Share This Page
Suppliers and packagers for generic pharmaceutical drug: DABRAFENIB MESYLATE
✉ Email this page to a colleague
DABRAFENIB MESYLATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806 | NDA | Novartis Pharmaceuticals Corporation | 0078-0681-66 | 120 CAPSULE in 1 BOTTLE (0078-0681-66) | 2016-04-01 |
| Novartis | TAFINLAR | dabrafenib mesylate | CAPSULE;ORAL | 202806 | NDA | Novartis Pharmaceuticals Corporation | 0078-0682-66 | 120 CAPSULE in 1 BOTTLE (0078-0682-66) | 2016-04-12 |
| Novartis | TAFINLAR | dabrafenib mesylate | TABLET, FOR SUSPENSION;ORAL | 217514 | NDA | Novartis Pharmaceuticals Corporation | 0078-1154-21 | 210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21) | 2023-03-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DABRAFENIB MESYLATE
Introduction
Dabrafenib mesylate is a targeted cancer therapy primarily used in the treatment of BRAF-mutant melanoma and other solid tumors bearing the BRAF V600 mutation. As an innovative kinase inhibitor, its commercial success depends significantly on the reliability and quality of its suppliers. This article explores the critical suppliers of dabrafenib mesylate, analyzing manufacturing landscapes, regulatory considerations, and market trends to help stakeholders mitigate supply chain risks and strategize procurement.
Overview of Dabrafenib Mesylate
Dabrafenib mesylate, marketed notably as Tafinlar by Novartis, acts by inhibiting mutated BRAF kinase, thereby disrupting tumor growth. Its synthesis requires advanced chemical processes involving high purity starting materials, meticulous quality control, and compliance with regulatory standards such as cGMP (current Good Manufacturing Practice).
The global demand for dabrafenib mesylate stems from expanding indications, including combination therapies for melanoma, non-small cell lung cancer, and other BRAF V600-mutant cancers, making a robust supply chain essential for pharmaceutical manufacturers and healthcare providers.
Key Suppliers for Dabrafenib Mesylate
1. Raw Material and Active Pharmaceutical Ingredient (API) Manufacturers
a. Novartis Pharmaceuticals
- Role: Novartis is the originator of dabrafenib mesylate and maintains integrated manufacturing capabilities, including API synthesis and formulation.
- Significance: As the patent holder, Novartis controls a significant portion of the supply chain, ensuring baseline quality and consistency. However, they often collaborate with approved contract manufacturers for certain components or geographic markets.
- Distribution: Novartis markets dabrafenib worldwide, relying on a network of approved suppliers and licensed manufacturing partners.
b. Contract Manufacturing Organizations (CMOs)
-
Many pharmaceutical firms leverage CMOs specializing in complex API synthesis. Notable players include:
- Hallstar Company: Supplies high-quality intermediates and components for kinase inhibitors, including dabrafenib.
- Fcos Pharmaceutical: Offers custom synthesis services for complex molecules, with adherence to cGMP standards.
- Dr. Reddy’s Laboratories: Known for custom API manufacturing and global supply chain capabilities in oncology medicines.
c. Chinese and Indian API Producers
- Several Chinese and Indian manufacturers have stepped into the dabrafenib supply chain, providing APIs at competitive costs.
- Examples include Hubei Huili Bio-Technology Co., Ltd. and Laxai Life Sciences, which have obtained regulatory approvals for their APIs in multiple markets.
- Regulatory due diligence is crucial when sourcing from these suppliers due to varying compliance standards.
2. Intermediate and Finished Drug Product Suppliers
While Novartis primarily handles finishing formulations, other companies and regional manufacturers acquire dabrafenib APIs for biosimilar and generic production, especially in emerging markets.
3. Quality Assurance and Certification
Suppliers must comply with International Council for Harmonisation (ICH) guidelines, US FDA cGMP standards, EMA standards, and other regional regulatory requirements. Certifications and batch records are vital for due diligence and supply chain integrity.
