Suppliers and packagers for zilretta

zilretta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pacira Pharms Inc	ZILRETTA	triamcinolone acetonide	FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR	208845	NDA	Pacira Pharmaceuticals, Inc.	65250-003-01	1 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01)	2017-10-06

ZILRETTA Supplier Landscape Analysis

Last updated: February 19, 2026

ZILRETTA (triamcinolone acetonide extended-release microspheres) is a non-opioid analgesic used for the management of knee pain due to osteoarthritis. The manufacturing and supply chain for ZILRETTA involves specialized components and services, critical for its sustained release mechanism.

What Are the Key Components of ZILRETTA?

ZILRETTA's formulation relies on specific inactive ingredients that facilitate its extended-release properties. The active pharmaceutical ingredient is triamcinolone acetonide. The extended-release formulation utilizes a biodegradable polymer matrix.

• Active Pharmaceutical Ingredient (API): Triamcinolone acetonide is a corticosteroid.
• Excipients: The proprietary blend of excipients creates the microsphere formulation for extended release. These include biodegradable polymers such as polylactic-co-glycolic acid (PLGA). Other common components in such formulations can include solubilizers and stabilizers, though specific details for ZILRETTA are proprietary.

Who Manufactures ZILRETTA?

ZILRETTA is manufactured by Flexion Therapeutics, Inc. [1]. Flexion Therapeutics oversees the entire product lifecycle, including drug substance manufacturing, formulation, fill-finish operations, and packaging.

• Primary Manufacturer: Flexion Therapeutics, Inc.

What Are the Critical Supply Chain Considerations for ZILRETTA?

The supply chain for ZILRETTA is complex due to its sterile injectable nature and extended-release technology. Key considerations include the sourcing of high-purity raw materials, specialized manufacturing processes, and rigorous quality control.

• Raw Material Sourcing: Reliable suppliers for triamcinolone acetonide and high-quality PLGA are essential. The pharmaceutical grade of these materials must meet stringent regulatory standards.
• Manufacturing Process: The encapsulation of triamcinolone acetonide within PLGA microspheres requires specialized equipment and expertise in controlled-release drug delivery. This process is sensitive to environmental conditions and requires aseptic manufacturing environments.
• Sterile Fill-Finish: The final product is an injectable suspension. Sterile fill-finish operations, conducted under Good Manufacturing Practices (GMP), are critical to ensure product sterility and prevent contamination.
• Packaging and Distribution: Specialized packaging is required to maintain product stability. Cold chain logistics may be necessary depending on storage requirements, though ZILRETTA is typically stored at controlled room temperature.

Which Companies Supply Key Excipients or Raw Materials for ZILRETTA?

Specific suppliers of raw materials for ZILRETTA are generally not publicly disclosed due to proprietary agreements between Flexion Therapeutics and its vendors. However, the industry standard for biodegradable polymers like PLGA used in extended-release injectables is supplied by a limited number of specialized chemical manufacturers.

• PLGA Suppliers: Companies that manufacture pharmaceutical-grade PLGA for injectable drug delivery systems include:
  • Evonik Industries AG
  • Boehringer Ingelheim (through its biopharmaceutical contract manufacturing business)
  • Poly-Med, Inc.
• Triamcinolone Acetonide API Manufacturers: The production of corticosteroid APIs is a specialized area. Global pharmaceutical ingredient manufacturers with strong expertise in steroid synthesis would be potential suppliers. Examples of companies that produce corticosteroid APIs include:
  • Viatris Inc.
  • Sanofi S.A. (through its API manufacturing divisions)
  • Hovione
  • Thermo Fisher Scientific (offering custom API synthesis services)

It is important to note that the selection of an API supplier involves extensive qualification processes to ensure quality, regulatory compliance, and supply chain security.

What Are the Regulatory Requirements for ZILRETTA Manufacturing?

The manufacturing of ZILRETTA must comply with global pharmaceutical regulatory standards, primarily those set by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities.

• Good Manufacturing Practices (GMP): All manufacturing facilities, processes, and quality control systems must adhere to current GMP guidelines [2]. This includes controls for facilities, equipment, personnel, materials, production, and laboratory testing.
• Drug Master Files (DMFs): Suppliers of critical raw materials, such as triamcinolone acetonide and PLGA, typically submit DMFs to regulatory agencies. These confidential documents detail the manufacturing, processing, packaging, and storage of the drug substance. Flexion Therapeutics references these DMFs in its drug applications.
• Process Validation: The manufacturing process for ZILRETTA, including microsphere formation and aseptic filling, undergoes rigorous validation to ensure consistency and reproducibility.
• Quality Control Testing: Each batch of ZILRETTA must pass comprehensive quality control tests, including assays for potency, purity, sterility, particulate matter, and drug release characteristics.

What Are the Packaging and Storage Requirements for ZILRETTA?

ZILRETTA is supplied as a sterile, injectable suspension in single-dose vials. The packaging and storage conditions are designed to maintain product integrity.

• Packaging:
  • Single-dose vials, typically glass.
  • Vials are sealed with stoppers and crimp caps.
  • Secondary packaging includes cartons with product labeling and prescribing information.
• Storage Conditions:
  • Store at 20°C to 25°C (68°F to 77°F) [3].
  • Excursions are permitted between 15°C and 30°C (59°F and 86°F).
  • Protect from light.
  • Do not freeze.

