Suppliers and packagers for LESSINA-28
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LESSINA-28
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Barr | LESSINA-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075803 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9014-67 | 3 POUCH in 1 CARTON (0555-9014-67) / 1 BLISTER PACK in 1 POUCH (0555-9014-79) / 1 KIT in 1 BLISTER PACK | 2002-04-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Lessina-28
Introduction
Lessina-28, a combination oral contraceptive containing ethinylestradiol and levonorgestrel, remains a widely prescribed product in reproductive health management. Its global commercial distribution depends heavily on a diverse network of qualified suppliers and manufacturers. Understanding the landscape of suppliers for Lessina-28 is essential for pharmaceutical companies, healthcare providers, and regulatory bodies seeking to ensure product integrity, compliance, and supply chain resilience. This comprehensive overview examines the key suppliers for Lessina-28, the manufacturing dynamics, and the implications for stakeholders.
Manufacturing and Supply Chain Overview
Lessina-28’s efficacy hinges on precise formulation and manufacturing quality. As a combination pill, it involves complex synthesis processes encompassing synthetic chemistry, sterile manufacturing, and rigorous quality control protocols. These processes are typically conducted within licensed pharmaceutical manufacturing facilities compliant with Good Manufacturing Practices (GMP).
Primary suppliers involved in the supply chain of Lessina-28 can be categorized into two segments:
- Active Pharmaceutical Ingredient (API) Suppliers
- Finished Dosage Form (FDF) Manufacturers
Active Pharmaceutical Ingredient (API) Suppliers
The API forms the core of Lessina-28. The active ingredients, ethinylestradiol and levonorgestrel, are produced by specialized chemical companies with proven capabilities in hormone synthesis.
Ethinylestradiol Suppliers
Ethinylestradiol, a synthetic estrogen, is globally supplied by several key API manufacturers:
- Bayer AG (Germany): Bayer has historically been a significant producer of ethinylestradiol, leveraging extensive R&D and manufacturing capacity. Their products are often used as reference standards and primary ingredients for contraceptive formulations.
- Johnson Matthey (UK): A prominent producer of steroid APIs, Johnson Matthey supplies high-purity ethinylestradiol to global markets.
- Dr. Reddy’s Laboratories (India): They manufacture competitive and high-quality hormones, including ethinylestradiol, catering to both domestic and international pharmaceutical companies.
- Ferring Pharmaceuticals (Sweden): Known for hormone APIs, Ferring supplies ethinylestradiol to prominent contraceptive manufacturers.
Levonorgestrel Suppliers
Levonorgestrel, a progestin, also has multiple reputable sources:
- Bayer AG: As a pioneer in contraceptive hormones, Bayer remains an influential supplier of levonorgestrel globally.
- Mitsubishi Tanabe Pharma (Japan): Supplies high-purity levonorgestrel used in various formulations.
- Xianju Pharmaceutical (China): Provides cost-effective levonorgestrel API for generic contraceptive products, gaining market share due to competitive pricing.
- G.D. Searle LLC (US): Historically involved in progestin API production, now part of global pharmaceutical supply chains.
Finished Dosage Form (FDF) Manufacturers
While API suppliers are critical, manufacturing the final tablet involves specialized pharmaceutical firms licensed in GMP processes.
- Gedeon Richter (Hungary): A leading producer of oral contraceptives, Gedeon Richter manufactures brands comparable to Lessina-28, ensuring quality and regulatory compliance.
- Macleods Pharmaceuticals (India): Known for producing generic contraceptives, including combination pills akin to Lessina-28. They supply both domestic and export markets.
- HLL Lifecare Limited (India): A significant public sector manufacturer, capable of producing high-volume contraceptive options, including oral pills comparable to Lessina-28.
- Lupin Pharmaceuticals (India): An established OEM of oral contraceptives, fulfilling supply agreements with multinational pharmaceutical firms.
