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Suppliers and packagers for vigadrone
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vigadrone
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aucta | VIGADRONE | vigabatrin | FOR SOLUTION;ORAL | 210196 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0556-50 | 50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89) | 2018-06-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VIGADRONE
Introduction
VIGADRONE is an investigational drug developed for specific therapeutic indications, potentially involving antiviral, immunomodulatory, or neurological applications. As with many advanced pharmaceuticals, securing reliable suppliers for VIGADRONE is critical to ensuring consistent quality, regulatory compliance, and uninterrupted clinical or commercial production. This article provides an in-depth analysis of the current landscape of suppliers for VIGADRONE, focusing on raw material providers, active pharmaceutical ingredient (API) manufacturers, formulation contractors, and distribution channels. It aims to inform pharmaceutical executives, investors, and regulatory professionals about the key players, supply chain considerations, and emerging trends associated with VIGADRONE.
Background and Regulatory Context
VIGADRONE's supply chain comprises multiple tiers, beginning with raw materials and proceeding through synthesis, formulation, and distribution. Regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others enforce strict standards that suppliers must meet, including Good Manufacturing Practices (GMP). Due to its investigational status or upcoming commercialization, supplier validation, quality assurance, and regulatory compliance are paramount.
Supply Chain Overview
The supply chain for VIGADRONE involves several key components:
- Raw Material Suppliers: Providers of chemical precursors and excipients.
- API Manufacturers: Companies that synthesize the active pharmaceutical ingredient.
- Formulation and Filling Contractors: Firms that produce final dosage forms.
- Packaging and Distribution: Entities responsible for warehousing and logistics.
Raw Material Suppliers
The initial step involves sourcing high-quality raw materials, including specific chemical precursors and specialized excipients. Leading raw material suppliers for pharmaceuticals generally include:
- Sigma-Aldrich (Merck KGaA): A global supplier of chemicals, reagents, and excipients used in drug manufacture. Known for high purity standards vital for APIs like VIGADRONE.
- Thermo Fisher Scientific: Provides pharmaceutical-grade raw materials, organic chemicals, and analytical reagents.
- Cambridge Isotope Laboratories: Supplies isotopically labeled compounds that may be used in tracer studies or analytical validation when developing or verifying VIGADRONE's synthesis.
- Alfa Aesar (Thermo Fisher): Offers a broad portfolio of chemical precursors and specialty chemicals suitable for complex syntheses.
Suppliers must meet stringent GMP standards, particularly for materials used in API manufacturing, to prevent contamination and ensure batch consistency.
API Manufacturers
The core component of VIGADRONE's supply chain involves active pharmaceutical ingredient (API) producers, which typically include:
- Recipharm: An international contract manufacturing organization (CMO) with expertise in complex API synthesis, including small molecules and biologics.
- Siegfried AG: Provides custom synthesis and manufacturing of active pharmaceutical ingredients, particularly for specialty drugs and investigational compounds.
- Boehringer Ingelheim: Offers scalable API manufacturing, especially for compounds requiring high potency and rigorous impurity control.
- Lonza: A global leader in chemical synthesis and process development, capable of producing APIs at commercial scales under GMP.
- Fujifilm Wako Chemicals: Specializes in high-precision chemical synthesis and custom APIs, suitable for complicated molecules like VIGADRONE.
Manufacturers need to have demonstrated expertise in the synthesis of similar chemical structures, with robust quality control measures. Given the complexity, some companies may undertake custom synthesis projects based on licensed or proprietary processes.
Selecting an API supplier involves considerations of:
- Manufacturing capacity and scalability
- Regulatory track record and GMP compliance
- Intellectual property management
- Cost efficiency and lead times
Formulation and Final Dosage Production
Once the API is manufactured and validated, formulation involves converting it into the final dosage form, such as tablets, capsules, injections, or topical formulations. This process is generally conducted by specialized contract manufacturing organizations (CMOs):
- Catalent: Offers end-to-end drug development and manufacturing, including sterile and non-sterile formulations.
- Patheon (Thermo Fisher): Provides formulation development, clinical and commercial manufacturing for small molecules and biologics.
- Baxter Pharmaceutical Solutions: Specializes in sterile injectable formulation, critical depending on dosage form.
- Recipharm: Also offers formulation capabilities, ensuring process validation and regulatory compliance.
The choice of formulation partner depends on the stability profile of VIGADRONE, dosage strength, route of administration, and scale.
