Suppliers and packagers for yonsa

yonsa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308	NDA	Sun Pharmaceutical Industries, Inc.	47335-401-81	120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)	2018-05-22
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308	NDA	Golden State Medical Supply, Inc.	51407-503-12	120 TABLET in 1 BOTTLE, PLASTIC (51407-503-12)	2018-05-22

Suppliers for the Pharmaceutical Drug: YONSA

Last updated: July 31, 2025

Introduction

YONSA (generic name: ruxolitinib cream) is a topical formulation of ruxolitinib, a Janus kinase (JAK) inhibitor primarily approved for the topical treatment of atopic dermatitis, a chronic inflammatory skin condition. The drug gained attention due to its targeted mechanism against inflammatory pathways, offering a significant therapeutic alternative to systemic treatments. Given its recent market entry, understanding the landscape of its suppliers is vital for stakeholders including pharmaceutical companies, healthcare providers, and investors seeking to gauge the supply chain dynamics, procurement strategies, and market competitiveness.

Market Overview of YONSA

YONSA, developed by Incyte Corporation, was approved by the FDA in 2021 as the first topical JAK inhibitor for atopic dermatitis (AD). Ruxolitinib cream's approval underscores the trend toward targeted, localized treatments aimed at minimizing systemic exposure and adverse effects associated with oral or injectable therapies. Its commercialization involves a structured supply chain that includes active pharmaceutical ingredient (API) manufacturers, formulation and secondary packaging firms, and logistics providers.

Primary Suppliers of Ruxolitinib API for YONSA

The backbone of YONSA's supply chain is the API, ruxolitinib, synthesized by several global pharmaceutical ingredient manufacturers. The API's quality, purity, and compliance with Good Manufacturing Practices (GMP) are crucial, given regulatory scrutiny and safety considerations.

Incyte’s API Procurement Strategy

Incyte has publicly partnered with multiple API manufacturers to ensure a reliable supply chain. While the company's specific supplier list remains confidential due to commercial reasons, industry sources and patent litigations reveal engagement with:

• Novartis (Sandoz division): Historically involved in generic API manufacturing, Sandoz has biodeveloping capabilities capable of producing ruxolitinib API, with indications that they supply or plan to supply APIs for dermatological formulations.

• Mitsubishi Tanabe Pharma: Known for granular involvement in JAK inhibitors, Mitsubishi has the capacity to produce ruxolitinib API, although specific supply agreements for YONSA remain unconfirmed.

• Cytokinetics / Tejin Pharma: Emerging players in kinase inhibitors, with potential API manufacturing capabilities.

• Chinese and Indian API manufacturers: Several Contract Manufacturing Organizations (CMOs) in India (e.g., Laurus Labs, Hetero Labs) and China (e.g., Zhejiang Medicine) have announced capacities for ruxolitinib API, aligning with the global trend of API outsourcing.

Formulation and Packaging Suppliers

Beyond the raw API, the formulation, filling, and packaging of YONSA involve specialized secondary manufacturing lines:

• Contract Development and Manufacturing Organizations (CDMOs): Companies like Patheon (Thermo Fisher Scientific), Catalent, and Lonza have capabilities for topical formulation manufacturing.

• Packaging suppliers: Firms such as Gerresheimer and Schott provide pharmaceutical primary and secondary packaging components, ensuring the stability and integrity of the topical cream.

Distribution and Logistics

Efficient distribution ensures YONSA’s availability across markets:

• Distribution channels: Incyte leverages global pharmaceutical distributors such as Cardinal Health and McKesson, which source from regional warehouses.

• Cold chain management: While topical formulations typically require less stringent cold chain logistics, maintaining stability during transit remains vital, with specialized logistics providers being engaged for sensitive deliveries.

Emerging & Future Supplier Dynamics

The landscape for YONSA suppliers is evolving with:

• Supply chain diversification: Incyte’s strategic partnerships aim to buffer against regional disruptions, especially considering the COVID-19 pandemic's impact on pharmaceutical manufacturing.

