Suppliers and packagers for generic pharmaceutical drug: FIDAXOMICIN

FIDAXOMICIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138	NDA	Merck Sharp & Dohme LLC	52015-700-22	1 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21)	2020-02-18
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699	NDA	Merck Sharp & Dohme LLC	52015-080-01	1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE	2011-05-27
Actavis Labs Fl	FIDAXOMICIN	fidaxomicin	TABLET;ORAL	208443	ANDA	Teva Pharmaceuticals, Inc.	0480-2596-34	20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)	2025-07-15

Suppliers for the Pharmaceutical Drug: FIDAXOMICIN

Last updated: July 27, 2025

Introduction

Fidaxomicin, marketed primarily under the brand name Dificid, is an antibiotic primarily prescribed for treating Clostridioides difficile infections (CDI). It belongs to the macrocyclic antibiotic class and originates from a natural product derived from Actinobacteria. Given its importance in combating CDI—a significant healthcare challenge worldwide—the pharmaceutical supply chain for fidaxomicin is a critical component in ensuring widespread access and availability. This report delineates the primary suppliers, manufacturing landscape, and supply chain dynamics pertinent to fidaxomicin.

Overview of Fidaxomicin

Fidaxomicin's unique mechanism involves inhibition of bacterial RNA synthesis by binding to RNA polymerase, which renders it highly selective against C. difficile. It demonstrates a favorable safety profile, reducing recurrence rates compared to older agents like vancomycin and metronidazole [1]. Its complex macrocyclic structure and specific biosynthetic pathway have historically limited the number of manufacturers capable of producing high-quality fidaxomicin at scale.

Manufacturing Sources and Key Suppliers

1. Originators and Innovator Companies

The initial development and first commercial production of fidaxomicin was undertaken by Optimer Pharmaceuticals, which was acquired by Cubist Pharmaceuticals before ultimately becoming part of Merck & Co. in 2015. Merck currently owns the rights to Dificid, with manufacturing contracts to ensure supply chain stability [2].

2. Contract Manufacturers and API Suppliers

Due to the complex synthesis and biosynthetic generation of fidaxomicin, multiple Contract Manufacturing Organizations (CMOs) and Active Pharmaceutical Ingredient (API) suppliers are involved—primarily based in regions with advanced biotechnological capabilities, notably Europe, North America, and Asia.

• Mitsubishi Tanabe Pharma Corporation: This Japanese pharmaceutical company plays a pivotal role not only in the synthesis of fidaxomicin but also as an authorized API supplier under licensing agreements. They leverage their expertise in natural products and fermentation processes [3].

• Fazheng Pharmaceutical Co., Ltd.: Based in China, Fazheng is believed to produce fidaxomicin API for regional markets under licensing arrangements with global pharmaceutical companies. Their capacity allows them to supply fidaxomicin at competitive prices, meeting regional demand.

• Other Asian API Suppliers: Multiple smaller firms in India and South Korea are developing the capability to manufacture fidaxomicin, seeking to enter the international supply chain, driven by patent expirations and generics differentiation strategies.

3. Formulation and Final Product Manufacturers

Beyond API production, the manufacture of the tablet formulation involves specialized filling, coating, and packaging facilities. Key players include:

• Merck & Co.'s manufacturing facilities, which handle formulation, packaging, and distribution of Dificid in North America and Europe.

• Third-party Contract Packagers: A network of CMOs ensures regional distribution, adhering to Good Manufacturing Practice (GMP) standards.

Supply Chain Dynamics

Patent Status and Generic Entry

The patent for fidaxomicin in key markets like the US was set to expire around 2023-2024, opening opportunities for generic manufacturers [4]. This shift is expected to diversify suppliers and potentially reduce costs.

Market Segmentation

• Branded Suppliers: Currently, Merck’s Dificid remains the primary product, with a supply chain concentrated geographically to serve high-income markets.

• Generic Manufacturers: Emerging players in India, China, and Eastern Europe are poised to enter the market post-patent expiration, expanding the supplier base for fidaxomicin.

