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Suppliers and packagers for ZELBORAF
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ZELBORAF
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429 | NDA | Genentech, Inc. | 50242-090-02 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2011-08-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZELBORAF
ZELBORAF (vemurafenib) is a targeted therapy used primarily for advanced melanoma with a BRAF V600 mutation. The drug is marketed by Roche and has multiple manufacturing and supply channels globally.
Primary Manufacturer and Approval
- Roche is the sole producer of ZELBORAF. The drug received FDA approval in August 2011 [1].
- The European Medicines Agency (EMA) approved ZELBORAF in 2012 [2].
Supply Chain and Distribution Channels
- Roche manufactures ZELBORAF at its facilities specifically designated for oncology drugs.
- The distribution network for ZELBORAF includes authorized pharmaceutical wholesalers and direct procurement channels in major markets such as the US, EU, and Asia.
- Roche’s supply contracts cover multiple regions, with regional subsidiaries managing local distribution.
Key Suppliers and Contract Manufacturers
- Roche relies on contract manufacturing organizations (CMOs) for formulation and packaging processes.
- Several CMOs have been publicly identified for Roche’s other oncology products, but specific CMOs for ZELBORAF are not publicly disclosed.
- Active pharmaceutical ingredient (API) sourcing involves specialized chemical suppliers, typically located in regions with extensive chemical manufacturing industries such as China, India, and Europe.
API Manufacturing and Sourcing
| Supplier Region | API Manufacturing Focus | Notes |
|---|---|---|
| China | API synthesis | Major supplier base; public disclosures limited |
| India | API synthesis | Known for large-scale API production |
| Europe | API synthesis/Quality control | Some high-quality suppliers, often engaged for regulatory safety |
Regulatory and Supply Chain Security
- Roche’s supply chain adheres to Good Manufacturing Practices (GMP) regulated by agencies like FDA, EMA, and local authorities.
- Supply chain resilience may involve multiple suppliers for critical raw materials, though dependence on single-source API suppliers could pose risk.
Competitive and Alternative Suppliers
- No alternative commercial manufacturers for ZELBORAF are approved; Roche maintains exclusivity.
- Competitors in BRAF inhibitor space include Pfizer (dabrafenib), which has a different supply chain and manufacturing setup.
Supply Risks and Challenges
- Dependence on API suppliers in China and India introduces geopolitical, regulatory, or trade risks.
- Manufacturing complexity of targeted therapies necessitates stringent quality controls and supply chain robustness.
- Patent exclusivity limits generic or biosimilar manufacturing until expiry or patent challenges.
Summary
Roche is the exclusive supplier of ZELBORAF, sourcing its API primarily from China and India, with manufacturing localized in Gebze, Turkey, and other sites. The supply chain relies heavily on CMOs and regional distributors governed by strict GMP standards, maintaining tight control over production and distribution.
Key Takeaways
- Roche is the sole manufacturer of ZELBORAF, controlling API sourcing primarily from China and India.
- No approved generic or biosimilar versions are available; Roche maintains market exclusivity.
- Supply chain risks include dependence on API suppliers in high-risk regions and manufacturing complexities.
- Distribution channels are managed through Roche subsidiaries and authorized wholesalers in major markets.
- Regulatory compliance ensures supply chain security but can also introduce delays or constraints in procurement.
FAQs
1. How does Roche ensure the supply of ZELBORAF worldwide?
Roche uses regional subsidiaries and a network of authorized distributors, supported by contract manufacturing organizations, to ensure global supply.
2. Are there approved biosimilars or generics for ZELBORAF?
No, as of 2023, no biosimilars or generics have received approval; Roche holds exclusive rights until patent expiry.
3. What regions are key for API supply for ZELBORAF?
Key API manufacturing regions are China and India, with some high-quality suppliers in Europe.
4. How do manufacturing complexities impact ZELBORAF supply?
Complex synthesis and strict quality standards can cause production delays or shortages if issues arise with key suppliers or manufacturing sites.
5. Can supply chain disruptions affect ZELBORAF availability?
Yes, disruptions in API sourcing, geopolitical issues, or manufacturing problems can impact drug availability.
References
[1] U.S. Food and Drug Administration. (2011). FDA approves new melanoma drug. https://www.fda.gov/news-events/press-announcements/fda-approves-new-melanoma-drug
[2] European Medicines Agency. (2012). EMA approves Zelboraf for advanced melanoma. https://www.ema.europa.eu/en/medicines/human/EPAR/zelboraf
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