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Suppliers and packagers for zilretta
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZILRETTA
Introduction
ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is a corticosteroid formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of osteoarthritis-related joint pain in the knee. Its unique extended-release mechanism offers sustained symptom relief, positioning it as a significant therapeutic option in intra-articular corticosteroid therapy. The supply chain for ZILRETTA involves multiple stakeholders, from raw material providers to manufacturing affiliates, ensuring consistent production and distribution. This article provides a comprehensive analysis of the key suppliers involved in the production process and the strategic considerations impacting their roles in the ZILRETTA supply chain.
Overview of ZILRETTA Supply Chain
The manufacturing and distribution of ZILRETTA hinge upon a complex network of suppliers supplying raw ingredients, excipients, and specialized delivery systems necessary for formulation. Abbott Laboratories developed ZILRETTA through its pharmaceutical subsidiary, AbbVie, leveraging advanced pharmaceutical manufacturing capabilities. The supply chain encompasses raw material suppliers for active pharmaceutical ingredients (APIs) and excipients, formulation specialists, manufacturing facilities adhering to Good Manufacturing Practices (GMP), and distribution channels ensuring timely delivery to healthcare providers.
Raw Material Suppliers
Active Pharmaceutical Ingredient (API) Supplier
The core active component of ZILRETTA, triamcinolone acetonide, is a synthetic corticosteroid. The key to its efficacy and safety profile lies in its purity and consistency. Major suppliers of triamcinolone acetonide include global pharmaceutical ingredients producers such as:
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Casda Chemical Co., Ltd. (China): One of the prominent manufacturers of corticosteroid APIs, supplying triamcinolone acetonide globally. Their manufacturing facilities adhere to international GMP standards.
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Northeast Pharmaceutical Group Co., Ltd. (China): Known for producing high-quality corticosteroid APIs, including triamcinolone derivatives, with significant export volume.
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Fagron GmbH & Co. KG (Germany): Offers specialty corticosteroid APIs tailored for injectable formulations, with strict quality controls.
Excipients and Carriers
ZILRETTA’s extended-release formulation relies on biodegradable microspheres composed of poly(lactic-co-glycolic acid) (PLGA). Suppliers for these components include:
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Evonik Industries (Germany): Provides pharmaceutical-grade PLGA polymers used in microsphere manufacturing.
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Iwaki Glass Co., Ltd. (Japan): Supplies biocompatible glass and polymeric excipients used in drug delivery systems.
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BASF SE (Germany): Offers various excipients, including stabilizers and surfactants used during formulation.
Formulation and Manufacturing Partners
AbbVie collaborates with specialized pharmaceutical manufacturing facilities capable of producing the sustained-release microspheres under GMP conditions. These facilities are often accredited by global regulatory agencies, including the FDA, EMA, and PIC/S standards. Strategic partnerships ensure capacity scalability and regulatory compliance.
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Manufacturing Facilities
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AbbVie's own facilities: The primary manufacturing site for ZILRETTA production is located in the United States, incorporating sophisticated aseptic processing units.
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Contract Manufacturing Organizations (CMOs): Several CMOs partner with AbbVie for microsphere formulation, including companies with expertise in controlled-release injectables, such as Patheon (a part of Thermo Fisher Scientific) and Samsung Biologics.
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Supply Chain Challenges and Considerations
The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, particularly concerning API availability and manufacturing bottlenecks. For ZILRETTA, manufacturing relies heavily on the stable supply of high-quality corticosteroid APIs and biocompatible polymers. Disruptions in key countries like China and India, which dominate corticosteroid API production, can impact global supply and pricing.
Additionally, the specialized nature of microsphere manufacturing induces dependency on advanced contract manufacturers with capable infrastructure. Quality assurance and regulatory adherence are paramount, complicating procurement and scaling efforts.
Distribution and Logistics
Post-manufacturing, ZILRETTA's distribution involves cold chain logistics, given its sensitivity to temperature fluctuations. Distribution partners work within regulated frameworks to ensure product integrity from manufacturing facilities to healthcare providers. Major distribution partners include:
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McKesson Corporation and AmerisourceBergen: Leading pharmaceutical distributors managing inventory, storage, and delivery.
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AbbVie's own logistics team: Overseeing supply chain management, ensuring compliance with regulatory standards.
Strategic Initiatives and Supplier Development
To mitigate risks, AbbVie employs multiple sourcing strategies, including dual sourcing of APIs and polymers, maintaining safety stocks, and engaging with local manufacturers in different regions. Investing in supply chain resilience has become increasingly vital to avoid shortages and meet rising demand.
Regulatory and Ethical Compliance
Suppliers across the supply chain must adhere to strict GMP standards, with regular audits by regulatory authorities. Transparency in sourcing and quality controls, including Certificate of Analysis (CoA) documentation, underpins confidence in the supply chain for ZILRETTA.
Conclusion
The supply of ZILRETTA depends on a diverse network of suppliers providing high-quality corticosteroid APIs, biodegradable polymers, and excipients. Strategic integration of raw material sourcing, robust manufacturing partnerships, and efficient distribution channels underpin the drug’s global availability. As market demand grows, supply chain resilience and diversification remain critical to avoid disruptions and uphold manufacturing standards.
Key Takeaways
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The primary API supplier for ZILRETTA is typically sourced from established corticosteroid manufacturers in China and Europe, emphasizing the importance of supply chain diversification.
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Biodegradable polymer suppliers like Evonik provide crucial components for the extended-release microsphere formulation, highlighting specialized vendor relationships.
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Strategic manufacturing partnerships with CMOs enhance scalability and compliance, crucial amid global supply chain disruptions.
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Cold chain logistics are integral to maintaining ZILRETTA’s stability during distribution, requiring meticulous logistics planning.
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Ongoing supplier development and quality assurance are vital for mitigating risks associated with API shortages and regulatory compliance.
FAQs
1. Who are the main raw material suppliers for ZILRETTA?
The core raw materials, such as triamcinolone acetonide, are predominantly supplied by pharmaceutical-grade API manufacturers in China, Europe, and North America, including companies like Casda Chemical and Northeast Pharmaceutical Group. Biodegradable polymers like PLGA are supplied by Evonik Industries and BASF.
2. Are there risks associated with ZILRETTA’s supply chain?
Yes. Reliance on API producers in high-volume manufacturing countries poses risks related to geopolitical issues, supply disruptions due to pandemics, and regulatory changes. Dependence on specialized contract manufacturers also introduces vulnerabilities in capacity and quality assurance.
3. How does AbbVie ensure the quality of ZILRETTA’s raw materials?
AbbVie enforces strict supplier qualification processes, audits, and requires Certificates of Analysis (CoA). They adhere to GMP standards and maintain comprehensive quality management systems to assure raw material integrity.
4. What logistical considerations are involved in distributing ZILRETTA?
ZILRETTA requires cold chain logistics due to temperature sensitivity. Distribution partners like McKesson manage storage, transportation, and delivery within regulated environments, ensuring product stability upon reaching healthcare providers.
5. Are there any emerging suppliers or alternatives for ZILRETTA components?
As the demand for controlled-release corticosteroid formulations grows, efforts are underway to diversify supplier pools for APIs and polymers. Innovations in biodegradable polymers and regional manufacturing initiatives aim to bolster supply resilience.
Sources
[1] FDA. ZILRETTA (triamcinolone acetonide extended-release injectable suspension) approval details.
[2] AbbVie. Official ZILRETTA product information.
[3] Global trade and pharmaceutical raw material reports.
[4] Industry reports on corticosteroid API production.
[5] GxP compliance and pharmaceutical manufacturing standards publications.
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