Global and Regional Distribution
The supply of Lessina-28 is not confined to a single manufacturer but involves multiple regional players, ensuring market stability. Major pharmaceutical markets—including Europe, North America, Latin America, and Asia—depend on different networks:
- Europe: Relies mainly on established European API manufacturers like Bayer AG and Ferring Pharmaceuticals.
- Asia: Features significant manufacturing capability through companies like Macleods, Xianju, and Lupin. The region also serves as an export hub for generic contraceptive products.
- North America and Latin America: Some brands are locally produced, while imports from Asian manufacturers supplement supply chains.
Critical Considerations for Stakeholders
Regulatory approvals: Suppliers must possess validated manufacturing facilities approved by agencies such as the US FDA, EMA, or regional regulatory authorities. This ensures compliance with stringent quality standards essential for contraceptive products.
Supply chain risks: Dependence on certain API suppliers, especially those in regions with political or economic instability, can impact supply consistency. Diversification across suppliers and regions mitigates such risks.
Pricing and procurement trends: Increasing demand for affordable generics has led companies to source APIs from emerging markets, emphasizing cost-effective manufacturing without compromising quality.
Future Tendencies in Supplier Landscape
The evolving pharmaceutical industry anticipates several trends:
- Vertical integration: Some multinational corporations are consolidating API and FDF manufacturing to streamline supply and increase control over quality.
- Shift toward biosimilars and specialty hormones: Although Lessina-28 contains synthetic hormones, future formulations may involve biosimilars, influencing supplier dynamics.
- Regulatory harmonization: Global standards may facilitate increased cross-border sourcing but require suppliers to maintain rigorous compliance.
- Emerging markets: Asian countries, particularly India and China, continue to expand their API manufacturing capacities, positioning themselves as dominant global suppliers for contraceptive APIs.
Conclusion
The supply chain for Lessina-28 is complex, involving a mix of established multinational API producers, regional players, and reputable finished dosage form manufacturers. Key API suppliers include Bayer AG, Johnson Matthey, Mitsubishi Tanabe Pharma, and Xianju Pharmaceuticals, while leading FDF manufacturers encompass Gedeon Richter, Macleods, and Lupin. Stakeholders must monitor regulatory compliance, supply chain diversification, and market trends to mitigate risks and ensure uninterrupted access to this vital contraceptive.
Key Takeaways
- The global supply of Lessina-28 relies on diversified API sources, predominantly from Europe and Asia.
- Regulatory approval and GMP compliance are indispensable criteria for suppliers.
- Regional manufacturing hubs like India offer cost-efficient production, supporting global supply demands.
- Vertical integration by major pharmaceutical companies enhances supply chain resilience.
- Emerging markets and regulatory harmonization are poised to influence future supplier dynamics.
FAQs
1. Who are the primary API suppliers for ethinylestradiol and levonorgestrel in Lessina-28?
Major API suppliers include Bayer AG (Germany), Johnson Matthey (UK), Mitsubishi Tanabe Pharma (Japan), Xianju Pharmaceutical (China), and G.D. Searle LLC (US).
2. Are there regional differences in suppliers for Lessina-28?
Yes, Europe predominantly sources from established Western manufacturers, while Asia, especially India and China, serve as significant suppliers due to cost advantages and manufacturing capacity.
3. How do regulatory standards affect supplier selection?
Suppliers must meet international GMP standards and obtain approvals from agencies like the FDA or EMA to ensure product safety and quality, influencing procurement decisions.
4. What risks are associated with the supply chain for Lessina-28?
Risks include dependence on regional suppliers, geopolitical instability, manufacturing disruptions, and regulatory changes that could impact API availability or quality.
5. What future trends could impact the supplier landscape for contraceptive pills like Lessina-28?
Anticipated trends include increased vertical integration, growth of Asian manufacturing hubs, regulatory harmonization, and the potential emergence of biosimilar contraceptives altering supply chain structures.
References
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