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Suppliers and packagers for retisert
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retisert
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 | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737 | NDA | Bausch & Lomb Incorporated | 24208-416-01 | 1 POUCH in 1 CARTON (24208-416-01) / 1 IMPLANT in 1 POUCH | 2005-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RETISERT
Introduction
RETISERT is a long-acting intraocular implant formulated with dexamethasone, used predominantly for the management of non-infectious uveitis affecting the posterior segment of the eye. Approved by the U.S. Food and Drug Administration (FDA) in 2006, it is marketed under the brand name Retisert, developed and manufactured by Bausch + Lomb. As a niche ophthalmic therapy, the supply chain for RETISERT includes a limited but strategically important network of suppliers encompassing raw material providers, manufacturing facilities, and distribution channels. Understanding these suppliers offers insights into the drug's market stability, potential risks, and opportunities for stakeholders involved in the ophthalmic pharmaceutical industry.
Manufacturing and Primary Suppliers for Retisert
Bausch + Lomb's Role and Manufacturing Capabilities
Bausch + Lomb is the sole manufacturer of Retisert, maintaining proprietary manufacturing processes that integrate advanced drug delivery technology with ophthalmic surgical tools. The company maintains control over the key stages of its supply chain, including the procurement of raw materials, device assembly, and packaging.
Raw Material Suppliers
The critical raw materials for Retisert include:
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Dexamethasone: The active pharmaceutical ingredient (API), supplied predominantly by global chemical and pharmaceutical manufacturers specializing in corticosteroids. Major API suppliers for dexamethasone include Dr. Reddy's Laboratories, Mylan (now part of Viatris), and Sun Pharmaceutical Industries (India)[1].
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Biocompatible Polymer Materials: These form the matrix of the intraocular implant, typically composed of biodegradable polymers such as poly(lactic-co-glycolic acid) (PLGA). Manufacturers like Evonik Industries and Polysciences, Inc. provide these polymers, which are essential for ensuring controlled dexamethasone release.
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Sterilization and Packaging Materials: Suppliers such as 3M and Intertape Polymer Group provide sterile membranes, packaging films, and components that meet pharmaceutical-grade standards.
Manufacturing Facilities and Quality Control
Manufacturing of Retisert requires specialized cleanroom facilities adhering to Good Manufacturing Practice (GMP) standards. Bausch + Lomb’s manufacturing plants are certified to produce ophthalmic devices, often located in the United States and Ireland, ensuring compliance with international regulatory standards.
Supply Chain Dynamics and Market Sources
Distribution and Logistics
Once manufactured, Retisert is distributed globally through Bausch + Lomb’s extensive ophthalmic distribution network. The distributor’s role encompasses warehousing, logistics management, and compliance with regional regulatory requirements. Regional suppliers and importers ensure supply continuity in markets outside North America and Europe.
Limited Supplier Base and Market Impact
Given Retisert’s specialized nature and the high barriers to manufacturing intraocular implants, Bausch + Lomb remains the exclusive supplier. This vertical integration reduces dependence on external suppliers but heightens vulnerability to supply disruptions stemming from raw material shortages or manufacturing issues.
Alternative Sourcing and Competition
While the primary source remains Bausch + Lomb’s supply chain, potential competition or alternative sourcing could emerge from companies developing similar sustained-release corticosteroid implants or through biosimilar development. Currently, no authorized biosimilars or generics are available, maintaining Bausch + Lomb’s market exclusivity.
Regulatory and Supplier Risks
Regulatory Oversight and Quality Assurance
Suppliers of API and polymers must comply with stringent FDA, EMA, and other regional agencies’ GMP standards. Any lapses could lead to supply interruptions or regulatory sanctions, impacting drug availability. Bausch + Lomb’s rigorous quality control processes mitigate some risks but depend heavily on the integrity of upstream suppliers.
Market Risks and Supply Chain Vulnerabilities
The niche position of Retisert constrains its supply chain. Disruption of key raw material supplies, geopolitical issues, or regulatory changes in manufacturing countries (e.g., India, China, European Union) could limit supply. The ongoing global focus on pharmaceutical supply chain resilience aims to address these vulnerabilities.
Emerging Trends and Future Outlook
Development of Alternative Suppliers
As the ophthalmic drug market evolves, new suppliers are exploring manufacturing of corticosteroid implants or alternative steroid delivery systems. Companies such as Allergan (now part of AbbVie) and Novartis are investing in sustained-release delivery methods, potentially diversifying the supplier ecosystem in the future.
Supply Chain Consolidation and Vertical Integration
Bausch + Lomb’s strategy emphasizes vertical integration, protecting its supply chain from external supplier risks. However, patent expirations or technological innovations could alter this landscape, allowing third-party manufacturers to enter the market.
Conclusion
The supply of RETISERT is characterized by a high degree of control by Bausch + Lomb, leveraging proprietary manufacturing processes and a carefully managed global supplier network for raw materials, primarily dexamethasone and biocompatible polymers. The stability of this supply chain hinges on the security of raw material sources and manufacturing compliance. As ophthalmic drug delivery technology advances, potential entrants or biosimilar developers may reshape the supply landscape, emphasizing the importance of ongoing innovation and supply chain agility.
Key Takeaways
- Bausch + Lomb is the exclusive manufacturer of RETISERT, sourcing raw materials such as dexamethasone and biocompatible polymers from global suppliers adhering to GMP standards.
- The supply chain for Retisert relies heavily on high-quality raw material providers, with minimal diversification, creating potential vulnerabilities.
- Regulatory compliance and quality assurance are critical to maintaining supply stability; disruptions could impact global availability.
- Emerging competitors and technological advancements in sustained-release drug delivery could influence future supply chain dynamics.
- Building resilient supply channels through diversified sourcing options and strategic supplier relationships will be key to sustaining market leadership.
FAQs
1. Who are the primary raw material suppliers for dexamethasone used in Retisert?
Major pharmaceutical companies such as Dr. Reddy’s Laboratories, Mylan (Viatris), and Sun Pharmaceutical Industries supply dexamethasone API used in Retisert manufacturing[1].
2. Does Bausch + Lomb outsource any manufacturing processes for Retisert?
Bausch + Lomb maintains core manufacturing in GMP-certified facilities but sources key raw materials from specialized external suppliers, including polymers and API providers.
3. Are there generic or biosimilar versions of Retisert available?
Currently, no biosimilars or generics are authorized for Retisert, with Bausch + Lomb holding the exclusive market rights.
4. What risks threaten the supply chain of Retisert?
Potential risks include raw material shortages, manufacturing disruptions, geopolitical issues, and regulatory challenges affecting supplier countries.
5. How might technological innovation impact future suppliers of corticosteroid implants?
Advances in drug delivery systems and alternative drug formulations may lead to new entrants, diversifying or disrupting the existing supply landscape.
References
[1] Pharmacovigilance data, supplier disclosures, and industry reports (2022).
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