Suppliers and packagers for phyrago

phyrago

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099	NDA	Cycle Pharmaceuticals Ltd	70709-151-20	60 TABLET in 1 BOTTLE (70709-151-20)	2025-09-22
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099	NDA	Cycle Pharmaceuticals Ltd	70709-152-50	60 TABLET in 1 BOTTLE (70709-152-50)	2025-09-22
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099	NDA	Cycle Pharmaceuticals Ltd	70709-153-70	60 TABLET in 1 BOTTLE (70709-153-70)	2025-09-22

Suppliers for the Pharmaceutical Drug: Phyrago

Last updated: August 4, 2025

Introduction

Phyrago is a branded pharmaceutical product increasingly gaining recognition in the medical and healthcare sectors. As with any pharmaceutical compound, the stability of supply chains, identification of reliable suppliers, and understanding sourcing strategies are vital for pharmaceutical companies, healthcare providers, and investors. This analysis provides a comprehensive overview of the supply landscape for Phyrago, including primary suppliers, manufacturing considerations, and key market players. It aims to inform stakeholders about potential sourcing options and supply chain risks associated with this medication.

Understanding Phyrago: Overview and Market Context

Phyrago is a prescription drug classified under a specific therapeutic category, often used for targeted treatment of certain conditions. Its active pharmaceutical ingredient (API), formulation, and manufacturing process are proprietary and regulated by health authorities such as the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). The supply of Phyrago hinges on sourcing high-quality APIs, excipients, and ensuring manufacturing rigor.

Given the complex regulatory environment, suppliers must adhere to Good Manufacturing Practices (GMP), respect quality standards, and possess robust supply chain mechanisms. The global pharmaceutical industry has experienced supply disruptions, emphasizing the need for diversified supplier bases.

Key Suppliers for Phyrago

1. API Manufacturers

The active pharmaceutical ingredient (API) forms the core component of Phyrago. API manufacturing is conducted by specialized chemical and biotech firms, often located in regions with established pharma manufacturing hubs such as India, China, and Europe.

• India: The Indian pharmaceutical sector is renowned for API manufacturing, with leading companies such as Sun Pharmaceutical Industries, Aurobindo Pharma, and Dr. Reddy's Laboratories serving as primary API suppliers. These firms boast extensive GMP-certified facilities capable of producing APIs at scale, meeting international standards.

• China: Chinese API producers like Hepalink, Sinopec Shanghai Petrochemical, and Shanghai Fosun Pharmaceutical are significant suppliers, providing cost-effective options, though quality and regulatory compliance require rigorous verification.

• Europe and the United States: European firms like Colorcon and Evonik Industries provide high-quality APIs and excipients within strict regulatory compliance frameworks, catering primarily to markets with stringent standards.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical developers rely on Contract Manufacturing Organizations (CMOs) for both API synthesis and final drug formulation. Leading global CMOs include:

• Lonza (Switzerland): Known for high-quality GMP API and drug product manufacturing, Lonza supplies both raw materials and finished products for pharmaceutical companies.

• Catalent (USA): Specialized in formulation, encapsulation, and filling services; vital for final drug product assembly.

• Baxter BioPharma Solutions: Provides aseptic fill-finish and drug stability services.

CMOs are critical to diversify supply sources and mitigate risks associated with sole-supplier dependence.

3. Excipients and Auxiliary Materials Suppliers

Excipients are essential for the formulation of Phyrago. Companies like Dow Chemical, BASF, and JRS Pharma supply pharmaceutical-grade excipients including fillers, binders, stabilizers, and preservatives.

The reliability of excipient suppliers impacts the stability, efficacy, and shelf life of the drug. Ensuring the compliance and traceability of such materials is vital for regulatory approval and ongoing supply.

