereocontrolled steps depending on the route.
- Regulatory readiness: Buyers often require DMF filings or access to a complete CMC package to avoid delays.
- Common quality gating:
- Polymorph and crystal form control (where applicable to the supplier’s validated process)
- Impurity profile matching ICH Q3A/Q3B expectations
- Genotoxicity-relevant impurity controls tied to manufacturing route
Which contract manufacturers can produce the EE + ETO finished contraceptive dosage forms?
Featured answer: Finished-dose suppliers depend on the delivery system. For EE + ETO combinations, the supply chain differs by formulation type, device integration, and release-profile requirements.
Delivery-system-dependent manufacturing
- If the product is an implant: manufacturing includes sterile implant packaging, controlled ethylene-vinyl acetate or polymer matrix filling, and device assembly qualification.
- If the product is oral: blending, granulation, tablet/capsule compression, coating, and stability-enabling packaging dominate.
- If the product is another controlled-release device: polymer casting and standardized release characterization are central.
How buyers evaluate contract manufacturer readiness
- Device integration capability (if applicable)
- Validation packages for dissolution/release equivalence
- Regulatory experience with combination hormonal contraceptives
- CMC transfer support for tech-transfer timelines
What Orange Book status exists for EE + ETO products and how does it affect supplier choices?
Featured answer: Orange Book status is product-specific. When a branded contraceptive is protected by formulation or method patents, suppliers often limit development to non-infringing routes and compatible CMC designs.
Practical impact on supplier qualification
- If formulation patents exist: suppliers need release profiles and impurity control aligned with allowed designs.
- If method-of-use patents exist: supplier work must support labeling-safe development approaches.
What patents typically protect ethinyl estradiol/etonogestrel products and how does that gate commercialization by new suppliers?
Featured answer: Patent estates for EE + ETO combinations tend to focus on delivery system design, controlled-release formulations, and sometimes dosing/regimen claims depending on the branded product.
Typical IP categories that suppliers must screen
- Controlled-release matrix patents
- Device-component patents (implant polymers, implant body design, release rate engineering)
- Manufacturing process patents (sterile filling, curing, sterilization and packaging)
- Method-of-use patents (age-group indications and contraceptive regimen statements in some regimes)
What generic entry risks exist for EE + ETO combinations and how does supplier selection mitigate them?
Featured answer: Main risks are (1) inability to match release profile for controlled-release systems, (2) patent design-around constraints, and (3) CMC comparability challenges for polymer/device-based products.
Supplier mitigation strategies
- Choose suppliers with prior regulatory history for the same dosage form class
- Use formulation and impurity analytics benchmarking early
- Secure tech-transfer documentation to reduce process drift risks
How do supplier geographies differ for EE and ETO APIs?
Featured answer: API supply is concentrated in Asia for cost-effective manufacturing, with EU/US and Japan/EU-aligned sites often used for regulatory assurance, specific impurity control, and lower-risk submissions.
Commercial procurement typical pattern
- Primary API procurement: Asia-based GMP sites with DMF coverage
- Second-source procurement: alternate API sites (often different geographies) for continuity
- Lab and analytical support: typically outsourced to testing partners with steroid impurity method capability
Which finished-dose companies and distributors typically control market access for EE + ETO?
Featured answer: Finished-dose market access is controlled by branded manufacturers and their affiliate distribution networks, with contract manufacturing supporting scale.
What to check in diligence
- Marketing authorization holder (MAH) and labeling entity
- GMP release site for each product presentation (including device packaging facility)
- Named batch release testing facility for quality assurance
What documentation do pharmaceutical buyers require from EE and ETO suppliers?
Featured answer: Buyers typically require regulatory and CMC documentation packages before committing to supply or tech transfer.
Core supplier documentation set
- GMP certificate for manufacturing site
- CoA format and batch release specifications
- DMF reference letter or CEP (where applicable)
- Impurity profile, including specified/unspecified impurities
- Stability protocol and stability data package
- Steroid-specific analytical methods for assay and impurities
Etinyl estradiol vs etonogestrel: supplier fit-for-purpose checklist
Featured answer: EE is usually easier to source broadly; ETO can be tighter due to steroid synthesis control, impurity profile requirements, and validated release for device-based systems.
Buyer screening differences
- EE sourcing tends to emphasize:
- pharmacopoeial compliance consistency
- residual solvents and impurity control
- DMF/CEP documentation speed
- ETO sourcing tends to emphasize:
- stereochemical control and impurity profile repeatability
- genotox-relevant impurity controls aligned to route
- evidence for consistent batch-to-batch performance
Key Takeaways
- API supply for ethinyl estradiol and etonogestrel is broad globally, with deep Asian GMP capacity for EE and a moderately tighter qualified base for ETO.
- Finished-dose supplier selection depends on the delivery system; device/controlled-release products narrow the contract manufacturer set.
- Supplier qualification is driven by CMC completeness: DMF/CEP status, impurity control package, and validated analytical methods for steroid hormones.
- Commercial risk concentrates around release profile matching and patent design constraints for controlled-release hormonal contraceptives.
FAQs
1) Who can supply ethinyl estradiol API for commercial manufacturing in GMP quality?
Multiple GMP suppliers support EE API, typically via DMF/CEP-backed dossiers and established steroid synthesis routes.
2) What differentiates etonogestrel API suppliers during qualification?
Consistency of stereochemical outcomes and impurity profile control tied to the manufacturing route, with regulatory package readiness for submissions.
3) Can contract manufacturers formulate EE + ETO into controlled-release products?
Only manufacturers with validated device or polymer-matrix expertise, including release testing, stability programs, and scalable manufacturing.
4) How do suppliers handle DMF and CMC package requirements for steroid hormones?
Through DMF filings or CEP pathways plus batch release specifications, stability data, and impurity methods aligned to ICH expectations.
5) What are the biggest supplier-related failure modes for EE/ETO products?
Non-matching release/availability for controlled-release dosage forms, drift in impurity profile across batches, and incomplete regulatory CMC documentation.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q3A/Q3B: Impurities in New Drug Substances/Drug Products. https://www.ich.org/
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