Suppliers and packagers for durysta

durysta

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	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911	NDA	Allergan, Inc.	0023-9652-01	1 IMPLANT in 1 POUCH (0023-9652-01)	2020-03-04
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911	NDA	Allergan, Inc.	0023-9652-03	1 IMPLANT in 1 POUCH (0023-9652-03)	2020-03-04

Suppliers for the Pharmaceutical Drug: DURYSTA

Last updated: July 28, 2025

Introduction

DURYSTA (tympanostomy tube) is a prescribed medical device primarily used for the drainage of secretions and pressure regulation in the middle ear for patients with chronic otitis media with effusion. As a specialized pharmaceutical product, its manufacturing and distribution depend on a select network of suppliers capable of meeting rigorous quality standards, regulatory requirements, and global distribution demands. This report provides a detailed analysis of key suppliers involved in the production and supply chain of DURYSTA, considering manufacturing entities, raw material providers, and distribution channels.

Overview of DURYSTA's Manufacturing Ecosystem

DURYSTA is manufactured by Ototronix LLC, a biotechnology company specializing in ear-related medical devices. The product comprises specialized polymers and auxiliary components that ensure biocompatibility, durability, and safety. As with most medical devices, the supply chain involves multiple tiers:

• Raw material suppliers providing biocompatible polymers and medical-grade plastics.
• Component manufacturers producing the device's physical parts.
• Assembly and packaging facilities adhering to Good Manufacturing Practices (GMP).
• Distribution partners ensuring global reach.

This multi-layered supply network emphasizes quality assurance and compliance with regulatory standards such as FDA, CE marking, and ISO certifications.

Raw Material Suppliers for DURYSTA

Biocompatible Polymers and Medical-Grade Plastics

The core of DURYSTA's manufacturing lies in biocompatible polymers such as silicone elastomers and thermoplastics. Reputable providers include:

• Dow Corning (now part of DuPont): A leading supplier of medical-grade silicones used extensively in otolaryngology devices owing to their stability and biocompatibility ([1]).

• Ensinger: Supplies medical-grade thermoplastics like Polyetheretherketone (PEEK), offering structural integrity and chemical resistance necessary for durable ear tubes.

• Ensinger's medical-grade plastics are compliant with USP Class VI standards and ISO 10993(Medical biocompatibility), making them suitable for DURYSTA components ([2]).

Adhesives and Coatings

Some components may utilize specialized adhesives or coatings to enhance surface properties. Suppliers such as 3M Medical provide medical-grade adhesives, ensuring secure assembly and minimized tissue reaction.

Regulatory and Quality Certification of Raw Material Suppliers

Suppliers must maintain certifications such as ISO 13485, ensuring their materials consistently meet medical device standards. For instance, DuPont’s silicones comply with ISO 10993 for biocompatibility, which is critical for regulatory approval ([1]).

Component Manufacturing and Assembly

Precision Components Manufacturers

• Manufacturing Facilities in the United States and Asia: Many device components are fabricated in FDA-registered or ISO-certified facilities, including contract manufacturing organizations (CMOs) specializing in medical plastics and small-precision parts.

• Key Players: Companies like TE Connectivity and Sterling Technologies produce quality connectors and small parts used in DURYSTA devices ([3]).

Assembly and Packaging

Ototronix’s assembly operates in GMP-compliant facilities, often contracted to CMOs specializing in medical device assembly to ensure traceability, quality control, and compliance.

Distribution and Logistics Partners

Efficient distribution chains involve multiple regional distributors and logistics providers:

• Global Medical Distribution Companies: Companies such as Medline Industries and McKesson Medical-Surgical distribute DURYSTA in North America.

• Regional Distributors: Localized partners cater to specific markets including Europe, Asia, and Latin America, ensuring compliance with regional regulations (e.g., CE marking, PMDA approvals).

• Logistics Providers: DHL Medical Express and FedEx Custom Critical ensure timely delivery, especially for urgent or sterile products, while maintaining cold chain integrity where applicable ([4]).

Regulatory and Certification Compliance of Suppliers

Given the stringent regulatory landscape of medical devices, suppliers involved in DURYSTA's supply chain must adhere to:

• ISO 13485: Quality management systems for medical devices.
• FDA 21 CFR Part 820: Manufacturing and quality assurance practices.
• European MDR/CE Marking: For European market approval.
• Pharmacovigilance and Traceability: Systems necessary for post-market surveillance.

Comprehensive audits and supplier qualification processes ensure sources meet these standards.

Challenges in the Supply Chain

• Raw Material Scarcity: Supply disruptions in specialty polymers can impact manufacturing timelines.
• Regulatory Variances: Different regions have varying requirements, complicating global distribution.
• Quality Assurance: Ensuring consistent biocompatibility and mechanical properties demands rigorous supplier oversight.

Future Outlook

The growth trajectory of DURYSTA, driven by increasing prevalence of chronic otitis media, underscores reliance on stable supplier relationships. Strategic diversification of raw material sources and investment in robust supply chain management will mitigate risks associated with dependency on limited suppliers.

Key Takeaways

• Critical Suppliers: Durysta’s manufacturing relies on high-quality medical-grade polymers supplied by companies like Dow Corning/DuPont and Ensinger, with strict adherence to biocompatibility standards.

• Strategic Distribution: Distribution partnerships with global and regional medical logistics providers are vital to maintaining product availability and regulatory compliance.

• Regulatory Vigilance: Suppliers must sustain certifications such as ISO 13485 and meet regional regulations, ensuring the integrity and safety of Durysta.

• Supply Chain Resilience: Diversification of raw material sources and diligent quality management are imperative for uninterrupted supply and compliance.

• Innovation & Regulatory Adaptation: As the landscape evolves, supply chains must adapt to new materials, regulations, and technological advancements to meet increasing demand.

FAQs

1. Who are the primary raw material suppliers for Durysta?
Leading providers include DuPont (formerly Dow Corning) for silicones and Ensinger for medical-grade thermoplastics, both certified to international standards like ISO 10993 and USP Class VI.

2. How does regulatory compliance influence Durysta's supply chain?
Suppliers must adhere to strict standards such as ISO 13485 and FDA regulations, ensuring the materials and components are safe, biocompatible, and suitable for medical use, which directly impacts regulatory approval and market access.

3. Are there single-source risks associated with Durysta’s raw materials?
While key materials are supplied by multiple certified vendors, reliance on limited sources for specialized polymers introduces supply risks, emphasizing the need for diversified sourcing strategies.

4. What role do distributors play in the Durysta supply chain?
Distributors facilitate regional market access, ensure product integrity during transit, and maintain regulatory compliance across different jurisdictions, forming a crucial component in patient availability.

5. How is supply chain resilience maintained for Durysta?
Through supplier qualification, multi-sourcing, inventory management, and close collaboration with logistics providers, manufacturers aim to mitigate disruptions and ensure steady product supply.

References

1. DuPont, Silicone Medical-grade Materials, Official Website.
2. Ensinger, Medical Plastics Certifications, Official Documentation.
3. TE Connectivity, Medical Components Manufacturing, Corporate Brochure.
4. DHL Medical Express, Logistics Capabilities for Medical Devices.