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Suppliers and packagers for STALEVO 150
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STALEVO 150
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 150 | 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 150 | 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 150 | 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 150 | 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 |
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Suppliers for the Pharmaceutical Drug: STALEVO 150
Introduction
STALEVO 150, a multifaceted pharmaceutical formulation primarily used in the management of Parkinson’s disease, is composed of levodopa, carbidopa, and entacapone. Its strategic importance in neurodegenerative therapy underscores the necessity for quality suppliers capable of meeting global demand with consistent efficacy and safety standards. This article analyzes key suppliers for STALEVO 150, considering their manufacturing footprint, regulatory compliance, supply chain reliability, and market presence.
Overview of STALEVO 150
Developed by Novartis, STALEVO 150 combines three active pharmacological ingredients to optimize dopaminergic pathways. Its formulation aims to enhance motor function, reduce "wearing-off" phenomena, and improve patient quality of life. Given its complex formulation involving multiple active ingredients, sourcing from suppliers with proven expertise in high-quality pharmaceutical manufacturing is critical.
Major Suppliers of the Active Pharmaceutical Ingredients (APIs)
Levodopa
Levodopa remains the cornerstone API in STALEVO 150. Its synthesis involves intricate chemical processes, necessitating robust manufacturing capabilities:
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Japan Tobacco Inc.
As a pioneer in pharmaceutical-grade APIs, Japan Tobacco supplies high-purity levodopa with extensive regulatory approvals. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), ensuring international compliance and consistent API quality [1]. -
Sun Pharmaceutical Industries Ltd.
Sun Pharma produces levodopa under stringent quality control parameters, with supplies currently exported extensively to major markets including the US, EU, and emerging economies. Their global manufacturing footprint supports reliable supply chains [2]. -
Jinan Dashi Biotechnology Co., Ltd. (China)
An emerging supplier, Jinan Dashi offers cost-effective levodopa, with GMP certifications. However, supply chain stability and regulatory acceptance remain evaluated by end-users [3].
Carbidopa
Carbidopa enhances levodopa bioavailability and reduces peripheral side effects. Key suppliers include:
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Cipla Limited (India)
Cipla manufactures high-quality carbidopa with a focus on compliance with USFDA and EMA standards. Their extensive API portfolio supports robust supply chains for Parkinson’s medications [4]. -
Nippon Chemiphar Co., Ltd. (Japan)
Known for pharmaceutical purity standards, Nippon Chemiphar supplies carbidopa widely used in neurological formulations globally. Their facilities meet strict GMP norms [5].
Entacapone
Entacapone prolongs the action of levodopa, critical for STALEVO 150's efficacy:
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Mochida Pharmaceutical Co., Ltd. (Japan)
As a leading manufacturer of COMT inhibitors like entacapone, Mochida maintains high standards validated through multiple regulatory approvals. -
Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A significant supplier with growing global market penetration, Hisun offers competitively priced entacapone meeting international standards, though supply security requires further validation.
Contract Manufacturing and Private Label Suppliers
Several pharmaceutical Contract Manufacturing Organizations (CMOs) are authorized to produce STALEVO 150 under licensing agreements:
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Alivio Therapeutics (India)
Provides formulation development and manufacturing services compliant with global standards for finished dosage forms, including fixed-dose combinations like STALEVO [6]. -
Sandoz (Novartis division)
As a global generics manufacturer, Sandoz may produce generic versions or similar formulations, contributing to supply resilience.
Distribution and Market Availability
Apart from direct manufacturers, distribution partnerships influence availability:
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Novartis’s Global Supply Network
Handles international logistics, ensuring product availability in key markets including North America, Europe, and Asia. -
Regional Distributors and Wholesalers
Localized suppliers and pharmacy chains play vital roles in drug distribution, often sourcing from certified primary suppliers to meet regulatory standards.
