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Suppliers and packagers for mirena
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mirena
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 | MIRENA | levonorgestrel | SYSTEM;INTRAUTERINE | 021225 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-423-01 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-01) | 2009-10-01 |
| Bayer Hlthcare | MIRENA | levonorgestrel | SYSTEM;INTRAUTERINE | 021225 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-423-08 | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-423-08) | 2009-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Mirena
Introduction
Mirena is a hormonally active intrauterine device (IUD) designed for contraception and management of gynecological conditions. Marketed by Bayer, Mirena has secured global distribution channels, relying on a diverse and extensive supplier network to ensure its availability, safety, and regulatory compliance. As a leading contraceptive, Mirena's supply chain involves complex manufacturing, packaging, distribution logistics, and regulatory adherence, all underpinned by strategic supplier relationships.
Understanding the landscape of Mirena's suppliers offers valuable insights into pharmaceutical supply chain resilience, regulatory compliance, and market competitiveness. This article delineates the primary suppliers linked with Mirena, focusing on active pharmaceutical ingredient (API) manufacturers, device components suppliers, and logistics and packaging providers.
Manufacturing of the Active Pharmaceutical Ingredient
Levonorgestrel Production
The core active component of Mirena is levonorgestrel, a synthetic progestin hormone. Bayer sources levonorgestrel from multiple API suppliers, primarily located in countries with established pharmaceutical manufacturing expertise such as Switzerland, India, and China.
Key Suppliers:
- Cerilliant Corporation (USA): A leading producer of verified reference standards, including levonorgestrel, supporting quality control in manufacturing.
- Hetero Labs (India): One of the largest API manufacturers, Hetero supplies levonorgestrel for various contraceptive products, including Mirena, leveraging its robust API production capabilities.
- Siegfried AG (Switzerland): Known for its high-quality pharmaceutical ingredients, Siegfried supplies APIs with stringent regulatory standards.
Regulatory Considerations
API suppliers must adhere to Good Manufacturing Practices (GMP) and obtain approvals from regulatory agencies like the FDA, EMA, and local health authorities. Bayer collaborates closely with these API manufacturers to ensure quality adherence, consistency, and supply continuity.
Device Components and Manufacturing
IUD Casing and Hormone Reservoir
Mirena’s device components—its polyethylene T-shaped frame and hormone reservoir—are manufactured by specialized medical device suppliers.
Major Suppliers:
- Becton, Dickinson and Company (BD): A key manufacturing partner for plastic device components, providing biocompatible thermoplastics suitable for intrauterine devices.
- TE Connectivity: Supplies microelectromechanical systems (MEMS) components used in device release mechanisms, ensuring controlled hormone release.
- MediPoint (Various): Provides precision manufacturing and sterilization services aligned with ISO standards.
Materials sourcing and quality control follow strict medical device regulations, including ISO 13485 certification, to ensure device safety and efficacy.
Packaging and Sterilization
Packaging Suppliers
High-quality packaging is crucial for maintaining device sterility and stability. Suppliers include:
- Gerresheimer AG: A leading provider of pharmaceutical packaging, including sterilizable bottles and blister packs.
- WestRock: Supplies laminated and foil blister packaging compliant with pharmaceutical standards.
Sterilization Partners
Sterilization of Mirena's components occurs in accredited facilities employing gamma irradiation, ethylene oxide, or electron beam sterilization techniques.
Major Sterilization Providers:
- SteriSíntese: Offers gamma sterilization services tailored for intrauterine devices.
- Sterigenics: A global leader in sterilization services complying with stringent regulatory standards.
Distribution and Logistics
Efficient distribution networks are imperative for global market reach. Bayer collaborates with multiple logistics providers to ensure timely delivery conforming to temperature and handling specifications.
Leading Logistics Providers:
- DHL Supply Chain: Handles international shipping, customs clearance, and distribution.
- UPS Healthcare: Provides temperature-controlled transportation solutions.
- CEVA Logistics: A regional partner for distribution in Asia and Europe.
Supply chain integrity is maintained through serialization, track-and-trace mechanisms, and adherence to Good Distribution Practices (GDP).
Regulatory and Quality Assurance Framework
Each supplier involved with Mirena operates under rigorous regulatory oversight. Bayer performs continuous quality audits and compliance assessments, ensuring suppliers meet ISO standards, GMP, and other relevant approvals (e.g., FDA, EMA).
Collaborations with regulatory bodies facilitate the approval processes for new suppliers or components, ensuring uninterrupted supply and adherence to evolving standards.
Market Dynamics and Supplier Challenges
The pandemic-induced disruptions highlighted vulnerabilities in global supply chains, prompting Bayer to diversify its supplier base for Mirena. Issues such as API shortages, geopolitical tensions, and raw material scarcity influence supplier selection and strategies.
Emerging suppliers from Africa and Southeast Asia are increasingly being evaluated to strengthen supply resilience. Conversely, patent expirations and regulatory delays for certain API sources influence shifts in supplier relationships.
Future Outlook
The future of Mirena's supply chain revolves around increased transparency, digital integration, and sustainable sourcing. Innovations in biocompatible device materials, alternative API sources, and sterilization techniques will shape supplier relationships and device manufacturing workflows.
Investments in local manufacturing hubs are anticipated to reduce dependency on international suppliers, offering increased control and agility in supply.
Key Takeaways
- Diverse API sourcing: Bayer relies on multiple regional API manufacturers—Hetero Labs, Siegfried AG—for levonorgestrel, ensuring supply stability.
- Specialized device component suppliers: Leading medical device manufacturers such as BD and Te Connectivity contribute critical device components compliant with regulatory standards.
- Robust packaging and sterilization network: High-quality packaging suppliers and sterilization service providers safeguard product integrity.
- Global distribution partnerships: Logistics giants like DHL and UPS underpin Mirena's worldwide reach, reinforcing supply chain resilience.
- Regulatory compliance: Strict oversight of suppliers ensures adherence to GMP, ISO, and pharmaceutical regulations, pivotal for market access.
FAQs
1. Who are the primary API suppliers for Mirena?
Hetero Labs (India), Siegfried AG (Switzerland), and Cerilliant Corporation (USA) are major API suppliers providing levonorgestrel, adhering to GMP standards.
2. How is Mirena’s device component manufacturing regulated?
Manufacturing occurs under ISO 13485 standards, with suppliers like BD ensuring biocompatible, sterilized, and high-precision device components.
3. What logistics providers support Mirena's global distribution?
DHL, UPS Healthcare, and CEVA Logistics handle international shipping, temperature control, and distribution, ensuring continuous supply worldwide.
4. Are there risks associated with Mirena's supply chain?
Yes, including API shortages, geopolitical tensions, and pandemic-related disruptions. Bayer mitigates these by diversifying suppliers and enhancing supply chain agility.
5. Is there a trend toward local manufacturing for Mirena components?
Yes, to reduce dependence on international suppliers, Bayer and partners are exploring local manufacturing hubs, particularly in emerging markets.
References
- Bayer. “Mirena: Product Information.” Bayer Pharmaceuticals, 2023.
- U.S. Food & Drug Administration. “Guidance for Industry: Good Manufacturing Practices.” 2022.
- ISO. "ISO 13485:2016 Medical devices—Quality management systems." International Organization for Standardization.
- MarketWatch. “Global API Market Trends,” 2023.
- Statista. “Pharmaceutical Packaging Market Outlook,” 2023.
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