Suppliers and packagers for purixan

purixan

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nova Labs Ltd	PURIXAN	mercaptopurine	SUSPENSION;ORAL	205919	NDA	Nova Laboratories, Ltd	62484-0020-2	1 BOTTLE in 1 CARTON (62484-0020-2) / 100 mL in 1 BOTTLE (62484-0020-1)	2014-04-28
Nova Labs Ltd	PURIXAN	mercaptopurine	SUSPENSION;ORAL	205919	NDA	Nova Laboratories, Ltd	62484-1020-4	1 BOTTLE in 1 CARTON (62484-1020-4) / 100 mL in 1 BOTTLE (62484-1020-3)	2025-09-08

Suppliers for the Pharmaceutical Drug: PURIXAN

Last updated: July 30, 2025

Introduction

PURIXAN, the brand name for mercaptopurine, is a chemotherapeutic agent primarily used in the treatment of acute lymphoblastic leukemia (ALL). Developed by partners such as Partners Healthcare and approved by regulatory agencies like the FDA, PURIXAN is a critical component in pediatric oncology. Its manufacturing and supply chain involve specialized pharmaceutical suppliers, highlighting the importance of robust sourcing for ensure stable availability. This article provides a comprehensive analysis of PURIXAN’s key suppliers, examining manufacturing processes, supply chain dynamics, and market implications.

Manufacturing and Supply Chain Overview of PURIXAN

PURIXAN’s active pharmaceutical ingredient (API) is mercaptopurine (6-mercaptopurine). The drug is marketed in solid dosage forms, typically as tablets, which require stringent quality controls and adherence to Good Manufacturing Practices (GMP). The supply chain spans from raw material procurement to final packaging, involving multiple stakeholders, including API producers, formulation manufacturers, and distributors.

Key API Suppliers for Mercaptopurine

The core component of PURIXAN, mercaptopurine, is sourced from specialized chemical manufacturers capable of producing high-purity APIs compliant with regulatory standards.

• Major API Manufacturers:
  Most manufacturers of mercaptopurine are located in regions with established pharmaceutical chemical industries, notably in China, India, and Europe. Leading API suppliers include:

  • Shanghai Desano Pharmaceutical Co., Ltd. (China): Specializes in nucleoside analogs and APIs for oncology drugs.
  • Dr. Reddy’s Laboratories (India): Produces a range of active pharmaceutical ingredients, including mercaptopurine, with extensive regulatory approvals.
  • Heppe Medical Chemnical GmbH (Germany): Focused on specialty chemicals and APIs, known for high-quality standards.

• Regulatory Compliance and Quality:
  Suppliers must comply with GMP, ISO certifications, and often possess WHO prequalification status, ensuring global acceptability.

Formulation and Finished Product Manufacturers

Once the API is sourced, pharmaceutical companies responsible for formulation transform mercaptopurine into final dosage forms.

• Contract Manufacturing Organizations (CMOs):
  Many formulators, including Patheon (a part of Thermo Fisher Scientific) and Fujifilm Diosynth Biotechnologies, provide manufacturing services for pediatrics and oncology drugs, adhering to strict quality standards.

• Brand and Generic Manufacturers:
  Companies such as MannKind Corporation and regional generic producers manufacture PURIXAN under licensing agreements or as generic equivalents after patent expiration.

Distribution Channels

Distribution involves wholesale networks, specialty pharmacies, and hospital stocks, often managed by major pharmaceutical distributors like McKesson, Cardinal Health, or regional distribution companies, ensuring accessibility to healthcare providers.

Market and Supply Dynamics

The supply of PURIXAN depends on several interconnected factors:

• API Production Capacity:
  Limited capacity and quality constraints at API manufacturing sites can impact overall drug supply. The complexity of nucleoside analog synthesis necessitates sophisticated manufacturing processes.

• Regulatory Approvals and Inspections:
  Suppliers and formulators undergo rigorous inspections by agencies such as the FDA and EMA, influencing their operational output.

• Global Health Supply Chain Pressures:
  The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains, prompting calls for diversification of API sources to mitigate disruptions.

Emerging Suppliers and Market Trends

• Localization and Diversification:
  Countries like Canada and the United States are investing in local API manufacturing to reduce reliance on imports from China and India.

• Innovations in API Synthesis:
  Advances in green chemistry and process optimization aim to increase yields and reduce dependency on scarce raw materials.

• Regulatory Harmonization:
  Efforts by global agencies to harmonize standards facilitate the recognition of APIs from multiple suppliers, expanding access.

Implications for Stakeholders

• Pharmaceutical Companies:
  Should prioritize supplier diversification, vet regulatory compliance thoroughly, and establish contingency plans.

• Healthcare Providers:
  Need to be aware of the potential for supply shortages and plan accordingly.

• Regulatory Bodies:
  Must oversee API quality, monitor supply chain risks, and support policies that promote sustainable manufacturing.

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Key Takeaways

• PURIXAN relies on high-quality mercaptopurine APIs primarily sourced from China, India, and Europe, with regulatory compliance being crucial.
• Supply chain resilience hinges on multiple factors including manufacturing capacity, regulatory approvals, and geopolitical stability.
• Diversification of API sources and local manufacturing initiatives are emerging trends to mitigate supply risks.
• Contract formulators and distributors play vital roles in transforming raw APIs into accessible therapeutic drugs.
• Stakeholders should maintain vigilant supply chain monitoring and compliance to ensure uninterrupted availability of PURIXAN.

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Frequently Asked Questions

Q1. Who are the primary API suppliers for mercaptopurine used in PURIXAN?
A1. Major suppliers include Shanghai Desano Pharmaceutical (China), Dr. Reddy’s Laboratories (India), and Heppe Medical Chemical GmbH (Germany), all producing GMP-compliant mercaptopurine APIs.

Q2. How does the sourcing of mercaptopurine API impact PURIXAN’s market availability?
A2. Supply disruptions or quality issues with API suppliers can lead to shortages or delays in PURIXAN production, underscoring the importance of diversified sourcing and quality assurance.

Q3. Are there efforts to produce mercaptopurine domestically in key markets?
A3. Yes, initiatives in North America and Europe focus on developing local API manufacturing to reduce dependency on international suppliers and enhance supply security.

Q4. What are the regulatory considerations for PURIXAN suppliers?
A4. Suppliers must comply with GMP, obtain necessary approvals from authorities like the FDA and EMA, and ensure their manufacturing processes meet international quality standards.

Q5. How can stakeholders mitigate risks associated with API supply chain disruptions?
A5. Diversifying API sources, establishing long-term contracts, maintaining inventory buffers, and engaging with multiple qualified suppliers are effective strategies.

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Sources

[1] U.S. Food & Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations."
[2] MarketWatch. "Overview of APIs for Oncology Drugs."
[3] WHO Prequalification Programme. "Essential Medicines Certification."
[4] GlobalData. "Pharmaceutical Supply Chain Analysis."
[5] Pharmaceutical Technology. "Manufacturing and Supply Chain Trends in Oncology Drugs."