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Suppliers and packagers for CORLANOR
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CORLANOR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964 | NDA | Amgen Inc | 55513-813-28 | 28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01) | 2019-04-19 |
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143 | NDA | Amgen Inc | 55513-800-60 | 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60) | 2015-04-20 |
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143 | NDA | Amgen Inc | 55513-800-99 | 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) | 2015-04-20 |
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143 | NDA | Amgen Inc | 55513-810-60 | 60 TABLET, FILM COATED in 1 BOTTLE (55513-810-60) | 2015-04-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Corlanor
Introduction
Corlanor (ivabradine) is a prescription medication used primarily to treat chronic heart failure and certain cases of angina pectoris. As an essential cardiovascular therapeutic, the drug’s supply chain involves a network of manufacturers, raw material producers, and distribution entities. This article explores the key suppliers involved in Corlanor’s manufacturing, from active pharmaceutical ingredient (API) sourcing to finished product distribution, providing insights into the global supply landscape crucial for stakeholders and healthcare providers.
Corlanor’s Composition and Manufacturing Overview
Corlanor’s active ingredient, ivabradine, is a selective sinus node If current inhibitor that reduces heart rate without impacting blood pressure substantially. The drug’s formulation and production rely heavily on high-quality API supplies, stringent manufacturing processes, and regulatory compliance. The supply chain is characterized by a few dominant pharmaceutical manufacturers and API producers, primarily located in Europe, North America, and Asia.
Active Pharmaceutical Ingredient (API) Suppliers
1. Sanofi’s Role in API Production
Sanofi, the originator and exclusive marketer of Corlanor, also controls a substantial segment of its API production, primarily through its manufacturing facilities in Europe. Sanofi’s integrated supply chain ensures quality control, regulatory compliance, and reliable distribution channels. However, Sanofi’s API sources are also complemented by external suppliers to mitigate risk and optimize costs.
2. Contract Manufacturing Organizations (CMOs) and API Suppliers
Sanofi collaborates with multiple Contract Manufacturing Organizations (CMOs) and API producers to bolster its supply chain. Leading API manufacturers producing ivabradine include:
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Corden Pharma: A subsidiary of Johnson Matthey, Corden Pharma specializes in sterile and non-sterile APIs for cardiovascular drugs, including ivabradine. Their facilities are located across Europe and North America.
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Jubilant Life Sciences: Based in India, Jubilant provides API manufacturing services for cardiovascular and other therapeutic APIs, including ivabradine, leveraging cost-efficient production while adhering to international quality standards.
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Biocon: An Indian biopharmaceutical leader, Biocon’s capabilities extend to small molecule APIs, and they have a proven track record supplying cardiovascular API components to global markets.
3. Additional API Suppliers
Other API suppliers include regional players in Asia, such as Zhejiang Huahai Pharmaceutical (China), which supplies various cardiovascular APIs, although their direct involvement in ivabradine supply remains less documented. The global API market’s increasing decentralization emphasizes diversification to assure supply resilience amid geopolitical uncertainties.
Manufacturing Facilities and Regulatory Compliance
Manufacturers for Corlanor and its API must adhere to Good Manufacturing Practices (GMP), with facilities regularly inspected by agencies such as the FDA (United States Food and Drug Administration), EMA (European Medicines Agency), and analogous bodies worldwide. Sanofi’s combination of in-house and contracted manufacturing ensures compliance and capacity to meet global demand.
Distribution and Supply Chain Dynamics
Sanofi, leveraging its extensive distribution networks in Europe, North America, and Asia, ensures that Corlanor reaches authorized pharmacies and healthcare institutions globally. The supply chain's robustness depends on coordinated logistics, inventory management, and continuous quality assurance, especially considering the precision required for cardiovascular therapies.
Key Challenges in Supply
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Raw Material Scarcity: Disruptions in sourcing high-purity intermediates or raw materials can constrain production. Geopolitical tensions, trade restrictions, and pandemics impact API availability.
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Regulatory Approvals: Maintaining compliance across multiple jurisdictions is critical. Manufacturers must adapt to evolving regulatory standards, which influence production timelines and supply continuity.
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Manufacturing Capacity Constraints: Limited facilities dedicated to ivabradine production pose risks of supply shortages during surges in demand or production delays.
Emerging Trends and Strategic Considerations
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API Diversification: To mitigate supply risks, Sanofi and other stakeholders are increasingly diversifying API sourcing across regions, including India, China, and Europe.
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Shift towards Contracted Manufacturing: Outsourcing to CMOs offers flexibility and cost advantages, but requires rigorous oversight for quality and compliance.
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Supply Chain Resilience: Post-pandemic strategies focus on establishing buffer inventories, multiregional sourcing, and enhancing supply chain transparency with digital tracking tools.
Conclusion
The supply of Corlanor hinges on a complex, multi-layered network of API producers, contract manufacturers, and logistics providers. While Sanofi maintains control over critical aspects of its manufacturing, the dependency on external API suppliers, particularly in India and Europe, underscores the importance of diversification, regulatory adherence, and supply chain agility. This landscape will continue to evolve as pharmacy benefit managers, healthcare providers, and regulatory agencies prioritize continuity and quality in cardiovascular therapeutics.
Key Takeaways
- Corlanor’s supply chain involves predominantly European and Indian API producers, including Corden Pharma, Jubilant, and Biocon.
- Sanofi’s integrated manufacturing strategy balances in-house production with contracting specialized CMOs to ensure supply resilience.
- Challenges such as raw material shortages and regulatory compliance significantly impact the stability of Corlanor’s supply.
- Diversification of API suppliers and regional manufacturing is vital for mitigating geopolitical and climatic risks.
- Stakeholders should monitor supply chain developments and regulatory changes to anticipate potential disruptions.
FAQs
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Who manufactures the active ingredient (API) for Corlanor?
The API for Corlinor, ivabradine, is primarily produced by Sanofi’s contracted suppliers including Corden Pharma, Jubilant Life Sciences, and Biocon. -
Are there alternative API sources for Corlanor?
Yes. Companies in India and China, such as Jubilant and Zhejiang Huahai Pharmaceutical, are potential alternative suppliers, helping diversify the supply chain. -
What regulatory standards must API manufacturers meet for Corlanor?
All API producers must comply with GMP standards set by agencies like the FDA and EMA, ensuring safety, efficacy, and consistent quality. -
How does supply chain disruption affect Corlanor availability?
Disruptions in raw material supply, manufacturing delays, or regulatory hurdles can lead to shortages, impacting patient access globally. -
What strategies are in place to improve the resilience of Corlanor’s supply chain?
Diversifying suppliers, increasing regional manufacturing, maintaining strategic stockpiles, and digital supply chain tracking are key strategies.
Sources
[1] Sanofi Corporate Website. "Corlanor (ivabradine) details."
[2] U.S. Food and Drug Administration. "API manufacturing standards."
[3] Industry Reports on API Market Trends.
[4] Global Pharmaceutical Supply Chain Analyses.
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