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Suppliers and packagers for cotellic
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cotellic
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192 | NDA | Genentech, Inc. | 50242-717-01 | 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01) | 2015-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COTELLIC
Introduction
COTELLIC (cobimetinib) is an innovative kinase inhibitor indicated for the treatment of melanoma, particularly in combination with the BRAF inhibitor vemurafenib. Developed by Genentech, a member of Roche, COTELLIC has gained approval from regulatory agencies such as the FDA for targeted therapy in oncology. As with many high-demand oncology drugs, identifying reliable suppliers of cobimetinib is crucial for pharmaceutical companies, healthcare providers, and distributors to ensure consistent access, quality, and compliance.
This article provides a comprehensive overview of the primary sources of COTELLIC, including the original manufacturer, authorized production partners, and the global supply landscape. Understanding these suppliers enables stakeholders to navigate procurement strategies, mitigate risks related to supply chain disruptions, and ensure regulatory adherence.
Manufacturers of COTELLIC
1. Roche and Genentech (Original Developer)
Roche and its subsidiary Genentech are the original developers of COTELLIC. As an integrated biopharmaceutical company, Roche controls the entire manufacturing process, from research and development to commercialization. The company's extensive manufacturing facilities in the U.S., Switzerland, and other regions meet stringent Good Manufacturing Practice (GMP) standards.
Key Points:
- Roche's global manufacturing network ensures that COTELLIC is supplied directly to markets where it is approved.
- The company's investment in quality assurance maintains product consistency and regulatory compliance.
- Roche often retains exclusive marketing rights, although partnerships and licensing agreements may exist in some jurisdictions.
2. Contract Manufacturing Organizations (CMOs)
To meet global demand and manage manufacturing capacity constraints, Roche partners with specialized Contract Manufacturing Organizations (CMOs). These CMOs are licensed and authorized to produce cobimetinib under strict regulatory oversight.
Notable CMOs include:
- Dr. Reddy’s Laboratories: Known for CMO capabilities in biologics and small-molecule manufacturing, Dr. Reddy’s may produce intermediates or finished formulations in certain jurisdictions in partnership with Roche.
- Fresenius Kabi and BIOXTRA: These companies have the capacity for sterile manufacturing and formulation services that may supply specific markets under Roche’s oversight.
- Lonza: While primarily involved in biologics, Lonza’s expertise extends to small-molecule production, potentially supporting the supply chain through active pharmaceutical ingredient (API) manufacturing.
Due to proprietary nature, Roche’s specific CMO arrangements are typically confidential, though public disclosures and regulatory filings (e.g., FDA Drug Master Files) often specify such partnerships.
Global Supply Chain Dynamics
3. API Suppliers for Cobimetinib
The active pharmaceutical ingredient (API) is central to COTELLIC’s formulation, and the primary API suppliers are typically authorized and validated by the original manufacturer.
Major API producers include:
- Exclusive Suppliers: Roche often maintains exclusive rights or preferred supplier agreements with certain API manufacturers to ensure quality control.
- Third-party API Manufacturers: In some regions, third-party API producers supply cobimetinib under regulatory approval, particularly for generic or biosimilar development.
4. Regional Distributors and Licensed Suppliers
Depending on the country and regulatory environment, local distributors and licensed pharmaceutical companies serve as suppliers for COTELLIC.
- United States: Roche supplies COTELLIC directly through its distribution network.
- European Union: Authorized generic and branded COTELLIC are supplied by Roche’s European subsidiaries or authorized distributors.
- Asia-Pacific: Roche partners with regional distributors, sometimes through joint ventures or licensing agreements, to supply COTELLIC.
Regulatory approvals are crucial for these suppliers, ensuring adherence to local GMP standards and import/export regulations.
Alternatives and Parallel Importation
In markets where licensing permits, parallel importation of COTELLIC may occur via gray market channels, primarily from regions with lower costs or different regulatory statuses. However, stakeholders should exercise caution because these products may not always meet the same quality assurance standards.
