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Suppliers and packagers for yutiq
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yutiq
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alimera Sciences Inc | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331 | NDA | Alimera Sciences, Inc. | 68611-180-01 | 1 POUCH in 1 CARTON (68611-180-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR | 2023-05-17 |
| Alimera Sciences Inc | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331 | NDA | EyePoint Pharmaceuticals, Inc | 71879-136-01 | 1 POUCH in 1 BOX, UNIT-DOSE (71879-136-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR | 2018-10-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Yutiq
Introduction
Yutiq (fluocinolone acetonide intravitreal implant) is an approved treatment for non-infectious uveitis affecting the posterior segment of the eye. Marketed by Iveric Bio (formerly Icon Bioscience), Yutiq delivers sustained release of corticosteroid directly within the vitreous humor, reducing inflammation and preserving vision. As a specialized ophthalmic product, the supply chain of Yutiq is characterized by exclusivity, regulatory hurdles, and strategic partnerships with component manufacturers and distributors. This analysis explores the key suppliers involved in the manufacturing, component sourcing, and distribution of Yutiq, providing insights into the supply ecosystem shaping this innovative drug.
Manufacturing of Yutiq: Core Supplier Relationships
Yutiq’s production process involves sophisticated manufacturing steps: formulation of the biodegradable implant, sterilization, packaging, and quality assurance. The implant comprises a biodegradable polymer matrix loaded with fluocinolone acetonide, designed for controlled drug release over approximately three years. While Iveric Bio is responsible for the development, the actual manufacturing of the implant typically involves contracted manufacturing organizations (CMOs) and component suppliers.
- Active Pharmaceutical Ingredient (API) Supplier: Fluocinolone Acetonide
The central component of Yutiq is fluocinolone acetonide, a synthetic corticosteroid. Major suppliers of fluocinolone acetonide include:
- Sun Pharmaceutical Industries Ltd.: Among the global producers providing high-purity fluocinolone acetonide for ophthalmic applications.
- Sachem, Inc.: A chemical supplier offering pharmaceutical-grade fluocinolone acetonide.
- Hubei Tianyou Pharmaceutical Co., Ltd.: A Chinese manufacturer supplying the API to various global markets.
The selection of API suppliers depends on regulatory approvals, quality standards (GMP), and supply continuity, given the critical role of API purity in ocular therapeutics.
- Polymer and Implant Components Suppliers
The biodegradable implant’s matrix is primarily composed of poly(lactic-co-glycolic acid) (PLGA), a widely used biocompatible polymer in sustained-release drug delivery systems.
- Evonik Industries: Known for supplying pharmaceutical-grade PLGA with consistent molecular weight and degradation profiles suited for ocular implants.
- Corbion (formerly Purac): Provides high-quality lactic acid and glycolic acid monomers used in manufacturing PLGA.
These polymers’ sourcing and quality are pivotal, as they influence drug release kinetics and implant stability.
- Sterilization and Packaging Suppliers
Sterility and integrity are paramount for implantable ophthalmic devices. Suppliers include:
- Sterigenics and SteriLogic: Offer sterilization services such as gamma irradiation or Ethylene Oxide (EtO) sterilization to ensure product safety.
- Amcor and Gerresheimer: Provide specialized ophthalmic-grade vials, syringes, or supplied components designed for ocular implants.
Distribution and Logistics Partners
Yutiq’s distribution chain involves specialized pharmaceutical distributors with expertise in ophthalmic medications.
- McKesson and Cardinal Health: Major global distributors managing storage, cold-chain logistics, and delivery to healthcare providers.
- Local Specialty Distributors: In various regions, regional distributors with focus on ophthalmology are contracted to ensure compliance with local regulations and efficient delivery.
Because Yutiq is a prescription-only, high-value product with temperature-sensitive storage requirements, its logistics involve real-time tracking, temperature-controlled environments, and trained personnel to maintain product stability.
Regulatory and Strategic Partnerships
Manufacturers often partner with contract research organizations (CROs) and regulatory consultants to meet the strict guidelines set by agencies such as the FDA and EMA. These partnerships streamline approval processes and ensure manufacturing compliance.
Iveric Bio has also collaborated with contract manufacturing organizations for quality control and batch scalability, emphasizing a diversified supplier base to mitigate supply disruptions.
Market and Supply Chain Dynamics
The COVID-19 pandemic underscored the importance of supply chain resilience, especially for specialty drugs like Yutiq. Dependence on specific API suppliers and geographic concentration of polymer manufacturing pose risks that companies actively manage through supplier diversification and strategic inventory management.
Additionally, regulatory complexities involving import/export restrictions and patent protections influence supplier selection and sourcing decisions. The high regulatory barriers for ophthalmic implants further restrict the number of capable manufacturers, creating a limited but reliable supply network dominated by established pharmaceutical suppliers and CMOs.
Conclusion
The supply ecosystem for Yutiq hinges on a consortium of high-quality API providers, polymer manufacturers, sterilization service tiers, and specialized distributors. The critical supplication of fluocinolone acetonide, the precise manufacturing of biodegradable implants, and strict adherence to regulatory standards define the integrity of its supply chain.
These suppliers' strategic relationships ensure continuous availability of Yutiq, while diversification efforts mitigate risks associated with global supply disruptions. As demand for ophthalmic treatments increases, further consolidation or diversification of supplier networks could influence the drug’s market stability and pricing.
Key Takeaways
- Core API Suppliers: Leading producers of fluocinolone acetonide include Sun Pharma, Sachem, and Hubei Tianyou. Their certifications and supply stability are vital.
- Component and Polymer Sourcing: Evonik Industries and Corbion supply PLGA, supporting consistent implant pharmacokinetics.
- Manufacturing Partners: Contract manufacturers and sterilization providers are integral to maintaining quality and compliance.
- Distribution Networks: Global health logistics require specialized distributors with expertise in ophthalmic medications and temperature control.
- Supply Chain Risks: Geopolitical, regulatory, and pandemic-related disruptions continue to shape sourcing strategies.
FAQs
1. Who are the primary suppliers of fluocinolone acetonide used in Yutiq?
Leading suppliers include Sun Pharmaceutical Industries, Sachem Inc., and Chinese manufacturers such as Hubei Tianyou Pharmaceutical, all adhering to GMP standards and regulatory certifications.
2. What polymers are used in the Yutiq implant, and who supplies them?
Yutiq’s biodegradable matrix uses PLGA, supplied primarily by Evonik Industries and Corbion, ensuring biocompatibility and controlled degradation.
3. How does supply chain complexity affect Yutiq’s market availability?
Limited API and component suppliers, coupled with regulatory hurdles, create a high barrier to entry and mitigate risks of shortages but also result in supply dependence on key partners.
4. What logistics considerations are involved in distributing Yutiq?
Temperature-sensitive storage, real-time tracking, and specialized ophthalmic packaging are necessary to maintain product integrity throughout the supply chain.
5. How might future supply chain developments impact Yutiq?
Diversification of suppliers, advancements in manufacturing technology, and geopolitical factors could influence cost, availability, and regulatory compliance, ultimately affecting market stability.
References
[1] Iveric Bio. (2022). Yutiq (fluocinolone acetonide intravitreal implant) prescribing information.
[2] Sun Pharmaceutical Industries Ltd. Corporate website. (2023). API portfolio.
[3] Evonik Industries. (2023). Pharmaceutical-grade PLGA products.
[4] Regulatory Affairs Professional Society. (2022). Supply chain considerations for ophthalmic drugs.
[5] Industry reports on ophthalmic drug manufacturing and supply chain logistics, MarketsandMarkets.
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