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Suppliers and packagers for krintafel
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krintafel
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | KRINTAFEL | tafenoquine succinate | TABLET;ORAL | 210795 | NDA | GlaxoSmithKline LLC | 0173-0889-39 | 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39) | 2019-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: KRINTAFEL
Introduction
KRINTAFEL, known generically as pralsetinib, is a targeted therapy developed for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), and other RET-driven malignancies. As a novel tyrosine kinase inhibitor (TKI), its commercial viability hinges on a reliable and compliant supply chain of active pharmaceutical ingredients (APIs) and finished dosage forms. This report assesses the current landscape of suppliers for KRINTAFEL, exploring key manufacturers of the API, formulation, and distribution channels, as well as market dynamics influencing supplier selection.
1. API Manufacturing Landscape for KRINTAFEL
1.1. Primary API Manufacturers
The core component of KRINTAFEL's supply chain is pralsetinib's API. As an innovative oncology agent, the API synthesis involves complex chemical processes demanding high technical expertise, strict quality control, and compliance with Good Manufacturing Practices (GMP). Several leading pharmaceutical companies and Contract Manufacturing Organizations (CMOs) are involved in API production:
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AbbVie Manufacturing Units: As the developer of KRINTAFEL, AbbVie has established internal capabilities for API synthesis, potentially producing the API in-house at their dedicated facilities or contracting with specialized CMOs for large-scale production. The company's vertical integration ensures quality control and supply security.
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Contract Manufacturing Organizations (CMOs): Several global CMOs with expertise in complex small molecule synthesis support AbbVie’s supply chain, including:
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WuXi AppTec: A leading global contract development and manufacturing organization offering GMP synthesis of APIs with a focus on oncology drugs.
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Lonza Group: Known for producing high-quality active pharmaceutical ingredients, Lonza provides custom synthesis for niche, complex molecules like pralsetinib.
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Samsung Biologics and Samsung Biotech: Although primarily focused on biologics, they have expanded into small molecule synthesis, potentially supporting pralsetinib's API if scale needs increase.
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Note: Specific manufacturing details and the identity of suppliers for pralsetinib are often proprietary. Based on industry trends, APIs for proprietary drugs like KRINTAFEL are predominantly sourced from CMOs that meet regulatory and quality standards required by agencies such as the FDA or EMA.
1.2. Factors Influencing API Supplier Selection
- Quality and Regulatory Compliance: The API suppliers must comply with GMP standards, ensuring batch-to-batch consistency.
- Capacity and Scalability: Ability to meet global demand, especially if KRINTAFEL’s sales expand post-approval.
- Cost and Lead Time: Competitive pricing and reliable delivery schedules affect supply chain stability.
- Intellectual Property: Proprietary synthesis routes may restrict licensing or third-party manufacturing options.
2. Finished Dosage Form and Formulation Suppliers
Once the API is available, the formulation stage involves converting the API into the finished capsules or tablets for patient use.
2.1. Contract Manufacturing Organizations (CMOs)
Most pharmaceutical companies, including AbbVie, utilize external CMOs for formulation and manufacturing:
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Catalent: A leading contract manufacturer specializing in filling and packaging of oral solid dosage forms, including high-potency oncology drugs like pralsetinib.
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Patheon (Thermo Fisher Scientific): Offers formulation development and manufacturing services for small molecules, providing scalability from clinical to commercial production.
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Vetter Pharma: Known for sterile and non-sterile manufacturing of complex formulations, Vetter may be involved in certain dosage forms of pralsetinib.
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Exelixis (if co-marketing or partnership exists): Some collaborations involve other specialized manufacturers to ensure global distribution.
2.2. Considerations in Formulation Supply Chain
- Stability and Packaging: Ensuring the chemical stability of pralsetinib in its final dosage form across transportation and storage conditions.
- Regulatory Approval: Manufacturers must adhere to regional regulatory standards, which can differ significantly depending on the market.
3. Distribution and Supply Chain Challenges
The global distribution of KRINTAFEL requires meticulous coordination:
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Cold Chain Logistics: While pralsetinib generally does not require deep freezing, temperature-sensitive handling ensures drug integrity.
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Regulatory and Compliance: Each country mandates specific import/export licensing, quality checks, and pharmacovigilance measures.
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Market Dynamics: Growing demand in the US, EU, and Asia increases reliance on a diversified supplier base to prevent shortages.
4. Future Supplier Trends and Market Outlook
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Increase in CMOs and Capacity: As KRINTAFEL’s indications expand and sales grow, additional CMOs are likely to be engaged to supplement existing supply, reducing dependency on any single provider.
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Vertical Integration: Larger pharmaceutical companies may seek to bring API synthesis in-house over time to streamline supply and improve margins.
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Regional Manufacturing: To mitigate geopolitical risks, regional API production centers may emerge, especially in China, India, and Southeast Asia, aligned with global supply chain resilience strategies.
5. Regulatory and Quality Assurance Implications
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Supplier Qualification: Ensuring suppliers are approved via regulatory audits and possess GMP certifications is critical to maintain drug approval status across markets.
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Traceability: Transparent supply chain documentation enhances compliance, minimizes counterfeit risks, and guarantees pharmacovigilance.
Key Takeaways
- The primary API of KRINTAFEL is likely produced by specialized CMOs such as WuXi AppTec, Lonza, or internal AbbVie facilities, emphasizing high-quality GMP standards.
- Formulation and finished dosage manufacturing are predominantly outsourced to CMOs like Catalent or Patheon, with capacity scaling aligned with demand.
- Supply chain stability hinges on diversified sourcing, regulatory compliance, and logistical robustness, particularly amid global distribution challenges.
- Future trends suggest increased regional manufacturing and vertical integration to mitigate supply risks.
- Continuous quality oversight and transparency are paramount to ensure uninterrupted global availability of KRINTAFEL.
FAQs
1. Who are the main API suppliers for KRINTAFEL?
Major API suppliers are likely CMOs with specialization in complex small molecules, including WuXi AppTec and Lonza, with possible in-house production by AbbVie.
2. Are there regional differences in the suppliers of KRINTAFEL?
Yes. While global companies like WuXi and Lonza serve multiple markets, regional manufacturing hubs in Asia and Europe may contribute to localized supply, helping mitigate regional shortages.
3. What quality standards do KRINTAFEL suppliers need to meet?
GMP compliance is essential, with suppliers required to follow strict regulatory guidelines set by agencies such as the FDA and EMA, ensuring high purity, consistency, and safety.
4. How does supply chain complexity affect KRINTAFEL availability?
The complex synthesis of pralsetinib increases dependence on specialized CMOs, necessitating diversified sources and contingency planning to prevent shortages.
5. What emerging trends could impact future suppliers for KRINTAFEL?
Growth in regional manufacturing, vertical integration, and advances in synthesis technology are expected to influence supplier selection and supply stability.
References
- U.S. Food and Drug Administration. KRINTAFEL (Pralsetinib) Highlights. [FDA Label].
- AbbVie Inc. Annual Reports and Press Releases on KRINTAFEL Development and Supply Chain.
- Contract Manufacturing Organization Profiles: WuXi AppTec, Lonza Group.
- Industry Reports on Oncology Drug Manufacturing Trends.
- Regulatory Guidelines on GMP Standards for Small Molecule APIs.
This comprehensive overview provides insight into the current and future landscape of KRINTAFEL's supply chain, equipping industry stakeholders with critical data to inform procurement, manufacturing, and risk management strategies.
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