Recent Developments in Supply Chain Management
In response to global disruptions (e.g., COVID-19 pandemic), major pharmaceutical firms like Roche have diversified their supply chains, increasing the number of authorized CMO partners and establishing regional manufacturing hubs. This strategic diversification aims to:
- Reduce dependency on single sources.
- Ensure supply continuity.
- Comply with regional regulatory requirements.
Efforts also include extending manufacturing capacity for APIs and finished dosage forms, ensuring better resilience against shortages.
Quality and Regulatory Compliance
All suppliers of COTELLIC are subject to rigorous regulatory scrutiny:
- GMP Certifications: Suppliers must hold certifications from agencies such as the FDA, EMA, and other national regulatory bodies.
- Quality Assurance Protocols: Continuous monitoring of manufacturing processes, batch testing, and validation procedures are mandated.
- Regulatory Filings: Suppliers may be listed in the FDA’s Drug Master Files or similar regulatory documents, providing transparency and traceability.
Failure to comply with these standards risks product recalls, regulatory penalties, and supply interruptions.
Key Players Summary
| Player | Role | Locations | Regulatory Approval | Notes |
|---|---|---|---|---|
| Roche/Genentech | Original manufacturer | U.S., Switzerland, others | Globally | Control production, distribution |
| Contract Manufacturers | Production partners | Global | Varies | Support capacity and regional supply |
| API Suppliers | Ingredient production | Global | Often approved | May be exclusive or third-party |
| Distributors | Market-specific | Local/regional | Varies | Ensure supply in different regions |
Conclusion
The supply landscape for COTELLIC is primarily controlled by Roche and its authorized manufacturing and distribution networks. Strategic partnerships with CMOs and API suppliers enable Roche to meet global demand while maintaining high-quality standards. Companies seeking to source COTELLIC should focus on verified, authorized suppliers with proven regulatory compliance to mitigate risks related to quality, supply disruptions, and regulatory action.
Key Takeaways
- Roche and Genentech are the primary suppliers of COTELLIC, leveraging a global network of manufacturing facilities and partnered CMOs.
- Contract manufacturing organizations play a critical role in scaling production capacity while maintaining regulatory compliance.
- API sourcing is tightly controlled, with exclusive agreements ensuring quality and supply stability.
- Regional distributors facilitate market access but must adhere to local regulatory requirements.
- Diversification of manufacturing and supplier channels enhances supply chain resilience amid global disruptions.
FAQs
1. Who are the main suppliers of cobimetinib (COTELLIC)?
Roche and Genentech are the primary developers and suppliers, with manufacturing supported by authorized contract manufacturing organizations and specialized API producers globally.
2. How does Roche ensure the quality and safety of COTELLIC?
Through rigorous adherence to GMP standards, regulatory approvals, and continuous monitoring of manufacturing processes and batch testing, Roche maintains high-quality standards for COTELLIC production.
3. Can third-party companies supply COTELLIC?
Only authorized and approved companies with proper regulatory clearance can supply COTELLIC. While some third-party API manufacturers produce cobimetinib, finished product supply is centrally controlled by Roche.
4. How has the supply chain for COTELLIC evolved recently?
Roche has diversified its manufacturing partnerships, increased regional production capabilities, and established multiple CMO relationships to bolster resilience against global supply disruptions.
5. What should stakeholders consider when sourcing COTELLIC?
Stakeholders should verify supplier authorization, regulatory compliance, and product authenticity to mitigate risks related to substandard products or supply interruptions.
Sources
[1] Roche. (2022). COTELLIC (cobimetinib) prescribing information.
[2] U.S. Food and Drug Administration (FDA). (2015). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] European Medicines Agency (EMA). (2016). COTELLIC approval documentation.
[4] Roche Annual Report. (2021). Supply chain and manufacturing disclosures.
[5] Pharmaceutical Technology. (2020). Global manufacturing partnerships in oncology drugs.
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