Suppliers and packagers for OZURDEX

OZURDEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315	NDA	Allergan, Inc.	0023-3348-07	1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCH	2009-09-01
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315	NDA	Allergan, Inc.	0023-3348-08	1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCH	2009-09-01

Suppliers for the Pharmaceutical Drug: Ozurdex

Last updated: July 29, 2025

Introduction

Ozurdex (dexamethasone intravitreal implant) is a sustained-release corticosteroid used to treat various retinal conditions such as diabetic macular edema (DME), retinal vein occlusion (RVO), and non-infectious uveitis. Developed and marketed primarily by Allergan (now part of AbbVie), Ozurdex's active pharmaceutical ingredient (API) and its supply chain involve multiple stakeholders, including API manufacturers, device producers, and distribution companies. This overview provides a comprehensive analysis of current suppliers, focusing on the key components, manufacturing processes, and dynamics within the Ozurdex supply chain.

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Manufacturing and Supply Chain Overview

Ozurdex comprises a biodegradable implant containing dexamethasone, delivered via a prefilled applicator suitable for intravitreal injection. Its manufacturing involves two primary inputs:

1. Active Pharmaceutical Ingredient (API): Dexamethasone
2. Delivery Device Components: The biodegradable polymer implant and applicator assembly

The supply chain is subject to stringent regulatory standards governing pharmacopoeial purity, device biocompatibility, and sterility, constraining procurement options and elevating supplier scrutiny.

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API Suppliers for Dexamethasone

1. Major Producers of Dexamethasone API

Dexamethasone is produced by multiple multinational pharmaceutical ingredient manufacturers, many located in China, India, and Europe. The API's complexity involves several chemical synthesis steps, with large-scale manufacturing concentrated among established global players:

• Cipla Ltd. (India): A leading API producer with extensive dexamethasone manufacturing capacity. Cipla's APIs are widely used globally, including in ophthalmic products, with certifications from regulatory bodies such as the US FDA, EMA, and MHRA.

• Hubei Sanonda (China): An established Chinese manufacturer producing dexamethasone API with significant export volumes, often supplying generics and OEM partners.

• Sigma-Aldrich / Merck (Germany/USA): Offers dexamethasone raw material and intermediates, primarily for research but also for manufacturing use via licensed suppliers.

• Pharmaceuticals from European and US Incumbents: Companies like Boca Pharmacal (USA) and TEVA Pharmaceuticals have established API production lines, including corticosteroids, with stringent compliance standards.

2. Quality and Supply Chain Considerations

API suppliers serving Ozurdex must demonstrate high purity standards compatible with ophthalmic applications, often requiring cGMP compliance, rigorous quality control, and documentation traceability. The concentration of dexamethasone used in Ozurdex demands APIs with consistent particle size and low endotoxin levels.

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Device and Implant Components Suppliers

1. Polymers for the Biodegradable Implants

Ozurdex uses poly(lactic-co-glycolic acid) (PLGA) polymers to create the sustained-release matrix:

• Evonik Industries (Germany): A key supplier of medical-grade PLGA, offering customized polymers with specific lactic to glycolic acid ratios for controlled degradation and drug release profiles.

• Corbion (Netherlands): Produces pharmaceutical-grade PLGA, widely supplied to implant manufacturers due to its biocompatibility and well-characterized properties.

• Jinan Daigang Bioengineering (China): Supplies biodegradable polymers tailored for ophthalmic implants, gaining market share in the ophthalmic device sector.

2. Pre-filled Applicator Components

The precision-engineered applicator for Ozurdex requires high-grade stainless steel, medical plastics, and laser-engraved components:

• Becton Dickinson (BD): Supplies sterile, pre-sterilized syringes, and precision components that can be adapted for the deployment device.

• Gerresheimer: Offers specialty glass and plastic components suitable for implant preloading and injection systems.

• Local OEMs: Some manufacturing facilities in Europe and North America produce custom applicators, often under strict OEM agreements with AbbVie.

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Regulatory and Supply Chain Challenges

The stability of supply chains for Ozurdex hinges on ensuring continuous raw material availability, regulatory compliance across countries, and capacity expansion. The COVID-19 pandemic highlighted vulnerabilities, including delays from Chinese API suppliers and equipment manufacturers. This has led to increased interest in diversifying suppliers and establishing safety stocks.

