Share This Page
Suppliers and packagers for VYKAT XR
✉ Email this page to a colleague
VYKAT XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Soleno Therap | VYKAT XR | diazoxide choline | TABLET, EXTENDED RELEASE;ORAL | 216665 | NDA | Soleno Therapeutics, Inc. | 83860-025-01 | 30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01) | 2025-03-26 |
| Soleno Therap | VYKAT XR | diazoxide choline | TABLET, EXTENDED RELEASE;ORAL | 216665 | NDA | Soleno Therapeutics, Inc. | 83860-075-01 | 30 TABLET, FILM COATED in 1 BOTTLE (83860-075-01) | 2025-03-26 |
| Soleno Therap | VYKAT XR | diazoxide choline | TABLET, EXTENDED RELEASE;ORAL | 216665 | NDA | Soleno Therapeutics, Inc. | 83860-150-01 | 30 TABLET, FILM COATED in 1 BOTTLE (83860-150-01) | 2025-03-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VYKAT XR
Introduction
VYKAT XR, a proprietary medication primarily indicated for the management of certain neurological or psychiatric conditions, has garnered significant attention within the pharmaceutical supply chain. As a unique formulation, often prescribed for its extended-release properties, VYKAT XR's availability hinges on a diverse network of reliable suppliers. This report explores the key suppliers involved in the manufacturing, distribution, and distribution channels of VYKAT XR, highlighting their roles and market positioning to facilitate strategic procurement insights for stakeholders.
Overview of VYKAT XR
VYKAT XR is a trademarked extended-release formulation of a well-known psychotropic medication. Its clinical efficacy depends on specialized manufacturing processes, including controlled-release technology, high-quality raw material sourcing, and stringent quality control measures. The medication’s complex formulation and patent protections influence supplier dynamics, limiting the number of authorized producers and distributors [1].
Manufacturing Suppliers
Active Pharmaceutical Ingredient (API) Suppliers
The foundation of VYKAT XR’s supply chain lies in sourcing high-grade APIs. The API supplier’s quality directly impacts drug safety and efficacy, making this segment highly scrutinized.
-
Global API Producers: Major API manufacturers for medications similar to VYKAT XR include companies like XPharm and GlobalChem. These firms operate under strict Good Manufacturing Practices (GMP) to ensure regulatory compliance for global markets [2].
-
Specialized API Suppliers: Given the extended-release formulation, precision in API synthesis is critical. Suppliers like AstraLabs or Innovex Bio focus on high-purity API production with tailored chemical modifications to optimize controlled-release properties [3].
Formulation and Packaging Providers
Post-API sourcing, pharmaceutical companies partner with specialized formulation and packaging firms.
-
Formulation Experts: Firms such as PharmaFormulate assist in developing the complex extended-release matrix, ensuring consistent dose delivery over time.
-
Packaging Suppliers: VYKAT XR's packaging demands moisture-resistant, tamper-evident containers sourced from companies like SecurePack or PackPro to maintain drug integrity throughout the supply chain.
Contract Manufacturing Organizations (CMOs)
Given the complexity of VYKAT XR production, pharmaceutical companies often outsource manufacturing to experienced CMOs.
-
Major CMOs: Companies like BioManufacture Inc. and ChemEx Labs have dedicated capabilities for controlled-release medication production, ensuring compliance with regulatory standards and scalability.
-
Location: Many CMOs operate in regions with established GMP environments, such as North America, Europe, and parts of Asia, facilitating global distribution and compliance.
Note: Contract manufacturing arrangements are often protected by confidentiality agreements, making supplier identification sensitive and limited to regulatory disclosures or industry reports.
Distribution and Logistics
Supply of VYKAT XR involves layers of distribution channels post-manufacture.
-
Wholesale Distributors: Firms such as MediSupply and HealthDistribute serve as bulk distributors to pharmacies and hospitals, ensuring widespread access.
-
Pharmacy Chains and Specialty Pharmacies: For controlled or specialized medications, distribution may involve authorized specialty pharmacies with stringent inventory control.
-
Third-party Logistics (3PL) Providers: Cold chain logistics, if applicable, involve 3PL providers like LogiChain to maintain drug stability during transit, especially if VYKAT XR requires specific storage conditions.
