AFINITOR: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0566-51	28 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61)	2009-03-31
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0567-51	28 BLISTER PACK in 1 CARTON (0078-0567-51) / 1 TABLET in 1 BLISTER PACK (0078-0567-61)	2009-03-31
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0594-51	28 BLISTER PACK in 1 CARTON (0078-0594-51) / 1 TABLET in 1 BLISTER PACK (0078-0594-61)	2010-07-09
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334	NDA	Novartis Pharmaceuticals Corporation	0078-0620-51	28 BLISTER PACK in 1 CARTON (0078-0620-51) / 1 TABLET in 1 BLISTER PACK (0078-0620-61)	2011-07-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Afinitor, known generically as everolimus, is a targeted oral therapy used primarily to treat various cancers and rare tumors. Developed and marketed by Novartis, Afinitor functions as an mTOR (mammalian target of rapamycin) inhibitor, disrupting cell division and proliferation. Given its therapeutic importance, understanding its supply chain is critical for stakeholders across the pharmaceutical industry, including healthcare providers, investors, and regulatory authorities. This report evaluates the key suppliers involved in the manufacturing, sourcing of raw materials, and distribution of Afinitor, emphasizing the global supply landscape and strategic considerations.

Manufacturing and Supply Chain Overview

1. Raw Material Suppliers

The core ingredient of Afinitor, everolimus, is a complex macrolide compound produced primarily through fermentation processes involving Streptomyces species. The manufacturing of everolimus hinges on high-quality fermentation inputs and chemical synthesis steps, necessitating specialized microbial culture suppliers and chemical intermediates producers.

a. Fermentation Inputs

Microbial cultures: Suppliers providing Streptomyces strains with optimized biosynthesis capabilities. Key players include biotech firms specializing in microbial strain development and fermentation technology, often custom-developed for API manufacturers.
Fermentation media and nutrients: Suppliers of fermentation media components—amino acids, carbon sources, vitamins—such as DSM (Deutsche Sammlung von Mikroorganismen), Thermo Fisher Scientific, and Sigma-Aldrich, serve as critical raw material streams.

b. Chemical Intermediates

Chemical synthesis of everolimus involves intermediates like methylating agents and complex organic compounds. Contract manufacturing organizations (CMOs) with specialty chemical capabilities are often contracted for these steps. Notable suppliers include:

Evonik Industries: Provides specialty chemicals and intermediates for pharmaceutical synthesis.
BASF: Supplies innovative chemical compounds used in the multi-step synthesis process.

2. API Manufacturers

Major pharmaceutical companies and Contract Manufacturing Organizations (CMOs) hold pivotal roles in producing the active pharmaceutical ingredient (API) at scale:

Novartis: As the original developer, Novartis has in-house manufacturing facilities optimized for high-volume API production, primarily based in Basel, Switzerland, and other sites globally.
Contract Manufacturers: In recent years, Novartis has contracted external API manufacturers to diversify the supply base. Notable CMOs include:
- Mitsubishi Tanabe Pharma: Known for high-quality fermentation-based API production.
- Dr. Reddy's Laboratories: An Indian pharmaceutical manufacturer with capacity in API synthesis for niche oncology agents.
- Viatris (formerly Mylan): Engages in API manufacturing for generic formulations.

3. Finished Dosage Formulators

Apart from active ingredients, the final formulation of Afinitor tablets is produced by specialized pharmaceutical manufacturing companies:

Novartis Manufacturing Units: The primary source.
Contract Packagers and Distributors: Certain regional markets utilize third-party packagers compliant with Good Manufacturing Practices (GMP) to meet local regulatory requirements.

Distribution and Logistics Partners

Once manufactured, Afinitor is distributed globally through Novartis’s established distribution network and third-party logistics providers, ensuring supply chain integrity. Prominent logistics partners include:

Kuehne + Nagel: Provides temperature-controlled pharmaceutical logistics.
DB Schenker: Handles global distribution, especially in emerging markets.
DHL Supply Chain: Facilitates regional and last-mile deliveries.

Strategic Suppliers and Market Implications

1. Supplier Diversification and Supply Security

Given the criticality of Afinitor’s API, Novartis maintains a diversified supplier base to mitigate risks such as supply disruptions, geopolitical issues, or pandemic-related manufacturing constraints. This strategic diversification is vital, especially considering the reliance on fermentation processes, which are sensitive to raw material variability.

