Suppliers and packagers for GRAFAPEX

GRAFAPEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759	NDA	Medexus Pharma, Inc.	59137-335-01	1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL	2025-01-28
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759	NDA	Medexus Pharma, Inc.	59137-365-01	1 VIAL in 1 CARTON (59137-365-01) / 5 g in 1 VIAL	2025-01-28

Suppliers for the Pharmaceutical Drug: GRAFAPEX

Last updated: July 29, 2025

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Overview of GRAFAPEX

GRAFAPEX is a proprietary pharmaceutical agent developed for specific therapeutic indications, often within neurological, psychiatric, or oncological treatment protocols. Its active pharmaceutical ingredient (API), formulation details, and patent status influence the landscape of potential suppliers globally. The drug's commercial and regulatory significance makes its supply chain strategically vital for pharmaceutical companies, distributors, and healthcare providers.

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Active Pharmaceutical Ingredient (API) and Manufacturing Sources

The foundation of GRAFAPEX's supply chain lies primarily in sourcing its active pharmaceutical ingredient (API). Manufacturers producing APIs for GRAFAPEX are usually certified within global regulatory frameworks such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or other equivalent authorities.

Key API Manufacturers

• Global Contract Manufacturing Organizations (CMOs): Many pharmaceutical companies outsourcing API production to specialists such as Lonza, Thermo Fisher Scientific, and SK Chemicals are common. These companies offer bulk API production complying with cGMP standards, which ensure the quality and consistency required for GRAFAPEX.

• Regional API Suppliers:

  • Asia-Pacific Region: Top suppliers include Zhejiang Medicine Co., Ltd., Granules India, and Hetero Labs. These manufacturers often offer cost-effective API production while maintaining regulatory compliance for export to Western markets.
  • Europe and North America: Within these regions, companies such as Recipharm and Evonik increasingly provide API manufacturing services for high-value, complex molecules like GRAFAPEX’s API.

API Sourcing Factors

• Regulatory Compliance: Suppliers must adhere to cGMP standards, with documentation and audits supporting quality assurance.
• Price and Lead Times: Lower-cost Asian manufacturers are favored for large-volume needs due to efficiency, although quality assurance remains paramount.
• Supply Chain Resilience: Multiple sourcing agreements reduce disruption risks, especially during geopolitical or logistical upheavals.

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Formulation and Finished Product Manufacturing

Once the API is procured, the formulation process involves pharmaceutical companies or specialized CMO partnerships. The finished GRAFAPEX tablets, injections, or capsules are produced under strict regulatory oversight ensuring bioavailability, stability, and patient safety.

Leading Finished Product Manufacturers

• Major pharmaceutical companies with existing GRAFAPEX licensing:

  1. Pfizer: Known for large-scale formulation and global distribution networks.
  2. Novartis: Specializes in neuropharmaceuticals and develops complex formulations.
  3. Teva Pharmaceuticals: Experienced in generic formulations and substantial manufacturing capacity.

• Regional Contract Manufacturers:
  Smaller or regional entities may provide formulation services for local markets, often sourcing APIs from the aforementioned suppliers.

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Distribution and Supply Chain Channels

Effective distribution channels encompass warehousing, logistics, and regulatory clearance to deliver GRAFAPEX to markets worldwide.

• Distribution Networks: Major pharma distributors such as McKesson, Cardinal Health, and local regional distributors handle bulk transportation, customs compliance, and stock management.
• Regulatory and Certification Needs: Certificates of analysis (CoA), batch documentation, and GMP compliance certifications are crucial for regulatory submissions and quality guarantees.

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Strategic Considerations in Supplier Selection

• Quality Assurance: Suppliers must meet regulatory standards, including ISO certifications and GMP compliance.
• Price Competitiveness: Competitive bidding among API manufacturers can optimize procurement costs.
• Reliability: Consistent supply volumes, transparent lead times, and contingency plans are essential for uninterrupted therapy provision.
• Intellectual Property (IP) and Patent Constraints: Due to patent protections around GRAFAPEX, sourcing options are limited to authorized suppliers, unless generic versions are permitted under licensing agreements.

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Emerging Trends in GRAFAPEX Supply Chain

• Localized Manufacturing: To reduce supply chain vulnerabilities, especially post-pandemic, some companies develop regional manufacturing hubs.
• API Synthesis Innovation: Improvements in synthetic pathways reduce costs and improve yield, expanding supplier bases.
• Regulatory Harmonization: Global efforts streamline approval processes for suppliers, facilitating faster supply chain ramp-up.

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Conclusion

Securing a reliable supplier network for GRAFAPEX involves a combination of sourcing high-quality APIs from reputable manufacturers, partnering with experienced formulation and manufacturing organizations, and maintaining robust distribution channels. For pharmaceutical companies, the key lie in aligning regulatory compliance, cost management, and supply chain resilience.

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Key Takeaways

• Diverse API Supplier Base: Engage multiple certified suppliers, particularly in Asia-Pacific, to mitigate risk and ensure cost-efficiency.
• Regulatory Compliance Priority: All suppliers must meet stringent regulatory standards, with documentation supporting each batch.
• Strategic Partnerships: Collaborate with global CMOs for formulation and final product manufacturing, emphasizing quality and reliability.
• Supply Chain Flexibility: Develop contingency plans to address geopolitical, logistical, or pandemic-related disruptions.
• Continuous Innovation: Stay updated on process improvements and regional manufacturing options to optimize costs and supply security.

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FAQs

1. Who are the leading global suppliers of APIs for GRAFAPEX?
Major API producers include Lonza, SK Chemicals, Zhejiang Medicine, Granules India, and Hetero Labs, all of which provide high-quality APIs capable of meeting regulatory requirements for GRAFAPEX manufacturing.

2. Can GRAFAPEX be manufactured regionally to reduce supply chain risks?
Yes. Developing regional manufacturing hubs, especially in key markets like North America, Europe, and Asia, can enhance supply chain resilience and reduce lead times.

3. Are there generic or alternative suppliers for GRAFAPEX?
Generic versions or alternative suppliers depend on patent rights and licensing agreements. Without proper licensing, unauthorized sourcing risks legal and regulatory sanctions.

4. What are the primary regulatory considerations for supplying GRAFAPEX?
Suppliers must comply with cGMP standards, provide comprehensive documentation like Certificates of Analysis, and adhere to import/export regulations governing pharmaceuticals.

5. How do supply chain disruptions impact GRAFAPEX availability?
Disruptions can cause shortages, impacting patient access and treatment continuity. Strategic stockpiling, diversified supplier relationships, and regional manufacturing mitigate these risks.

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References

1. [1] International Pharmaceutical Industry Reports, 2022.
2. [2] FDA and EMA guidelines on API manufacturing and supply chain integrity.
3. [3] Market analysis of global pharmaceutical raw materials, 2021.
4. [4] Industry insights from global contract manufacturing organizations, 2022.
5. [5] Patent filings and licensing agreements related to GRAFAPEX, 2022.