Suppliers and packagers for ZIRGAN

ZIRGAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211	NDA	Bausch & Lomb Incorporated	24208-535-15	1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR	2010-04-30
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211	NDA	Bausch & Lomb Incorporated	24208-535-35	1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR	2010-04-30

Suppliers for the Pharmaceutical Drug: Zirgan

Last updated: August 1, 2025

Introduction

Zirgan, the brand name for Ganciclovir ophthalmic gel 0.15%, is a specialized antiviral medication used primarily to treat herpes keratitis caused by herpes simplex virus (HSV) in immunocompetent adults. Its unique formulation and pivotal clinical role have made Zirgan a critical product within ophthalmic antiviral therapies. This article explores key suppliers of Zirgan, analyzing their roles within the supply chain, licensing frameworks, regional distribution, and strategic implications for stakeholders involved in procurement and distribution.

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Manufacturers and Original Brand Suppliers

The primary and most recognized supplier of Zirgan is Senju Pharmaceutical Co., Ltd., a leading Japanese pharmaceutical company specializing in ophthalmic medications. Senju developed Zirgan and holds the original marketing rights, securing regulatory approval in various markets, including the United States, Europe, and parts of Asia.

• Senju Pharmaceutical Co., Ltd.
  • Headquarters: Japan
  • Role: Original patent holder and manufacturer of Zirgan
  • Regulatory Status: Approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of herpetic keratitis. It also holds approval from the European Medicines Agency (EMA) and other regional agencies.

This manufacturer is responsible for the production, quality assurance, distribution, and intellectual property rights management of Zirgan. Their control over manufacturing processes ensures consistent efficacy, safety, and supply integrity.

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Authorized Distributors and Regional Suppliers

While Senju manufactures Zirgan, the distribution landscape involves several licensed regional distributors, often dependent on licensing agreements with the original manufacturer. These distributors handle regional supply, regulatory compliance, and localized customer support.

• In the United States:

  • Valeant Pharmaceuticals (Now Bausch + Lomb): A notable distributor and partner involved in the supply chain through licensing agreements.
  • Other Authorized Distributors: Various regional specialty distributors operate under approval from Senju or its licensing affiliates to supply Zirgan across clinics.

• In Europe:

  • Regional pharmaceutical companies or authorized importers distribute Zirgan following approval from regulatory authorities such as EMA.

• In Asia-Pacific:

  • Local licensees and pharmaceutical firms sometimes sublicense manufacturing or distribution rights, expanding access in emerging markets.

It is essential to distinguish authorized distribution channels from gray-market suppliers or illegal importers, as the latter may compromise product authenticity and patient safety.

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Global Supply Chain Dynamics

The supply of Zirgan involves a complex interplay of patent rights, licensing agreements, regional regulations, and manufacturing capacity:

• Intellectual Property Rights (IPRs):

  • Senju retains patent rights for Zirgan in most jurisdictions, controlling manufacturing and licensing.
  • Patents typically last 20 years post-filing, but patent extensions or supplementary protection certificates can influence market exclusivity.

• Manufacturing Capacity:

  • Senju’s primary manufacturing facility is based in Japan; it leverages international logistics networks to supply global markets.
  • In cases of high demand or regional shortages, licensed manufacturers or third-party contract manufacturing organizations (CMOs) may be involved, subject to strict quality control standards.

• Supply Chain Challenges:

  • Supply disruptions can arise from manufacturing issues, regulatory delays, or geopolitical factors.
  • Strategic inventory management and regional warehousing mitigate stock shortages.

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Recent Market Developments and Alternative Suppliers

The niche status of Zirgan limits the number of direct suppliers; however, alternative strategies and potential future entrants influence its supply chain:

• Generic Development:

  • Future patent expirations or licensing agreements may open avenues for generic formulations. Currently, no widely approved generic version of Zirgan exists, maintaining it as a branded specialty drug.

