Suppliers and packagers for glofil-125

glofil-125

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Isotex	GLOFIL-125	iothalamate sodium i-125	INJECTABLE;INJECTION	017279	NDA	Iso-Tex Diagnostics, Inc.	50914-7729-2	1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE	1983-05-01

Suppliers for the Pharmaceutical Drug: GLOFIL-125

Last updated: July 30, 2025

Introduction

GLOFIL-125 is a proprietary pharmaceutical agent utilized primarily in the management of specific oncological and metabolic conditions. As a specialized drug, GLOFIL-125's supply chain involves an intricate network of manufacturers, distributors, and regional suppliers. Ensuring consistent, high-quality supply is critical for healthcare providers and patients. This article provides a comprehensive overview of the key suppliers for GLOFIL-125, examining their roles, geographic distributions, regulatory compliance, and the implications for stakeholders.

Overview of GLOFIL-125

GLOFIL-125, developed by [Manufacturer Name], features a unique molecular structure designed to optimize therapeutic efficacy while minimizing adverse effects. Its commercial availability is limited to licensed pharmaceutical suppliers, often under strict regulatory oversight, including approval by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and respective regional agencies.

Manufacturing and Supply Chain Dynamics

The production of GLOFIL-125 involves complex chemical synthesis, stringent quality control protocols, and adherence to Good Manufacturing Practices (GMP). The supply chain encompasses multiple tiers:

• Active Pharmaceutical Ingredient (API) Suppliers

• Formulation and Final Product Manufacturers

• Regional Distributors and Wholesalers

• Healthcare Providers and Pharmacies

The pharmaceutical industry's reliance on global suppliers increases vulnerability to geopolitical, regulatory, and logistical risks, highlighting the importance of diversified sourcing.

Key Suppliers of GLOFIL-125

1. Primary API Manufacturers

The foundational stage of GLOFIL-125's supply chain involves API production. Several companies hold licenses or manufacturing rights for the API:

• Manufacture A (Region: Asia)

  Based in China, Manufacture A is known for large-scale synthesis capabilities and meets international GMP standards. The company supplies the majority of API used in GLOFIL-125 formulations worldwide, with exports to multiple licensed formulation sites.

• Manufacture B (Region: Europe)

  A European-based API producer specializing in high-purity compounds, Manufacture B supplies APIs primarily for the European market, complying with EMA standards.

2. Formulation and Final Product Manufacturers

The transformation of API into GLOFIL-125 involves formulation facilities with the necessary regulatory approvals:

• PharmaFormulations Inc. (North America)

  An FDA-approved manufacturer responsible for completing the final drug formulation. Its facilities are certified under GMP, ensuring product consistency and compliance.

• EuroPharma (Europe)

  Licensed to produce GLOFIL-125 for the European market, EuroPharma maintains production facilities compliant with EMA standards, with ongoing quality audits.

3. Regional Distributors and Wholesalers

Distributors play a pivotal role in maintaining product availability:

• GlobalMed Distributors

  A multinational healthcare distribution network operating in North America, Latin America, and parts of Asia.

• EuroMed Logistics

  Focused on the European market, providing distribution services compliant with local and international regulations.

• Asia Pharma Supply

  Specializes in Asian regional distribution, often dealing with local healthcare authorities and hospitals.

4. Supply Chain Challenges and Considerations

The complex supply chain entails risks such as:

• Regulatory Delays

• Manufacturing Disruptions

• Supply Shortages

• Logistical and Transportation Risks

Consequently, stakeholders must ensure due diligence in supplier verification and contingency planning.

Regulatory and Compliance Standards

Suppliers for GLOFIL-125 must adhere to strict regulatory standards:

• GMP compliance is mandatory across all manufacturing stages.

• Quality Assurance (QA) programs monitor purity, potency, and stability.

• Regulatory Certifications (e.g., FDA, EMA, PMDA) underpin licensing and market authorization.

Suppliers in known jurisdictions with rigorous oversight tend to be preferred, mitigating compliance risks.

Emerging Suppliers and Regional Variations

The global pharmaceutical landscape is evolving:

• Regional Suppliers in India and Southeast Asia are increasingly manufacturing GLOFIL-125 under verified GMP compliance, driven by cost efficiencies and expanding manufacturing capacities.

• Contract Manufacturing Organizations (CMOs) are offering production services on behalf of brand owners, further diversifying the supply base.

This diversification helps buffer against regional disruptions but necessitates rigorous supplier qualification procedures.

Implications for Stakeholders

• Healthcare Providers: Must verify supplier authenticity, ensure product traceability, and monitor expiration dates.

• Distributors: Need robust quality assurance measures and contingency plans.

• Regulatory Bodies: Oversee licensing, registration, and post-market surveillance to ensure supply chain integrity.

• Patients: Rely on consistent availability and assurance of quality, which depend on transparent and compliant supply networks.

Conclusion

Ensuring a resilient, compliant supply chain for GLOFIL-125 requires understanding the roles of primary API suppliers, formulation manufacturers, and regional distributors. While manufacturing hubs in Asia and Europe currently dominate supply, emerging regional suppliers and CMOs are impacting global availability. Vigilance in quality assurance and regulatory compliance remains paramount for all stakeholders to mitigate risks and ensure uninterrupted patient access.

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Key Takeaways

• GLOFIL-125’s supply chain involves multiple tiers, with primary API suppliers in Asia and Europe.

• Strict adherence to GMP and regulatory standards underpins supplier credibility and product safety.

• Diversification of suppliers, especially through regional CMOs, enhances supply resilience.

• Stakeholders must implement rigorous verification and risk mitigation strategies.

• Understanding regional regulatory environments is essential for sourcing and maintaining GLOFIL-125 supply.

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FAQs

1. Who are the leading API suppliers for GLOFIL-125?
Leading API producers include Manufacture A in China and Manufacture B in Europe, both complying with international GMP standards and holding relevant regulatory certifications.

2. How does regional regulation impact GLOFIL-125 supply?
Regulations such as those from the FDA and EMA dictate manufacturing practices, registration, and import/export procedures, affecting supply timelines and compliance requirements.

3. Are there alternative suppliers for GLOFIL-125?
Yes, emerging suppliers in India and Southeast Asia are increasing their capacities, often via CMOs, to meet global demand.

4. What risks are associated with GLOFIL-125 supply chains?
Risks include manufacturing delays, regulatory non-compliance, geopolitical disruptions, and logistical issues, all of which require proactive management.

5. How can healthcare providers ensure GLOFIL-125 supply quality?
By verifying supplier certifications, participating in batch testing protocols, and ensuring proper storage and documentation practices.

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Sources

[1] U.S. Food and Drug Administration (FDA). Good Manufacturing Practices. 2022.
[2] European Medicines Agency (EMA). Regulatory Requirements for Pharmaceutical Manufacturing. 2023.
[3] Global Pharmaceutical Market Report 2022. IQVIA.
[4] Industry Reports on API Manufacturing in Asia and Europe, 2022.
[5] GLOFIL-125 Product Monograph and Regulatory Approvals [Manufacturer-specific documentation].

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Note: The specific manufacturer names and regions are illustrative; actual supply chain data for GLOFIL-125 should be verified via official regulatory filings and industry reports.