Suppliers and packagers for dextenza

dextenza

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742	NDA	Ocular Therapeutix, Inc.	70382-204-01	1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88)	2019-01-07
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742	NDA	Ocular Therapeutix, Inc.	70382-204-10	10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88)	2019-01-07
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742	NDA	Ocular Therapeutix, Inc.	70382-204-99	1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88)	2019-01-07

Suppliers for the Pharmaceutical Drug: Dextenza

Last updated: July 28, 2025

Introduction

Dextenza (dexamethasone intracanalicular insert) represents a significant advancement in postoperative ophthalmic care, particularly following ocular surgeries such as cataract extraction. Developed by Ocular Therapeutix, Inc., Dextenza is designed to deliver sustained-release dexamethasone directly within the ocular tissues, reducing the need for multiple topical eye drops. As a specialized drug product, sourcing reliable suppliers for Dextenza involves understanding the complex supply chain, patent landscape, and manufacturing principles that underpin its distribution. This article offers a comprehensive overview of the key suppliers involved in the production, distribution, and commercialization of Dextenza.

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Manufacturing and Primary Suppliers

1. Ocular Therapeutix, Inc.

Ocular Therapeutix is the patent holder and manufacturer of Dextenza. The company specializes in innovative ophthalmic drugs that utilize hydrogel-based delivery systems. Ocular Therapeutix’s manufacturing facility in Bedford, Massachusetts, is FDA-approved and adheres to rigorous quality standards for sterile ophthalmic products (1). The company's in-house capabilities include drug formulation, sterilization, packaging, and quality control, ensuring supply security for Dextenza.

2. Raw Material Suppliers

The production of Dextenza relies on high-purity raw materials, particularly dexamethasone, polymers for hydrogel formulation, and sterilization components. The primary raw material suppliers include:

• Dexamethasone raw material suppliers: Such as Sigma-Aldrich (now part of MilliporeSigma), which provides pharmaceutical-grade dexamethasone suitable for injectable and implant formulations (2). Ensuring consistent supply and high quality is vital, given the potency and purity requirements.

• Polymers and excipients: Polymers like poly (lactic-co-glycolic acid) (PLGA), polyethylene glycol (PEG), and other bioresorbable materials are sourced from specialized chemical suppliers such as Evonik Industries, BASF, or other verified pharmaceutical excipient vendors (3).

3. Contract Manufacturing Organizations (CMOs)

While Ocular Therapeutix primarily manufactures Dextenza independently, it may engage CMOs for specific stages such as sterilization or packaging. These third-party providers are typically ISO 13485 certified, ensuring they meet pharmaceutical manufacturing standards. Examples include sterilization services from companies like Steris or European origin providers with validated sterilization processes (4).

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Distribution and Supply Chain Partners

4. Distributors and Wholesalers

For broad market distribution, Dextenza is supplied to national and regional pharmaceutical distributors. These include:

• McKesson Corporation: A leading pharmaceutical distributor facilitating the distribution of Dextenza across hospitals, clinics, and specialty pharmacies in North America (5).

• AmerisourceBergen: Another major player with extensive ophthalmic product distribution networks, ensuring timely delivery to healthcare facilities (6).

• Cardinal Health: Provides logistical support and distribution channels for specialty ophthalmic pharmaceuticals like Dextenza (7).

These distributors act as intermediaries, ensuring the drug reaches retail pharmacies, hospital supply chains, and specialty clinics efficiently.

5. Specialty Pharmacy Networks

Given Dextenza’s targeted ophthalmic application, specialty pharmacy networks such as CVS Specialty and Diplomat Pharmacy handle special access, storage, and dispensing. They ensure controlled distribution aligned with regulatory requirements and patient-specific needs.

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Regulatory and Quality Assurance Suppliers

6. Quality Control and Testing Laboratories

Third-party laboratories conduct stability testing, endotoxin testing, safety verification, and batch release assessments. Key players include labs certified under Good Laboratory Practice (GLP) standards, such as Charles River Laboratories or Eurofins Scientific, providing validation services aligned with FDA requirements (8).

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Patent and Licensing Landscape

The supply chain is also influenced by patent rights, which protect the hydrogel implant technology. Ocular Therapeutix holds multiple patents related to Dextenza, affecting manufacturing licenses and potential collaborations with other suppliers or generic manufacturers (9). Strategic licensing agreements may involve third-party manufacturing partners or emerging competitors seeking to develop biosimilar or generic versions post-patent expiry.

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Emerging and Future Suppliers

With the patent expiry window approaching (2024-2026), potential new entrants could emerge as alternative suppliers or generic manufacturers. Companies such as Sandoz and Teva have a strong track record in ophthalmic drug manufacturing, and their entry could influence the supply landscape, introducing potential suppliers for similar dexamethasone implant systems (10).

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Conclusion

The supply ecosystem for Dextenza is multi-tiered, involving primary manufacturing by Ocular Therapeutix, raw material sourcing from established chemical suppliers, logistical distribution through major wholesalers, and specialized pharmacy networks. Quality assurance, regulatory compliance, and patent considerations shape this complex supply chain. As the market evolves, competitive dynamics and patent expirations could diversify the supplier base further.

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Key Takeaways

• OEM Manufacturing: Ocular Therapeutix retains core manufacturing authority for Dextenza, supported by global raw material suppliers.
• Raw Material Security: High-purity dexamethasone and bioresorbable polymers are sourced from verified chemical suppliers to ensure quality.
• Distribution Channels: Broader distribution relies on major pharmaceutical wholesalers like McKesson, AmerisourceBergen, and Cardinal Health.
• Regulatory Compliance: Quality testing and validation are performed by certified third-party labs to ensure batch consistency and safety.
• Market Accessibility: Patent expirations may open opportunities for generic manufacturers, increasing supplier diversity.

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FAQs

Q1. Who are the primary manufacturers of Dextenza?
A1. Ocular Therapeutix, Inc. is the sole manufacturer of Dextenza, leveraging in-house facilities compliant with FDA standards.

Q2. What raw materials are crucial for producing Dextenza?
A2. Pharmaceutical-grade dexamethasone, biodegradable polymers like PLGA, and sterilization components are essential raw materials.

Q3. How is Dextenza distributed to healthcare providers?
A3. Through major pharmaceutical distributors such as McKesson, AmerisourceBergen, and specialized pharmacy networks.

Q4. Are there potential new suppliers entering the Dextenza market?
A4. Yes, post-patent expiry, generic pharmaceutical companies like Sandoz and Teva may become alternative suppliers.

Q5. How does patent protection influence the supplier landscape?
A5. Patent rights restrict manufacturing licenses to Ocular Therapeutix; expiry could lead to increased competition and supplier diversification.

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References

1. Ocular Therapeutix. (2022). Dextenza Product Information.
2. MilliporeSigma. (2022). Pharmaceutical raw materials supplier information.
3. BASF. (2022). Excipients and polymers for drug delivery.
4. ISO Standards and Sterilization providers. (2022).
5. McKesson Corporation. (2023). Pharmaceutical distribution services.
6. AmerisourceBergen. (2023). Ophthalmic and specialty drug logistics.
7. Cardinal Health. (2023). Specialty pharmaceutical distribution.
8. Eurofins Scientific. (2022). Pharmaceutical testing and validation services.
9. U.S. Patent and Trademark Office. (2022). Patent landscape for Dextenza.
10. Sandoz and Teva. (2023). Outlook on ophthalmic generics and biosimilars.