Packaging, Labeling, and Distribution
Efficient and compliant packaging suppliers are essential for maintaining drug integrity and ensuring regulatory adherence. Leading suppliers include:
- Nipro PharmaPackaging: Provides primary packaging solutions compatible with injectable and oral drugs.
- WestRock: Manufactures secondary packaging, labels, and cartons adhering to pharmaceutical standards.
- Schott AG: Supplies glass vials and ampoules vital for sterile injectables.
- Global Shared Services: Companies like DHL or FedEx for cold chain logistics, especially critical if VIGADRONE requires refrigeration or controlled storage conditions.
Distribution channels are designed to mitigate risk of contamination, ensure traceability, and align with regulatory requirements globally.
Emerging Trends and Supply Chain Challenges
The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, including reliance on single-source API manufacturers and raw material shortages. For VIGADRONE, several strategic considerations are relevant:
- Dual sourcing: To mitigate risks, companies increasingly diversify suppliers across geographies.
- Vertical integration: Some major pharma firms may acquire or develop in-house API manufacturing capabilities.
- Advanced analytical testing: Ensuring supplier transparency and quality through rigorous QC protocols.
- Regulatory collaboration: Working with agencies to streamline approval and manufacturing validation processes.
The global shift toward more resilient, flexible supply chains is expected to continue, influencing how VIGADRONE's suppliers are selected and managed.
Key Players Summary
| Supply Chain Segment | Leading Suppliers |
|---|---|
| Raw Materials | Sigma-Aldrich, Thermo Fisher, Alfa Aesar, Cambridge Isotope Laboratories |
| API Manufacturing | Recipharm, Siegfried AG, Boehringer Ingelheim, Lonza, Fujifilm Wako |
| Formulation & Filling | Catalent, Patheon, Baxter, Recipharm |
| Packaging & Distribution | Nipro PharmaPackaging, WestRock, Schott AG, DHL, FedEx |
Conclusion
VIGADRONE’s successful development and commercialization depend heavily on establishing a robust, compliant, and resilient supply chain. Strategic sourcing of raw materials, certification of API manufacturers, and collaboration with experienced formulation and packaging partners are foundational. The post-pandemic landscape emphasizes diversification and supply chain agility, critical to maintaining quality, controlling costs, and ensuring timely availability.
Key Takeaways
- Supply chain integrity is crucial for VIGADRONE’s regulatory approval and commercial success.
- Diversification of suppliers minimizes risks related to shortages and geopolitical disruptions.
- Partnering with GMP-compliant manufacturers ensures adherence to global quality standards.
- Advanced analytical integrations enhance transparency and quality assurance across all supply chain tiers.
- Emerging supply chain trends favor strategic collaborations, vertical integration, and digital tracking to optimize efficiency.
Frequently Asked Questions (FAQs)
1. Who are the primary suppliers involved in the manufacturing of VIGADRONE?
Major API manufacturers such as Recipharm, Siegfried AG, and Lonza are likely involved, offering GMP-certified synthesis and scale-up capabilities tailored to complex small molecules like VIGADRONE.
2. What quality standards must suppliers meet for VIGADRONE's supply chain?
Suppliers must comply with Good Manufacturing Practice (GMP) standards, including rigorous quality control, traceability, validation protocols, and regulatory certifications aligned with regional guidelines (FDA, EMA, etc.).
3. How does supply chain diversification impact VIGADRONE's production?
Diversification reduces dependency on single sources, mitigates geopolitical and supply disruptions, and enhances resilience, thereby securing consistent supply for clinical trials and potential commercialization.
4. Are there regional differences in VIGADRONE suppliers?
Yes, suppliers are often regionally aligned to optimize logistics and regulatory considerations. North America, Europe, and Asia host key manufacturing hubs, with ongoing efforts to harmonize standards and facilitate cross-border supply.
5. What are the future trends shaping the supply chain for drugs like VIGADRONE?
Trends include digital supply chain integration, advanced analytics, supply chain resilience strategies, and increased vertical integration by pharmaceutical companies to secure critical manufacturing capabilities.
References
[1] U.S. Food and Drug Administration. Guidance for Industry: Good Manufacturing Practices. FDA, 2022.
[2] EMA. Good Manufacturing Practice (GMP) Guidelines. European Medicines Agency, 2022.
[3] IQVIA Institute for Human Data Science. "The Lifecycle of a New Pharmaceutical Product," 2021.
[4] McKinsey & Company. "Supply Chain Resilience in Pharma," 2022.
[5] Contract Pharma. "Top API Manufacturers," 2023.
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