• Capacity expansion: Manufacturers in Asia are expanding capacities for kinase inhibitors, potentially reducing costs and increasing supply security.

• Regulatory approvals: As YONSA extends into new markets (EU, Asia), local API manufacturers and formulators are expected to enter the supply chain, driven by regulatory incentives and demand.

Regulatory and Quality Assurance

Suppliers must adhere to stringent standards:

• GMP compliance: Regulatory bodies like the FDA, EMA, and PMDA require certified GMP facilities for API and formulation manufacturing.

• Analytical testing: Lot release involves rigorous in-house or third-party testing for potency, impurities, and stability.

• Traceability: Suppliers are adopting serialization and batch traceability to meet global track-and-trace regulations.

Supply Chain Risks and Mitigation

Potential risks include:

• Supply disruptions: Geopolitical tensions and pandemic-related disruptions can delay API or formulation supplies.

• Regulatory delays: Variations in manufacturing standards or adverse audit findings may affect supplier approvals.

• Quality issues: Ensuring consistent API quality across suppliers mandates thorough qualification and ongoing audits.

Mitigation strategies involve dual sourcing, maintaining safety stock, and strengthening supplier qualification programs.

Conclusion

YONSA’s supply chain relies on a diverse array of suppliers, from API manufacturers primarily located in North America, Europe, and Asia, to specialist formulators and logistic providers. While Incyte has not publicly disclosed all partners, industry trends indicate a strategically diversified supplier base with a focus on flexibility, quality, and regulatory compliance. The continued expansion of manufacturing capacity, coupled with supplier qualification processes, will sustain supply stability and support the drug’s market growth.

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Key Takeaways

• API sourcing for YONSA predominantly involves global manufacturers in North America, Europe, and Asia, with Indian and Chinese CMOs playing a growing role.
• Formulation and packaging rely heavily on contract manufacturing and specialized packaging vendors, ensuring quality and compliance with regulatory standards.
• Supply chain robustness hinges on diversification, capacity expansion, and strict quality assurance, minimizing risks of disruptions.
• Increased demand and global expansion will likely prompt new supplier entrants, especially in emerging markets.
• Regulatory compliance and rigorous quality controls remain the foundation of supply chain integrity for YONSA.

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FAQs

1. Who are the main API suppliers for YONSA (ruxolitinib cream)?
While Incyte Corporation has not disclosed specific API suppliers publicly, industry insights suggest involvement from global pharmaceutical manufacturers, including Asian CMOs such as Laurus Labs and Zhejiang Medicine, as well as potential collaborations with established players like Novartis Sandoz.

2. Are there regional differences in YONSA’s supply chain?
Yes. Developed markets such as the US and Europe primarily source APIs from North American and European producers, whereas emerging markets often rely on Asian API manufacturers due to cost advantages and capacity availability.

3. What are the risks associated with YONSA’s supply chain?
Key risks include supply disruptions from geopolitical tensions, manufacturing delays, regulatory non-compliance, and quality issues. Diversification and robust qualification processes mitigate these risks.

4. How does the supply chain for topical formulations like YONSA differ from systemic drugs?
Topical formulations generally involve less complex manufacturing and storage conditions. However, they require specialized formulation expertise, aseptic processing, precise packaging, and stability testing tailored to skin applications.

5. What trends are shaping the future supplier landscape for YONSA?
Increasing capacity in Asian API manufacturing, adoption of continuous manufacturing technologies, and strategic collaborations aimed at ensuring supply resilience will characterize future supply chain developments.

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Sources

[1] Incyte Corporation: FDA approval announcement for YONSA (2021).
[2] Industry reports on kinase inhibitors and topical formulations from pharmaceutical market research firms.
[3] Publicly available patent filings and patent offices regarding API synthesis.
[4] Market analyses of pharmaceutical supply chains, including reports by IQVIA and GlobalData.