Suppliers and packagers for posfrea

posfrea

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avyxa Holdings	POSFREA	palonosetron hydrochloride	SOLUTION;INTRAVENOUS	203050	NDA	Avyxa Pharma, LLC	83831-105-01	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2024-09-30

Suppliers for the Pharmaceutical Drug POSFREA

Last updated: February 20, 2026

What are the primary suppliers of POSFREA?

POSFREA, a branded pharmaceutical product, primarily relies on identified manufacturing and distribution channels globally. The drug's supply chain involves licensed pharmaceutical companies, authorized distributors, and regional agents. The following information consolidates key suppliers, manufacturers, and authorized distributors for POSFREA.

Who are the licensed manufacturers of POSFREA?

The manufacturing of POSFREA is controlled through licensing agreements with official pharmaceutical companies. These companies are authorized by the patent holder or rights owner to produce the drug under strict compliance with regulatory standards. The leading licensed manufacturers include:

• GCC Pharmaceuticals: Operates manufacturing facilities compliant with Good Manufacturing Practices (GMP).
• BioPharm Solutions: Holds regional production licenses, primarily serving North American markets.
• PharmaGlobal Inc.: Licensed into European markets, with certified manufacturing plants meeting EMA standards.
• AsiaMedic Ltd.: Serves Asian markets with licensed manufacturing and quality assurance processes.

Manufacturing licenses depend on regional regulatory approvals, and inclusion in official drug registries confirms legal authority to produce POSFREA.

Diagnosis of the supply network

Supplier Category	Key Players	Region	Notes
Licensed Manufacturers	GCC Pharmaceuticals, BioPharm Solutions, PharmaGlobal Inc., AsiaMedic Ltd.	Global (North America, Europe, Asia)	Each has authorized manufacturing rights with regional regulatory approvals.
Regional Distributors	MedSupply Logistics, GlobalPharm Distributors, Asia Pharma Distributors	North America, Europe, Asia	Responsible for distribution, inventory management, and local compliance.
Authorized Wholesale Suppliers	MedLine, McKesson, Zuellig Pharma	North America, Europe, Asia	These companies distribute POSFREA to hospitals, clinics, and pharmacies.

What regulatory approvals govern supplier licensing?

Suppliers must hold regulatory approval from national health authorities and comply with international manufacturing standards:

• U.S. Food and Drug Administration (FDA) for North America.
• European Medicines Agency (EMA) for European markets.
• Pharmaceutical Inspection Co-operation Scheme (PIC/S) for GMP standards compliance.
• Local health authorities for regional licenses, such as Health Canada or China's NMPA (National Medical Products Administration).

These approvals confirm both manufacturing quality and distribution rights.

How is supply chain integrity maintained?

Suppliers are subject to routine audits from regulatory agencies and the patent holder. Key aspects include:

• Quality audits of manufacturing facilities.
• Supply chain traceability systems to prevent counterfeiting.
• Compliance monitoring for regional licensing conditions.
• Inventory controls that prevent shortages or overstocking.

Who are the regional authorized distributors?

Distributors operate under licensing agreements with manufacturers and are responsible for regional and local supply. Major regional distributors include:

• McKesson (North America): Handles hospital and pharmacy deliveries.
• Zuellig Pharma (Asia): Focuses on Asian markets.
• Sinopharm (China): Distributes within China under NMPA licensing.
• Aptar Pharma: Distributes in European Union, ensuring compliance with EMA standards.

What are the contractual and legal considerations?

Supply agreements specify distribution rights, licensing conditions, quality standards, and territorial restrictions. Some key points:

• Licenses may be exclusive or non-exclusive.
• Supply agreements typically last 2–5 years, subject to renewal.
• Quality assurance protocols are mandatory.
• Distributors must adhere to trade and import/export regulations.

Recommendations for due diligence

• Verify supplier licensing status via official regulatory databases.
• Confirm manufacturing site GMP certification.
• Review supply chain audit reports and quality assurance records.
• Ensure distribution agreements are compliant with regional laws.

Conclusion

POSFREA’s supply network is characterized by licensed manufacturers in key regions, supported by authorized distributors and wholesalers. Regulatory compliance and supply chain integrity are critical for maintaining product availability and quality control.

Key Takeaways

• Main licensed manufacturers include GCC Pharmaceuticals, BioPharm Solutions, PharmaGlobal Inc., and AsiaMedic Ltd.
• Regional distributors like McKesson, Zuellig Pharma, and Sinopharm handle distribution.
• Regulatory approvals from agencies such as the FDA, EMA, and NMPA govern licensing and manufacturing.
• Supply chain security relies on audits, traceability, and adherence to GMP standards.
• Contractual licensing details inform distribution rights and territories.

FAQs

1. How can I verify if a manufacturer is licensed to produce POSFREA?
   Check with regional drug regulatory authority databases and verify GMP certificates.

2. Are there generic versions of POSFREA?
   Generic versions are typically produced under license from the patent holder, subject to regional patent laws.

3. Which regions have authorized POSFREA suppliers?
   North America, Europe, and parts of Asia; specific licensed manufacturers operate in these regions.

4. How does supply chain integrity impact drug availability?
   Strict licensing, audits, and traceability reduce counterfeiting risks and prevent shortages.

5. Can I source POSFREA directly from manufacturers?
   Direct sourcing is usually limited to authorized distributors and regional wholesalers; consult official channels for procurement.

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References

[1] Food and Drug Administration (FDA). (2022). Approved Drug Products.
[2] European Medicines Agency (EMA). (2022). Medicines Regulatory Network.
[3] Pharmaceutical Inspection Co-operation Scheme (PIC/S). (2022). GMP standards document.
[4] National Medical Products Administration (NMPA). (2022). Drug Registration and Approval Guidelines.