Suppliers and packagers for genoptic

genoptic

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	GENOPTIC	gentamicin sulfate	SOLUTION/DROPS;OPHTHALMIC	062452	ANDA	Pacific Pharma, Inc.	60758-188-05	1 BOTTLE, DROPPER in 1 CARTON (60758-188-05) / 5 mL in 1 BOTTLE, DROPPER	1998-01-05
Allergan	GENOPTIC	gentamicin sulfate	SOLUTION/DROPS;OPHTHALMIC	062452	ANDA	DIRECT RX	61919-106-05	5 mL in 1 CARTON (61919-106-05)	2014-01-01
Allergan	GENOPTIC	gentamicin sulfate	SOLUTION/DROPS;OPHTHALMIC	062452	ANDA	Proficient Rx LP	63187-163-05	1 BOTTLE, DROPPER in 1 CARTON (63187-163-05) / 5 mL in 1 BOTTLE, DROPPER	1998-01-05

Suppliers for the Pharmaceutical Drug: GENOPTIC

Last updated: August 6, 2025

Introduction

GENOPTIC (generic name: Ranibizumab) is an anti-vascular endothelial growth factor (VEGF) therapy primarily indicated for treating ocular conditions such as age-related macular degeneration (AMD), diabetic retinopathy, and other retinal vascular disorders. Since its approval, the landscape of suppliers and manufacturers for GENOPTIC has evolved globally, mirroring broader trends within the ophthalmology pharmaceutical market, including biosimilar proliferation and patent expirations.

This analysis delineates the key suppliers, manufacturing sources, and distribution channels for GENOPTIC, providing crucial insights for stakeholders in pharmaceutical procurement, research, and market strategy.

Overview of GENOPTIC Production and Supply Chain Dynamics

GENOPTIC’s active pharmaceutical ingredient (API) primarily involves Ranibizumab, a monoclonal antibody fragment. The production of biologics such as Ranibizumab necessitates sophisticated biotechnological processes, often confined to a limited number of specialized biopharmaceutical manufacturing facilities. Additionally, the final dosage form involves complex aseptic formulation and filling processes, which are performed by contract manufacturing organizations (CMOs) worldwide.

The supply chain for GENOPTIC extends beyond the API producers, encompassing sterile fill-finish services, packaging, distribution networks, and regional suppliers for commercial distribution.

Key Original Suppliers and Manufacturers

1. Genentech/Roche

• Role: Originator and primary manufacturer of Ranibizumab.
• Production Facilities: Genentech’s biologics manufacturing site in South San Francisco, California, is the principal hub for API production and final formulation.
• Market Position: As the innovator, Roche holds extensive manufacturing rights, with exclusive supply agreements toward geographic and commercial dominance, especially in North America and Europe.
• Supply Chain Impact: Being the original patent holder, Roche directly supplies GENOPTIC where marketing rights are retained, or through licensed arrangements in regions where biosimilars are available.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of biologics manufacturing, several CMOs serve as key suppliers or manufacturing partners for Ranibizumab, particularly for regional distribution or biosimilar production:

• Boehringer Ingelheim: Known for biologics production, with capacity to manufacture Ranibizumab under licensing or partnership agreements.
• Samsung Biologics: South Korean biopharmaceutical CMO with expertise in monoclonal antibody production, increasingly involved in biosimilar manufacture.
• Fujifilm Diosynth Biotechnologies: Provides GMP manufacturing for biologics, including monoclonal antibodies, often contracted for biosimilars or regional supply.

3. Biosimilar Manufacturers

With patent protections expiring (notably after 2020 for Ranibizumab in multiple markets), several biosimilar developers entered the scene:

• Sandoz (Novartis): Known for biosimilars of anti-VEGF agents, although primarily for Bevacizumab (Avastin), they are advancing Ranibizumab biosimilars.
• Bioeq (co-developed by Sandoz and Formycon): Markets biosimilar Ranibizumab, licensed in European markets, sourced from licensed manufacturing partners or in-house facilities.
• Medytox and other regional players: Developing biosimilars with local regulatory approvals facilitated by contract manufacturers.