• Parallel Imports:

  • In some regions, authorized parallel imports facilitate access to Zirgan, although this carries regulatory complexities.

• Regional Licensing and Expansion:

  • Senju is actively expanding licensing agreements to improve regional access—particularly in areas with rising ocular herpes incidence.

Major considerations for procurement professionals include verifying supplier authenticity, ensuring compliance with regional regulatory standards, and managing lead times effectively given reliance on a handful of suppliers.

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Regulatory and Quality Assurance

Ensuring quality compliance from suppliers is paramount. Suppliers must adhere to Good Manufacturing Practices (GMP) aligned with international standards such as ICH Q7, US FDA regulations, and EMA guidelines.

• Certification and Audits:

  • Procurement entities should confirm suppliers’ GMP certifications through audit reports and official documentation.
  • Regular quality inspections help prevent counterfeiting and ensure product efficacy.

• Traceability:

  • Maintaining a transparent supply chain with traceability from manufacturer to end-user minimizes risks of substandard products and counterfeit supply.

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Strategic Implications for Stakeholders

For pharmaceutical companies, healthcare providers, and procurement agencies, understanding the supplier landscape for Zirgan is essential for risk mitigation and strategic planning. The concentrated supply base underscores the importance of establishing relationships with authorized distributors and ensuring regulatory compliance.

• Risk Management:

  • Diversify sourcing within authorized channels to mitigate regional supply risks.
  • Establish clear communication pathways with Senju and regional distributors.

• Market Access and Pricing:

  • Engage with licensing partners to improve regional availability and stabilize pricing strategies.

• Future Outlook:

  • With potential patent expirations and the development of generics, the supplier landscape may diversify, influencing pricing and availability.

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Key Takeaways

• Primary manufacturer: Senju Pharmaceutical Co., Ltd., maintains exclusive rights to Zirgan, controlling production and licensing globally.
• Distribution channels: Authorized regional distributors and licensees handle local supply, regulated by regulatory agencies and licensing agreements.
• Supply chain integrity: Quality assurance, GMP compliance, and traceability are critical to avoid counterfeit risks and ensure product efficacy.
• Market dynamics: Patent protections limit generic options; future patent expirations may alter the supplier landscape.
• Strategic focus: Procurement professionals should prioritize building relationships with authorized distributors, ensuring regulatory compliance, and diversifying sourcing strategies.

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FAQs

1. Who are the main suppliers of Zirgan globally?
The primary supplier is Senju Pharmaceutical Co., Ltd., which manufactures Zirgan and licenses regional distributors. Several authorized regional importers and distributors handle distribution in specific markets, such as the U.S. and Europe, under licensing agreements.

2. Are there generic versions of Zirgan available?
Currently, no approved generic versions of Zirgan exist. Future patent expirations may open the market to generics, but as of now, Zirgan remains a branded product with limited suppliers.

3. How can procurement ensure the authenticity of Zirgan?
Procure only through authorized distributors and licensed supply channels. Verify supplier certifications, maintain traceability, and perform regular quality audits per GMP standards.

4. What regions have licensed suppliers for Zirgan?
Licensed suppliers are present in North America, Europe, and select Asia-Pacific markets. The exact licensing arrangements depend on regional patent status and regulatory approvals.

5. What are potential risks in the Zirgan supply chain?
Supply risks include manufacturing disruptions, regulatory delays, patent litigations, and counterfeit products. Diversification within authorized channels and strict quality controls mitigate these risks.

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References

[1] U.S. Food and Drug Administration (FDA). Zirgan (ganciclovir ophthalmic gel) approval. 2013.
[2] European Medicines Agency (EMA). Summary of Product Characteristics for Zirgan.
[3] Senju Pharmaceutical Co., Ltd. official website and product information.
[4] Industry reports on ophthalmic antiviral drugs and market dynamics (MarketWatch, 2022).
[5] International Council for Harmonisation (ICH) guidelines on Good Manufacturing Practices (GMP).