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Suppliers and packagers for generic pharmaceutical drug: ivacaftor
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ivacaftor
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-300-01 | 56 GRANULE in 1 CARTON (51167-300-01) | 2015-03-23 |
| Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-400-01 | 56 GRANULE in 1 CARTON (51167-400-01) | 2015-03-23 |
| Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-600-01 | 56 GRANULE in 1 CARTON (51167-600-01) | 2019-04-29 |
| Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-770-01 | 56 GRANULE in 1 CARTON (51167-770-01) | 2023-05-03 |
| Vertex Pharms Inc | KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-785-01 | 56 GRANULE in 1 CARTON (51167-785-01) | 2023-05-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ivacaftor
Introduction
Ivacaftor, marketed as Kalydeco, is a groundbreaking prescription medication developed by Vertex Pharmaceuticals. It belongs to the class of drugs known as CFTR potentiators and is primarily prescribed for cystic fibrosis (CF) patients who harbor specific genetic mutations, notably G551D. Since its FDA approval in 2012, Ivacaftor has revolutionized CF treatment, prompting a substantial global supply chain involving multiple stakeholders. Identifying and understanding the key suppliers—ranging from active pharmaceutical ingredient (API) producers to formulation and packaging companies—is crucial for stakeholders ensuring supply security, quality, and regulatory compliance.
Manufacturers and Suppliers of Ivacaftor API
1. Key Active Pharmaceutical Ingredient (API) Suppliers
The foundation of Ivacaftor’s supply chain hinges on the sourcing of high-quality API. Currently, several pharmaceutical-grade API manufacturers supply Ivacaftor globally, predominantly based in Asia, Europe, and North America.
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Sun Pharmaceutical Industries Ltd.
One of India's largest pharmaceutical companies, Sun Pharma, has demonstrated capabilities in synthesizing complex APIs, including CFTR modulators like Ivacaftor, through strategic collaborations and in-house R&D efforts. They possess facilities compliant with Good Manufacturing Practices (GMP) and are approved by global regulatory agencies. -
Cayman Chemical Company
A US-based specialty chemicals and research products firm, Cayman Chemical supplies research-grade compounds and may provide early-stage or research-grade versions of Ivacaftor, although not the commercial API. -
Collaborations & Licensing Partners
Vertex Pharmaceuticals has licensed production to various manufacturers to meet global demand. The company’s partnerships include contract manufacturing organizations (CMOs) globally capable of synthesizing Ivacaftor at scale, with strict quality controls to meet FDA, EMA, and other regulators’ standards.
2. Chinese and Indian API Manufacturers
The majority of CFTR modulator APIs, including Ivacaftor, Melitor Pharmaceuticals and Hainan Sanyalekang Pharmaceutical Co., Ltd., are among several Chinese and Indian enterprises actively manufacturing APIs under rigorous GMP certifications. Their large-scale facilities and cost-advantage production provide vital components in the supply chain, although regulatory scrutiny and quality assurance are critical considerations.
Formulation and Finished Dosage Manufacturer
Creating the final Ivacaftor tablet involves formulation specialists and finished dosage manufacturers.
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Vertex Pharmaceuticals (In-house manufacturing)
Initially, Vertex contracted manufacturing to CMOs but has increasingly brought production in-house to ensure control over supply and quality. -
Contract Manufacturing Organizations (CMOs)
Leading CMOs like Dr. Reddy’s Laboratories, Teva Pharmaceutical Industries, and Sandoz are involved in scaling up production, often partnering with Vertex for large-scale formulations following successful API procurement. -
Global Contract Manufacturers
Several generic manufacturers across India, China, and Eastern Europe have obtained approvals (including FDA ANDA or equivalent) to produce Ivacaftor generics, which become available in markets outside the US where patent restrictions allow.
Regulatory and Supply Chain Considerations
The supply chain for Ivacaftor is heavily regulated; manufacturers must comply with GMP standards set by regulators such as the FDA, EMA, and WHO. Such adherence ensures consistency, potency, and safety of the drug. Manufacturers also navigate patent protections and licensing agreements; Vertex maintains tight control of key patents, influencing the sourcing and licensing of manufacturing rights.
