Suppliers and packagers for tekturna

tekturna

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-141-30	30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)	2019-03-04
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-142-30	30 TABLET, FILM COATED in 1 BOTTLE (66993-142-30)	2019-03-04
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985	NDA	LXO US Inc.	70839-150-30	30 TABLET, FILM COATED in 1 BOTTLE (70839-150-30)	2007-03-05

Suppliers for the Pharmaceutical Drug: TEKTURNA

Last updated: July 30, 2025

Introduction

TEKTURNA is the commercial name for tafasitamab-cxix, a monoclonal antibody developed by MorphoSys (company) in partnership with Incyte Corporation (co-development and commercialization). It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients. Understanding the supplier landscape for TEKTURNA is essential for stakeholders involved in procurement, distribution, and manufacturing within the pharmaceutical supply chain.

Manufacturers and Supply Chain Structure

The primary manufacturer responsible for the production of TEKTURNA is MorphoSys, leveraging its proprietary antibody technology platform. As of the drug's approval in 2020, MorphoSys's manufacturing facilities in Germany and partnerships with contract manufacturing organizations (CMOs) play a pivotal role in the supply chain. Incyte collaborates extensively for global commercialization, but the manufacturing and distribution channels of the drug are predominantly managed by MorphoSys’s manufacturing operations.

Key Suppliers in the TEKTURNA Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

   TEKTURNA’s efficacy hinges on the production of tafasitamab, the monoclonal antibody’s active component. Although MorphoSys develops and controls the production, the sourcing of raw materials such as cell culture media, bioreactors, and other bioprocessing components involves specialized raw material suppliers. Key raw materials include:

   • Cell culture media and supplements: Suppliers such as Lonza, Thermo Fisher Scientific, and GE Healthcare provide high-quality media for monoclonal antibody production.
   • Bioreactors and filtration systems: Companies like Sartorius and MilliporeSigma supply equipment used in bioprocessing.

2. Bioprocessing and Manufacturing CMOs

   MorphoSys partners with contract manufacturing organizations (CMOs) to produce tafasitamab at scale. These CMOs are responsible for the large-scale fermentation, purification, formulation, and fill-finish processes. Known CMOs involved include:

   • Samsung Biologics: One of the key suppliers for biologics manufacturing, with capacity for large-scale monoclonal antibody production.
   • Cytiva (formerly GE Healthcare Life Sciences): Supplies bioprocessing equipment, chromatography resins, and filtration systems essential for manufacturing.

3. Fill-Finish and Packaging Suppliers

   Final drug product assembly is carried out by specialized facilities that package TEKTURNA into vials for distribution. Companies involved include:

   • Rentschler Biopharma AG: Provides fill-finish manufacturing services with expertise in sterile filling of monoclonal antibody products.
   • Subcontracted packaging firms: Various regional packaging providers that adapt to regulatory standards for pharmaceuticals.

4. Distribution and Cold Chain Logistics

   Due to its biological nature, TEKTURNA requires temperature-controlled logistics. Major logistics providers include:

   • DHL Healthcare: Provides temperature-sensitive shipping solutions for biologics.
   • FedEx Express: Offers cold chain logistics, especially for international distribution.

   These logistics partners ensure the drug remains within required temperature ranges during transit, typically refrigerated at 2°C to 8°C.

5. Regulatory and Quality Control Suppliers

   Ensuring quality compliance involves sourcing from suppliers of critical reagents for testing, quality control (QC), and validation. These include:

   • IDEXX Laboratories: Supplies microbiological testing kits.
   • Bio-Rad Laboratories: Provides reagents and instruments for assay development.

Global Manufacturing Footprint and Supply Risks

MorphoSys’s partnership with CMOs like Samsung Biologics helps mitigate supply risks, providing access to advanced manufacturing capacities. However, reliance on a limited number of manufacturing sites poses potential vulnerabilities, including disruptions from geopolitical events, pandemics, or production downtimes. To counter these, supply chain diversification is ongoing, with MorphoSys expanding to additional CMOs and regional manufacturing hubs in Europe and Asia.

Supply Chain Challenges and Strategic Implications

• Scale-up and capacity constraints: Monoclonal antibody production is complex, with capacity constraints affecting supply during peak demand.
• Regulatory compliance: Suppliers must meet stringent Good Manufacturing Practice (GMP) standards, impacting sourcing options and timelines.
• Cold chain logistics: Maintaining temperature stability from manufacturing to patient requires robust logistics, elevating costs and complexity.
• Raw material shortages: Fluctuations in demand for raw materials, such as chromatography resins or cell culture media, can introduce supply bottlenecks.

Industry Trends and Future Perspectives

The biopharmaceutical industry increasingly leverages Digital Manufacturing, real-time analytics, and supply chain analytics to enhance supply chain robustness. For TEKTURNA, this means potential integration of supply chain visibility tools, predictive analytics for demand forecasting, and increased investment in regional manufacturing plants.

Conclusion

The supply landscape for TEKTURNA revolves around MorphoSys’s proprietary manufacturing network, supplemented by strategic partnerships with CMOs like Samsung Biologics. Raw material suppliers, contract manufacturers, logistic providers, and quality assurance entities form an integrated network ensuring the drug’s availability. As the demand for monoclonal antibodies grows, supply chain resilience, diversification, and technological innovation remain paramount for uninterrupted access.

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Key Takeaways

• Manufacturing control: MorphoSys oversees the production of TEKTURNA, relying heavily on CMOs for large-scale manufacturing.
• Critical raw materials: Suppliers of cell culture media, bioreactors, and chromatography resins are vital for antibody production.
• Global logistics: Cold chain logistics providers ensure temperature-sensitive distribution, crucial for maintaining drug efficacy.
• Supply chain risks: Capacity limitations and geopolitical factors pose potential disruptions, necessitating diversification.
• Future outlook: Embracing digital supply chain solutions will enhance resilience and forecasting accuracy.

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FAQs

1. Who are the primary manufacturers of TEKTURNA?
MorphoSys is the main manufacturer, working with contract manufacturing organizations such as Samsung Biologics to produce tafasitamab at commercial scale.

2. What raw materials are essential for TEKTURNA production?
Cell culture media, bioreactors, chromatography resins, filtration supplies, and packaging components are key raw materials sourced from specialized suppliers.

3. How is TEKTURNA transported while maintaining its efficacy?
It is transported via temperature-controlled cold chain logistics, primarily using refrigerated shipping services from providers like DHL Healthcare and FedEx.

4. Are there risks associated with the current supply chain?
Yes, reliance on a limited number of manufacturing sites, raw material availability, and cold chain logistics pose risks that could impact drug availability.

5. Is the supply chain for TEKTURNA expected to evolve?
Indeed, ongoing efforts include expanding manufacturing capacity, diversifying suppliers, and integrating digital tools to improve supply resilience.

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References

[1] FDA. (2020). TAFRESTO (tafatasimab-cxix) Injection, for Intravenous Injection. Food and Drug Administration.
[2] MorphoSys. (2023). TAFSTROTE Overview.
[3] Samsung Biologics. (2023). Biologics Manufacturing Services.
[4] DHL Healthcare. (2023). Cold Chain Logistics Solutions.
[5] Incyte. (2023). Partnership with MorphoSys for Tafasitamab Development.