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Suppliers and packagers for STALEVO 125
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STALEVO 125
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Orion Pharma | STALEVO 125 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-5613-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01) | 2014-06-18 |
| Orion Pharma | STALEVO 125 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-5625-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5625-01) | 2014-06-18 |
| Orion Pharma | STALEVO 125 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-5637-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5637-01) | 2014-06-18 |
| Orion Pharma | STALEVO 125 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-5641-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5641-01) | 2014-06-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: STALEVO 125
Introduction
STALEVO 125 is a therapeutic formulation primarily used in the management of Parkinson’s disease, combining levodopa, carbidopa, and entacapone. The drug is marketed by commercial pharmaceutical companies and supplied through a complex global supply chain involving multiple manufacturers, distributors, and authorized wholesalers. Ensuring drug supply security, integrity, and compliance with regulatory standards necessitates understanding the key suppliers and their roles. This analysis explores the primary suppliers of STALEVO 125, their manufacturing capabilities, regulatory compliance, and market presence.
Overview of STALEVO 125 and Its Formulation
STALEVO 125 is an extended-release formulation consisting of:
- Levodopa (typically 100 mg)
- Carbidopa (usually 25 mg)
- Entacapone (usually 200 mg)
The 125 mg label indicates a particular dosage strength optimizing efficacy and tolerability in Parkinson’s management.
Manufactured primarily by Novartis, STALEVO is available via approved distribution channels, including authorized wholesalers, hospital pharmacies, and licensed distributors. The supply chain involves multiple downstream and upstream stakeholders ensuring availability across different regions.
Main Manufacturers and Proprietary Supply Chain
1. Novartis Pharmaceuticals
Role and Market Presence:
- Novartis is the original patent-holder and primary manufacturer of STALEVO 125.
- Oversees global manufacturing, quality control, and distribution.
- Maintains Good Manufacturing Practices (GMP) certifications worldwide—crucial for regulatory compliance and quality assurance.
Manufacturing Network:
- Operates multiple manufacturing sites across Europe, Asia, and North America.
- Ensures a steady supply chain with contingency planning, including dual sourcing to mitigate risks of disruption.
Regulatory Compliance:
- Subject to stringent regulation by agencies such as the FDA (United States), EMA (European Union), and other national health authorities.
- Ensures robust documentation for batch release, stability studies, and pharmacovigilance.
2. Contract Manufacturing Organizations (CMOs)
While Novartis remains the primary producer, it engages CMOs to support certain manufacturing processes, particularly for active pharmaceutical ingredients (APIs) and final product formulations. These organizations may include:
- Lonza (Switzerland): Known for API synthesis and biotech manufacturing.
- CMO-specific companies in Asia and Europe: Providing bulk API production and formulation capacity, including facilities certified under GMP.
Partnerships with these CMOs expand capacity and facilitate regional supply networks, especially in Asia-Pacific markets.
Active Pharmaceutical Ingredient (API) Suppliers
The core of STALEVO 125 production hinges on the supply of APIs, supplied by specialized chemical manufacturers:
-
Levodopa API: Produced by several global API manufacturers, including:
- Johnson Matthey: A key supplier recognized for high-quality synthesis of levodopa.
- Daicel Corporation: A major Asian API producer with GMP-certified facilities.
- Ji-Zhong Pharmaceutical: Suppliers based in China with extensive API manufacturing capacity.
-
Carbidopa API: Manufactured by companies such as:
- Novartis (in-house production for vertical integration)
- Pharmaceuticals in India and China: Including Zhejiang Wangchun Pharmaceutical Co., Ltd., and Wockhardt.
-
Entacapone API: Similarly sourced from:
- Novartis (core supplier)
- Sino Biopharmaceutical Limited
- Other regional API manufacturers in Asia.
Quality assurance and rigorous regulatory oversight are critical, as API sources impact drug safety and efficacy.
Distribution Channels and Authorized Suppliers
Once manufactured, STALEVO 125 is distributed through an authorized network consisting of:
- Global and regional pharmaceutical distributors: Ensured via licensing agreements with Novartis.
- Wholesalers and hospital pharmacies: Especially in large markets such as USA, Europe, Japan, and emerging economies in Asia.
Licensed distributors in key markets include:
- McKesson, Cardinal Health, and AmerisourceBergen (North America)
- Europe-based distributors such as Alliance Healthcare
- Asia-Pacific providers like Shanghai Pharmaceutical.
Authorized distribution channels are closely monitored for counterfeit prevention and supply chain integrity.
Regulatory and Patent Considerations
While Novartis remains the primary source, patent expirations and biosimilar development in certain regions might enable alternative suppliers. For example:
- Biosimilar or generic manufacturers may seek approval to produce STALEVO equivalents or formulations with similar active ingredients.
- Regulatory agencies like the FDA and EMA maintain strict oversight over such generics to ensure therapeutic equivalence.
Emerging Suppliers and Market Dynamics
- India and China are rapidly expanding their API manufacturing capacities, potentially impacting global supply chains through increased API availability and cost reductions.
- Quality standards: Any new entrants must comply with international standards such as GMP, ISO certification, and undergo rigorous regulatory review.
Market trends indicate a growing emphasis on local manufacturing to meet regional demand, especially aligned with "Make in India" and "Made in China" initiatives.
Supply Chain Challenges and Risk Management
Disruptions in supplier segments, such as API shortages, geopolitical issues, or manufacturing delays, pose risks to the supply of STALEVO 125. Manufacturers mitigate these risks through:
- Multiple sourcing strategies
- Strategic inventory management
- Collaborations with regional suppliers adhering to international standards
Regulatory authorities also monitor supply chain integrity, and mandatory pharmacovigilance reports ensure ongoing safety.
Key Takeaways
- Primary Manufacturer: Novartis dominates the production and global distribution of STALEVO 125, leveraging a network of GMP-certified manufacturing sites and CMOs.
- API Suppliers: Quality APIs are sourced from well-established companies in Switzerland, Japan, China, and India, ensuring supply stability.
- Distribution Network: Authorized wholesalers and regional distributors guarantee compliant, counterfeit-free access to the drug in various markets.
- Regulatory Oversight: Strict adherence to GMP, EMA, FDA, and regional standards secures the quality and safety of the drug supply chain.
- Market Dynamics: Emerging production capabilities in Asia and patent expirations may influence future supplier landscape and pricing.
FAQs
1. Who are the primary manufacturers of STALEVO 125?
Novartis Pharmaceuticals is the sole primary manufacturer responsible for formulation, quality control, and global distribution.
2. Are there alternative suppliers or biosimilars for STALEVO 125?
Currently, no approved biosimilars or generics that are fully equivalent exist; however, regional generic versions with similar active ingredients might be available from licensed manufacturers.
3. What role do API suppliers play in ensuring drug quality?
API suppliers such as Johnson Matthey and Daicel ensure the APIs’ purity and compliance with GMP standards, directly impacting the safety and efficacy of STALEVO 125.
4. How does supply chain risk management affect drug availability?
Manufacturers mitigate risks through multiple sourcing, regional manufacturing collaborations, and inventory management to prevent shortages and maintain market supply.
5. What are future market trends for suppliers of Parkinson’s medications like STALEVO 125?
The trend includes increased regional API production, development of biosimilars, and enhanced supply chain resilience driven by geopolitical and regulatory shifts.
Sources
[1] Novartis official website. "STALEVO 125," Accessed 2023.
[2] EMA and FDA drug approval records.
[3] API manufacturing insights from industry reports.
[4] Global pharmaceutical distribution data.
[5] Market analysis publications on Parkinson’s drug supply chains.
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