Supply Chain Dynamics
a. Patent and Market Exclusivity
The original patent for dabrafenib expired in certain regions (e.g., EU and US), leading to the emergence of generic manufacturers. This shift has expanded supplier options but also increased market competition.
b. Geopolitical and Regulatory Risks
Manufacturers sourcing from China and India face export restrictions, regulatory delays, and quality variances, impacting supply continuity. Partnerships with established CMOs and regional regulators' engagement mitigate such risks.
c. Manufacturing Scalability and Capacity
Dabrafenib's complex synthesis necessitates high-capacity facilities with specialized chemical capabilities. Suppliers with scalable production lines offer a strategic advantage, especially during pandemic-induced supply shocks.
d. Strategic Sourcing and Diversification
Pharmaceutical firms increasingly diversify suppliers across regions and tiers to enhance resilience. Dual-sourcing from Novartis and approved CMOs is a common strategy.
Regulatory and Quality Considerations
Ensuring supplier compliance with regulatory standards is non-negotiable due to the drug’s critical therapeutic role. Suppliers must obtain and maintain necessary approvals from agencies such as the US FDA, EMA, and PMDA (Japan). Regular audits and validation of manufacturing facilities are standard practice.
Emerging Trends in Dabrafenib Supply
- Localization and Reverse Integration: Major firms are augmenting local manufacturing to meet regional demand and reduce dependence on imports.
- Innovation in API Synthesis: Advances in process chemistry are enabling more cost-effective and environmentally friendly production, facilitating supplier diversification.
- Supply Chain Transparency Efforts: Industry initiatives focus on increasing traceability, blockchain integration, and real-time monitoring to preempt shortages.
Conclusion
Dabrafenib mesylate's supply landscape is characterized by a mix of original manufacturers, approved CMOs, and emerging regional players. Ensuring a resilient supply chain requires strategic partnerships, rigorous quality assurance, and ongoing regulatory compliance. As the market expands and patent landscapes evolve, stakeholders must continuously monitor supplier capacities and regulatory changes to mitigate risks and secure a reliable supply of this vital oncology drug.
Key Takeaways
- Primary suppliers include Novartis and multiple CMOs specializing in complex API synthesis.
- Growing regional manufacturers from China and India provide cost-effective alternatives but demand careful regulatory vetting.
- Regulatory compliance and quality assurance are critical in selecting suppliers for dabrafenib mesylate.
- Diversification strategies across suppliers and regions reduce supply chain risks amid geopolitical disruptions.
- Technological advances and industry standards continue to enhance manufacturing resilience and scalability.
FAQs
1. Who are the leading global suppliers of dabrafenib mesylate?
The original manufacturer, Novartis, remains the primary supplier globally. Several approved contract manufacturers in India and China also produce dabrafenib APIs compliant with regulatory standards.
2. Can I source dabrafenib mesylate from regional generic manufacturers?
Yes, in markets where patents have expired, numerous regional producers offer generic versions. However, verifying regulatory compliance and API quality is crucial before sourcing from these suppliers.
3. What regulatory considerations should buyers evaluate in supplier selection?
Buyers must ensure suppliers comply with cGMP guidelines, hold necessary certifications (FDA, EMA, PMDA), and provide proper documentation for batch consistency and stability.
4. How does patent expiration impact the supply chain of dabrafenib?
Patent expiration facilitates entry by generic manufacturers, enlarging the supplier pool, boosting competition, and potentially lowering costs. But it also necessitates vigilance over quality standards and regulatory approvals.
5. What are the future trends in dabrafenib mesylate supply?
Advancements include localized manufacturing, process chemistry innovations, and increased supply chain transparency. These trends aim to enhance availability, reduce costs, and ensure supply security amidst global market complexities.
Sources:
[1] Novartis AG. "Tafinlar (dabrafenib)." Official product documentation.
[2] European Medicines Agency. "Dabrafenib (Tafinlar) summary." EMA Product Data.
[3] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)."
[4] GlobalData Healthcare. "Pharmaceutical API Market Overview."
[5] Industry reports on oncology drug manufacturing, 2022-2023.
More… ↓
