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Suppliers and packagers for dificid
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dificid
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DIFICID®
Introduction
DIFICID®, the brand name for fidaxomicin, is an advanced oral antibiotic primarily used in the treatment of Clostridioides difficile infections (CDI). Since its approval by the U.S. Food and Drug Administration (FDA) in 2011, DIFICID® has gained recognition for its targeted mechanism and reduced recurrence rates compared to traditional therapies. As a specialty drug with complex manufacturing and distribution processes, identifying reliable suppliers for DIFICID® is critical for healthcare providers, distributors, and pharmacy chains aiming to ensure a consistent supply chain. This report comprehensively examines key suppliers involved in the production, distribution, and supply chain of DIFICID®.
Manufacturers of DIFICID® (Fidaxomicin)
1. Merck & Co., Inc.
Overview:
Merck is the original developer and sole manufacturer of DIFICID® (fidaxomicin). The company developed the drug following an extensive research and development phase, culminating in FDA approval in 2011. Merck’s commitment encompasses manufacturing, distribution, and post-market regulation of DIFICID®.
Manufacturing Process:
Merck produces fidaxomicin through a complex fermentation process involving Streptomyces species, utilizing advanced organic synthesis and purification methods. The drug is manufactured under stringent Good Manufacturing Practice (GMP) standards to ensure quality, potency, and safety.
Supply Chain Control:
Merck maintains control over the entire production cycle, including sourcing of raw materials, manufacturing, and distribution. This vertical integration ensures quality assurance and consistent supply but also positions Merck as the primary supplier globally.
2. Contract Manufacturing Organizations (CMOs)
While Merck conducts the bulk of fidaxomicin manufacturing in-house, it historically may engage CMOs for specific components like intermediates or formulation stages. However, detailed public records on CMOs for DIFICID® are limited.
Potential CMOs Involved:
- Several biotech firms specializing in fermentation and complex organic synthesis may have been contracted for pilot or scale-up manufacturing phases.
- Such partnerships enable Merck to increase production capacity or streamline supply chain disruptions.
Distribution Partners and Authorized Distributors
1. Merck’s Global Distribution Network
Merck distributes DIFICID® directly to pharmaceutical wholesalers, hospitals, and large pharmacy networks. Its global reach ensures availability across North America, Europe, Asia-Pacific, and other regions.
Distribution Channels Include:
- Large pharmaceutical distributors such as Cardinal Health, McKesson, and AmerisourceBergen.
- Hospital formularies and specialty pharmacies.
2. Wholesalers and Pharmacies
Authorized pharmacy networks and specialty distributors act as secondary suppliers, ensuring resupply to regional pharmacies and healthcare providers. These entities are vetted by Merck and adhere to strict storage and handling protocols, particularly given the drug’s stability requirements.
Raw Material and Intermediates Suppliers
1. Raw Material Sourcing
Fidaxomicin’s complex biosynthesis requires rare organic compounds, fermentation inputs, and advanced chemical catalysts. The raw materials for fidaxomicin production include:
- Streptomyces species cultures: Cultivated under controlled bioreactor conditions.
- Organic solvents and reagents: Sourced from multiple specialty chemical suppliers with GMP compliance.
2. Key Raw Material Suppliers
While Merck maintains confidentiality over specific raw material suppliers, industry patterns indicate reliance on:
- Specialty chemical companies that provide fermentation media, precursors, and catalysts.
- Biotech suppliers that offer certified strains and fermentation inputs.
3. Challenges in Raw Material Availability
Given the complexity of fidaxomicin’s synthesis, raw materials are often procured from high-quality, regulated sources with limited number of suppliers, introducing potential risks in supply continuity.
Regional and Local Suppliers
1. Regional Distributors
In various markets, licensed regional distributors and wholesalers facilitate access to DIFICID®. These entities hold licenses from regulatory authorities such as the EMA (Europe) or TGA (Australia).
2. Importers and Exporters
For non-U.S. markets, importers play a critical role in transporting DIFICID® from Merck’s manufacturing facilities to local pharmacies, often involving complex logistics, especially given the drug’s sensitivity.
Regulatory and Patent Considerations
Although Merck is the sole patent holder for fidaxomicin, generic manufacturers have sought approval following patent expirations or patent challenges. The availability of generics or biosimilars can diversify supplier sources, but as of 2023, DIFICID® remains primarily supplied by Merck.
Emerging Trends and Future Suppliers
1. Biosimilar Development
Biotech firms working on biosimilar versions of fidaxomicin could expand future supply options, although none have yet received regulatory approval.
2. New Manufacturing Partnerships
Merck may establish new partnerships with CMOs in emerging markets to expand production capacity, respond to global demand, or reduce costs.
Key Challenges in Supplier Management
- Complex manufacturing process: The intricate fermentation and chemical synthesis processes limit the number of capable manufacturers.
- Raw material supply risks: Limited sources of specialized raw materials can impact production continuity.
- Regulatory hurdles: Variations in regional approvals and patent statuses influence the supplier landscape.
- Pricing pressures: Competition from generics or biosimilars could influence supplier diversity.
Conclusion
The supply chain for DIFICID® is predominantly controlled by Merck, which handles manufacturing, quality assurance, and distribution. While the primary source of fidaxomicin is Merck, dependency on raw materials sourced from specialized chemical and biotech suppliers presents vulnerability points. Future expansions in manufacturing capacity, especially through new CMO partnerships and biosimilar entrants, may diversify supplier options. Ensuring a resilient supply chain will require ongoing collaboration with regulatory authorities, raw material suppliers, and distribution partners.
Key Takeaways
- Merck remains the sole manufacturer and primary supplier of DIFICID®, maintaining strict quality and supply controls.
- Raw material sourcing is specialized, with limited suppliers of fermentation inputs and chemical precursors, posing potential supply risks.
- Distribution channels include major wholesalers and specialty pharmacies that ensure broad geographic coverage.
- Emerging biosimilar candidates and new CMO partnerships could diversify supply options in the future.
- Supply chain resilience depends on managing raw material availability, regulatory navigation, and distribution logistics.
FAQs
1. Who manufactures DIFICID® globally?
Merck & Co., Inc. is the sole manufacturer responsible for global production and distribution of DIFICID® (fidaxomicin).
2. Are there any generic versions of fidaxomicin available?
As of 2023, generic fidaxomicin has not received widespread regulatory approval; Merck retains exclusive rights, though patents may expire, opening the potential for generics.
3. What raw materials are used in fidaxomicin production?
Fidaxomicin is derived from fermentation of Streptomyces species, utilizing specialized organic reagents and fermentation media supplied by select chemical and biotech companies.
4. How does Merck ensure quality in the manufacturing process?
Merck adheres to GMP standards, conducts rigorous quality control testing, and maintains regulatory compliance across production sites.
5. Could new suppliers emerge for DIFICID®?
Yes, future biosimilar manufacturers and contract manufacturing partnerships may introduce new sources, especially post-patent expiration or amid supply chain restructuring.
References
[1] U.S. Food and Drug Administration. FDA Approves Fidaxomicin Tablets for C. difficile Infection. 2011.
[2] Merck & Co. Official Product Information for DIFICID®.
[3] European Medicines Agency. Assessment Report for Fidaxomicin.
[4] Healthcare Industry Reports on Pharmaceutical Supply Chains.
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