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Bulk Pharmaceutical API Sources for STALEVO 75
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Bulk Pharmaceutical API Sources for STALEVO 75
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Starshine Chemical | ⤷ Get Started Free | 2023-05-5H00538 | ⤷ Get Started Free |
| RR Scientific | ⤷ Get Started Free | R6267804 | ⤷ Get Started Free |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for: STALEVO 75
Introduction
STALEVO 75 combines entacapone, levodopa, and carbidopa into a single formulation for the management of Parkinson’s disease. At the core of this medication are three active pharmaceutical ingredients (APIs): entacapone, levodopa, and carbidopa. The sourcing of high-quality APIs is critical for pharmaceutical manufacturers aiming to ensure product safety, efficacy, and regulatory compliance. This article provides a comprehensive overview of bulk API sources for STALEVO 75, including key suppliers, quality considerations, and industry trends.
Overview of API Components in STALEVO 75
Entacapone
Entacapone inhibits catechol-O-methyltransferase (COMT), extending the half-life of levodopa. It is a selective, reversible COMT inhibitor with molecular formula C13H18N4O5.
Levodopa
Levodopa (L-DOPA) is a dopamine precursor critical for symptom management in Parkinson’s. Its molecular formula is C9H11NO4.
Carbidopa
Carbidopa enhances levodopa’s central nervous system availability by inhibiting peripheral decarboxylation, with a molecular formula of C12H14N2O4.
Major API Suppliers for STALEVO 75
1. Entacapone API Suppliers
Eli Lilly and Co.
- Details: As the original developer of entacapone, Eli Lilly supplies bulk APIs to qualified manufacturers, often through licensing or third-party contract manufacturing arrangements.
- Quality Standards: GMP-compliant, with extensive documentation and regulatory approval worldwide.
- Availability: Limited to partners with approved manufacturing and quality compliance.
Zhejiang Topfond Pharmaceutical Co., Ltd.
- Location: China.
- Market Position: Noted for producing high-purity entacapone APIs compliant with international standards.
- Certifications: GMP, ISO 9001.
Sichuan Jingshun Bio-Pharmaceutical Co., Ltd.
- Location: China.
- Strengths: Competitive pricing and large-scale manufacturing capabilities.
- Quality: GMP-certified, with robust QC testing.
2. Levodopa API Suppliers
Jiangsu Hengrui Medicine Co., Ltd.
- Market Presence: Leading Chinese manufacturer of levodopa, compliant with international pharmacopoeias.
- Certifications: GMP, ISO 9001, and other regional approvals.
- Quality Focus: Strict control over raw materials and synthesis processes.
AbbVie Inc. (formerly licensed from other suppliers)
- Details: Historically, AbbVie has supplied levodopa APIs directly or via licensing agreements.
- Availability: Limited to approved partners; proprietary manufacturing processes.
Sun Pharmaceutical Industries Ltd.
- Location: India.
- Position: Major supplier of generic APIs, including levodopa, with extensive manufacturing facilities.
- Standards: WHO GMP, US FDA, and EMA compliant.
3. Carbidopa API Suppliers
Yunnan Baiyao Group Co., Ltd.
- Location: China.
- Strengths: Comprehensive portfolio of amino acids and decarboxylase inhibitors.
- Certifications: GMP, ISO 9001, with focus on bioavailability and purity.
Novartis AG
- Details: Historically involved in supplying high-quality carbidopa to licensed manufacturers.
- Availability: Through licensing agreements and authorized distributors.
Suzhou North Nova Pharmaceutical Co., Ltd.
- Location: China.
- Capabilities: Large-scale GMP production, consistent quality controls.
Quality and Regulatory Considerations
- GMP Compliance: Ensures APIs meet rigorous quality standards, essential for products like STALEVO 75 associated with CNS activity.
- Certifications: Suppliers should possess certifications such as FDA, EMA, or equivalent regional GMP approvals.
- Documentation: Manufacturers must verify Certificates of Analysis (COA), Stability Data, Impurity Profiles, and Batch Records.
- Raw Material Control: Verification of starting materials, synthesis processes, and adherence to pharmacopoeial standards (USP, EP, JP) is crucial.
Industry Trends and Challenges in API Sourcing
Globalization of Supply Chains
The supply chain for APIs, especially from China and India, continues to expand, offering cost-advantages but raising concerns regarding quality consistency and regulatory compliance. Many Western manufacturers are now integrating Quality by Design (QbD) principles and audit programs to monitor suppliers.
API Policy and Regulatory Dynamics
Stringent regulations post-2019, especially during the COVID-19 pandemic, emphasize the need for robust quality control and transparency in API sourcing. Countries are promoting on-shore manufacturing and developing strategic API reserves.
Supply Chain Disruptions
Pandemic-related logistics and geopolitical issues increasingly threaten API continuity, prompting manufacturers to diversify suppliers and establish dual sourcing paths.
Conclusion
The procurement of APIs for STALEVO 75 involves a complex network of global suppliers committed to maintaining quality and compliance. Leading Chinese and Indian manufacturers dominate the market, offering competitively priced, GMP-compliant APIs. Strategic partnerships and rigorous due diligence are essential for pharmaceutical companies to ensure the integrity of their supply chains and maintain regulatory approvals worldwide. As the industry evolves, embracing diversification, technological innovation, and transparent supplier audits will be critical to ensuring continuous, high-quality API supply for Parkinson’s disease therapies.
Key Takeaways
- Secure API sources from GMP-certified, regulatory-compliant suppliers with verifiable documentation.
- Diversify supply chains to mitigate risks from geopolitical or logistical disruptions.
- Prioritize suppliers with proven track records in high purity and consistent quality for APIs used in CNS treatments.
- Monitor industry trends toward on-shoring and strategic API reserves to safeguard supply stability.
- Incorporate robust quality agreements and audit protocols to ensure adherence to international standards.
FAQs
Q1: What are the primary regions supplying APIs for STALEVO 75?
A: China and India dominate API manufacturing, with significant contributions from companies in China (Zhejiang Topfond, Sichuan Jingshun, Yunnan Baiyao) and India (Sun Pharmaceutical, others).
Q2: How does API quality impact the safety and efficacy of STALEVO 75?
A: High-quality APIs ensure consistent potency, minimize impurities, and reduce adverse effects, which are critical for CNS-active drugs like STALEVO 75.
Q3: Are there concerns regarding API supply chain security?
A: Yes; reliance on suppliers from regions with geopolitical or logistical challenges can impact supply stability. Diversification and strategic stockpiling are recommended.
Q4: What regulatory standards should API suppliers meet?
A: Suppliers should be GMP-compliant and certified by recognized authorities such as the FDA, EMA, or equivalent regional agencies.
Q5: Can bulk APIs for STALEVO 75 be sourced from generic manufacturers?
A: Yes, if the supplier meets quality and regulatory requirements; however, original developer APIs (e.g., from Eli Lilly) are generally licensed and may not be available for bulk purchase outside licensing agreements.
References
[1] Generic API manufacturer data and certifications.
[2] Regulatory agency guidelines on API quality standards.
[3] Industry reports on supply chain trends in pharmaceutical APIs.
[4] Pharmacopoeial standards (USP, EP, JP).
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