Regulatory Considerations and Supplier Reliability
Ensuring supplier compliance with pharmacopoeial standards and regulatory approvals (FDA, EMA, PMDA) remains paramount. The following criteria are critical:
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GMP Certification
All listed suppliers maintain GMP certifications, a pre-requisite for pharmaceutical API production and finished drug manufacturing. -
Quality Audits and Certifications
Regular audits by regulatory agencies or third-party organizations underpin supplier reliability. -
Supply Chain Continuity
Suppliers with diversified manufacturing sites and backup inventories mitigate risks of shortages, especially vital in longstanding therapies like Parkinson’s management.
Impact of Supply Chain Dynamics
Global geopolitical issues, disruptions caused by pandemics, and economic fluctuations influence supplier reliability. Recent years have seen:
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Diversification of Suppliers: Pharmaceutical companies increasingly diversify supplier bases across geographies to buffer against regional disruptions.
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Locally Sourced APIs: Some markets incentivize local API production to minimize import dependencies.
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Regulatory Harmonization: International initiatives like ICH guidelines promote harmonized standards, facilitating easier approval and quality assurance of imported APIs.
Key Manufacturers and Market Players
| Component | Major Suppliers | Regulatory Status | Notes |
|---|---|---|---|
| Levodopa | Japan Tobacco, Sun Pharma, Jinan Dashi | GMP-certified | Marketed widely, varying cost bases |
| Carbidopa | Cipla, Nippon Chemiphar | GMP-certified | Reliable for global supply |
| Entacapone | Mochida, Zhejiang Hisun | GMP-certified | Price competitiveness varies |
Future Outlook and Opportunities
The evolving landscape presents opportunities:
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Enhanced API Manufacturing Capabilities: Increasing capacity and quality standards for APIs, particularly in emerging markets, could enhance supply security.
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Supply Chain Digitization: Blockchain and IoT technologies enable transparency and traceability, ensuring quality and provenance.
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Strategic Partnerships: Collaborations between pharmaceutical companies and API manufacturers can streamline development and secure supply chains.
Key Takeaways
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Diversification Is Critical: Relying on multiple suppliers across regions such as Japan, India, and China ensures resilience for STALEVO 150 production.
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Regulatory Compliance Must Be Mandatory: Suppliers adhering to global GMP standards and holding necessary certifications offer safety and quality assurance.
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Supply Chain Visibility Enhances Reliability: Integrating digital tracking and quality audits minimizes risks of shortages and substandard products.
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Market Dynamics Influence Supply Strategies: Geopolitical factors and pandemic-related disruptions necessitate flexible, diversified sourcing policies.
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Emerging Suppliers Offer Cost Advantages: While they may provide competitive pricing, comprehensive validation of quality and regulatory compliance is essential before engagement.
FAQs
1. Who are the primary global suppliers of levodopa API for STALEVO 150?
Major suppliers include Japan Tobacco Inc., Sun Pharmaceutical Industries Ltd., and Jinan Dashi Biotechnology, with their manufacturing facilities compliant with international GMP standards.
2. How does supplier certification impact the quality of STALEVO 150?
Certifications such as GMP and regulatory approvals from agencies like the FDA and EMA ensure API quality, batch consistency, and safety, directly affecting final product efficacy.
3. What role do contract manufacturing organizations play in the supply of STALEVO 150?
CMOs facilitate formulation, production, and packaging of finished drugs, leveraging their manufacturing expertise to meet demand while maintaining quality standards.
4. How are geopolitical factors shaping API sourcing strategies?
Trade tensions and regional disruptions are prompting pharmaceutical firms to diversify supplier bases, build safety stocks, and increasingly source locally when feasible.
5. What emerging trends could influence the future supply of STALEVO 150?
Advances in API synthesis, digital supply chain management, and increased regulatory harmonization will likely improve supply reliability and product quality.
References
[1] Japan Tobacco Inc. Quality Standards, 2022.
[2] Sun Pharmaceutical Industries Ltd. Annual Report, 2022.
[3] Jinan Dashi Biotechnology Co., Ltd. GMP Certification Records, 2022.
[4] Cipla Limited. API Manufacturing Certifications, 2022.
[5] Nippon Chemiphar Co., Ltd. Regulatory Approvals, 2022.
[6] Alivio Therapeutics. Contract Manufacturing Services, 2022.
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