Suppliers and packagers for KYLEENA

KYLEENA

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	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-424-01	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)	2016-09-19
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-424-08	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)	2016-09-19
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-424-71	1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)	2016-09-19

Suppliers and packagers for KYLEENA

Last updated: May 24, 2026

Kyleena (levonorgestrel) IUD suppliers: who makes Kyleena and key upstream manufacturers

Kyleena is a branded levonorgestrel intrauterine system (LNG-IUS). Public supply chain visibility for the “Kyleena” finished device points to Bayer as the brand owner/labeler in the US; the upstream supplier list is narrower in publicly indexed sources. The most reliable, consistently citable “supplier” information centers on the labeler/manufacturer of record for the device and the primary manufacturing entities tied to FDA device establishment data.

Who is the labeler and finished-device manufacturer for Kyleena (levonorgestrel IUD)?

US labeling (device manufacturer/labeler): Kyleena is marketed in the US by Bayer (brand owner/US labeler). FDA device registration data typically ties the finished device to Bayer-affiliated manufacturing sites listed under the device establishment.

Practical sourcing implication: For procurement, licensing, or litigation diligence, the legal “supplier” starting point is the FDA device listing and device establishment record for Kyleena, not standalone component vendors.

Where do you find the authoritative “manufacturer of record” for Kyleena?

1. FDA Device Registration and Listing (DRLM)
2. FDA UDI/labeler data (for the specific NDC/label configuration used in the market)
3. Global regulatory product dossiers (EU national competent authorities, if needed for non-US procurement)

Which companies supply components for Kyleena (levonorgestrel IUD), such as reservoir, core, and inserter system?

Kyleena is an LNG-IUS consisting of a drug-containing core embedded in a device body and delivered via an introducer/inserter system. Component supplier names are often treated as confidential in regulatory submissions and commercial agreements, so publicly indexed “component-level suppliers” are less consistently discoverable than the finished-device manufacturer of record.

What is usually observable in public sources:

• The finished device manufacturing sites.
• The inserter/packaging manufacturing sites when disclosed in establishment records or packaging labeling.
• Limited contract manufacturing disclosures in device establishment listings.

What usually is not reliably observable publicly:

• Specific “who makes the levonorgestrel core/reservoir” at the subcomponent level.
• Specific resin, drug-loaded core, or inserter mechanism suppliers unless they appear in FDA establishment records by facility.

Procurement takeaway: Build supplier lists from FDA establishment data by Kyleena labeler/UDI, then map each facility to contract roles (device assembly vs. packaging vs. drug-device integration), using facility-level evidence rather than press sources.

How many manufacturing sites supply Kyleena worldwide and how is capacity split?

A defensible count requires facility-by-facility extraction from FDA device establishment registration and (separately) manufacturing authorization records outside the US. Public, consolidated “worldwide supplier count” is not consistently available in one page.

What you can do from a compliance and sourcing standpoint (without speculation):

• Use the labeler and Kyleena UDI/NDC configurations to pull the exact FDA-registered manufacturing establishments for the product.
• Identify whether multiple establishments are listed under the same labeler for:
  • Sterilization
  • Device assembly
  • Packaging and labeling
  • Drug-device integration steps

Which FDA registrations identify Kyleena suppliers (device establishments) and what roles do they play?

Supplier identification method:

• Start with the labeler and product entry for Kyleena in FDA’s Device Registration and Listing system.
• Record each listed establishment name, address, and device manufacturing/processing activity codes where available.
• Translate establishment roles into a supply chain map:
  • Manufacturing/processing
  • Sterilization
  • Packaging and labeling

Key business point: In disputes and audits, the relevant “supplier” is the entity performing the registered manufacturing/processing activity tied to the device listing, not just the marketing brand.

Who supplies Kyleena’s levonorgestrel drug substance for the IUD?

The LNG-IUS’s drug component is levonorgestrel. However, publicly available supplier attribution for the drug substance (the levonorgestrel API producer) is not consistently linked to Kyleena device establishment listings. In practice:

• API sourcing can change over time due to GMP qualification and supply continuity.
• Device submissions may not publish API supplier names as a current, evergreen list in a way that supports a single fixed “Kyleena API supplier” claim.

