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Suppliers and packagers for IMPLANON
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IMPLANON
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon | IMPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529 | NDA | Organon LLC | 78206-145-01 | 1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK | 2021-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for IMPLANON
Implanon (etonogestrel implant) suppliers: who manufactures, who supplies, and what supply-chain risks exist
Implanon is an etonogestrel contraceptive implant distributed under a Merck brand. Commercial supply has historically depended on a small set of implant manufacturing and packaging contractors plus Merck’s controlled distribution. Identifying specific “suppliers” requires mapping (1) the implant product holder and labeler, (2) implant manufacturing sites, (3) packaging/sterile handling steps, and (4) API and polymer/silicone-to-rod material sourcing.
Because only the drug name “Implanon” was provided and no jurisdiction, dosage form strength, or market (US/EU/UK/etc.) was specified, a complete supplier map cannot be produced with high confidence.
What company supplies Implanon and who is the product labeler?
Featured snippet answer: Implanon is supplied under Merck’s brand ownership and distribution, with manufacturing conducted by Merck and/or named contract manufacturing organizations on product labels and registration dossiers.
What does “supplier” mean for an implant contraceptive
Implanon supply chains typically break into these supplier categories:
- Product/labeler (marketing authorization holder and US FDA labeler)
- Implant drug-device manufacturing (rod + drug loading + assembly)
- Sterile packaging and distribution labeling
- Etogestrel API supply
- Device materials supply (rod, polymer components, inert excipients)
- Logistics contractors (cold chain rarely required, but controlled handling may apply)
Which manufacturers make the etonogestrel implant product (Implanon) in practice?
Featured snippet answer: The manufacturing footprint is not the same across all geographies; implant assembly and packaging are commonly performed at dedicated device-capable sites controlled by the brand owner and/or validated contract manufacturers.
Typical manufacturing steps that determine supplier list size
- Drug loading of etonogestrel into an implantable matrix or rod system
- Assembly into an implant delivery component
- Quality control release testing (drug content uniformity, implant dimensions)
- Packaging in an applicator system with patient leaflet inserts
- Distribution under controlled batch traceability
Who supplies etonogestrel API for contraceptive implants?
Featured snippet answer: Etongestrel API sourcing is usually handled by large-scale steroid or progestin API suppliers for branded contraceptives; the exact vendor list is product- and geography-specific.
API supply-chain dependencies
- Steroid intermediate sourcing (precursor supply continuity is often the highest risk)
- GMP compliance and drug substance traceability
- Change control: API supplier switches can trigger comparability work and regulatory notifications
What packaging and device applicator suppliers support Implanon?
Featured snippet answer: Device applicator and packaging are typically supplied by device manufacturing contractors or integrated device operations at the brand owner’s manufacturing network.
Why applicator suppliers matter
Implanon is a drug-device combination:
- Applicator reliability affects usability and market acceptance
- Device component material specs must match implant dimensions and insertion requirements
- Tamper-evident and batch-traceable packaging is a release gate
How do supplier substitutions work if an implant contractor changes?
Featured snippet answer: Substitutions are managed via change control with comparability testing, batch release validation, and regulatory filing depending on jurisdiction.
Common triggers for supplier changes
- Contract manufacturing relocation
- Yield or capacity constraints at an implant assembly line
- API sourcing changes due to plant shutdowns
- Packaging line conversions (label language, NDC updates, blister changes)
What supply-chain risks exist for etonogestrel implant products?
Featured snippet answer: The biggest practical risks are capacity bottlenecks in implant assembly/packaging and API precursor continuity, not retail distribution.
Risk pattern by layer
- API layer: upstream precursor risk and GMP issues
- Device layer: applicator component supply constraints
- Packaging: label/leaflet language conversions and serialization controls
- Release: slow release testing or QC capacity limits
Key Takeaways
- Implanon supply is anchored by Merck’s brand ownership and distribution, with manufacturing and packaging performed through Merck sites and/or validated contractors.
- A reliable “supplier list” depends on the specific market (US vs EU vs UK) and the implant strength/form (standard Implanon vs region-specific packaging).
- For implant contraceptives, the most important supplier categories are implant assembly, drug substance (etonogestrel) API, applicator/device components, and packaging/labeling release.
FAQs
- Who is the manufacturer of Implanon in the US market?
- Is Implanon manufactured by Merck or by contract manufacturers?
- Who supplies etonogestrel API for contraceptive implants?
- What companies make the Implanon applicator and insertion device components?
- How does a change in implant manufacturing site affect regulatory status and supply timelines?
References
- No citable sources were provided in the prompt.
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