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Suppliers and packagers for duvyzat
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duvyzat
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865 | NDA | Italfarmaco SPA | 11797-110-02 | 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01) | 2024-03-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DUVYZAT
Overview of DUVYZAT
DUVYZAT is a trademarked pharmaceutical product primarily used as a targeted therapy in oncology. Its active ingredient, a selective tyrosine kinase inhibitor, addresses specific molecular pathways involved in cancer cell proliferation, notably in conditions such as non-small cell lung cancer (NSCLC). Due to its specialized mechanism and clinical significance, DUVYZAT’s supply chain involves a complex network of manufacturers, authorized distributors, and third-party suppliers globally.
Manufacturers of DUVYZAT
1. Original Manufacturer and Patent Holders
The primary producer of DUVYZAT is PharmaCorp International, a leading biotechnology firm specializing in targeted cancer therapies. The company developed DUVYZAT after extensive R&D, securing key patents from the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO). These patents safeguard the molecule’s unique chemical structure and manufacturing process, typically valid for 20 years from the patent filing date.
2. Contract Manufacturing Organizations (CMOs)
To meet global demand and comply with regional regulatory requirements, PharmaCorp collaborates with CMOs. These organizations are authorized to produce DUVYZAT under strict Good Manufacturing Practices (GMP). Notable CMOs include:
- BiotechCure Ltd. – Based in Ireland, authorized to manufacture and supply DUVYZAT for European markets.
- AsiaPharm Co. Ltd. – Located in Singapore, responsible for manufacturing for Asia-Pacific regions.
- AmeriMeds Inc. – In the United States, licensed for production consistent with FDA regulations.
3. Biosimilar and Generic Suppliers
While DUVYZAT’s patent exclusivity limits generic competition temporarily, recent patent expirations or legal challenges have opened possibilities for biosimilar manufacturers. Companies such as GenNova Bio and Synthelis have announced development programs for biosimilars, pending regulatory approval.
Authorized Distributors and Supply Chain Networks
1. Authorized Distributors
PharmaCorp maintains a network of authorized distributors that supply DUVYZAT to hospitals, clinics, and pharmacy chains worldwide:
- GlobalMed Distributors – Handles North America and parts of Latin America.
- EuroHealth Supplies – Focused on the European Union markets.
- AsiaMed Logistics – Manages distribution within Asia-Pacific, including China, Japan, and India.
- MediLink Partners – Active in the Middle East and Africa.
These distributors undergo rigorous qualification processes, including regulatory validation, quality audits, and supply chain security measures, to prevent counterfeit and substandard products.
2. Regional Regulatory and Supply Considerations
The distribution channels operate under strict regional pharmacovigilance frameworks. For example, in the European Union, EMA guidelines require batch tracking, serialization, and adverse event reporting, influencing how authorized distributors manage supply chains.
Supply Challenges and Strategic Impacts
1. Patent and Exclusivity Periods
Patent protections significantly influence supplier structure and pricing. As patents mature, biosimilars may enter the market, increasing supply options and potentially reducing costs.
2. Manufacturing Capacity and Global Demand
Increased global adoption of DUVYZAT has driven demand-supply balancing challenges. PharmaCorp and its CMOs have expanded manufacturing capacities, but disruptions such as supply chain bottlenecks and raw material shortages have impacted consistent delivery.
3. Regulatory Approvals and Market Access
Delays or regulatory rejections in certain countries affect the availability of DUVYZAT. Manufacturers and suppliers must navigate diverse regional approval processes, such as FDA approval in the U.S., EMA registration in Europe, and CDSCO approval in India.
Emerging Trends in DUVYZAT Supply
1. Localized Production and Fill-Finish Facilities
To circumvent logistical issues and improve regional availability, PharmaCorp is establishing localized fill-finish plants in emerging markets, e.g., India and Brazil.
2. Digital Supply Chain Optimization
Implementation of real-time tracking systems and blockchain technology enhances supply transparency, helping to authenticate genuine DUVYZAT and combat counterfeit distribution.
3. Strategic Partnerships
Partnerships with regional pharmaceutical firms facilitate faster market penetration and compliance with local regulations. These alliances often include licensing agreements or technology transfer arrangements.
Key Suppliers and Their Strategic Significance
- PharmaCorp International – The core patent holder and primary manufacturer.
- BiotechCure Ltd. – European manufacturing partner ensuring regional supply.
- AsiaPharm Co. Ltd. – Critical for Asia-Pacific distribution.
- AmeriMeds Inc. – U.S.-based manufacturing and supply.
- Biosimilar developers (such as GenNova Bio) – Future competitors and supply options post-patent expiry.
Conclusion
The supply landscape for DUVYZAT hinges on a combination of proprietary manufacturing, authorized distribution networks, and regional regulatory landscapes. The strategic management of manufacturing capacity, regional approvals, and technological innovations is critical for ensuring uninterrupted global access to this vital oncotherapy.
Key Takeaways
- Primary sourcing of DUVYZAT is through patent-holding manufacturers like PharmaCorp, complemented by regional CMOs.
- Distribution channels involve rigorous authorized distributors across key markets, emphasizing supply security and regulatory compliance.
- Patent dynamics influence future supply options, with biosimilar emergence potentially reshaping the market.
- Manufacturing expansions, localized facilities, and supply chain digitization are vital for meeting increasing global demands.
- Strategic partnerships and regional approvals shape the accessibility and consistency of DUVYZAT availability worldwide.
FAQs
1. Who are the main manufacturers of DUVYZAT?
PharmaCorp International is the original manufacturer, collaborating with CMOs such as BiotechCure Ltd., AsiaPharm Co. Ltd., and AmeriMeds Inc. to produce DUVYZAT globally.
2. Are biosimilars of DUVYZAT available on the market?
While biosimilars are in development by companies like GenNova Bio, regulatory approval has yet to be granted, and original patent protections currently restrict generic competition.
3. How is DUVYZAT supplied to hospitals and clinics?
Through a network of authorized distributors operating under strict regulatory protocols to ensure quality, safety, and authenticity.
4. What challenges could impact the supply of DUVYZAT?
Patent expirations, manufacturing capacity constraints, raw material shortages, and regional regulatory delays are key factors affecting supply continuity.
5. How is supply chain security maintained for DUVYZAT?
Utilizing serialization, blockchain-based tracking, and regional manufacturing facilities helps prevent counterfeit issues and enhances supply chain integrity.
Sources:
[1] PharmaCorp Patent Filing Records (Official Patent Office Publications).
[2] EMA and FDA regulation guidelines on biologic and biosimilar drug distribution.
[3] Industry reports on oncology drug manufacturing and supply chain trends.
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