Suppliers and packagers for FULVICIN-U/F

FULVICIN-U/F

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569	ANDA	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	23155-865-01	100 TABLET in 1 BOTTLE, PLASTIC (23155-865-01)	2023-06-30
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569	ANDA	Chartwell RX, LLC.	62135-496-01	100 TABLET in 1 BOTTLE (62135-496-01)	1971-09-09
Chartwell Rx	FULVICIN-U/F	griseofulvin, microsize	TABLET;ORAL	060569	ANDA	Chartwell RX, LLC.	62135-496-30	30 TABLET in 1 BOTTLE (62135-496-30)	1971-09-09

Suppliers for the Pharmaceutical Drug: FULVICIN-U/F

Last updated: August 7, 2025

Introduction

FULVICIN-U/F is a pharmaceutical product whose formulation, market presence, and supply chain logistics are pivotal to ensuring consistent patient access and regulatory compliance. As a critical component in the treatment landscape—potentially for conditions related to immune modulation or infection control—the availability of reliable suppliers is essential for manufacturers, healthcare providers, and regulatory agencies. This analysis explores the current landscape of suppliers for FULVICIN-U/F, examining manufacturing sources, distribution channels, and strategic considerations affecting supply chain stability.

Understanding FULVICIN-U/F

Before identifying suppliers, it is vital to clarify the product profile of FULVICIN-U/F. While specific formulation details are often proprietary, this drug commonly contains active pharmaceutical ingredients (APIs) designed for therapeutic efficacy, possibly as an immunostimulant or antimicrobial agent. Its nomenclature suggests a potential classification within antiviral or immune-boosting medications, although precise medical indications should be verified through official sources such as the FDA or EMA.

The manufacturing of FULVICIN-U/F involves complex synthesis or extraction processes, quality control, and compliance with Good Manufacturing Practices (GMP). These factors influence supplier selection and reliability.

Key Suppliers and Manufacturers

1. Originator Companies

The primary suppliers are typically the patent holders or original manufacturers who developed the formula. These entities often have exclusive rights to produce and distribute the drug under patent protection or licensing agreements.

• Pharmaceutical Manufacturers:
  Prominent pharmaceutical companies with research and manufacturing capacity in immunomodulatory or antimicrobial drugs may be the contracted suppliers. Examples include multinational corporations such as Pfizer, Roche, or GlaxoSmithKline, depending on the drug's origin and licensing agreements.

• Licensed Generic Producers:
  Post-patent expiration, multiple generic manufacturers may produce FULVICIN-U/F, expanding supply sources. These include regional companies authorized through regulatory agencies like the FDA or EMA.

2. Contract Manufacturing Organizations (CMOs)

CMOs play a vital role in the supply chain, especially for drugs with high demand or complex manufacturing processes.

• Major CMOs in the Industry:
  Firms such as Catalent, Patheon, and Lonza are recognized for their capacity to manufacture complex pharmaceuticals under GMP conditions, often producing formulations for multiple brands or generic versions.

• Regional CMOs:
  Smaller, regional CMOs in Asia, Europe, and North America also contribute to the production, particularly in fulfilling regional regulatory requirements.

3. API Suppliers and Raw Material Providers

The sourcing of high-quality APIs is crucial.

• Major API Suppliers:
  Companies like BASF, Novartis API manufacturing units, and Dr. Reddy’s Laboratories supply APIs for immunomodulatory drugs. Reliable API sourcing ensures consistent quality and adherence to regulatory standards.

• Bulk Raw Material Providers:
  Suppliers of excipients, stabilizers, and other raw materials for formulation are typically diversified to avoid disruptions.

4. Distributors and Wholesalers

Effective distribution networks are essential to distributing FULVICIN-U/F globally.

• Global Distributors:
  Entities such as McKesson, AmerisourceBergen, and Cardinal Health supply pharmaceuticals across the US and international markets.

• Regional Distributors:
  In regions like Asia or Africa, local distributors and licensed pharmacies form the backbone of supply.

Regulatory and Supply Chain Considerations

Regulatory approvals significantly influence supplier options. Only manufacturers compliant with GMP and holding proper certifications (e.g., FDA clearance, EMA approval, or WHO prequalification) can legally supply the drug.

Supply chain disruptions can arise from geopolitical issues, raw material shortages, or manufacturing delays. COVID-19 underscored vulnerabilities in global pharmaceutical supply chains, emphasizing the need for strategic diversification of suppliers.

Emerging Trends Affecting Suppliers

1. Diversification and Localization

Manufacturers increasingly seek diversified supplier bases across multiple regions to mitigate risks from geopolitical instability or trade restrictions.

2. Contract Manufacturing Expansion

Pharmaceutical companies are expanding CMO partnerships, particularly in regions with cost advantages (India, China, Southeast Asia), to increase capacity and reduce dependency on single sources.

3. API Synthesis Innovation

Advancements in synthetic chemistry and biotechnological production methods are enabling alternative API sourcing, allowing supply chains to bypass bottlenecks in traditional raw material markets.

Strategic Recommendations

• Engage multiple suppliers: To ensure supply continuity, organizations should establish relationships with several approved manufacturers and distributors.
• Prioritize regulatory compliance: Suppliers must hold valid certifications and adhere to GMP standards.
• Monitor geopolitical risks: Regular supply chain assessments can mitigate disruptions.
• Invest in supply chain transparency: Digitalization and real-time tracking improve responsiveness and inventory management.

Key Takeaways

• The supply of FULVICIN-U/F hinges on a network of originator manufacturers, generic producers, CMOs, and authorized distributors.
• Diversification across regions and manufacturers mitigates risks stemming from geopolitical or logistical disruptions.
• Regulatory compliance remains paramount; only certified and GMP-compliant suppliers can legally supply the drug.
• Evolving manufacturing technologies and strategic partnerships influence the robustness and capacity of the supply chain.
• Proactive supply chain management ensures consistent access for healthcare providers and patients.

FAQs

1. Who are the primary manufacturers of FULVICIN-U/F?
The exact manufacturers vary based on regional licensing and patent status. Initially developed by the originator company, subsequent generic production and contract manufacturing organizations contribute significantly to the supply.

2. Can I source FULVICIN-U/F from regional suppliers?
Yes. Regional approvals often authorize local generic manufacturers and distributors to supply FULVICIN-U/F. Always verify that suppliers hold relevant regulatory certifications.

3. What risks threaten the supply of FULVICIN-U/F?
Global supply chain disruptions, raw material shortages, manufacturing delays, geopolitical tensions, and regulatory hurdles pose significant risks.

4. How can healthcare providers ensure a reliable supply of FULVICIN-U/F?
By establishing relationships with multiple certified suppliers, maintaining buffer stock, and monitoring supply chain alerts.

5. Are there alternative suppliers if current sources are disrupted?
Potentially, but any alternative must meet strict regulatory standards and possess the necessary GMP certifications to ensure safety and efficacy compliance.

References

1. U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations.
2. European Medicines Agency. Summary of Product Characteristics.
3. IMS Health. Global Pharmaceutical Market Outlook.
4. McKesson Corporation. Pharmaceutical Distribution Services.
5. Contract Manufacturing Organizations in Pharma. Pharmaceutical Technology.