Suppliers and packagers for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xiromed | LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 214640 | ANDA | Xiromed, LLC | 70700-177-85 | 3 BLISTER PACK in 1 CARTON (70700-177-85) / 1 KIT in 1 BLISTER PACK | 2023-08-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Last updated: June 10, 2026
Suppliers for Levonorgestrel and Ethinyl Estradiol and Ferrous Fumarate (API and Finished Dosage)
Major supply-chain risk is concentrated in the steroid hormones (levonorgestrel and ethinyl estradiol) rather than in ferrous fumarate. Finished-combination product supply is typically routed through branded/authorized generics using sourced APIs or toll manufacturing for solid oral tablets, with multiple worldwide API suppliers and contract manufacturers supporting alternative strengths and packaging formats.
Who supplies levonorgestrel and ethinyl estradiol APIs for combination tablets?
The API supply base for levonorgestrel and ethinyl estradiol is broad globally because both are long-established contraceptive hormones with extensive generic penetration. Commercial supply is generally split across (1) API manufacturers and (2) formulation contractors that compress and package the finished tablets and blister packs.
Common API supplier archetypes
- Specialty hormone API manufacturers with controlled impurity profiles and dedicated manufacturing lines for steroid hormones.
- Large-scale generic API producers that manufacture both actives under DMF-supported dossiers and sell to tablet manufacturers.
- Vertical players that make API and also produce solid oral dosage forms for authorized generics.
What matters for sourcing
- DMF status and regulatory history for each API. For EU use, supplier qualification typically tracks CEP/DMF-equivalent documentation.
- Impurity specification consistency across batches, especially for ethinyl estradiol, which has tight process-impurity and genotoxic impurity controls in many supplier files.
- Particle size and polymorph control for downstream blend uniformity in low-dose steroid-containing tablets.
- Supply reliability and lead times aligned to seasonal demand and contraceptive purchasing cycles.
Which companies supply ferrous fumarate (iron) as the API?
Ferrous fumarate is more commoditized than the hormones. Supply tends to be more stable with many qualified manufacturers, since the API is widely used in supplements and anemia indications.
Key supplier constraints
- Assay and Fe content within monograph specs.
- Particle size and flow properties for tablet compression performance and content uniformity.
- Contaminant controls (heavy metals) consistent with pharma-grade iron excipient standards.
- Compatibility with steroid actives in the finished blend (no degradation under typical process stresses).
What finished-dose manufacturers supply levonorgestrel/ethinyl estradiol plus iron tablets?
Finished-dose supply for combination contraceptive regimens that include an iron component is usually delivered by:
- Brand owners for the originator product markets, and
- Authorized generic and private label tablet manufacturers for other geographies.
The practical sourcing structure for most commercial launches is:
- Tablet manufacturer buys hormone APIs directly or via distributors.
- Tablet manufacturer contracts formulation and packaging steps (or does internally).
- Packaging and distribution are handled under QA release and serialization requirements by the finished-dose holder.
How do supply routes differ by region (US vs EU vs other markets)?
Supply-chain documentation differs, which affects who can be used as a supplier:
United States
- API and finished products typically rely on DMF references for APIs and ANDA/505(b)(2) documentation for generics.
- Tablet manufacturers must manage cGMP compliance and often require supplier change controls tied to regulatory filings.
European Union / UK
- API suppliers frequently provide CEP-style documentation or dossiers aligned to EU requirements.
- Finished-dose manufacturing is commonly validated to EU GMP and local pharmacovigilance and QP release expectations.
Other regulated markets
- Many countries accept reference information from US/EU filings but still impose local batch QA release.
- Suppliers often use regional distributors to meet local import licensing.
What formulation and packaging suppliers are typically used for combination hormone plus iron tablets?
These products are solid oral dosage forms, most often:
- Tablet strengths that vary by hormone content and iron amount.
- Blister packaging aligned to daily regimens.
Contract manufacturing targets
- Blend uniformity validation for low-dose hormones combined with iron.
- Compression and coating process capability to keep tablet appearance and dissolution consistent.
- Stability programs for steroid hormones and iron in the presence of packaging headspace.
Packaging and serialization
- Blister and carton line capabilities for serialization where required.
- Moisture and light protection is a key technical screening step for the hormone-containing component.
What supply risks exist for levonorgestrel and ethinyl estradiol vs ferrous fumarate?
Hormones (levonorgestrel, ethinyl estradiol)
- Higher risk from upstream synthesis yield volatility, solvent recovery constraints, and dedicated steroid impurity control requirements.
- More frequent supplier audits due to tighter impurity specifications.
Ferrous fumarate
- Lower risk relative to hormones.
- Main risk is raw material lot variability affecting particle characteristics and dissolution performance.
Which supplier choices affect regulatory approval and interchangeability?
Regulatory acceptability is driven by:
- The DMF-backed API used in the commercial manufacturing process.
- Comparability of the finished dosage manufacturing method for generics and supplements.
- For iron-containing regimens, stability and dissolution and uniformity are critical in evidence packages.
How to map the supplier ecosystem for a specific product strength and dosage schedule
A practical supplier map is structured around three layers:
Layer 1: APIs
- Levonorgestrel API supplier(s)
- Ethinyl estradiol API supplier(s)
- Ferrous fumarate API supplier(s)
Layer 2: Finished-dose manufacturing
- Tablet compression and coating sites (if applicable)
- In-process QC and tablet uniformity controls
- Packaging line operator (blistering, cartoning, label printing)
Layer 3: Distribution
- Authorized distribution networks
- Local market release and pharmacovigilance interfaces
Supplier dataset (what to document for procurement and compliance)
To support sourcing decisions for LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE tablet products, supplier documentation should cover:
| Supply Item | Contract/Document Needed | Audit Focus |
|---|---|---|
| Levonorgestrel API | DMF/CEP references, CoA, impurity profile | impurity consistency, sterile/bioburden not relevant, chemical impurity controls |
| Ethinyl estradiol API | DMF/CEP references, CoA, genotoxic and process impurity strategy | impurity limits and analytical method transfer |
| Ferrous fumarate API | GMP certificate, Fe assay, metal contaminants | particle size, dissolution, heavies |
| Tablet manufacturing | Batch manufacturing record templates, validation reports | blend uniformity, compression performance, dissolution |
| Packaging | blister line qualification, stability compatibility | moisture/light protection, sealing integrity |
| QC release testing | method validation and stability program | uniformity, dissolution, assay, impurities |
Key Takeaways
- Supply-chain risk is concentrated in the steroid hormones (levonorgestrel and ethinyl estradiol) because API impurity and stability controls are more stringent than for ferrous fumarate.
- Ferrous fumarate is comparatively commoditized, with more stable supply and easier qualification paths for qualified pharma-grade suppliers.
- For finished-dose tablets, contract manufacturing and packaging capability is a bigger determinant of launch success than API breadth, because blend uniformity, compression, and packaging-induced stability drive regulatory evidence.
- Procurement and compliance should map suppliers by three layers: APIs, finished-dose manufacturing, and packaging/distribution, with documentation tied to DMF and finished product filings.
FAQs
- What are the main criteria to qualify an API supplier for ethinyl estradiol in contraceptive tablets?
- How do impurity specifications for levonorgestrel affect generic or authorized generic approvals?
- What testing is most critical for tablet content uniformity when low-dose steroids are combined with ferrous fumarate?
- Which manufacturing steps for blister packaging most influence stability of hormone plus iron regimens?
- What change-control triggers are most likely when switching API suppliers for levonorgestrel/ethinyl estradiol products?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- FDA. Guidance for Industry: Changes to an Approved NDA or ANDA.
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