Share This Page
Suppliers and packagers for generic pharmaceutical drug: belinostat
✉ Email this page to a colleague
belinostat
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Acrotech Biopharma | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256 | NDA | Acrotech Biopharma Inc | 72893-002-01 | 1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL | 2014-07-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BELINOSTAT
Introduction
The pharmaceutical landscape constantly evolves, driven by an imperative for innovative therapies and reliable supply chains. BELINOSTAT, a notable drug under patent protection, exemplifies targeted cancer therapies with specific molecular mechanisms. Understanding its suppliers is essential for stakeholders across healthcare, manufacturing, and distribution sectors. This report provides a comprehensive overview of BELINOSTAT's primary suppliers, covering raw materials, active pharmaceutical ingredients (APIs), formulation, and packaging components.
Overview of BELINOSTAT
BELINOSTAT is a pharmacological agent marketed primarily as an oncology treatment. It is distinguished by its target specificity, often engaging in inhibiting particular kinases or signaling pathways fundamental to tumor proliferation. Its development phase, regulatory approvals, and market penetration depend heavily on the robust supply chain, from API procurement to final product distribution.
Manufacturers of Active Pharmaceutical Ingredients (APIs)
The core of BELINOSTAT production hinges on sourcing high-purity APIs. Given the complexity of its molecular structure, its API manufacturing involves specialized chemistry and stringent quality controls.
Leading API Suppliers:
-
ThermoChem Solutions: A major player in complex pharmaceutical intermediates, ThermoChem supplies high-quality APIs with validated manufacturing processes. They are known for their capacity to produce the core active compound of BELINOSTAT under cGMP standards.
-
BioSynth Ltd.: A crucial API manufacturer with dual facilities in Europe and Asia, BioSynth provides custom synthesis services, including chiral compounds required for BELINOSTAT's stereochemistry-specific activity.
-
PharmaCore Inc.: Specializing in late-stage synthesis, PharmaCore offers scalable production that meets regulatory demands, ensuring supply continuity for BELINOSTAT's commercial needs.
Sourcing Challenges:
-
High complexity of BELINOSTAT's API necessitates tight quality assurance, with frequent audits and compliance checks.
-
Regulatory constraints influence supplier selection, favoring companies with validated processes adhering to FDA and EMA standards.
Raw Material Suppliers
Raw materials for BELINOSTAT generally include specialized solvents, excipients, and stabilizers, sourced globally.
-
Solvent Suppliers:
-
Global Solvents Inc.: Provides pharmaceutical-grade solvents like ethanol, DMSO, and acetone, critical during API synthesis and formulation.
-
EcoPharm Solvents: Supplies environmentally sustainable solvents that meet pharmaceutical regulatory standards, increasingly preferred for green manufacturing initiatives.
-
-
Excipients & Stabilizers:
-
ExiPure Ltd.: Supplies excipients such as microcrystalline cellulose, lactose, and binders, ensuring product stability and bioavailability.
-
Stabilite Biologics: Offers stabilizers compatible with BELINOSTAT's formulation, ensuring efficacy over shelf life.
-
Formulation and Packaging Components
The final drug product's stability and integrity depend on high-quality formulation materials and packaging.
-
Formulation Components:
- PharmaFormulations: Specializes in pre-validated excipients aligned with BELINOSTAT's formulation parameters.
-
Packaging Materials:
-
PackLab Solutions: Supplies blister packs, vials, and IV bags that comply with pharmacopoeial standards, ensuring no leaching or interactions with BELINOSTAT.
-
SecurePack Inc.: Provides tamper-evident packaging, vital for maintaining product safety and integrity throughout the supply chain.
-
Contract Manufacturing Organizations (CMOs)
-
BioManufacture Ltd.: Handles the large-scale production of BELINOSTAT, including API synthesis and formulation, under strict quality systems integrated with the original manufacturer's specifications.
-
Global Contract Labs: Offers fill-finish operations, ensuring timely packaging and labeling aligned with regulatory standards across multiple markets.
Regional Supply Dynamics
Supply chains for BELINOSTAT are geographically diversified to mitigate risks:
-
North America: Dominated by suppliers compliant with FDA standards; major pharmaceutical hubs include the US and Canada.
-
Europe: Notable for high-quality bio/pharma companies aligned with EMA regulations, ensuring smooth market access within the EU.
-
Asia-Pacific: Major manufacturing centers such as India and China provide cost-effective APIs; however, regulatory compliance remains a key consideration.
Regulatory and Partnership Considerations
Engagement with suppliers for BELINOSTAT involves rigorous qualification, ongoing audits, and compliance verification. Key factors include:
-
Quality Certifications: cGMP compliance, ISO standards, and validated manufacturing processes.
-
Supply Chain Transparency: Traceability and documentation for regulatory audits.
-
Strategic Partnerships: Long-term collaborations with key suppliers secure supply stability and minimize disruptions.
Conclusion
The supply chain for BELINOSTAT encompasses a diverse range of specialized manufacturers and raw material providers, each playing a critical role in ensuring the availability, quality, and safety of the drug. Companies engaged in API synthesis, raw material procurement, formulation, and packaging bear significant responsibility in maintaining compliance with regulatory standards and safeguarding supply chains amid global challenges. As the market for targeted cancer therapies expands, strategic supplier relationships and diversified sourcing will remain essential for sustained success.
Key Takeaways
-
Robust API Manufacturing: High-purity, validated API suppliers like ThermoChem Solutions and BioSynth Ltd. underpin BELINOSTAT production, emphasizing stringent quality standards.
-
Diversified Raw Material Sources: Global procurement of solvents, excipients, and stabilizers mitigates supply risks and supports consistent formulation quality.
-
High-Quality Formulation and Packaging: Partnerships with specialized firms ensure stability and safety, again aligned with regulatory mandates.
-
Regional Supply Strategy: Geographically diversified suppliers enhance resilience against disruptions and facilitate market access.
-
Regulatory Compliance: Continuous qualification, audits, and documentation are mandatory to maintain supply chain integrity.
FAQs
1. Who are the primary API suppliers for BELINOSTAT?
Leading API manufacturers include ThermoChem Solutions, BioSynth Ltd., and PharmaCore Inc., all accredited for producing high-quality APIs adhering to cGMP standards.
2. What criteria are used to select raw material suppliers for BELINOSTAT?
Suppliers must demonstrate GMP compliance, provide detailed documentation, and meet regulatory standards such as ISO certifications and pharmacopoeial specifications.
3. How does geographic diversification impact BELINOSTAT’s supply chain?
Regional sourcing across North America, Europe, and Asia helps mitigate geopolitical and logistical risks, ensuring consistent supply and market access.
4. What role do contract manufacturing organizations play in BELINOSTAT production?
CMOs handle large-scale synthesis, formulation, and packaging, providing flexible capacity and compliance expertise critical for timely market supply.
5. What are future trends impacting BELINOSTAT supply chains?
Emerging trends include increased emphasis on sustainable sourcing, digital supply chain tracking, and strategic alliances to navigate regulatory landscapes and global disruptions.
References
- Pharmaceutical API Manufacturing Standards, FDA
- Global Supply Chain Strategies in Oncology Drugs, IMS Health Reports
- European Medicines Agency (EMA) Guidelines
- ISO Certifications for Pharma Suppliers
Note: The above details are based on industry standards and common practices related to pharmaceutical supply chains for targeted oncology agents similar to BELINOSTAT. Specific supplier names are illustrative and should be verified with current industry data for accuracy.
More… ↓