Best-evidence approach: Treat the labeler/manufacturer-of-record as the procurement anchor, then use:

• DMF references (where publicly indexed) tied to the product submission,
• or facility-level evidence from regulatory filings, to name API sources where such naming is explicit.

Does Kyleena use contract manufacturing, and what are the common contract supplier models?

For device-drug combination products like LNG-IUS, the common contract manufacturing patterns are:

• Contract assembly of the IUD frame and inserter packaging under the brand owner’s QMS.
• Contract sterilization and final packaging.
• Contract manufacture of subassemblies (for example, inserter components), while the integrated drug-device assembly remains tightly controlled.

Publicly defensible evidence is establishment-based (FDA device establishment records), because that shows who is authorized to manufacture/process/sterilize/pack the specific marketed device.

Are there biosimilar or generic suppliers for Kyleena that compete on supply?

Kyleena is a device product. “Generics” in the usual FDA drug sense are not a direct analog for IUDs. Competition typically comes from:

• Other LNG-IUS products (different brands with similar indications)
• Different devices delivering levonorgestrel (dose and size differ)
• Off-patent procedural alternatives (other contraceptive modalities)

Supply implication: When market share shifts, the “supplier” story usually changes by brand transition, not by a universal generic supply chain.

How does Kyleena’s supply chain compare with other levonorgestrel IUD brands (Mirena, Liletta, Skyla)?

Comparable LNG-IUS products often share some manufacturing ecosystem traits:

• Manufacturer of record is brand owner (commonly a pharma/device company).
• FDA device establishment records show facility-by-facility roles for each brand.
• Component supply chains differ by device design and dosing.

Analytical frame for diligence: For each comparator (Mirena, Liletta, Skyla), extract:

• labeler/manufacturer of record,
• FDA-registered establishments,
• packaging/sterilization processing roles.

Then compare overlap in manufacturing sites. Overlap can indicate shared contract manufacturing or shared packaging lines.

Which upstream constraints most affect Kyleena supply (regulatory, device sterilization, or drug-device integration)?

For LNG-IUS supply continuity, the main constraints tend to be:

• Sterilization capacity for finished devices
• GMP integration steps for combining the drug component with the device structure
• Packaging and labeling lead times, including UDI mark requirements
• Quality system deviation resolution at the registered manufacturing establishments

This constraint map is derived from device manufacturing operational realities and is best validated by establishment inspection history and field quality communications, which are tied back to the manufacturing establishments listed for the product.

---

Key Takeaways

• The most defensible “Kyleena suppliers” are the FDA-registered manufacturing establishments tied to the Kyleena labeler/manufacturer of record (Bayer).
• Public sources usually support finished-device and facility-level supplier identification, while component-level supplier names are less consistently disclosed.
• For procurement, licensing, or dispute work, the supplier list should be built from FDA Device Registration and Listing records tied to the specific Kyleena listing/UDI configurations rather than from general levonorgestrel IUD assumptions.

FAQs

1. How do I identify the legal manufacturer of record for Kyleena in the US?
   Use FDA Device Registration and Listing (labeler and product entry) and the corresponding establishment records.

2. Where can I find Kyleena’s FDA-registered manufacturing establishments and processing roles?
   FDA Device Registration and Listing for Kyleena’s device listing under the relevant labeler and UDI/NDC configuration.

3. Are API suppliers for levonorgestrel publicly listed for Kyleena?
   Not in a single consistent public place; it typically requires mapping to submission-linked documentation such as DMF references where available.

4. Can multiple manufacturing sites supply Kyleena under the same brand?
   Yes, and the only reliable confirmation is the establishment list tied to the marketed Kyleena device listing.

5. How do supplier ecosystems differ between LNG-IUS products like Kyleena and Mirena?
   Differences are best proven through facility overlap and labeler establishment lists for each product extracted from FDA registration records.

---

References

1. U.S. Food and Drug Administration. Device Registration and Listing (DRLM) database. FDA.
2. U.S. Food and Drug Administration. FDA UDI and labeler/product data (as applicable to Kyleena listings). FDA.