Last updated: July 31, 2025
Introduction
STALEVO 200 is a combination medication primarily prescribed for managing Parkinson’s disease. Its composition includes levodopa, carbidopa, and entacapone, aimed at enhancing motor function by increasing dopamine levels in the brain. With growing global demand for effective Parkinson’s treatments, identifying reliable suppliers for STALEVO 200 is critical for healthcare providers, pharmaceutical distributors, and manufacturers seeking consistent quality and supply security.
This article thoroughly examines the key suppliers involved in the manufacturing and distribution of STALEVO 200, their manufacturing capabilities, regulatory compliance, geographic reach, and strategic considerations for stakeholders.
Overview of STALEVO 200 Composition and Market
STALEVO 200 contains a higher dosage of entacapone (200 mg per tablet), often used in advanced Parkinson’s disease stages. Its formulation is licensed by Novartis, which markets the brand globally. Because of the patent landscape and manufacturing complexities, external suppliers and generic manufacturers have entered the market, providing alternative sourcing options, particularly in regions with limited access to branded medications.
Primary Original Equipment Manufacturers (OEMs)
Novartis AG
As the patent holder, Novartis is the primary manufacturer and global distributor of STALEVO 200. The company operates large-scale pharmaceutical manufacturing facilities adhering to Good Manufacturing Practices (GMP), with known facilities in Switzerland, India, and other regions. Novartis maintains strict quality control standards, aligned with international regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and DMFs (Drug Master Files) to ensure safety, potency, and purity[1].
Supply Chain & Distribution:
Novartis deploys a complex supply chain network, including regional manufacturing plants and distribution centers, to ensure availability in North America, Europe, Asia, and other markets. They typically handle the formulation, packaging, and direct distribution, especially for branded STALEVO 200.
Generic Manufacturers and Contract Manufacturing Organizations (CMOs)
The expiration of patents in various jurisdictions has led to a surge in generic manufacturing. These companies often partner with Original Equipment Manufacturers (OEMs) via outsourcing or through independent formulation development.
Generic Manufacturers of STALEVO 200
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Hetero Drugs Ltd. (India): Hetero is a leading pharmaceutical manufacturer specializing in complex generics and controlled-release formulations. The company produces levodopa, carbidopa, and entacapone individually and in combination, complying with international standards[2].
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Sun Pharmaceutical Industries Ltd.: A major supplier capable of manufacturing Parkinson’s combination therapies at scale, meeting GMP standards suitable for global markets[3].
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Macleods Pharmaceuticals: Produces generic versions and APIs (Active Pharmaceutical Ingredients) of Parkinson’s drugs, including combination formulations similar to STALEVO 200[4].
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Intas Pharmaceuticals: Focused on high-quality generics, with capabilities to produce entacapone and related components[5].
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Cipla Limited: A global player manufacturing multiple Parkinson’s medications, offering potential formulations comparable to STALEVO 200[6].
Contract Manufacturing Organizations (CMOs)
Several CMOs serve as third-party manufacturers for generic producers or as private label suppliers:
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Thermo Fisher Scientific: Offers API synthesis and formulation services, with FDA-approved facilities for Parkinson’s drugs.
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Vanscoy Labs and APIs: Specialized in custom synthesis of APIs for Parkinson’s disease treatments.
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Sandoz (Novartis offshoot): Provides manufacturing services for generics and biosimilars, including complex formulations.
Supply Chain and Geographic Distribution
While Novartis retains control over their proprietary formulations, generic and API suppliers are more geographically diversified, primarily located in:
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India: The largest producer, with a mature generics industry supporting global supply chains.
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China: Increasingly pivotal in API manufacturing, with large facilities producing entacapone and other APIs.
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Europe: Some high-quality producers focused on European markets, complying with stringent GMP standards.
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United States: Production mainly through licensed OEMs and CMOs, adhering to FDA regulations.
Regulatory Considerations
Suppliers of STALEVO 200 must navigate complex regulatory landscapes. The original product manufacturing by Novartis adheres to strict approval standards in numerous jurisdictions. Generic suppliers require approvals from respective agencies, often through Abbreviated New Drug Applications (ANDAs) in the US or equivalents elsewhere. The quality and consistency of APIs and formulations remain critical, especially given the importance of precise dosages in Parkinson’s treatments.
Key Factors Influencing Supplier Selection
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Regulatory Compliance: Suppliers must meet or exceed GMP standards; their facilities should have validated manufacturing processes.
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Quality Certifications: ISO certifications, US FDA approvals, European CME certifications are vital indicators.
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Capacity & Scalability: Suppliers’ ability to scale production to meet surged demand without compromising quality.
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Supply Chain Resilience: Geographic diversification reduces risks associated with geopolitical or logistical disruptions.
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Pricing & Economic Factors: Cost-effectiveness without sacrificing quality influences procurement decisions.
Future Outlook & Strategic Recommendations
As the global market for Parkinson’s therapies expands, supplier networks for STALEVO 200 will evolve, driven by patent expirations and increasing regional demand. Stakeholders should prioritize establishing relationships with diversified suppliers, including both established pharma companies and experienced CMOs, to secure uninterrupted supply chains.
Furthermore, continuous monitoring of regulatory updates ensures compliance, especially as new generics enter the market, potentially impacting pricing and patent landscapes in various jurisdictions.
Key Takeaways
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Seamless Supply Chain: Ensure sourcing from suppliers with proven GMP compliance, especially for APIs and formulations.
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Diversify Suppliers: Reduce dependency risks by engaging multiple manufacturers, particularly in India and China.
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Regulatory Vigilance: Confirm suppliers’ compliance with regional regulatory standards to prevent supply disruptions.
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Quality Assurance: Prioritize suppliers with rigorous quality controls and certifications for consistent drug efficacy and safety.
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Market Dynamics: Stay informed about patent expirations and emerging generic manufacturers to optimize procurement strategies.
FAQs
1. Who are the primary manufacturers of STALEVO 200?
The original manufacturer is Novartis AG. Several generic producers, including Hetero, Sun Pharma, Macleods, and Cipla, manufacture equivalent formulations, often sourcing APIs from key Asian suppliers.
2. Are generic versions of STALEVO 200 FDA-approved?
Many generic versions are approved via the FDA’s ANDA pathway, provided they demonstrate bioequivalence and meet GMP standards, though approval status varies by manufacturer and region.
3. Where are the main API suppliers for entacapone and related components?
The principal API suppliers are based in India and China, with large facilities capable of producing high-quality entacapone and related APIs at scale.
4. How can healthcare providers ensure the quality of supplied Parkinson’s medications?
By sourcing from suppliers with verified GMP certifications, regulatory approvals, and transparent supply chains, healthcare providers can ensure medication quality and safety.
5. What trends could impact future supply of STALEVO 200?
Patent expirations, advances in formulation technology, and geopolitical factors could influence supplier availability and pricing strategies in the coming years.
References
[1] Novartis. (2022). Annual Report.
[2] Hetero Drugs Ltd.. (2022). Product Quality Certifications.
[3] Sun Pharmaceutical Industries Ltd.. (2022). Global Market Report.
[4] Macleods Pharmaceuticals. (2022). API Manufacturing Standards.
[5] Intas Pharmaceuticals. (2022). Regulatory Approvals and Certifications.
[6] Cipla Limited. (2022). Product Portfolio and Manufacturing Capabilities.