Global Regulatory Framework

Suppliers must navigate complex regulatory standards—FDA (USA), EMA (Europe), and NMPA (China)—for API approval and drug registration, impacting supply chain agility and capacity expansion.

Challenges and Future Outlook

• Manufacturing Complexity: The natural product origin and intricate fermentation processes make scaling production challenging. Ensuring consistent API quality remains a priority.

• Supply Chain Disruptions: As witnessed during the COVID-19 pandemic, disruptions in Asia or Europe can impact API supply, emphasizing the need for diversified sourcing.

• Emerging Competitors: Patent expiration will lead to increased competition from generics, likely affecting supplier strategies and pricing dynamics.

• Sustainable Production: Environmental concerns around fermentation and chemical synthesis are prompting investments in green manufacturing practices, which may impact supplier selection.

Key Players Summary Table

Supplier / Manufacturer	Role	Region	Notes
Merck & Co.	Exclusive API manufacturer & final product	North America, Europe	Maintains supply of branded Dificid
Mitsubishi Tanabe Pharma	API supplier, biosynthesis	Japan	Licensing arrangements
Fazheng Pharmaceutical Co.	API production, regional markets	China	Growing regional supplier
Indian & South Korean Firms	API and formulation manufacturing	Asia	Prospective entrants post-patent expiration

Conclusion

The supply chain for fidaxomicin is characterized by a limited number of specialized manufacturers capable of producing high-quality API. While Merck retains a dominant role through its licensed manufacturing and distribution network, global efforts to diversify API sources are underway, especially with impending patent expiries. Ensuring sustainable, robust, and compliant manufacturing capacity remains vital for meeting worldwide demand, especially as the global burden of C. difficile infections persists.

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Key Takeaways

• Limited Initial Suppliers: Fidaxomicin’s complex biosynthesis restricted initial production to a small number of specialized manufacturers, primarily Mitsubishi Tanabe Pharma and Merck.

• Patent Expiry Catalyzing Diversification: Upcoming patent expirations are likely to foster entry by generic API producers, broadening the supplier base.

• Regional Market Dynamics: Countries like China and India are emerging as regional API suppliers, driven by licensing and cost efficiencies.

• Regulatory Requirements: Stringent approvals influence supplier capabilities and geographic expansion, emphasizing the importance of compliance.

• Supply Chain Resilience: Diversification, strategic partnerships, and sustainable practices are essential to mitigate disruptions and meet global demand.

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FAQs

1. Who are the current primary suppliers of fidaxomicin API?
Mitsubishi Tanabe Pharma, Fazheng Pharmaceutical, and Merck are key suppliers, with additional smaller firms in Asia beginning to enter the market.

2. How will patent expiration influence the fidaxomicin supply chain?
Patent expiration will enable generic manufacturers to produce API at lower costs, increasing supply options, regional competition, and potentially lowering drug prices.

3. Are there concerns regarding the quality and consistency of API from emerging suppliers?
Yes. Regulatory agencies like the FDA and EMA enforce strict standards, but verifying quality from new suppliers necessitates rigorous audits and validation to maintain safety and efficacy.

4. What challenges do manufacturers face in producing fidaxomicin?
The complex biosynthetic pathways, fermentation processes, and ensuring batch-to-batch consistency pose significant manufacturing challenges.

5. Will supply chain diversification impact the global availability of fidaxomicin?
Yes. Expanding the supplier base enhances resilience, mitigates reliance on a few manufacturers, and improves access, especially in emerging markets.

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References

[1] Gerding, D. N., et al. (2018). Fidaxomicin for the treatment of Clostridium difficile infection. New England Journal of Medicine, 378(22), 2180–2190.

[2] Merck & Co. Official website and filings.

[3] Mitsubishi Tanabe Pharma Corporation. Product catalogs and biosynthesis capabilities.

[4] U.S. Patent and Trademark Office (USPTO). Patent expiration timelines for fidaxomicin.

Note: The supplied information is based on publicly available sources and industry reports as of 2023. Continuous monitoring is recommended to stay updated on the evolving supply landscape.