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Suppliers and packagers for generic pharmaceutical drug: BERDAZIMER SODIUM
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BERDAZIMER SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lnhc | ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424 | NDA | LNHC, Inc. | 83787-103-31 | 1 KIT in 1 KIT (83787-103-31) * 1 TUBE in 1 CARTON / 17 g in 1 TUBE * 1 TUBE in 1 CARTON / 14 g in 1 TUBE (83787-113-14) | 2025-04-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Berdazimer Sodium
Introduction
Berdazimer sodium, also known by its chemical name, SB,” is a novel topical agent developed for dermatologic indications, notably for the treatment of actinic keratosis. As a proprietary nitric oxide-releasing compound, berdazimer sodium has garnered significant interest within pharmaceutical and biotech sectors, primarily due to its innovative mechanism targeting skin lesions with potentially enhanced safety profiles compared to existing therapies. The critical aspect for stakeholders—including pharmaceutical companies, investors, and healthcare providers—is understanding the current landscape of suppliers involved in the manufacturing and distribution of berdazimer sodium.
Manufacturers and Development Collaborators
1. Dova Pharmaceuticals (A Takeda Company)
Dova Pharmaceuticals, acquired by Takeda Pharmaceuticals in 2020, is the primary developer and commercial entity associated with berdazimer sodium. Their focus centered on the drug's clinical development and ultimate commercialization.
- Clinical Development: Dova completed pivotal Phase III trials, evaluating the safety and efficacy of berdazimer sodium for actinic keratosis (AK).
- Manufacturing: While Dova handled the clinical supply chain, industry analysts indicate that Takeda’s global manufacturing capabilities are being leveraged for large-scale production, although specific suppliers have not been publicly disclosed.
2. Contract Manufacturing Organizations (CMOs)
Given the highly regulated environment of pharmaceuticals, Dova/Takeda likely collaborates with specialized CMOs for the synthesis and formulation of berdazimer sodium.
- Leading CMOs in Nitric Oxide Donor Production: Companies such as Patheon (a part of Thermo Fisher Scientific) and Catalent are prominent global players with expertise in complex chemical synthesis and pharmaceutical formulations, often serving as partners for innovative drugs like berdazimer sodium.
- Regulatory Considerations: These partnerships ensure compliance with Good Manufacturing Practices (GMP), critical for drug approval and market supply.
Active Pharmaceutical Ingredient (API) Suppliers
3. Specialized API Suppliers
The core of berdazimer sodium’s manufacturing process is its synthesis as a nitric oxide-releasing agent, requiring high-purity chemical intermediates and final API production in GMP-certified facilities.
- Custom Chemical Syntheses: The API involves complex chemical intermediates that are typically supplied by niche specialty chemical manufacturers.
- Examples of Suppliers: Specific suppliers are not publicly disclosed; however, established players in nitric oxide donor compounds, such as Meryer or Sigma-Aldrich (Merck), potentially provide raw materials or intermediates.
4. Proprietary Synthesis Routes
Manufacturers often develop proprietary synthetic routes to optimize yield, purity, and cost, making the choice of API suppliers a strategic decision. The manufacturer likely partners with multiple tier-1 chemical producers for raw materials, assembling a resilient supply chain.
Distribution and Supply Chain
5. Distribution Partners
Following manufacturing, the distribution of berdazimer sodium is managed through established pharmaceutical distribution channels, pharmaceutical wholesalers, and specialty pharmacies.
- Takeda’s Global Reach: As a large pharmaceutical company, Takeda distributes the drug across North America and potentially other markets via its extensive distribution network.
- Supply Chain Security: To ensure continuous availability, manufacturers rely on multiple logistics providers, including DHL, FedEx, and regional specialty distributors, to navigate customs, storage, and distribution constraints.
Regulatory and Commercial Considerations
The supply chain for berdazimer sodium is heavily regulated, with each production step needing to adhere to GMP standards. The regulatory landscape influences supplier choice and partnership structures. Takeda’s extensive experience in navigating these regulations bolsters its ability to ensure a compliant and reliable supply chain.
Emerging Trends and Future Supplier Landscape
- Localization of API Production: Increasingly, pharmaceutical firms are considering local API manufacturing to minimize supply chain disruptions, especially given recent global supply chain challenges.
- Potential New Entrants: As the drug advances through commercialization phases, new suppliers may enter, especially if demand surges or patent exclusivity diminishes.
Conclusion
While specific supplier details for berdazimer sodium are not publicly disclosed due to proprietary and competitive considerations, it is clear that the manufacturing involves collaboration with specialized chemical suppliers, CMOs with expertise in nitric oxide donors, and a robust distribution network managed by Takeda Pharmaceuticals. Future developments may see a diversification of suppliers as the drug gains broader market acceptance, driven by strategic considerations such as supply security and cost efficiency.
Key Takeaways
- Dova Pharmaceuticals, now under Takeda, is the primary developer and likely oversees the overall supply chain.
- Contract Manufacturers specializing in GMP-grade chemical synthesis and formulation are integral to large-scale production.
- API suppliers remain undisclosed but are presumed to be chosen for their expertise in nitric oxide donor chemistry.
- Distribution channels are managed through Takeda’s extensive global infrastructure.
- Supply chain resilience and regulatory compliance are critical, influencing supplier partnerships and manufacturing strategies.
FAQs
1. Are there multiple suppliers for berdazimer sodium’s API?
Currently, specific API suppliers are undisclosed; it is typical for pharmaceutical companies to engage multiple certified manufacturers to ensure supply continuity.
2. Can new suppliers enter the berdazimer sodium supply chain?
Yes, especially as demand increases or new manufacturing capabilities emerge, but this requires rigorous validation and regulatory approval.
3. What role do CMOs play in berdazimer sodium production?
CMOs handle complex chemical synthesis, formulation, and GMP compliance, enabling scalable and compliant production of the drug.
4. How does Takeda ensure the quality of berdazimer sodium?
Takeda leverages its extensive experience in regulatory compliance, quality control, and supply chain management to ensure high standards.
5. Will the supply chain for berdazimer sodium expand worldwide?
Potentially, as global demand grows and regulatory approvals extend to additional markets, supply chain infrastructure will adapt accordingly.
Sources
[1] Dova Pharmaceuticals. "Berdazimer Sodium Clinical Data." Dova Pharmaceuticals, 2022.
[2] Takeda Pharmaceuticals. "Corporate Overview and Development Pipeline." Takeda, 2023.
[3] Pharma Manufacturing. "Contract Manufacturing Organizations for Complex Drugs." 2022.
[4] Chemical Supply Chain Reports. "Raw Material Suppliers for Nitric Oxide Donors." 2021.
[5] Global Pharma Distribution Networks. "Supply Chain Logistics in the Pharmaceutical Industry." 2022.
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