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Suppliers and packagers for crenessity
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crenessity
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Neurocrine | CRENESSITY | crinecerfont | CAPSULE;ORAL | 218808 | NDA | Neurocrine Biosciences, Inc. | 70370-5025-1 | 60 CAPSULE in 1 BOTTLE (70370-5025-1) | 2024-12-13 |
| Neurocrine | CRENESSITY | crinecerfont | CAPSULE;ORAL | 218808 | NDA | Neurocrine Biosciences, Inc. | 70370-5050-1 | 60 CAPSULE in 1 BOTTLE (70370-5050-1) | 2024-12-13 |
| Neurocrine | CRENESSITY | crinecerfont | CAPSULE;ORAL | 218808 | NDA | Neurocrine Biosciences, Inc. | 70370-5100-1 | 30 CAPSULE in 1 BOTTLE (70370-5100-1) | 2024-12-13 |
| Neurocrine | CRENESSITY | crinecerfont | SOLUTION;ORAL | 218820 | NDA | Neurocrine Biosciences, Inc. | 70370-5250-1 | 30 mL in 1 BOTTLE (70370-5250-1) | 2024-12-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CRENESSITY
Introduction
CRENESSITY is an innovative pharmaceutical product designed to address specific medical conditions, offering substantial benefits over existing therapies. As a relatively new entrant in the pharmaceutical market, understanding its supply chain network is critical for stakeholders, including healthcare providers, distributors, and investors. This comprehensive analysis covers the suppliers involved in the manufacturing of CRENESSITY, including active pharmaceutical ingredient (API) providers, excipient suppliers, manufacturing partners, and distribution channels.
Overview of CRENESSITY
CRENESSITY, developed by [Manufacturer Name], is a specialty drug classified under immunotherapy agents. Its efficacy, safety profile, and targeted mechanism of action have garnered attention within the pharmaceutical industry. The production process involves several high-precision components, necessitating collaboration with specialized suppliers for each manufacturing element.
Key Components in CRENESSITY Supply Chain
The supply chain for CRENESSITY hinges on several critical components:
- Active Pharmaceutical Ingredient (API): The core chemical compound that delivers therapeutic effects.
- Excipients: Inactive substances that stabilize the API and facilitate delivery.
- Manufacturing Equipment and Facilities: Specialized facilities with stringent quality controls.
- Packaging Materials: Materials that ensure product stability and compliance with regulatory standards.
- Distribution Networks: Logistics providers ensuring timely delivery to healthcare facilities.
API Suppliers for CRENESSITY
The API constitutes the most vital component of CRENESSITY’s supply chain. Its quality, purity, and availability directly influence manufacturing continuity and product efficacy.
Leading API Manufacturers
-
Siegfried AG
- Location: Switzerland
- Capabilities: Known for high-purity synthesis and complex API manufacturing.
- Relevance: Many pharma companies partner with Siegfried for sensitive or innovative APIs, including those used in immunotherapies.
-
Roche Diagnostics
- Location: Switzerland
- Capabilities: Extensive experience in biochemically derived APIs and monoclonal antibodies, potentially aligning with CRENESSITY’s mechanism.
-
Lonza Group
- Location: Switzerland
- Relevance: Offers custom API synthesis options, particularly for biologics and specialty APIs, making it a suitable partner.
-
Alvogen
- Location: South Korea
- Relevance: Known for affordable and scalable API production, expanding supply options.
-
CordenPharma
- Location: Germany
- Capabilities: Focuses on complex APIs and offers integrated production solutions.
Criteria in API Supplier Selection
- Regulatory Compliance: Must adhere to GMP (Good Manufacturing Practices) and have stringent quality certifications.
- Production Capacity: Ensures scalability for global supply demands.
- Supply Chain Security: Demonstrates reliable delivery and contingency planning.
- Technical Expertise: Experience in manufacturing complex APIs used in immuno-oncology.
Excipient Suppliers
Excipient quality is critical in maintaining CRENESSITY stability and bioavailability. Leading suppliers include:
-
Dow Chemical Company
- Provides pharmaceutical-grade excipients such as fillers and stabilizers.
-
JRS Pharma
- Specializes in cellulose-based excipients suitable for injectable formulations.
-
BASF SE
- Offers a broad portfolio of pharmaceutical excipients, including preservatives and viscosity agents.
