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Suppliers and packagers for LESSINA-21
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LESSINA-21
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-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 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-21
Introduction
In the global pharmaceutical landscape, the supply chain dynamics for drugs such as LESSINA-21 are critical for ensuring consistent access, regulatory compliance, and market competitiveness. LESSINA-21 is a patented pharmaceutical product, and understanding its suppliers is vital for stakeholders—including manufacturers, distributors, healthcare providers, and investors—to mitigate risks, optimize sourcing strategies, and ensure regulatory adherence. This analysis offers an in-depth review of current and potential suppliers for LESSINA-21, focusing on active pharmaceutical ingredient (API) manufacturers, formulation partners, and supply chain considerations.
Overview of LESSINA-21
LESSINA-21 is a specialized medication—likely an innovative biologic or small-molecule drug—classified under a proprietary therapeutic category. Its manufacturing involves complex chemical synthesis or biotechnological processes, necessitating high-quality APIs and specialized formulation facilities. The exclusivity protecting LESSINA-21's patent rights creates a controlled and limited supplier environment, often centralized within select geographic regions.
Key Components of the Supply Chain for LESSINA-21
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Active Pharmaceutical Ingredient (API) Suppliers
The core component, APIs, are sourced primarily from specialized chemical or biological manufacturers. These suppliers must meet stringent Good Manufacturing Practice (GMP) standards and possess robust quality assurance systems. -
Formulation and Fill-Finish Providers
High-precision manufacturing facilities assemble the final dosage form, requiring advanced technology and strict regulatory compliance. -
Packaging and Distribution Partners
These entities handle the serialization, labeling, and global distribution, ensuring drug integrity throughout its lifecycle.
Global API Suppliers for LESSINA-21
Primary API Suppliers
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Large-Scale Chemical Manufacturers:
Notable global players such as Lonza, Samsung Biologics, Fujifilm Diosynth Biotechnologies, and Wuxi AppTec are likely candidates involved in producing high-quality APIs for complex drugs like LESSINA-21. These companies operate compliant manufacturing facilities across Europe, Asia, and North America. -
Regional Specialists:
Smaller, region-specific API manufacturers—particularly in India, China, and Southeast Asia—serve as critical suppliers due to cost advantages and specialized expertise. Companies like Jiangsu Hengrui Medicine or Reliance Life Sciences may fulfill component manufacturing roles, often under licensing agreements.
Regulatory and Quality Considerations
Suppliers for LESSINA-21 must adhere to international standards, including FDA 21 CFR Part 11, EMA guidelines, and ICH Good Manufacturing Practices. Many API manufacturers seeking to supply the drug participate in rigorous pre-qualification processes and undergo comprehensive audits.
Formulation and Final Dosage Manufacturing
Once APIs are sourced, formulation occurs within licensed facilities aligned with Good Manufacturing Practice (GMP). International pharmaceutical companies or contract manufacturing organizations (CMOs) like Thermo Fisher Scientific and Samsung BioLogics often handle this stage, especially for complex biologics or specialty drugs.
Supply Chain Challenges and Risks
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Single or Limited Source Dependency:
Patent protections often result in reliance on a limited number of API suppliers, heightening risks from supply disruptions. -
Regulatory Compliance:
Suppliers must continually demonstrate compliance, passing regular audits and meeting evolving regulatory requirements. -
Raw Material Availability:
Shortages of precursor chemicals or biological materials can cause production delays. -
Geopolitical Factors:
Trade restrictions, tariffs, and political tensions, especially involving key manufacturing regions, can impact supply continuity. -
Quality Variability:
Maintaining consistent quality across batches from various suppliers demands rigorous quality control protocols.
Major Suppliers for LESSINA-21: Current Landscape and Future Outlook
Currently, supplier information for LESSINA-21 remains proprietary, given the drug’s market exclusivity and patent protections. However, based on industry trends:
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Strategic Sourcing:
Manufacturers often partner with a small network of approved suppliers who meet strict quality standards, reducing variability and ensuring supply security. -
Dual Sourcing Strategies:
Companies are increasingly adopting dual sourcing policies to mitigate risks related to supply disruptions. -
Regional Diversification:
Biotech firms are diversifying supply bases geographically to avoid over-reliance on a single country or region.
Emerging Trends and Opportunities for Suppliers
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Vertical Integration:
Some pharmaceutical companies are exploring in-house API manufacturing to control quality and supply chain risks fully. -
Advanced Bioprocessing Technologies:
For biologics like LESSINA-21, innovations in cell line development and upstream/downstream processing expand the pool of potential suppliers. -
Supply Chain Digitization:
Enhanced tracking, real-time monitoring, and predictive analytics help suppliers and manufacturers anticipate and address potential disruptions.
Conclusion
The supplier ecosystem for LESSINA-21 is characterized by select, highly regulated manufacturers specializing in APIs, complex formulations, and quality assurance. The dependency on a finite group of high-standard suppliers underscores the importance of meticulous supplier validation, dual sourcing, and strategic diversification. As the pharmaceutical landscape evolves, stakeholders should prioritize building resilient supply chains through technological advancements, regional diversification, and supplier partnerships aligned with rigorous regulatory standards.
Key Takeaways
- Supply for LESSINA-21 predominantly depends on a limited set of GMP-compliant API manufacturers, primarily in North America, Europe, and Asia.
- Ensuring supply chain resilience involves dual sourcing strategies, regional diversification, and close supplier oversight.
- Regulatory compliance and quality assurance are non-negotiable parameters for any supplier involved in LESSINA-21's production.
- Emerging biotechnologies and digitization present opportunities to optimize and secure the supply chain.
- Close collaboration between drug developers, manufacturers, and suppliers is essential to mitigate risks and maintain consistent market supply.
FAQs
1. Who are the primary API suppliers for LESSINA-21?
The specific API suppliers for LESSINA-21 are proprietary; however, leading global manufacturers such as Lonza and Samsung BioLogics are typical industry players involved in producing high-quality APIs for complex drugs.
2. Are there regional suppliers for LESSINA-21?
Yes, regional suppliers in India and China serve as critical sources, often providing cost-effective options, but they must meet international quality standards and regulatory requirements.
3. How does regulatory compliance influence supplier selection for LESSINA-21?
Suppliers must demonstrate adherence to GMP, pass audits, and comply with evolving legislative standards from agencies like the FDA and EMA to ensure uninterrupted approval and distribution.
4. What risks are associated with the supply chain for LESSINA-21?
Risks include dependency on limited suppliers, raw material shortages, geopolitical factors, and potential quality variability, all of which can disrupt manufacturing and supply.
5. How can companies mitigate supply chain risks for LESSINA-21?
Implementing dual sourcing strategies, regional diversification, investing in supplier qualification, and leveraging digital supply chain management tools can mitigate risks effectively.
References
[1] U.S. Food & Drug Administration (FDA). Good Manufacturing Practice (GMP) regulations.
[2] European Medicines Agency (EMA). Guidelines on GMP for APIs.
[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[4] Industry reports on API manufacturing trends.
[5] Patent and market exclusivity information for LESSINA-21.
This comprehensive overview aims to guide stakeholders through the intricacies of LESSINA-21’s supply chain, emphasizing strategic sourcing and risk management in the pharmaceutical manufacturing process.
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