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Suppliers and packagers for cystadrops
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cystadrops
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | CYSTADROPS | cysteamine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 211302 | NDA | RECORDATI RARE DISEASES, INC. | 55292-410-05 | 1 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS | 2020-08-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cystadrops
Introduction
Cystadrops, a pivotal therapeutic agent used predominantly in ophthalmology, specifically addresses the management of corneal epithelial erosions associated with deficient or unstable tear film conditions such as the Reiss-Bundgaard syndrome and several other ocular surface disorders. Marketed primarily as a preservative-free, hyaluronic acid-based eye drop, Cystadrops enhances corneal healing, alleviates discomfort, and stabilizes the ocular surface.
A thorough understanding of the suppliers involved in the manufacturing and distribution of Cystadrops is vital for stakeholders across pharmaceutical, healthcare, and supply chain sectors. This report provides a comprehensive overview of current suppliers, manufacturing players, and key distribution channels involved in Cystadrops' global supply chain.
1. Manufacturer Overview
Dompé Pharmaceutical Company
The primary producer of Cystadrops is Dompé, an Italian biopharmaceutical company with a global footprint. Established in 2000, Dompé specializes in innovative therapies for ophthalmology, dermatology, and rare diseases. The company holds the manufacturing rights and is responsible for the formulation, quality control, and overall production of Cystadrops.
Manufacturing Facilities and Capabilities
Dompé operates manufacturing facilities strategically located in Italy, equipped with state-of-the-art technology for aseptic production of ophthalmic solutions. Their facilities adhere to Good Manufacturing Practices (GMP) standards, ensuring high-quality output suitable for international markets.
2. Raw Material Suppliers
The production of Cystadrops relies heavily on high-quality raw materials, notably hyaluronic acid and preservative-free bottles.
a. Hyaluronic Acid Suppliers
Hyaluronic acid (HA) is the core component providing viscoelastic properties to Cystadrops. Key suppliers include:
- Contipro a.s. (Czech Republic): A leading producer of pharmaceutical-grade HA, supplying high-purity, biofermented HA used in ophthalmic products.
- Novozymes (Denmark): Engaged in producing bioengineered HA, ensuring consistent quality for pharmaceutical applications.
- Fauchier Group (France): Supplies medical-grade HA with certifications suitable for ocular formulations.
b. Packaging Material Suppliers
The preservative-free bottles used in Cystadrops typically originate from specialized packaging manufacturers that meet strict sterility standards:
- Corning Incorporated: Supplies borosilicate glass vials designed for ophthalmic use.
- Nipro Corporation: Manufactures ophthalmic-specific, preservative-free plastic bottles with precise droplet dosing features.
3. Contract Manufacturers and Outsourcing
In addition to Dompé's internal manufacturing, certain components and production stages are outsourced:
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Third-party Contract Manufacturing Organizations (CMOs)
Major CMOs specializing in sterile ophthalmic product manufacturing include:
- Stada Arzneimittel AG (Germany): Provides fill-finish services, particularly for sterile ophthalmic solutions.
- SPM Pharmaceuticals (USA): Offers manufacturing and packaging services complying with international standards.
These partnerships support scalability and ensure regulatory compliance across various markets.
4. Distribution Channels and Logistics
Distribution of Cystadrops spans multiple regions. Key distributors include:
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Pharmaceutical Distributors
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McKesson Corporation (USA): A primary distributor in the North American market.
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Phoenix UK Ltd. (UK): Distributes within European markets.
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Direct Supply Agreements
Dompé often maintains direct supply contracts with large hospital chains and ophthalmology clinics to facilitate immediate availability.
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Specialized Ophthalmic Distributors
Companies like Alcon and Johnson & Johnson sometimes engage in distribution partnerships for ophthalmic products, although Cystadrops remains primarily distributed through Dompé's direct relationships.
5. Regional Market Variability
While Dompé maintains control over production, regional regulatory approvals influence local supplier networks. For example:
- In the European Union, the approval by EMA (European Medicines Agency) simplifies procurement.
- In the US, FDA approval and importation protocols influence distribution channels.
- Emerging markets rely extensively on regional importers and authorized distributors, often sourced through partnerships with global logistics providers.
6. Key Challenges and Strategic Considerations
- Supply Chain Resilience: Disruptions in raw material supply, such as hyaluronic acid shortages, can impact production capacity. Strategic stockpiling and diversified sourcing mitigate risks.
- Regulatory Variability: Navigating regional approval processes influences supplier and distributor selection.
- Quality Assurance: Maintaining high GMP standards across all suppliers ensures product consistency and safety.
7. Future Opportunities and Market Dynamics
The increasing prevalence of dry eye syndrome and ocular surface disorders amplifies demand for Cystadrops, prompting suppliers to consider scaling manufacturing capacities. Innovations in biopolymer sourcing, packaging technology, and distribution networks could further optimize the supply chain.
Key Takeaways
- Major Manufacturer: Dompé holds primary responsibility for Cystadrops production, sourcing raw materials like biofermented hyaluronic acid from specialized suppliers.
- Raw Material Suppliers: Contipro and Novozymes are key providers of ophthalmic-grade hyaluronic acid, crucial for formulation efficacy.
- Packaging Suppliers: Corning and Nipro supply sterile, preservative-free containers integral to maintaining product integrity.
- Outsourcing & Logistics: CMOs like Stada and SPM Pharmaceuticals support manufacturing scalability; distribution is managed through strategic partnerships and regional authorized distributors.
- Supply Chain Vulnerabilities: Raw material shortages and regulatory delays necessitate diversified sourcing and strategic planning to ensure continuous availability.
FAQs
1. Who are the main manufacturers and suppliers of Cystadrops?
Dompé exclusively manufactures Cystadrops, sourcing key raw materials like hyaluronic acid from suppliers such as Contipro and Novozymes. Packaging components are provided by Corning and Nipro.
2. Can new suppliers enter the Cystadrops supply chain?
Yes. Although Dompé maintains exclusive manufacturing rights, alternative suppliers can be approved through regulatory processes, especially for raw materials like hyaluronic acid. Supplier qualification and regulatory compliance are critical.
3. What are the risks associated with the Cystadrops supply chain?
Risks include raw material shortages, manufacturing disruptions, regulatory delays, and logistical challenges. Strategic diversification and robust quality management are vital to mitigate these risks.
4. Are there regional differences in Cystadrops suppliers?
Yes. Distribution channels vary largely due to regional regulatory approvals, leading to localized partnerships with distributors in North America, Europe, and emerging markets.
5. How is the supply chain evolving with increasing demand?
Scaling production capacities, innovation in sourcing, and enhanced distribution networks are key focus areas. Dompé might expand manufacturing facilities or form new partnerships to meet growing global demand.
References
- Dompé Group Official Website.
- European Medicines Agency (EMA). Cystadrops approval documentation.
- Contipro a.s. Product datasheets.
- Novozymes Annual Report.
- Industry reports on ophthalmic supply chain management.
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