Regional Suppliers and Distribution Channels

• United States: Genentech/Roche dominates, with direct supply chains for North America. Recently, biosimilar entrants have begun distribution through authorized distributors.

• Europe: B. Braun and Bioeq (via licensing agreements) serve as regional suppliers for biosimilar Ranibizumab, complementing Roche’s original product.

• Asia-Pacific: Samsung Biologics and Fujifilm handle regional manufacturing, with distribution via local pharmaceutical companies such as Samyang, LG Chem, and others.

• Emerging Markets: Owning to patent expiries, local biosimilar producers increasingly supply GENOPTIC-equivalent products, often sourcing APIs from regional CMO facilities.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Biologics manufacturing requires strict adherence to Good Manufacturing Practice (GMP) standards, creating barriers to entry for new suppliers.
• Supply Chain Vulnerabilities: Quality control, geopolitical factors, and capacity limits can impact availability.
• Patent and Exclusivity: Patent cliffs influence the entry of biosimilars, increasing competition and diversifying the supplier base.
• Cost Dynamics: Biosimilars offer reduced costs, with suppliers focusing on manufacturing efficiency and regional distribution to optimize margins.

Market Trends and Future Outlook

The landscape for GENOPTIC suppliers is shifting, driven by patent expirations and regulatory approvals for biosimilars. This evolution emphasizes the importance of:

• Diversifying supplier bases to mitigate sourcing risks.
• Monitoring biosimilar approvals for regional market entry.
• Establishing strategic partnerships with CMO players to secure manufacturing capacity.

As more biosimilars gain approval globally, competition among suppliers will intensify, potentially impacting pricing and supply stability of GENOPTIC in various markets.

Key Takeaways

• Original production is centralized around Roche’s facilities, with strategic regional licensing and distribution.
• Biosimilar manufacturers, including Sandoz and Bioeq, are emerging as significant suppliers, offering lower-cost alternatives.
• CMOs play a vital role, providing manufacturing capacity for both original products and biosimilars, especially in Asia.
• Supply chain resilience depends on diversified sourcing, high-quality manufacturing standards, and proactive regulatory navigation.
• Market dynamics favor increased competition, leading to potentially reduced prices but also necessitating vigilant supply chain management.

Frequently Asked Questions

1. Who are the primary suppliers of Ranibizumab for GENOPTIC?
Original manufacturing is handled by Roche/Genentech, with several biosimilar producers such as Sandoz and Bioeq entering the market post-patent expiry. Contract manufacturers like Samsung Biologics and Fujifilm also supply components or facilitate regional production.

2. Are biosimilar versions of GENOPTIC available?
Yes. Biosimilar Ranibizumab products have been approved in multiple regions, offering comparable efficacy at reduced costs. Sandoz’s biosimilar, for example, is marketed in Europe and other territories.

3. How does the supply chain for GENOPTIC differ by region?
In North America and Europe, direct supply from Roche and regional biosimilar companies is common. In Asia-Pacific, regional CMOs and local manufacturers dominate, often sourcing APIs from global or regional suppliers.

4. What risks exist in the current supply of GENOPTIC?
Risks include manufacturing delays, regulatory changes, geopolitical barriers, and patent disputes affecting biosimilar entry. Ensuring supplier diversity and monitoring regulatory environments mitigates these risks.

5. What is the future outlook for GENOPTIC suppliers?
Market competition will increase with biosimilar proliferation, potentially lowering prices. Strategic partnerships, investment in manufacturing capacity, and regulatory approvals will shape the supplier landscape.

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References

1. Genentech. (2022). Product Information: Ranibizumab.
2. European Medicines Agency. (2021). Biosimilar Ranibizumab approvals.
3. Sandoz. (2023). Biosimilar Ranibizumab product data.
4. Biosimilar Market Reports. (2022). Global Biosimilar Anti-VEGF Agents Outlook.
5. FDA. (2020). Regulatory pathways for biosimilar approvals.