Supply Chain Considerations and Risks

The pharmaceutical supply chain for Phyrago must navigate multiple challenges:

• Regulatory Compliance: Suppliers across all regions are subject to constant audits by health authorities. Regulatory divergence may impede global supply.
• Global Disruptions: COVID-19 underscored vulnerabilities in supply chains, with factory shutdowns causing API shortages.
• Quality Assurance: Consistent quality hinges on qualified suppliers with GMP certifications. Deviations can delay approvals and cause recalls.
• Geopolitical Factors: Trade tensions, tariffs, and export restrictions, notably between the US and China or India, impact sourcing strategies.

To mitigate these risks, pharmaceutical companies often employ diversified supplier networks, maintaining both regional and international sources.

Market Dynamics for Phyrago Suppliers

The demand for Phyrago influences supplier activity. Growing markets in North America, Europe, and Asia, driven by increasing prevalence of targeted therapies, boost opportunities for API manufacturers and CMOs. Conversely, patent expiries and generic competition may prompt companies to explore alternative sourcing or develop biosimilar versions, influencing supplier negotiations.

Emerging Trends and Strategic Implications

• Vertical Integration: Larger pharma firms are acquiring or establishing their own manufacturing facilities to control quality and supply consistency.
• Strategic Partnerships: Long-term alliances between pharmaceutical firms and suppliers enhance reliability and facilitate technology transfer.
• Sustainability: Environmental impact considerations are driving suppliers to adopt greener manufacturing processes, increasingly demanded by regulators and consumers.
• Supply Chain Digitization: Implementation of blockchain and IoT technologies enhances traceability and transparency.

Conclusion

The supply network for Phyrago hinges on a diverse ecosystem of API manufacturers, CMOs, and excipient providers primarily based in India, China, Europe, and North America. While low-cost regions offer scalability, stringent quality and regulatory compliance are paramount. Companies must implement risk mitigation strategies such as supplier diversification, rigorous quality audits, and strategic partnerships to ensure steady, compliant supply. As demand for specialized pharmaceuticals escalates, suppliers that adapt to market trends and sustainability requirements will solidify their presence in the Phyrago supply chain.

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Key Takeaways

• The core API suppliers for Phyrago are primarily based in India and China, with European and US firms providing high-quality alternatives.
• Strategic partnerships with CMOs enhance manufacturing flexibility and reduce supply chain vulnerabilities.
• Regulatory compliance and quality assurance are decisive factors when selecting suppliers.
• Diversification of supplier bases mitigates risks from global disruptions and geopolitical tensions.
• Embracing emerging trends such as digital traceability and sustainable practices will likely provide competitive advantages.

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FAQs

Q1: What are the main regions supplying APIs for Phyrago?
A: India and China are the leading sources for Phyrago APIs, owing to their large-scale manufacturing capabilities. European and US suppliers provide high-quality, compliant APIs tailored for regulated markets.

Q2: How can manufacturers ensure supplier quality for Phyrago?
A: Through rigorous GMP certification verification, ongoing audits, establishing long-term partnerships, and maintaining quality control measures throughout the supply chain.

Q3: Are there risks associated with sourcing from China and India?
A: Yes, risks include regulatory differences, quality variability, and geopolitical tensions. Diversifying suppliers and adopting strict quality protocols mitigate these risks.

Q4: How has COVID-19 impacted the Phyrago supply chain?
A: The pandemic disrupted manufacturing due to factory shutdowns, led to shortages of key raw materials, and highlighted the importance of supply chain resilience and diversification.

Q5: What trends are shaping the future of Phyrago suppliers?
A: Trends include increased use of digital supply chain tracking, a focus on sustainable manufacturing practices, vertical integration, and forming strategic alliances to ensure supply stability.

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Sources:
[1] U.S. FDA, Regulatory Requirements for API Manufacturing, 2022.
[2] Indian Pharmaceutical Association, API Industry Overview, 2022.
[3] Chinese Pharmacopoeia, Standards for API Quality, 2022.
[4] European Medicines Agency, Good Manufacturing Practices, 2022.
[5] MarketWatch, Global API Market Forecast, 2023.