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 for the Pharmaceutical Drug: KYLEENA

Last updated: July 28, 2025

Introduction
KYLEENA is a hormonal intrauterine device (IUD) designed for long-term contraception. Marketed under Bayer, KYLEENA combines a progestin, levonorgestrel, with a T-shaped plastic frame that is inserted into the uterus to prevent pregnancy. Its popularity stems from its efficacy, safety profile, and duration of use, which extends up to five years. Identifying primary suppliers and understanding the supply chain dynamics of KYLEENA is crucial for stakeholders, including healthcare providers, investors, and policymakers.

Manufacturing and Supply Chain Overview
As a regulated pharmaceutical product, KYLEENA's production involves multiple stages: active pharmaceutical ingredient (API) synthesis, device manufacturing, sterilization, packaging, and distribution. Bayer, headquartered in Germany, is the principal manufacturer and sole supplier of KYLEENA, maintaining strict control over production and distribution channels. The company’s global manufacturing facilities ensure compliance with medical device standards such as ISO 13485 and regulatory authorities like the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency).

Key Suppliers in the Supply Chain

1. Bayer AG
   Bayer is responsible for the complete manufacturing process of KYLEENA. This includes sourcing raw materials such as levonorgestrel and biocompatible polymers, manufacturing the IUD device, and quality control testing. Bayer has manufacturing plants in Europe, notably in Germany, and possibly in other regions to support global distribution.

2. Raw Material Suppliers
   The raw materials used in KYLEENA’s production include:

   • Levonorgestrel: A synthetically produced progestin, supplied by specialized chemical manufacturers. Major producers include companies like BASF, Teva Pharmaceuticals, and Sicor. These manufacturers often serve multiple pharmaceutical firms and provide high-grade APIs under strict quality standards.
   • Biocompatible Polymers: The plastic frame of KYLEENA is typically made from polyethylene or similar materials conforming to medical-grade standards. Suppliers include companies such as Evonik Industries and BASF that supply medical-grade polymers.

3. Component Manufacturers
   Specific components, such as delivery system parts, require precise manufacturing. Outsourcing to specialized contract manufacturing organizations (CMOs) may occur for components like inserters or packaging materials, especially when supporting global markets.

4. Sterilization and Packaging Suppliers
   Sterilization services, often outsourced, include ethylene oxide (EtO) sterilization for devices. Packaging suppliers supply sterile, tamper-evident packaging. Companies like Amcor and Gerresheimer are key global providers of pharmaceutical packaging solutions.

5. Distribution Partners
   Post-manufacturing, Bayer manages the distribution network across various regions, collaborating with logistics companies such as Kuehne + Nagel, DB Schenker, or DHL for efficient delivery worldwide. These logistics providers ensure compliance with cold chain and pharmaceutical storage standards.

Regional and Market-Specific Suppliers
While Bayer centrally manages production, regional distributors often serve as local suppliers, ensuring availability in different countries. They may source KYLEENA through Bayer’s regional warehouses or authorized distributors complying with local regulatory approvals.

Regulatory and Licensing Considerations
As a regulated medical device, KYLEENA's supply chain is tightly controlled. Bayer retains exclusive rights over manufacturing unless it establishes licensing agreements or partnerships with local manufacturers for regional production, particularly in markets with local manufacturing mandates (e.g., certain Asian or Latin American countries).

Emerging Trends and Supply Chain Risks
The ongoing global disruptions, such as supply chain bottlenecks during the COVID-19 pandemic, have heightened awareness of the vulnerabilities in the supply chain for medical devices like KYLEENA. Dependency on specific raw material suppliers or manufacturing facilities can lead to risks of shortages and delays. To mitigate these, Bayer and other stakeholders invest in multiple sourcing strategies and regional manufacturing alliances.

Conclusion
Bayer remains the primary and exclusive supplier of KYLEENA, overseeing the entire manufacturing process and global distribution. The supply chain incorporates raw material suppliers for levonorgestrel and polymers, component manufacturers, sterilization, packaging, and logistics providers. Ensuring product quality, regulatory compliance, and supply chain resilience is critical, especially amid geopolitical and logistical challenges. Stakeholders must maintain transparency, diversify supplier relationships where feasible, and track regulatory developments to uphold a steady supply of KYLEENA worldwide.

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Key Takeaways

• Bayer is the sole manufacturer and primary supplier of KYLEENA, controlling the entire supply chain.
• Raw material sourcing involves multiple high-quality suppliers for levonorgestrel and biocompatible polymers, with notable providers like BASF and Teva.
• External vendors are engaged for sterilization, packaging, and logistics, emphasizing the importance of integrated quality management.
• Supply chain resilience is vital; diversification and regional manufacturing partnerships help mitigate risks.
• Ongoing regulatory compliance and strategic planning are necessary to sustain global supply amidst geopolitical and logistical challenges.

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FAQs

1. Who manufactures KYLEENA globally?
Bayer is the exclusive manufacturer of KYLEENA worldwide, overseeing all stages from raw material sourcing to final product distribution.

2. How does Bayer ensure the quality of KYLEENA’s raw materials?
Bayer sources levonorgestrel and polymers from certified suppliers such as BASF and Teva, enforcing strict quality standards and supplier audits in compliance with international pharmaceutical regulations.

3. Are there regional alternative suppliers for KYLEENA?
Currently, Bayer primarily relies on centralized manufacturing. However, regional licensing agreements or partnerships with local manufacturers may exist to facilitate local production in certain markets.

4. What are the biggest supply chain challenges for KYLEENA?
Disruptions in raw material supply, global logistic constraints, regulatory hurdles, and geopolitical tensions pose risks to timely manufacturing and distribution.

5. How is Bayer addressing supply chain risks for KYLEENA?
The company employs diversified sourcing, regional manufacturing collaborations, and robust logistics networks to enhance supply chain resilience and meet global demand.

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References
[1] Bayer KYLEENA Product Information. Bayer AG.
[2] Global API Suppliers for Hormonal Contraceptives. Chemical & Pharmaceutical Industries Data.
[3] ISO 13485 Medical Device Standards. International Organization for Standardization.
[4] EMA and FDA Medical Device Regulations. European Medicines Agency and U.S. Food and Drug Administration.