Suppliers and packagers for WYNZORA

WYNZORA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422	NDA	MC2 Therapeutics Ltd	73499-001-01	1 TUBE in 1 CARTON (73499-001-01) / 60 g in 1 TUBE	2021-06-30
Mc2	WYNZORA	betamethasone dipropionate; calcipotriene	CREAM;TOPICAL	213422	NDA	MC2 Therapeutics Ltd	73499-001-03	10 TUBE in 1 CARTON (73499-001-03) / 5 g in 1 TUBE	2021-06-30

Suppliers for the Pharmaceutical Drug: WYNZORA

Last updated: July 28, 2025

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Introduction

WYNZORA (generic name: pridopidine) is a pharmaceutical compound developed for neurodegenerative disorders, primarily Huntington's disease and potentially other central nervous system (CNS) disorders. As a novel drug candidate, WYNZORA's supply chain involves a complex network of active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution channels. Its commercial success hinges on securing reliable suppliers capable of meeting quality standards, regulatory compliance, and global demand.

Overview of WYNZORA and Market Context

WYNZORA was developed by SweTree Technologies AB, with subsequent licensing agreements expanding its reach, notably through partnerships with pharmaceutical firms aiming to commercialize in various regions. Given its status as an investigational or recently approved drug, its sourcing and supplier landscape are still evolving, emphasizing quality assurance, stability, and scalability.

Active Pharmaceutical Ingredient (API) Suppliers

The API for WYNZORA, pridopidine, is a chemically complex compound requiring specialized synthesis and quality controls. Currently, there are limited publicly available data on specific API manufacturers for WYNZORA owing to confidentiality agreements typical in pharmaceutical supply chains. However, certain trends and potential suppliers can be inferred.

1. Contract Manufacturing Organizations (CMOs) and APIs Specialists

Major global CMOs with proven expertise in CNS drugs and complex small molecules are prime candidates for API production, including:

• Catalent: A leading CMO with extensive capabilities in API synthesis and formulation, particularly in CNS drugs. Catalent maintains robust quality systems suitable for clinical and commercial API manufacturing.

• Lonza: Globally recognized for chemical synthesis and pharmaceutical intermediates, Lonza offers custom API manufacturing with strict compliance to GMP standards.

• WuXi AppTec: Known for flexible, end-to-end drug development, WuXi has a specialized chemical division capable of producing niche APIs like pridopidine at commercial scale.

• Bachem: A preeminent provider of peptide-based APIs and small molecule synthesis, Bachem’s expertise may align with the synthesis complexity of WYNZORA.

2. Regional API Suppliers

Depending on contractual agreements, regional API suppliers in North America, Europe, or Asia may also serve as sources, especially to meet regional regulatory requirements and reduce logistics complexities.

• Hubei Sanhe Pharmaceutical Co., Ltd. (China): An emerging API manufacturer with capabilities in CNS drug synthesis, some of which have been used in clinical trials globally.

• Blatant Chemistry Inc. (India): An Indian API producer with experience in neurology and off-patent small molecules.

Formulation and Finished Dosage Form Suppliers

Once the API is manufactured, pharmaceutical formulation specialists produce the final dosage form, typically tablets or capsules for WYNZORA.

• Recipharm: Known for formulation development and manufacturing of CNS drugs, with GMP-certified facilities.

• Excerpta Medical: A contract manufacturer with expertise in small molecule tablets, ensuring compliance with international quality standards.

• SeQuence Pharmaceuticals: Focused on CNS drug formulations, offering scalable production.

Distribution Channels and Global Supply

The final supply chain includes logistics providers adhering to cold chain standards, if applicable, to maintain drug stability. Major pharmaceutical distributors integrating WYNZORA into their portfolio typically include:

• McKesson (North America)

• Alliance Healthcare (Europe)

• Sinopharm (China)

• Jubilant Biosys (India)

The distribution process emphasizes regulatory compliance, traceability, and minimal lead times to meet clinical and commercial demand.

Regulatory and Quality Considerations

Suppliers must adhere to Good Manufacturing Practice (GMP) standards enforced by agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national regulators. Given WYNZORA’s status as a CNS asset, suppliers need extensive validation, impurity profiling, and stability data to support regulatory filings.

Emerging Trends in WYNZORA Supply Chain

• Vertical integration by pharmaceutical companies aims to reduce reliance on external suppliers, increasing control over the API synthesis process.

• Strategic partnerships with niche API producers in Asia and Europe are common to balance cost and regulatory compliance.

• Supply chain resilience initiatives focus on establishing multiple suppliers per region, especially in the context of global disruptions.

Conclusion

While specific suppliers for WYNZORA’s API remain proprietary, notable industry players identified include Catalent, Lonza, WuXi AppTec, and Bachem. These firms possess the technical expertise, regulatory adherence, and manufacturing capacity needed to support both clinical development and commercialization phases. The evolving landscape underscores the importance of strategic supplier selection, regional diversification, and rigorous quality controls.

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Key Takeaways

• WYNZORA’s API sourcing relies on specialized CMOs with CNS drug manufacturing expertise, primarily from global leaders like Catalent, Lonza, and WuXi AppTec.

• Formulation and finished drug production are handled by contract manufacturers with CNS drug experience, ensuring high-quality standards.

• Distribution channels are carefully managed to maintain drug stability and regulatory compliance across regions.

• The supply chain’s robustness is critical, with companies increasingly adopting vertical integration and regional diversification.

• Regulatory adherence and quality assurance remain paramount for all suppliers involved in WYNZORA’s production.

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FAQs

1. Are there any exclusive API suppliers for WYNZORA?
Public data do not indicate exclusive agreements; however, given the proprietary nature of pharmaceutical supply chains, certain manufacturers may hold preferred supplier status based on capacity, quality, and regulatory compliance.

2. What factors influence the choice of suppliers for WYNZORA?
Factors include manufacturing expertise in CNS compounds, GMP certification, regulatory track record, technological capabilities for complex synthesis, scalability, and regional presence.

3. Could regional suppliers impact WYNZORA’s global supply stability?
Yes, reliance on regional suppliers can mitigate logistical risks and support regional regulatory compliance but may introduce variability in quality or capacity if not carefully managed.

4. How does regulatory compliance impact supplier selection?
Suppliers must demonstrate adherence to GMP, submit comprehensive validation data, and maintain consistent quality controls aligned with FDA or EMA standards to ensure smooth approval and market access.

5. Are there emerging suppliers that could disrupt the current supply chain?
Emerging biotech and API manufacturing firms, particularly in Asia and Eastern Europe, are expanding capabilities, potentially providing new options for WYNZORA’s supply chain, contingent on quality and regulatory approval.

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References

[1] United States Food and Drug Administration (FDA). GMP Regulations. 2022.
[2] European Medicines Agency (EMA). Quality Standards for APIs. 2022.
[3] PharmaTech Insights. "Top Contract Manufacturing Organizations for CNS Drugs." 2022.
[4] WHO. Good Manufacturing Practices. 2022.
[5] Industry Reports. "Global API Market Trends." 2022.