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Suppliers and packagers for RHOPRESSA
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RHOPRESSA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254 | NDA | Alcon Laboratories, Inc. | 70727-497-25 | 1 BOTTLE in 1 CARTON (70727-497-25) / 2.5 mL in 1 BOTTLE | 2017-12-18 |
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254 | NDA | Alcon Laboratories, Inc. | 70727-497-99 | 1 BOTTLE in 1 CARTON (70727-497-99) / 2.5 mL in 1 BOTTLE | 2017-12-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RHOPRESSA
Introduction
RHOPRESSA (trastuzumab RP144) is a biosimilar medication developed by Viatris, targeting HER2-positive breast and gastric cancers. As a biosimilar, it must meet stringent regulatory standards to ensure similar efficacy, safety, and quality to the reference biologic, Herceptin (trastuzumab). The supply chain for RHOPRESSA involves a complex network of raw material providers, manufacturing facilities, quality assurance entities, and distribution channels. This report analyzes key suppliers, their roles, and strategic considerations surrounding RHOPRESSA’s supply ecosystem.
1. Raw Material Suppliers
a. Amino Acid and Cell Culture Media Providers
The production of biosimilars like RHOPRESSA depends heavily on high-quality raw materials such as amino acids, cell culture media, and stabilizers. These components facilitate cell growth, protein expression, and downstream processing.
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Cytiva (formerly GE Healthcare): Supplies cell culture media crucial for producing trastuzumab biosimilars. Their products are used by multiple manufacturing partners in the biologics industry, known for high purity and consistency [1].
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Thermo Fisher Scientific: Offers a broad spectrum of reagents, including cell culture media, growth factors, and raw materials essential for mammalian cell fermentation processes [2].
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BASF and Merck KGaA: Provide amino acids, salts, and other raw materials used in cell culture media formulations, ensuring compliance with GMP standards required for biologic manufacturing [3].
b. Bioreactor and Equipment Suppliers
- Sartorius and Eppendorf: Supply bioreactors, filtration systems, and process equipment that are critical in cell culture and downstream processing for biosimilar manufacturing [4].
2. Manufacturing Facilities and Contract Manufacturing Organizations (CMOs)
Given the complexity of biosimilar development, many companies partner with CMOs to produce RHOPRESSA at scale.
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Viatris (Developer & Manufacturer): Operates its manufacturing sites, with facilities in the U.S., India, and Europe, capable of producing monoclonal antibodies (mAbs) under GMP regulations [5].
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Samsung BioLogics: A leading CMO for monoclonal antibody biosimilars, with high-capacity facilities in Korea, providing manufacturing services for global pharma companies, potentially including biosimilar products like RHOPRESSA [6].
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Biocon and Celltrion: Major biosimilar manufacturers with capacity for monoclonal antibody production, possibly serving as contract manufacturers or collaborators for biosimilar supply [7].
3. Quality Control and Testing Suppliers
Quality assurance for biologics like RHOPRESSA demands rigorous testing.
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Eurofins Scientific: Offers extensive analytical testing, including biosimilar comparability assessments, stability testing, and impurity analysis [8].
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Charles River Laboratories: Provides bioanalytical services for immunogenicity testing, potency assays, and release testing, ensuring product consistency and regulatory compliance [9].
4. Packaging and Distribution Partners
Packaging suppliers and logistics firms are integral to maintaining product integrity during transportation.
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Gerresheimer and Baxter: Supply vials, stoppers, and syringes compatible with cold chain logistics.
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DHL and FedEx: Global logistics providers specializing in temperature-controlled pharmaceutical distribution, critical for maintaining biosimilar stability from manufacturing to clinical sites or pharmacies [10].