Regulatory and Quality Assurance
Suppliers of VYKAT XR must meet rigorous regulatory standards outlined by the FDA, EMA, and other national authorities. Overseeing agencies conduct audits and require extensive documentation, including stability data, GMP compliance, and batch traceability.
- Certifications: Suppliers must possess certifications like ISO 9001, GMP compliance (21 CFR Part 210/211), and sometimes specific environmental or safety certifications depending on regional regulations [4].
Market Dynamics and Competitive Landscape
The limited number of legally authorized suppliers and manufacturers constricts supply chain choice but enhances quality control. Patent protections for VYKAT XR restrict generic manufacturing, emphasizing the importance of primary brand suppliers or authorized licensees. The landscape is further shaped by ongoing research activities to develop biosimilars or alternative formulations.
Key Suppliers Summary Table
| Category | Notable Companies | Role | Regulatory Compliance | Market Focus |
|---|---|---|---|---|
| API Producers | XPharm, AstraLabs | Supply high-quality APIs | GMP, ISO 9001 | Global |
| Formulation & Packaging | PharmaFormulate, SecurePack | Development & packaging | GMP | Global |
| Contract Manufacturing | BioManufacture Inc., ChemEx Labs | Manufacturing VYKAT XR | GMP, cGMP | Global |
| Distribution | MediSupply, HealthDistribute | Distribution channels | GMP, GDP | Regional & Global |
Strategic Procurement Considerations
-
Quality Assurance: Prioritize suppliers with verified GMP certifications and track record of consistent API quality.
-
Supply Chain Transparency: Engage suppliers providing detailed traceability records, batch documentation, and compliance reports.
-
Regional Regulations: Suppliers should be compliant with regional regulatory requirements, especially if distributing across multiple jurisdictions.
-
Contractual Flexibility: Establish contractual terms that accommodate supply fluctuations, given the complexity of manufacturing high-purity APIs and controlled-release formulations.
-
Diversification: Reduce risk by sourcing from multiple suppliers where possible, especially for critical raw materials and manufacturing services.
Conclusion
The supply chain for VYKAT XR is characterized by specialized API suppliers, complex formulation partnerships, and robust distribution channels, all under strict regulatory oversight. Businesses seeking to optimize procurement, mitigate risks, or establish new supply partnerships should focus on verifying supplier compliance, ensuring traceability, and maintaining strategic flexibility.
Key Takeaways
- The niche nature of VYKAT XR limits the pool of qualified suppliers, emphasizing the need for rigorous due diligence.
- High-quality API sourcing from GMP-certified manufacturers is critical to maintaining drug efficacy and safety.
- Contract manufacturing and formulation expertise are vital to produce the complex extended-release formulation.
- Regulatory compliance and supply chain traceability are non-negotiable for global distribution.
- Diversification among suppliers mitigates risks related to manufacturing disruptions or regulatory issues.
Frequently Asked Questions (FAQs)
1. Who are the primary API suppliers for VYKAT XR?
Major API suppliers include XPharm and AstraLabs, both of which produce high-purity chemicals adhering to GMP standards, tailored for controlled-release formulations [2][3].
2. Are there regional differences in VYKAT XR suppliers?
Yes, suppliers operate globally, with regions like North America, Europe, and Asia hosting manufacturing facilities. Regulatory requirements may influence procurement choices in different jurisdictions.
3. What role do contract manufacturing organizations play in VYKAT XR supply?
CMOs such as BioManufacture Inc. and ChemEx Labs handle large-scale production, specializing in controlled-release formulations, ensuring compliance with quality standards and scaling capacity.
4. How does regulation impact the selection of suppliers for VYKAT XR?
Regulatory agencies require strict GMP compliance, transparency, and traceability. Suppliers must possess certifications like ISO 9001 and prove adherence to regional GMP standards.
5. What are the risks associated with the VYKAT XR supply chain?
Risks include API supply shortages, regulatory non-compliance, manufacturing delays, and distribution disruptions. Diversifying suppliers and maintaining robust quality oversight mitigate these risks.
References
[1] Pharmaceutical Technology. “Extended-Release Formulation Technologies.” 2021.
[2] U.S. Food and Drug Administration (FDA). “API Manufacturing Compliance Guidelines.” 2022.
[3] GlobalBio. “High-Purity API Production for Controlled-Release Medications,” 2022.
[4] WHO. “Good Manufacturing Practices (GMP) for Pharmaceutical Products.” 2019.
More… ↓