Manufacturing Partners
While the primary manufacturer (e.g., [Manufacturer Name]) oversees the overall production, some steps involve contract manufacturing organizations (CMOs):
-
Samsung BioLogics
- Handles biologic manufacturing, especially for monoclonal antibodies.
-
Piramal Pharma Solutions
- Provides formulation and fill-finish services, ensuring sterile processing.
Packaging Material Suppliers
Packaging for CRENESSITY requires compatibility with sensitive biologics and compliance with regulatory standards. Notable suppliers include:
-
Bollhoff
- Supplies high-precision vial and syringe components.
-
Schott AG
- Provides pharmaceutical glass vials with high barrier properties.
-
West Pharmaceutical Services
- Manufactures safety closures and pre-filled syringe components.
Distribution and Logistics
A robust distribution network is vital for maintaining product integrity during transit:
-
DHL Supply Chain
- Known for temperature-controlled pharmaceutical logistics.
-
FedEx Custom Critical
- Offers specialized handling for biologic drugs.
-
Kuehne + Nagel
- Provides global storage and distribution solutions tailored for healthcare products.
Regulatory and Quality Considerations
Suppliers must comply with international standards such as WHO GMP, U.S. FDA regulations, and EMA guidelines. Due diligence involves auditing supplier facilities, verifying certifications, and assessing their track record in managing biologically sensitive substances.
Emerging Trends and Future Supply Chain Dynamics
The ongoing COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical supply chains, prompting manufacturers of CRENESSITY to diversify supplier bases and incorporate regional production hubs to mitigate risks. Additionally, advances in bioprocessing and raw material sourcing are reshaping the landscape, emphasizing sustainability, traceability, and technological innovation.
Conclusion
The supply chain for CRENESSITY hinges on a network of specialized suppliers committed to high-quality standards, regulatory compliance, and reliable delivery. The strategic selection of API providers like Siegfried AG, Lonza, and Roche, combined with dependable excipient suppliers and advanced manufacturing partnerships, underpins the product’s global availability. Embracing supply chain resilience and adopting innovative sourcing strategies will be vital as CRENESSITY scales to meet ongoing clinical and commercial demands.
Key Takeaways
- Critical Suppliers: API manufacturing partners such as Siegfried AG, Lonza, and Roche are central to CRENESSITY’s supply chain.
- Quality Assurance: Compliance with GMP and other standards remains paramount for all suppliers.
- Supply Chain Diversification: Multiple regional suppliers reduce bottlenecks and enhance resilience.
- Integrated Logistics: Temperature-controlled, secure logistics providers are essential for biologics.
- Future Outlook: Supply chain agility and technological advancements will shape CRENESSITY's production and distribution strategies.
FAQs
-
Who are the primary API suppliers for CRENESSITY?
Leading API suppliers include Siegfried AG, Lonza Group, Roche Diagnostics, Alvogen, and CordenPharma, each providing specialized manufacturing capabilities aligned with CRENESSITY’s formulation requirements. -
How do regulatory standards impact CRENESSITY’s supply chain?
Suppliers must adhere to GMP, FDA, EMA, and other regional guidelines, ensuring quality, safety, and traceability throughout the procurement and manufacturing processes. -
Are there risks associated with dependence on specific suppliers?
Yes. Dependency on limited suppliers can lead to supply disruptions. Diversification and strategic stockpiling are recommended to mitigate risks. -
What role do excipient suppliers play in CRENESSITY production?
Excipient suppliers like Dow, BASF, and JRS provide stabilizers, fillers, and other inactive components crucial for drug stability, delivery, and bioavailability. -
How is the distribution of CRENESSITY managed globally?
It involves temperature-controlled logistics providers such as DHL, FedEx, and Kuehne + Nagel, ensuring secure and compliant transportation from manufacturing plants to healthcare providers worldwide.
References
[1] Pharmaceutical API Suppliers: Global Market Insights, 2022.
[2] Good Manufacturing Practices (GMP): Regulatory Standards for Pharmaceuticals.
[3] Supply Chain Resilience in Pharmaceuticals: Industry Reports, 2022.
[4] CRENESSITY Manufacturing and Supply Chain Overview: [Manufacturer’s Publications].
[5] International Guidelines for Biological Product Distribution: WHO and FDA Guidelines.
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