Suppliers and packagers for LILETTA

LILETTA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229	NDA	Allergan, Inc.	0023-5858-01	1 TRAY in 1 CARTON (0023-5858-01) / 1 INTRAUTERINE DEVICE in 1 TRAY	2016-05-31

Liletta (levonorgestrel intrauterine system) supplier landscape: who makes the drug, device components, and commercial supply chain

Last updated: May 26, 2026

Liletta is a branded levonorgestrel-releasing intrauterine system (IUS) distributed by AbbVie. The commercial product is manufactured as a complete IUS drug-device combination, with supply constrained by specialized device manufacturing, sterile assembly, and drug-substance/drug-product integration. The supplier footprint is typically split across: (1) levonorgestrel and sterile product manufacturing, (2) the IUS device components and sterile packaging, and (3) finished-goods release and distribution.

Who supplies Liletta’s finished product and who are the key manufacturing sites?

Short answer: Liletta is manufactured at specialized sterile manufacturing and IUS-device assembly sites that support drug-device combination production, with final release and distribution under AbbVie’s commercial responsibility.

What does the term “supplier” mean for Liletta (drug-device system)?

For Liletta, “suppliers” usually map to three operational tiers:

1. Drug substance and drug product manufacturing (levonorgestrel-containing unit and sterile drug-device integration)
2. Device component suppliers (frame, inserter system parts, membrane/cores that form the rate-control reservoir and drug-loading interface)
3. Finished-goods sterile assembly, labeling, and packaging for distribution in the US market

What companies supply the Liletta IUD device and the inserter system components?

Short answer: The IUS core components and inserter assembly are produced through qualified device manufacturing partners with sterile assembly capability, using tightly controlled materials and process parameters.

What device components are typically supplier-separated?

The parts commonly attributed to distinct suppliers or manufacturing steps include:

• Sterile IUS frame and drug-containing reservoir assembly
• Rate-controlling structure that governs levonorgestrel release
• Insertion mechanism and delivery system (applicator/inserter)
• Packaging system (sterile barrier packaging and outer carton)

What supplier categories matter for Liletta risk and continuity?

For supply planning and vendor qualification, the relevant constraints are:

• Sterile assembly capacity for drug-device combinations
• Supplier control over polymer/inner components that affect release kinetics
• Validation capacity for aseptic processing, sterilization, and integrity testing

What are the AbbVie manufacturing and distribution responsibilities for Liletta?

Short answer: AbbVie holds commercial responsibility in the US, including distribution and branded product lifecycle management. Manufacturing is executed by qualified sites under current Good Manufacturing Practice.

Does AbbVie manufacture Liletta in-house?

Liletta’s supply chain is commonly structured so the sponsor manages quality systems and release, while manufacturing and sterile assembly occur at contracted or AbbVie-owned qualified sites. The key practical point for procurement is that the “supplier” at point-of-sale is AbbVie, while production suppliers are site-specific.

What does Liletta’s regulatory file imply about its supply chain?

Short answer: US FDA regulatory submissions require disclosed manufacturing information tied to each labeled strength, dosage form, and packaging configuration.

What to look for in FDA manufacturing disclosures

A supplier mapping is typically derived from:

• CMC/manufacturing site listings in the FDA application
• Labeling “Manufactured for/Distributed by” language
• NDA/BLA holder and site-specific manufacturing roles (manufacturing, packaging, sterilization, release)

How to identify Liletta suppliers for procurement, licensing, or sourcing due diligence?

Short answer: Use the combination of product label labeling language plus FDA manufacturing site disclosures to build a “tiered supplier” map.

Practical supplier-identification checklist for Liletta

• Extract “manufactured by” and “distributed by” text from the US carton and insert.
• Cross-reference with FDA application manufacturing site designations for the labeled drug-device configuration.
• Confirm sterile packaging and release roles (not just “packaging”).
• Map component procurement at the supplier level only if disclosed in filings or verified via quality agreements.

Key takeaway tables

Liletta supplier mapping framework (tiered)

Supplier tier	Typical supplier role	What impacts supply continuity
Finished-goods manufacturer	Sterile drug-device assembly and release testing	Aseptic/sterile capacity, batch release throughput
Device component manufacturing	Frame/reservoir and inserter system components	Material sourcing, device qualification timelines
Packaging supplier	Sterile barrier system, cartons, inserts	Sterile packaging line capacity and integrity validation
Sponsor/distributor	AbbVie distribution, labeling ownership	Forecasting, inventory allocation, regulatory commitments

Key Takeaways

• Liletta is a drug-device combination, so “suppliers” are best understood as manufacturing and sterile-assembly partners plus packaging/distribution roles, not a single generic commodity supplier.
• Supplier continuity is driven by sterile manufacturing capacity, device-component qualification, and validated release testing rather than only levonorgestrel API sourcing.
• For sourcing due diligence, map suppliers using product labeling language and FDA CMC manufacturing-site disclosures to build a tiered supply chain profile.

FAQs

1) Who is the marketing authorization holder for Liletta in the US?

AbbVie is the branded product distributor/holder of commercial responsibility in the US supply chain for Liletta.

2) Are Liletta suppliers the same as API suppliers for levonorgestrel?

No. The dominant constraints for Liletta supply are sterile drug-device assembly and device-specific component qualification, which can be separate from API sourcing.

3) What supplier bottlenecks most often disrupt IUS supply?

Sterile assembly line capacity, insertion-system applicator manufacturing, and validated sterile packaging throughput are common bottlenecks.

4) How can companies verify Liletta manufacturing sites for vendor qualification?

By reviewing the FDA application manufacturing-site listings and the US labeling text for “manufactured by” and packaging roles.

5) What parts of Liletta’s device are most sensitive to supplier changes?

Drug reservoir integration, rate-controlling structures, and the inserter/delivery system components due to performance and release-kinetics requirements.

References

1. U.S. Food and Drug Administration. Liletta (levonorgestrel) intrauterine system, labeling and product information in FDA database. (Accessed via FDA product resources).