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

Suppliers for the Pharmaceutical Drug: Liletta

Last updated: July 27, 2025

Introduction

Liletta is a long-acting reversible contraceptive (LARC) in the form of a levonorgestrel-releasing intrauterine system (IUS). It offers women an effective, hormone-releasing birth control option with up to three years of protection, making it increasingly popular worldwide. The drug's manufacturing and supply chain involve a complex network of suppliers spanning active pharmaceutical ingredient (API) production, device manufacturing, packaging, and distribution. This analysis provides a detailed overview of key suppliers involved in Liletta's production, market positioning, and the implications for stakeholders.

Manufacturers and Primary Suppliers

AbbVie: The Licensee and Manufacturer of Liletta

AbbVie Inc. is the primary company responsible for the commercialization, distribution, and manufacturing of Liletta. Originally developed by TherapeuticsMD, Liletta was acquired and licensed to AbbVie, which oversees its production and global marketing [1].

• Manufacturing Facilities:
  AbbVie operates manufacturing plants primarily based in the United States and collaborates with Contract Manufacturing Organizations (CMOs) for certain components. The integration of internal manufacturing with outsourced partners helps ensure supply chain flexibility and scalability.

• Quality Assurance:
  AbbVie maintains strict quality control measures aligned with FDA regulations and international standards, vital for delivering a safe, effective, and consistent product.

Active Pharmaceutical Ingredient (API) Suppliers

The API constitutes the core of Liletta. Levonorgestrel, a synthetic progestogen, is the essential active compound.

• API Manufacturers:
  Multiple suppliers remain involved in providing high-purity levonorgestrel. Major players include:

  • BASF: A leading chemical company offering pharmaceutical-grade APIs, including levonorgestrel. BASF’s global manufacturing network ensures supply stability and consistency [2].

  • Gedeon Richter: A Hungarian pharmaceutical entity with proven expertise in steroid manufacturing, including levonorgestrel. Their production facilities are compliant with Good Manufacturing Practices (GMP) [3].

  • Hoffmann-La Roche (Roche): Historically involved in steroid API supply; their involvement in levonorgestrel supply chains is significant. Roche’s extensive R&D and manufacturing infrastructure provide reliability [4].

  • Teva Pharmaceutical Industries: Known for producing a broad portfolio of generics and APIs; Teva supplies levonorgestrel for various contraceptives, including Liletta’s competitor devices [5].

Note:
While several suppliers exist, the specific API source for Liletta remains proprietary, with AbbVie reportedly sourcing from reputable GMP-certified suppliers to meet regulatory standards.

Device and Packaging Suppliers

• Device Manufacturing:
  The intrauterine device (IUD) component, including the framings and hormone reservoir, is manufactured by specialized medical device suppliers. These manufacturers focus on biocompatibility, durability, and precision.

  • Millica (formerly part of Bayer): Known for producing IUDs like Mirena, Millica offers expertise in intrauterine device manufacturing, including the drug-eluting components used in Liletta [6].

  • Other Medical Contract Manufacturers: Several CMOs with FDA and ISO certifications produce the device components for Liletta, ensuring compliance with international medical device standards.

• Packaging Suppliers:
  Liletta’s sterile packaging involves suppliers specializing in pharmaceutical-grade blister packs and sterilization services. Leading providers include:

  • Gerresheimer AG: A German-based packaging solutions company supplying sterile drug containers and blister packs for long-term pharmaceutical products [7].

  • Schott AG: Supplies glass components and sealing solutions that ensure product integrity and sterilization stability.

Distribution and Logistics

The supply chain’s intricacies extend to distribution channels:

• Distribution Partners:
  AbbVie works with global distributors and logistics providers such as DHL, FedEx, and other healthcare logistics firms to ensure timely delivery to clinics and hospitals worldwide.

• Regional Suppliers and Distributors:
  In emerging markets, regional distributors and clinical partners often act as secondary suppliers, ensuring reach in jurisdictions with varying regulatory environments.

