Suppliers and packagers for generic pharmaceutical drug: plerixafor

plerixafor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311	NDA	Sanofi-Aventis U.S. LLC	0024-5862-01	1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE	2013-09-01
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311	NDA AUTHORIZED GENERIC	Fresenius Kabi Usa, LLC	65219-284-12	1 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USE	2023-06-22
Amneal	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	215334	ANDA	Amneal Pharmaceuticals LLC	70121-1694-2	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1694-2) / 1.2 mL in 1 VIAL, SINGLE-DOSE	2023-07-25

Suppliers for the Pharmaceutical Drug: Plerixafor

Last updated: July 28, 2025

Introduction
Plerixafor, marketed under the brand name Mozobil, is a critical pharmaceutical agent used predominantly in stem cell mobilization for hematopoietic stem cell transplantation. Its mechanism targets the CXCR4 receptor, disrupting the CXCL12-CXCR4 interaction, thereby facilitating the release of stem cells from the bone marrow into peripheral blood. The drug's importance in oncology and hematology has elevated its demand globally, influencing the supply chain dynamics significantly. This report explores the key suppliers, manufacturing landscape, and market influences shaping the availability of plerixafor.

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Manufacturers of Plerixafor
The initial and primary supplier of plerixafor originated from Genentech (a Roche subsidiary), which developed the drug through extensive clinical research and obtained regulatory approvals globally. Genentech/Roche remains the principal manufacturer with exclusive rights until the introduction of generic competitors.

• Genentech/Roche: As the original developer, Roche has maintained manufacturing capacity at its facilities, ensuring a consistent supply of Mozobil for regions where it has regulatory approval. Roche's global distribution network supports supply chains across North America, Europe, and select Asian markets.

• The Other Patent Holders and Licensees: Though Roche's exclusive rights have been prominent, other pharmaceutical entities, either through licensing agreements or regional partnerships, have engaged in downstream distribution or manufacturing processes, especially in emerging markets.

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Generic Manufacturers and Market Entry
Following patent expiration or litigation rulings, generic manufacturers began producing plerixafor to meet rising demand and lower costs.

• Teva Pharmaceutical Industries: As a leading global generic drug producer, Teva has secured rights to produce generic versions of plerixafor in various jurisdictions, notably in the United States and Europe. Teva’s manufacturing facilities adhere to stringent regulatory standards, ensuring biosimilar quality and supply resilience.

• Intas Pharmaceuticals: Based in India, Intas has developed its own formulation of plerixafor, targeting emerging markets with cost-effective options. Their production facilities are certified by agencies such as the US FDA and EMA, enabling broader distribution.

• Sandoz (Novartis): Sandoz has announced plans to manufacture biosimilar or generic equivalents, leveraging its extensive biosimilar production expertise, although specific approvals remain pending in many regions.

• Other Regional Suppliers: Smaller players in countries like China, South Korea, and Latin America have also entered the market, focusing on regional supply, often through licensing agreements with patent holders or independent biosimilar development.

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Supply Chain Factors and Challenges

Manufacturing Complexity
Plerixafor’s synthesis involves intricate biotechnological processes typical of peptide-based or biologic drugs. The manufacturing involves complex cell culture, purification, and formulation steps, necessitating advanced biopharmaceutical facilities. This complexity limits the number of qualified producers, which can lead to supply bottlenecks.

Regulatory Approvals
Manufacturers must obtain regulatory approval through agencies like the FDA, EMA, and other regional bodies. Supply continuity depends heavily on successful approval processes, which can cause delays, especially for biosimilars or generics in territories with stringent regulatory standards.

Global Supply Dynamics
Supply chain disruptions caused by geopolitical tensions, pandemics (notably COVID-19), and raw material shortages have affected product availability. Manufacturers with diversified manufacturing bases mitigate these risks more effectively.

Pricing and Market Competition
Patent expiration in 2018 opened the market to generics, leading to price erosion. Price competition influences profit margins and, consequently, the capacity of smaller manufacturers to sustain production levels.

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Distribution and Regional Availability
The primary supplier dynamics indicate a concentration of manufacturing efforts primarily in North America, Europe, and Asia. Developed markets tend to rely on original brand supplies (Roche), while emerging markets increasingly depend on biosimilars from regional manufacturers.

Supply Security
Large pharmaceutical companies like Roche provide supply security through comprehensive infrastructure, but they also face challenges in scaling rapid demand spikes. Generics companies, while cost-effective, sometimes face manufacturing delays due to limited capacity or regulatory hiccups.

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Future Trends and Market Outlook

• Increase in Biosimilar Production: As more biosimilars get approved, supply will likely become more diversified, reducing dependency on a single manufacturer.

• Expanding Regional Manufacturing: Growing investments in biopharmaceutical manufacturing in Asia and Latin America will improve regional availability, potentially lowering costs and increasing resilience.

• Regulatory Harmonization: Efforts to streamline approval processes for biosimilars globally can accelerate market entry, diversifying supply sources.

• Supply Chain Innovation: Adoption of advanced manufacturing techniques, such as continuous manufacturing, may enhance production capacity, reducing shortages.

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Key Takeaways

• Roche remains the primary global supplier of branded plerixafor (Mozobil), leveraging its extensive manufacturing and distribution network.
• The market has seen entry from several generic manufacturers, including Teva, Intas, and others, expanding supply options and reducing costs.
• Manufacturing complexity and regulatory requirements serve as barriers to new entrants, constraining supply diversification.
• Geopolitical, pandemic, and raw material challenges influence overall market supply stability.
• Future developments in biosimilar approvals and regional manufacturing investments promise greater supply resilience and accessibility.

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FAQs

1. Who are the leading manufacturers of generic plerixafor?
   Teva Pharmaceutical Industries and Intas Pharmaceuticals are among the leading producers of generic plerixafor, providing cost-effective alternatives post-patent expiry.

2. What challenges do manufacturers face in supplying plerixafor globally?
   Manufacturing complexity, regulatory hurdles, supply chain disruptions, and pricing pressures limit production scalability and regional availability.

3. Are biosimilars of plerixafor available?
   While biosimilars are in development and some have received approval in select regions, widespread availability remains limited due to the complexity of biologic manufacturing and regulatory pathways.

4. How has patent expiration impacted the supply landscape?
   Patent expiration has facilitated the entry of generic manufacturers, increasing supply volume, reducing prices, and broadening regional access, especially in emerging markets.

5. What future trends could influence the supply of plerixafor?
   Enhanced biosimilar approvals, regional manufacturing investments, and technological advancements in biomanufacturing are poised to improve supply stability and reduce costs.

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References

1. Roche. (2018). Mozobil (plerixafor) prescribing information.
2. U.S. Food and Drug Administration. (2020). Generic drug approvals.
3. MarketWatch. (2022). Global biosimilar market outlook.
4. Intas Pharmaceuticals. (2021). Product portfolio updates.
5. Sandoz/Biosimilar News. (2023). Pipeline developments in biologics.