What is the Expected Lifespan or Shelf Life of ZILRETTA?

The shelf life of ZILRETTA is determined through stability studies and approved by regulatory agencies.

• Shelf Life: ZILRETTA has a shelf life of 24 months when stored under recommended conditions [3].

Who Are the Contract Manufacturing Organizations (CMOs) Potentially Involved in ZILRETTA's Supply Chain?

While Flexion Therapeutics manufactures ZILRETTA, large pharmaceutical companies often engage CMOs for specific aspects of their supply chain, such as API synthesis, specialized formulation steps, or sterile fill-finish operations. Identifying specific CMOs for ZILRETTA is challenging without direct disclosure from Flexion Therapeutics. However, companies with expertise in complex sterile injectables and controlled-release formulations are typically considered.

• Potential CMO Capabilities:
  • Sterile Injectable Manufacturing: Companies specializing in aseptic processing, lyophilization, and complex sterile formulations.
  • Microsphere Technology: CMOs with experience in encapsulating APIs into polymer microspheres.
  • Biologics and Small Molecule Manufacturing: Large CMOs capable of handling both API production and finished drug product manufacturing.
• Examples of Large CMOs with Relevant Capabilities:
  • Catalent, Inc.
  • Lonza Group AG
  • Thermo Fisher Scientific (Patheon)
  • Recipharm AB

These organizations provide capacity and specialized expertise that can support pharmaceutical manufacturers.

What Are the Risks Associated with the ZILRETTA Supply Chain?

Risks in pharmaceutical supply chains can impact product availability, quality, and cost. For a product like ZILRETTA, these risks are amplified by its specialized technology and sterile nature.

• Supplier Dependence: Reliance on a limited number of qualified suppliers for critical raw materials (e.g., PLGA, triamcinolone acetonide) creates a risk of disruption if a supplier experiences production issues, quality failures, or regulatory actions.
• Manufacturing Process Complexity: The specialized microsphere encapsulation process requires significant technical expertise and specialized equipment. Any deviation or failure in this process can lead to batch rejection and supply delays.
• Sterility Assurance: Maintaining sterility throughout the manufacturing and packaging process is paramount. Any breach in aseptic conditions can result in product contamination, necessitating recalls and halting production.
• Regulatory Compliance: Changes in GMP regulations, or failure to meet evolving standards, can lead to manufacturing halts or product recalls.
• Geopolitical and Environmental Factors: Global supply chains are vulnerable to disruptions from geopolitical events, trade disputes, natural disasters, and pandemics, which can affect raw material availability and logistics.
• Intellectual Property and Counterfeiting: Protecting the proprietary manufacturing processes and ensuring product integrity against counterfeiting are ongoing concerns for specialized pharmaceuticals.

Key Takeaways

• ZILRETTA's extended-release formulation relies on triamcinolone acetonide and proprietary biodegradable polymers, primarily PLGA.
• Flexion Therapeutics, Inc. is the sole manufacturer of ZILRETTA, managing its supply chain from raw materials to finished product.
• Key supply chain considerations include sourcing high-purity raw materials, specialized microsphere manufacturing, and sterile fill-finish operations under strict GMP compliance.
• While specific suppliers are proprietary, companies like Evonik and Boehringer Ingelheim are major global producers of pharmaceutical-grade PLGA, and various specialized API manufacturers produce corticosteroids.
• The supply chain is subject to rigorous regulatory oversight by agencies such as the FDA and EMA, requiring adherence to GMP and comprehensive quality control.
• Risks include supplier dependence, manufacturing complexity, sterility assurance, and broader geopolitical or environmental disruptions.

Frequently Asked Questions

1. Are there generic versions of ZILRETTA available? As of the latest available information, generic versions of ZILRETTA are not approved or marketed. The proprietary nature of its extended-release formulation and associated patents likely contribute to its market exclusivity.
2. What is the typical scale of ZILRETTA production? Specific production volumes are proprietary. However, the scale would be dictated by market demand, clinical use patterns, and Flexion Therapeutics' commercialization strategy, managed through its internal manufacturing and any potential CMO partnerships.
3. How is the quality of triamcinolone acetonide ensured for ZILRETTA? The quality is ensured through stringent supplier qualification, comprehensive testing of incoming raw materials against pharmacopeial standards and internal specifications, and adherence to GMP throughout the API manufacturing process, often detailed within Drug Master Files referenced by Flexion Therapeutics.
4. What are the implications of a disruption in PLGA supply for ZILRETTA? A disruption in PLGA supply would directly impact Flexion Therapeutics' ability to manufacture ZILRETTA. This could lead to product shortages, necessitating the qualification of alternative suppliers or reformulation, which would require significant regulatory review and revalidation.
5. Does ZILRETTA require cold chain logistics for transport? No, ZILRETTA does not typically require cold chain logistics. It is stored at controlled room temperature (20°C to 25°C with excursions permitted) and protected from light, simplifying its distribution chain compared to biologics or certain vaccines.

Citations

[1] Flexion Therapeutics, Inc. (2023). Investor Relations. Retrieved from [Flexion Therapeutics official website] (Note: Specific URL not provided as it may change. Access via company's investor relations page.)

[2] U.S. Food and Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from [FDA website] (Note: Specific section on pharmaceutical CGMP.)

[3] ZILRETTA Prescribing Information. (2023). Retrieved from [ZILRETTA official website or FDA drug database] (Note: Specific version and URL may vary.)