Share This Page
Suppliers and packagers for posluma
✉ Email this page to a colleague
posluma
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Blue Earth | POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023 | NDA | Blue Earth Diagnostics | 69932-002-50 | 25 mL in 1 VIAL, MULTI-DOSE (69932-002-50) | 2023-05-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: POSLUMA
Introduction
POSLUMA (alisertib) is a targeted cancer therapy developed by Pfizer, primarily indicated for treating specific types of advanced or metastatic solid tumors. As with many high-value pharmaceuticals, the supply chain ecosystem surrounding POSLUMA is intricate, involving multiple suppliers at various stages—from active pharmaceutical ingredient (API) manufacturing to formulation, packaging, and distribution. This article analyzes the current landscape of POSLUMA suppliers, highlighting key manufacturers, supply chain considerations, and implications for stakeholders.
Overview of POSLUMA
POSLUMA is an orally administered selective kinase inhibitor designed to target the aurora kinase A. Its pharmacological profile necessitates strict manufacturing standards to ensure potency, stability, and safety. Given the drug’s complex synthesis and bioavailability requirements, the supply chain relies on specialized suppliers capable of adhering to Good Manufacturing Practices (GMP).
Active Pharmaceutical Ingredient (API) Supply
1. API Manufacturing Sources
The core component of POSLUMA is its active ingredient, alisertib. Currently, Pfizer sources API components from multiple suppliers to mitigate risk and ensure adequate production capacity.
- Primary API Manufacturers:
- CSPC Pharmaceutical Group (China): Known for manufacturing APIs for oncology drugs, CSPC possesses the scale and technical capacity for complex kinase inhibitors. CSPC has historically supplied APIs to Pfizer and other global pharmaceutical firms, leveraging state-of-the-art synthesis facilities compliant with GMP standards.
- Santen Pharmaceutical (Japan): Though primarily focused on ophthalmology, Santen has diversified into oncology API synthesis, offering high-quality compounds with stringent quality control measures.
- Contract Manufacturing Organizations (CMOs): Pfizer collaborates with international CMOs specializing in complex chemical synthesis, including companies like Hovione and Lonza, which provide process development and large-scale manufacturing capabilities for proprietary APIs.
2. Supply Chain Risks and Management
API sourcing is susceptible to disruptions caused by geopolitical tensions, regulatory changes, and raw material shortages. To counter this, Pfizer maintains multiple API suppliers and actively monitors quality metrics through audit programs.
Excipients and Formulation Components
Beyond the API, POSLUMA’s formulation requires excipients that ensure drug stability, bioavailability, and patient acceptability.
- Excipients Suppliers:
- DuPont Nutrition & Health: Supplies pharmaceutical-grade excipients, including fillers and binders.
- BASF: Provides stabilizers, disintegrants, and coating agents compliant with pharmacopeial standards.
- JRS Pharma: Offers disintegrating agents and moisture control substances.
These suppliers are chosen based on their compliance with pharmacopoeial standards (USP, Ph. Eur.), and rigorous quality assurance protocols.
Manufacturers and Formulation Providers
Pfizer is responsible for converting raw APIs and excipients into final dosage forms—tablets or capsules.
- Manufacturing Facilities:
- Pfizer’s Global Manufacturing Network: Pfizer’s own facilities in the United States, Ireland, and Puerto Rico produce POSLUMA, ensuring standardized quality and supply chain security.
- Contract Manufacturing Organizations: As part of its external supplier strategy, Pfizer collaborates with CMOs such as Aenova, Cambrex, and Fujifilm Wako Chemical for formulation, filling, and packaging, especially in regional markets.
Distribution and Supply Chain Management
The finished product distribution relies on Pfizer’s extensive global distribution network.
- Distribution Centers: Pfizer operates distribution centers strategically located worldwide, ensuring timely delivery to healthcare providers and pharmacies.
- Supply Chain Partners: Logistics providers such as DHL and Kuehne+Nagel manage temperature-sensitive shipping, particularly for drugs with stability concerns.
The importance of a resilient supply chain is accentuated by the increasing demand for targeted cancer therapies, including POSLUMA, across global markets.
Regulatory and Quality Assurance Considerations
Suppliers must comply with stringent regulatory standards, including:
- GMP Certifications: Ensures quality, consistency, and safety in API and excipient manufacturing.
- FDA and EMA Approvals: Suppliers and manufacturing sites are frequently audited by regulatory agencies.
- Supply Chain Transparency: Pfizer’s quality management systems involve regular audits and supplier qualification processes to mitigate risks of substandard ingredients entering the supply chain.
Emerging Trends and Future Supply Chain Developments
- Supply Chain Diversification: Increasing diversification of suppliers, especially for raw materials, reduces vulnerability.
- Advanced Manufacturing Techniques: Adoption of continuous manufacturing processes enhances efficiency and scalability.
- Sustainability Initiatives: Suppliers are progressively adopting environmentally friendly practices, aligning with global sustainability standards.
Conclusion
The supply ecosystem for POSLUMA involves a complex network of API manufacturers, excipient suppliers, formulation partners, and logistics providers, predominantly led by Pfizer’s internal manufacturing capability supplemented by specialized CMOs. Ensuring a resilient and compliant supply chain is critical for maintaining continuous availability of this vital cancer therapy, especially amid global supply chain disruptions impacting raw material availability and manufacturing throughput.
Key Takeaways
- Diverse Supplier Base: Pfizer employs multiple API suppliers, including CSPC and CMOs like Hovione, to mitigate risks.
- Regulatory Compliance: Suppliers adhere to strict GMP standards, maintained through regular audits and certifications.
- Integrated Manufacturing: Pfizer’s own manufacturing facilities produce POSLUMA, supplemented by strategic partnerships with CMOs.
- Supply Chain Resilience: The company maintains diversified logistics and regional distribution centers to ensure patient access.
- Future Outlook: Emphasis on supply chain diversification, sustainable practices, and manufacturing innovations will shape POSLUMA’s supply landscape.
FAQs
-
Who are the main suppliers of POSLUMA’s active pharmaceutical ingredient?
CSPC Pharmaceutical Group in China is among the primary API suppliers, supported by contract manufacturers like Hovione and Lonza. -
How does Pfizer ensure the quality of POSLUMA’s raw materials?
Through rigorous supplier qualification, GMP compliance, and regular audits aligned with regulatory standards such as FDA and EMA. -
Are there regional differences in POSLUMA’s manufacturing?
Yes, Pfizer’s own manufacturing plants operate globally, with regional CMOs supporting local markets to ensure supply continuity. -
What risks exist in the POSLUMA supply chain, and how are they mitigated?
Risks include geopolitical issues, raw material shortages, and regulatory changes. Mitigation strategies involve supplier diversification and advanced inventory management. -
Is there a push towards sustainable sourcing for POSLUMA?
Increasingly, yes. Suppliers are adopting environmentally sustainable practices, which Pfizer monitors as part of its supply chain sustainability initiatives.
References
- Pfizer Inc. (2022). PosLUMA (alisertib) prescribing information.
- U.S. Food and Drug Administration. (2023). Guidance for Industry: Good Manufacturing Practices.
- CSPC Pharmaceutical Group. (2022). Annual Report.
- Hovione. (2023). API manufacturing capabilities.
- Pfizer Corporate Website. (2023). Supply Chain Overview.
More… ↓