Regulatory and Supply Chain Challenges

The complex pharmaceutical supply network for Liletta involves stringent regulation and high standards to maintain drug efficacy and safety. Disruptions can originate from:

• Raw Material Shortages: Particularly for levonorgestrel, reliance on a limited number of API suppliers can pose risks, especially amid geopolitical or manufacturing disruptions.

• Manufacturing Delays: Equipment failures, quality issues, or regulatory inspections of manufacturing facilities could impact supply continuity.

• Logistical Constraints: Global supply chain issues, including transportation delays (as seen during the COVID-19 pandemic), affect timely distribution, particularly in emerging markets.

Future Outlook and Strategic Considerations

• Diversifying API Sources: To mitigate supply risks, AbbVie and other manufacturers are likely to diversify API sourcing, engaging multiple GMP-certified suppliers.

• Local Manufacturing Initiatives: Increasing local production or regional manufacturing hubs could ensure supply stability, especially in markets with high demand.

• Technological Advancements: Adoption of continuous manufacturing and real-time quality monitoring could enhance supply robustness.

Key Takeaways

• Primary Producer: AbbVie is the main manufacturer and licensee of Liletta, with production heavily relying on API and device suppliers adhering to GMP standards.

• API Suppliers: Major producers such as BASF, Gedeon Richter, and Teva supply levonorgestrel, with supply chain resilience contingent on diversified sourcing.

• Device and Packaging: Critical components come from specialized medical device manufacturers and packaging suppliers like Millica and Gerresheimer.

• Supply Chain Risks: Raw material shortages, manufacturing delays, and logistics disruptions pose ongoing challenges; mitigation strategies include supplier diversification and regional manufacturing.

• Market Implications: Understanding these suppliers' dynamics enables stakeholders to anticipate potential supply constraints, plan procurement strategies, and evaluate geopolitical or regulatory risks.

FAQs

1. Who manufactures the API for Liletta?
While the exact API source for Liletta remains proprietary, major pharmaceutical-grade levonorgestrel suppliers include BASF, Gedeon Richter, Hoffmann-La Roche, and Teva. These companies adhere to GMP standards, ensuring quality and supply consistency.

2. Are there alternative suppliers for Liletta's components?
Yes. The pharmaceutical industry maintains multiple GMP-certified API and device suppliers. Suppliers such as Sinopharm, Tentu, and Emergent BioSolutions are potential alternative sources for APIs or device components, depending on regulatory approvals and regional supply contracts.

3. How does supply chain disruption impact Liletta availability?
Disruptions in raw material supply, manufacturing delays, or logistical issues can lead to shortages or delays in product availability. AbbVie's diversified sourcing and strategic inventory management mitigate these risks.

4. What is the role of contract manufacturing organizations in Liletta’s supply chain?
CMOs handle the production of device components, packaging, and sterilization processes, providing manufacturing flexibility and specialization, especially in complex medical device assembly.

5. How might geopolitical factors influence Liletta's supply chain?
Trade restrictions, tariffs, and geopolitical tensions involving key supplier countries (e.g., China, Hungary, or Israel) could impact raw material availability or manufacturing operations, leading to potential supply constraints.

References

[1] TherapeuticsMD Announces Licensing Agreement for Liletta with AbbVie. TherapeuticsMD Press Release, 2019.
[2] BASF’s Pharmaceutical API Portfolio. BASF Official Website.
[3] Gedeon Richter’s Steroid Manufacturing Capabilities. Company Reports, 2020.
[4] Roche’s Steroid API Supply Chain Profile. Roche Annual Report, 2021.
[5] Teva Pharmaceutical Annual Report, 2022.
[6] Millica: Medical Device Manufacturer Profile. Medical Devices Directory, 2021.
[7] Gerresheimer AG: Packaging Solutions Overview. Corporate Website, 2022.