The recent expiry of certain patents in select regions has led to an increase in generic manufacturing, expanding supplier options globally. Nevertheless, supply chain resilience depends on diversified sourcing, strong supplier relationships, and regulatory approvals.
Emerging and Strategic Suppliers
As the demand for cystic fibrosis therapies grows, suppliers also innovate on APIs and formulation methods. Companies investing in novel synthesis pathways or biosimilar development can influence future supply dynamics. Notably, Vertex’s strategic alliances with contract manufacturers and continuous R&D efforts ensure ongoing supply stability.
Supply Chain Risks and Opportunities
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Risks: Dependence on specific regional suppliers introduces risks related to geopolitical issues, supply disruptions, and quality variability. The complexity of Ivacaftor's synthesis increases vulnerability to manufacturing setbacks.
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Opportunities: Patent expirations and expanding global markets open avenues for new suppliers, especially in India and China. Certifications aligning with international standards enable these players to access multiple markets.
Key Players in the Ivacaftor Supply Chain
| Company/Entity | Role | Region / Country | Certification & Notes |
|---|---|---|---|
| Vertex Pharmaceuticals | Developer & primary manufacturer (in-house) | USA | Leads API sourcing & formulation |
| Sun Pharmaceutical | API supplier | India | GMP-certified, active API production |
| Sandoz / Novartis | Generic formulations | Switzerland / Global | Approved generics |
| Teva | Finished product manufacturing | Israel / Global | Regulatory approvals |
| Contract Manufacturers | API & formulation | China / India | GMP-compliant, diversified sources |
Conclusion
The supply chain for Ivacaftor comprises a complex web of API producers, formulation specialists, and regulatory bodies, with pivotal roles played by North American, European, Indian, and Chinese firms. While Vertex remains the primary orchestrator of supply, global manufacturers expand alternatives, particularly as patent protections evolve. Ensuring uninterrupted availability hinges on diversified sourcing strategies, stringent quality controls, and adherence to regulatory standards.
Key Takeaways
- Diversification of Suppliers is fundamental to mitigate supply chain risks, especially in API procurement from Asian manufacturers.
- Regulatory Compliance remains critical; all suppliers must adhere to GMP standards to ensure drug quality and safety.
- Patent Lifecycles and Licenses influence supplier options; patent expirations are expanding generic production capabilities.
- Manufacturing Capacity Expansion by CMOs and regional manufacturers supports increased global demand.
- Strategic Partnerships between Vertex and contractual manufacturers underpin supply stability for Ivacaftor.
FAQs
1. Who are the primary API suppliers for Ivacaftor globally?
Major API suppliers include Sun Pharmaceutical Industries (India), Chinese companies such as Hainan Sanyalekang Pharmaceutical, and contract manufacturing organizations globally approved for GMP production, including Vertex’s in-house facilities.
2. Are there generic versions of Ivacaftor available?
Yes. Following patent expirations in certain regions, generic manufacturers, mainly in India and China, have obtained regulatory approval to produce Ivacaftor generics, increasing global access.
3. What regulatory standards must manufacturers meet for Ivacaftor production?
Manufacturers must comply with GMP standards established by agencies like the FDA, EMA, and WHO. These standards ensure product quality, purity, potency, and safety.
4. How has patent protection influenced the supply chain of Ivacaftor?
Patent protections have restricted generic manufacturing initially. Expiry of key patents in specific regions has enabled increased global manufacturing and introduced more suppliers into the market.
5. What risks are associated with the current Ivacaftor supply chain?
Risks include supply disruptions due to geopolitical issues, quality variability from some suppliers, and reliance on a limited number of high-volume API producers, emphasizing the need for supply diversification.
Sources:
[1] Vertex Pharmaceuticals. Kalydeco (ivacaftor) Prescribing Information. [online] Available at: vertexpharma.com
[2] U.S. Food and Drug Administration. FDA Approvals of CFTR Modulators. [online] Available at: fda.gov
[3] European Medicines Agency. Ivacaftor (Kalydeco) Summary. [online] Available at: ema.europa.eu
[4] Indian Pharmaceutical Market Reports. Sun Pharmaceutical API Capabilities. [online] Available at: sundrugmaker.com
[5] Patent and Market Data for CFTR Modulators. International Patent Office Records.
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