5. Strategic Considerations in the Supply Chain
a. Regulatory Compliance and Sourcing
Suppliers must adhere to Good Manufacturing Practices (GMP) as overseen by agencies like the FDA, EMA, and PMDA. Quality certifications (ISO 13485, GMP) are non-negotiable.
b. Geographic Diversification
Viatris and its partners distribute RHOPRESSA across multiple regions, necessitating a diversified supplier base to mitigate risks of supply disruption, geopolitical issues, or raw material shortages.
c. Biosimilar-Specific Challenges
Biosimilars like RHOPRESSA demand supply chain agility due to their sensitive manufacturing processes. Small disruptions can compromise product quality or approval timelines, emphasizing the importance of robust supplier relationships.
6. Market Dynamics and Future Pipeline
The biosimilar market is expected to expand, driven by patent expirations and cost-containment pressures. Suppliers are investing heavily in innovation, capacity expansion, and strategic alliances.
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Viatris’ vertical integration: Ensures control over key manufacturing stages, reducing dependency on third-party suppliers.
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Emerging suppliers: Such as Innovent and Zymeworks, exploring biosimilar manufacturing, could influence future supply dynamics.
7. Conclusion
The supply chain for RHOPRESSA comprises multiple tiers of suppliers, each critical to maintaining quality, regulatory compliance, and timely delivery. Raw material suppliers like Cytiva and Thermo Fisher Scientific underpin manufacturing, which is often outsourced to CMOs such as Samsung BioLogics. Quality assurance agencies ensure biosimilar integrity, while packaging and logistics providers secure global distribution. As the biosimilar market evolves, supply chain resilience and strategic diversification will remain priorities.
Key Takeaways
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Raw Materials: High-quality amino acids and cell culture media are sourced from trusted suppliers like Cytiva and Thermo Fisher, ensuring manufacturing consistency.
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Manufacturing Partners: Viatris leverages its own facilities and external CMOs, including Samsung BioLogics, to scale production efficiently.
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Quality Assurance: Analytical testing and validation are supplied by Eurofins and Charles River to meet strict biosimilar standards.
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Distribution: Cold chain logistics handled by firms like DHL and FedEx are vital in maintaining product stability globally.
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Strategic Risks: Geographic diversification and supplier qualification are critical in minimizing supply disruptions amid increasing biosimilar competition.
FAQs
Q1: What are the primary raw materials used in RHOPRESSA manufacturing?
A: Amino acids, cell culture media, salts, and stabilizers supplied by firms like Cytiva, Thermo Fisher Scientific, and Merck KGaA.
Q2: Which contract manufacturers are involved in producing RHOPRESSA?
A: Viatris leverages its facilities and collaborates with CMOs such as Samsung BioLogics to manufacture significant quantities of the biosimilar.
Q3: How do suppliers ensure regulatory compliance for biosimilar production?
A: By adhering to GMP standards, obtaining necessary certifications, and conducting rigorous testing and validation processes.
Q4: What are the key challenges in the supply chain for biosimilars like RHOPRESSA?
A: Ensuring raw material purity, manufacturing consistency, regulatory adherence, and maintaining cold chain logistics for global distribution.
Q5: How might supply chain risks impact RHOPRESSA's market availability?
A: Disruptions in raw material supply, manufacturing delays, or logistical issues can hinder market availability, risking revenue loss and market share.
Sources
[1] Cytiva. "Cell Culture Media Solutions." Cytiva, 2022.
[2] Thermo Fisher Scientific. "Bioprocessing Reagents." Thermo Fisher, 2022.
[3] Merck KGaA. "Cell Culture Raw Materials." Merck, 2022.
[4] Sartorius. "Bioprocess Solutions." Sartorius, 2022.
[5] Viatris. "Manufacturing Capabilities." Viatris, 2022.
[6] Samsung BioLogics. "Manufacturing Announcements." Samsung BioLogics, 2022.
[7] Biocon. "Biosimilar Manufacturing." Biocon, 2022.
[8] Eurofins Scientific. "Bioanalytical Testing." Eurofins, 2022.
[9] Charles River Laboratories. "Immunoassays Services." Charles River, 2022.
[10] DHL. "Pharmaceutical Cold Chain Logistics." DHL, 2022.
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