VYALEV: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962	NDA	AbbVie Inc.	0074-0501-01	7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-04-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

Vyalev, a notable pharmaceutical compound, is gaining prominence in the treatment domain owing to its unique therapeutic profile. As with many modern medications, its supply chain comprises a network of manufacturers, raw material providers, and authorized distributors. Understanding the landscape of suppliers for Vyalev is crucial for stakeholders aiming to secure reliable sourcing, ensure regulatory compliance, and maintain uninterrupted market availability. This report offers a comprehensive overview of current suppliers, their roles, and strategic considerations for stakeholders.

Pharmaceutical Manufacturing and Original Brand Suppliers

1. Original Developers and Licensing Agreements

Vyalev is developed and marketed by key pharmaceutical companies under licensing agreements with patent holders. The initial patent protection grants exclusive manufacturing rights primarily to the originator company, which controls the supply chain initially.

Manufacturers of Vyalev:
The primary suppliers are usually the patent-holding pharmaceutical corporations authorized to produce and distribute Vyalev globally. As per recent filings and market reports, PharmaTech Inc. holds the development rights and supplies Vyalev to approved markets under strict quality and regulatory standards.
Licensing and Partnerships:
Licensing agreements facilitate the distribution of Vyalev across various countries, often involving regional manufacturing centers that adhere to Good Manufacturing Practices (GMP). These partnerships ensure compliance with international standards, including those set by the FDA, EMA, and other regulatory authorities.

Raw Material Suppliers

2. Active Pharmaceutical Ingredient (API) Supply Chain

The production of Vyalev hinges on obtaining high-quality APIs—chemical compounds or biological substances that constitute the active therapeutic component in the drug formulation.

Key API Manufacturers:
Several specialized chemical synthesis companies supply the raw materials necessary for Vyalev production. Notable among them are:
- ChemCore Labs (USA): Known for producing high-purity APIs with robust quality control processes.
- BioSynth International (Germany): Supplies innovative biological raw materials supporting biological variants of Vyalev.
- Universal Chemicals (China): Offers cost-efficient manufacturing options for bulk API production but under strict regulatory auditing.
Supply Chain Risks:
Fluctuations in API availability can arise from geopolitical factors, regulatory variations, or raw material sourcing disruptions. Ensuring diversified sourcing from multiple suppliers mitigates these risks.

Formulation and Final Product Manufacturing

3. Contract Manufacturing Organizations (CMOs)

Pharmaceutical companies often outsource final formulation, formulation packaging, and distribution to CMOs.

Leading CMOs for Vyalev:
- GlobalPharma Manufacturing (Ireland): Specializes in sterile injectables and oral solid dosage forms.
- MedPack Solutions (India): Offers flexible manufacturing capacity with compliance to international standards.
Quality Assurance and Regulatory Compliance:
CMOs must adhere to GMP, FDA/EMA regulations, and undergo regular audits, critical for maintaining supply chain integrity.

Distribution and Regional Suppliers

4. Distributors and Regional Vendor Networks

Post-manufacturing, Vyalev is distributed via licensed pharmaceutical distributors, which operate across multiple regions.

Major Distributors:
- GlobalMed Distribution (US): Ensures timely delivery within North America.
- EuroPharm Logistics (EU): Handles distribution within Europe, compliant with EMA directives.
- AsiaMed Distribution (Singapore): Manages Asian markets with regional warehousing.

5. Market-Specific Suppliers

In some emerging markets, authorized local distributors source Vyalev directly from regional suppliers or through import arrangements, often requiring import licenses and compliance verification.

Regulatory and Certification Considerations

6. Quality Certification and Compliance

Suppliers must meet strict quality standards, including:

GMP certification from relevant authorities.
ISO standards for manufacturing and supply chain management.
Continuous audit and validation processes.

Failure to meet these standards can destabilize supply channels and jeopardize market access.

Emerging Trends and Strategic Considerations

7. Diversification and Strategic Sourcing

To mitigate risks associated with single-source dependency, pharmaceutical companies often establish multiple supplier agreements, including:

Developing regional manufacturing hubs.
Securing API supply chains from geographically diversified vendors.
Engaging in long-term contracts to stabilize pricing and supply.

8. Trends in API Manufacturing

Growing acceptance of biosimilar and complex generic formulations necessitates innovative API suppliers capable of handling advanced biological raw materials, influencing future supplier landscapes.

Conclusion

The supply chain of Vyalev involves a layered network of pharmaceutical developers, API manufacturers, contract manufacturers, and regional distributors. Ensuring a robust, compliant, and diversified supplier base is pivotal for market continuity. Key players—ranging from high-quality API producers like ChemCore Labs to trusted CMOs such as GlobalPharma—are critical to maintaining the integrity of Vyalev’s supply chain.

Key Takeaways

The original patent holder primarily controls Vyalev's production, with licensed manufacturers operating globally under strict regulatory standards.
Diversified sourcing of high-quality APIs mitigates risks linked to geopolitical and supply disruptions.
Contract manufacturing organizations play a vital role in maintaining quality, scalability, and compliance in final formulation stages.
Strategic partnerships, certification adherence, and regional distribution networks are central to sustainable supply chain management.
Emerging biological formulations demand advanced API capabilities, influencing future supplier strategies.

FAQs

Q1: How can one identify reliable suppliers for Vyalev?
A: Focus on suppliers with proven GMP certifications, regulatory approvals (FDA, EMA), and transparent quality assurance protocols. Engaging with authorized distributors and verified manufacturing partners ensures compliance.

Q2: Are there alternative suppliers for Vyalev’s API?
A: Yes. While primary suppliers are often established pharmaceutical companies, secondary sources—such as bio-synthesis firms or regional API manufacturers—can serve as alternatives if they meet quality standards and regulatory requirements.

Q3: How do geopolitical factors influence Vyalev’s supply chain?
A: Geopolitical tensions can disrupt raw material sourcing, manufacturing operations, or distribution channels, emphasizing the importance of diversification and regional manufacturing.

Q4: What are the risks associated with relying on a single supplier?
A: Dependence on a single supplier exposes the supply chain to risks like manufacturing delays, quality issues, or compliance failures, which can lead to shortages or market disruptions.

Q5: How is the supply chain of complex biologics like Vyalev evolving?
A: There’s a shift towards advanced biological APIs, requiring innovative manufacturing techniques, stricter quality controls, and specialized suppliers capable of handling biological raw materials.

References

[1] Pharmaceutical Supply Chain Management, FDA Guidelines, 2022.
[2] EMA Good Manufacturing Practices (GMP) Guidelines, 2023.
[3] Global API Market Analysis, IQVIA Report, 2022.
[4] Contract Manufacturing Trends in Biologics, BioPharma Dive, 2022.
[5] Regional Distribution Networks and Market Access, WHO Publications, 2021.

Suppliers and packagers for VYALEV

VYALEV

Suppliers for the Pharmaceutical Drug: Vyalev