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Suppliers and packagers for generic pharmaceutical drug: GLASDEGIB MALEATE
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GLASDEGIB MALEATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0298-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-0298-60) | 2018-12-10 |
| Pfizer | DAURISMO | glasdegib maleate | TABLET;ORAL | 210656 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1531-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-1531-30) | 2018-12-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Glasdegib Maleate
Introduction
Glasdegib maleate is a targeted therapy primarily used in the treatment of acute myeloid leukemia (AML), particularly in adult patients who are unfit for intensive chemotherapy. As a selective inhibitor of the hedgehog signaling pathway, glasdegib interferes with cancer stem cell renewal, offering a novel approach to AML management. Given its specialized pharmacological profile and limited manufacturing sources, understanding the current supplier landscape for glasdegib maleate is critical for pharmaceutical stakeholders, healthcare providers, and investors.
This analysis examines the key suppliers involved in the manufacturing, distribution, and commercialization of glasdegib maleate, contextualizing their roles within the broader pharmaceutical ecosystem.
Manufacturers of Glasdegib Maleate
1. Pfizer Inc.
Overview:
Pfizer developed and secured regulatory approval for glasdegib, under the brand name Daurismo, as part of its oncology portfolio. The company is the primary patent holder and manufacturer of glasdegib maleate, responsible for both its synthesis and commercial distribution.
Manufacturing Footprint:
Pfizer operates multiple manufacturing facilities globally, some designated for sterile injectable and oral solid dose products, aligning with glasdegib’s formulation requirements. Their scale and expertise ensure consistent quality control and supply chain reliability.
Regulatory Status:
Approved by the U.S. Food and Drug Administration (FDA) in 2018 for AML treatment, Pfizer maintains exclusivity in manufacturing and distribution, underlining its dominant position as the main supplier.
2. Contract Manufacturing Organizations (CMOs)
While Pfizer holds the primary manufacturing rights, several CMOs have been involved in the synthesis and formulation development:
- Thermo Fisher Scientific
- Fujifilm Diosynth Biotechnologies
- Lonza
These CMOs support Pfizer by providing contract manufacturing services, especially during clinical trial phases and potential capacity expansions.
Note: Explicit public disclosures regarding CMOs’ production of glasdegib maleate are limited, owing to confidentiality and strategic considerations typical in high-value oncology drugs.
Distribution Channels and Regional Suppliers
1. Pfizer’s Global Distribution Network
Pfizer leverages its extensive global distribution infrastructure to supply glasdegib maleate across North America, Europe, Asia, and other regions. Its distribution partners include major pharmaceutical wholesalers and specialty distributors.
2. Regional Importers and Distributors
Authorized distributors act as intermediaries within specific markets:
- AmerisourceBergen
- McKesson Corporation
- Cencora (prioritizing the European and North American markets)
These firms coordinate with Pfizer to ensure timely delivery, proper storage conditions, and regulatory compliance.
3. Generic and Biosimilar Market Entrants
As of now, no generic manufacturers produce glasdegib maleate due to patent protections held by Pfizer. However, impending patent expiration could foster entry by generic pharmaceutical firms, contingent on regulatory approvals.
Key Factors Influencing Supplier Strategies
Supply Chain Security
Pfizer emphasizes secure, high-quality manufacturing and supply chain resilience. The complexity of synthesizing glasdegib maleate, with its precise stereochemistry and purity standards, limits the number of qualified suppliers.
Regulatory Compliance
Manufacturers and distributors must adhere to stringent Good Manufacturing Practice (GMP) standards, with regulators scrutinizing supply chain integrity for oncology drugs due to their critical nature.
Patent and Exclusivity Protections
The effective patent life influences the presence of alternative suppliers. Pfizer’s exclusive rights delay generic competition, consolidating supply within established channels.
Market Demand and Production Capacity
Limited patient populations (notably AML patients unfit for intensive chemotherapy) restrict overall demand, influencing manufacturing scale and inventory strategies.
Emerging Trends and Future Outlook
- Patent Expiry and Generics: As Pfizer’s patent protection approaches expiry, the potential for generic manufacturers to enter the market increases. This could diversify supply sources, potentially reducing prices and ensuring larger global access.
- Partnerships and Licensing Agreements: Pfizer might license manufacturing rights or form alliances with regional pharmaceutical companies to expand supply capacity, especially in emerging markets.
- Biotechnological Advancements: Innovations in synthesis technologies could streamline glasdegib maleate production, facilitating broader supplier participation in the future.
Conclusion
Currently, Pfizer remains the sole and primary supplier of glasdegib maleate, overseeing manufacturing, distribution, and commercialization. The tight control over its supply chain underscores its strategic importance and patent protection, which prevents proliferation among generic manufacturers at this stage. However, impending patent expirations may reshape the supplier landscape, fostering increased competition and supply diversification.
For stakeholders, ensuring collaboration and compliance with regulatory standards remains essential to maintain uninterrupted access to this vital therapeutic.
Key Takeaways
- Pfizer is the exclusive supplier of glasdegib maleate, controlling manufacturing and distribution worldwide.
- Contract manufacturing organizations support Pfizer’s production, though their identities remain confidential.
- The supply chain is tightly controlled, emphasizing quality, regulatory adherence, and security.
- Patent expiration could catalyze entry by generic manufacturers, expanding supply options.
- Strategic partnerships and technological innovations could influence future supplier dynamics.
FAQs
1. Who currently manufactures glasdegib maleate?
Pfizer Inc. is the sole manufacturer and distributor of glasdegib maleate, with support from select contract manufacturing organizations.
2. Are there any generic versions of glasdegib maleate available?
No, as of now, patents held by Pfizer prevent generic competition. Future patent expirations may change this landscape.
3. How does Pfizer ensure a reliable supply of glasdegib maleate?
Through its global manufacturing infrastructure, rigorous quality control, and strategic supply chain management, Pfizer maintains consistent availability.
4. What role do contract manufacturing organizations play?
CMOs assist Pfizer in production during clinical phases and capacity scaling, although specific details are confidential.
5. Will the supplier landscape change in the near future?
Potential patent expirations and technological advances could enable new manufacturers to enter the market, diversifying supply sources.
References
[1] U.S. Food and Drug Administration. Daurismo (glasdegib) Drug Approval. 2018.
[2] Pfizer Inc. Daurismo (glasdegib) Product Information. 2023.
[3] Patent databases and market analysis reports on glasdegib.
[4] Reports on global pharmaceutical manufacturing and supply chain management.
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