2. Regulatory and Quality Standards

All suppliers adhere to strict cGMP standards mandated by agencies such as the FDA, EMA, and other regulatory entities. Compliant suppliers are essential to maintain product quality, efficacy, and regulatory approval across markets.

3. Supply Chain Challenges

Global supply chain disruptions, exemplified during the COVID-19 pandemic, have heightened focus on securing reliable sources for API intermediates and raw materials. Additionally, the complex synthesis of everolimus means that capacity limitations at key suppliers could impact global supply levels, underscoring the need for strategic stockpiling and flexible manufacturing agreements.

Emerging Trends and Future Outlook

Biotechnological Advances: Innovations in microbial fermentation are expected to improve yield efficiency, broadening the pool of suppliers and reducing costs.
Supply Chain Resilience Initiatives: Companies are increasingly adopting digital supply chain management tools to enable real-time tracking and rapid response to disruptions.
Regional Production Expansion: Countries like India and China are expanding their API manufacturing capacities, potentially altering the traditional supply landscape for Afinitor.

Key Suppliers Summary Table

Supplier Category	Examples and Notable Companies	Role in Afinitor Supply Chain
Microbial Strain Developers	DSM, Thermo Fisher Scientific	Source of fermentation cultures
Chemical Intermediates Providers	BASF, Evonik Industries	Supply of key chemical synthesis intermediates
API Contract Manufacturers (CMOs)	Mitsubishi Tanabe Pharma, Dr. Reddy's, Viatris	API production and scale-up
Finished Product Packagers/Distributors	Novartis, third-party OEMs	Formulation, packaging, distribution
Logistics Providers	Kuehne + Nagel, DHL, DB Schenker	Global distribution and cold chain logistics

Conclusion

The supply landscape for Afinitor involves a complex web of specialized suppliers, optimized manufacturing capacities, and resilient logistics frameworks. Novartis’s strategic sourcing—balancing in-house manufacturing with contracted suppliers—ensures consistent API availability while mitigating risks associated with fermentation-dependent processes. Ongoing investments in bioproduction technology and supply chain resilience are essential to maintaining a steady supply of Afinitor in a competitive and regulatory-intensive environment.

Key Takeaways

Diversified Supplier Base: Ensures supply chain resilience amidst geopolitical and pandemic challenges.
Regulatory Compliance: Suppliers must adhere to GMP standards to sustain global approvals.
Technological Innovation: Advances in fermentation and chemical synthesis are critical for cost efficiency and capacity expansion.
Strategic Stockpiling: Essential to buffer against supply disruptions in the API manufacturing sector.
Regional Production Growth: Emerging markets are increasing their API manufacturing capacities, potentially influencing global supply dynamics.

FAQs

1. Who are the primary manufacturers of the API for Afinitor?
Novartis primarily manufactures the API in-house, with additional supply from contracted CMOs such as Mitsubishi Tanabe Pharma, Dr. Reddy’s Laboratories, and Viatris.

2. What raw materials are critical in the production of everolimus?
Fermentation strains (Streptomyces species), fermentation media, methylating agents, and complex organic intermediates are essential raw materials.

3. How do supply chain disruptions affect Afinitor availability?
Disruptions at any point—raw material sourcing, fermentation capacity, chemical synthesis, or logistics—can delay or reduce the availability of Afinitor, impacting patient access and market stability.

4. Are there regional variations in Afinitor suppliers?
Yes, while Novartis primarily controls production, regional manufacturers, especially in India and China, are increasingly contributing to supply capacity for generic formulations or intermediates.

5. What future trends could impact the supply of Afinitor?
Advancements in biotechnological production, increased regional manufacturing in emerging markets, and digital supply chain management are poised to enhance supply resilience and reduce costs.

References

[1] Novartis official website, "Afinitor (everolimus): Product Information," 2023.
[2] U.S. Food and Drug Administration, "ANDA Approvals and Market Data," 2023.
[3] Industry reports on pharmaceutical supply chains, IQVIA Institute, 2022.
[4] Global trade databases and raw material sourcing reports, Statista, 2022.
[5] Articles on fermentation technology and specialized chemical synthesis, BioPharm International, 2021.

Suppliers and packagers for AFINITOR

AFINITOR

Suppliers for the Pharmaceutical Drug: Afinitor