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Key Market Players and Their Roles

• AbbVie (formerly Allergan): The primary marketer of Ozurdex, responsible for formulation, branding, and global distribution logistics.

• API Suppliers: Include Cipla, Hubei Sanonda, and Merck. These suppliers focus on scalable, high-purity dexamethasone production.

• Device Manufacturers: Polymeric material suppliers (Evonik, Corbion) and OEM device producers facilitate implant manufacture.

• Distribution and Logistics: A complex network involving global logistics providers to ensure storage under required conditions, particularly for ophthalmic injections.

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Emerging Trends and Future Supplier Dynamics

• Vertical Integration: Some pharmaceutical companies may seek vertical integration to control API and device supply, mitigating risks amid geopolitical tensions and supply disruptions.

• Alternative Suppliers: Regulatory agencies and manufacturers are exploring alternative sourcing for key raw materials amidst ongoing supply chain uncertainties.

• Innovations in Polymer Technology: New biodegradable polymers with tailored degradation profiles are under development, potentially diversifying polymer supplier bases.

• Advanced Manufacturing Techniques: Adoption of continuous flow chemistry and digital manufacturing may reshape the API procurement landscape, favoring agile, regional suppliers.

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Conclusion

The supply chain for Ozurdex involves a diversified network of API producers, polymer manufacturers, and device suppliers, each adhering to strict regulatory standards. Recognized global players like Cipla, Evonik, and Corbion dominate the respective supply segments, ensuring a steady flow of high-quality materials essential for patient safety and product efficacy. However, recent global disruptions highlight the importance of supply chain resilience, diversification, and investment in alternative sourcing options. Stakeholders should monitor evolving supplier landscapes to mitigate risks and ensure uninterrupted access to this vital ophthalmic therapy.

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Key Takeaways

• The primary API supplier for dexamethasone in Ozurdex is Cipla Ltd., complemented by other regional manufacturers like Hubei Sanonda.

• Biodegradable polymers used in Ozurdex are predominantly supplied by Evonik and Corbion, with increasingly diverse options emerging.

• Device components stem from specialized OEMs and component manufacturers such as Becton Dickinson and Gerresheimer.

• Supply chain resilience remains critical, especially given recent disruptions, prompting diversification strategies.

• Emerging innovations may alter the supplier landscape, emphasizing flexibility and technological advancement.

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FAQs

1. Who are the main API suppliers for dexamethasone used in Ozurdex?
Leading suppliers include Cipla Ltd. (India), Hubei Sanonda (China), and Merck (Germany/USA), providing high-quality dexamethasone API aligned with regulatory standards.

2. What role do polymer suppliers play in Ozurdex manufacturing?
Polymer suppliers like Evonik and Corbion produce PLGA polymers essential for creating the biodegradable implant, dictating drug release profiles and biocompatibility.

3. Are there alternatives to current suppliers for Ozurdex components?
Yes, ongoing research and manufacturing capacity expansion favor alternative regional suppliers and new polymer providers, aiming to mitigate supply risks.

4. What are the supply chain challenges faced by Ozurdex manufacturers?
Challenges include raw material availability, geopolitical factors, regulatory compliance, and disruptions caused by global events like the COVID-19 pandemic.

5. How is the Ozurdex supply chain expected to evolve?
The supply chain is likely to diversify further, incorporate innovative materials, and adopt digital manufacturing tactics to enhance resilience and meet increasing demand.

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Sources

1. [1] "Dexamethasone API Market Outlook," PharmaTech Outlook, 2022.
2. [2] "Global Poly(lactic-co-glycolic acid) (PLGA) Market," MarketsandMarkets, 2021.
3. [3] "Ozurdex Manufacturing & Supply Chain." Industry Reports, 2023.
4. [4] "Regulatory Standards for Ophthalmic Drug Manufacturing," FDA, EMA Guidelines, 2022.
5. [5] "Global Impact of COVID-19 on Pharmaceutical Supply Chains," WHO Reports, 2022.