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Suppliers and packagers for EMFLAZA
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EMFLAZA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ptc Therap | EMFLAZA | deflazacort | SUSPENSION;ORAL | 208685 | NDA | PTC Therapeutics, Inc. | 52856-505-22 | 13 mL in 1 BOTTLE (52856-505-22) | 2018-09-10 |
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684 | NDA | PTC Therapeutics, Inc. | 52856-501-01 | 100 TABLET in 1 BOTTLE (52856-501-01) | 2018-09-10 |
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684 | NDA | PTC Therapeutics, Inc. | 52856-502-03 | 30 TABLET in 1 BOTTLE (52856-502-03) | 2018-09-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EMFLAZA
Introduction
EMFLAZA (deflazacort) is a corticosteroid medication primarily approved for the treatment of Duchenne Muscular Dystrophy (DMD), a severe genetic disorder characterized by progressive muscle degeneration. Its unique formulation and patent status have positioned it as a critical drug in neuro-muscular therapeutics. Given the complexities of its manufacturing, regulatory dynamics, and supply chain, understanding the key suppliers behind EMFLAZA is vital for stakeholders ranging from pharmaceutical companies to healthcare providers. This analysis explores the main suppliers of EMFLAZA, their roles, and implications for the drug’s availability and market stability.
Manufacturing and Raw Material Suppliers
Deflazacort Active Pharmaceutical Ingredient (API) Providers
The core component of EMFLAZA is deflazacort, an active pharmaceutical ingredient synthesized through complex chemical processes. Identifying primary API suppliers is essential, as they influence drug quality, cost, and supply consistency:
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Mallinckrodt Pharmaceuticals
Mallinckrodt was initially authorized to market EMFLAZA in the United States. The company is involved in the API's manufacturing or sourcing, given its role as the drug’s sole distributor in the US market. Historically, Mallinckrodt has relied on third-party manufacturers, possibly including contract manufacturing organizations (CMOs) specializing in corticosteroid APIs. -
Biocon Limited
As an India-based biopharmaceutical company renowned for generic and active ingredient manufacturing, Biocon produces corticosteroid APIs and may supply deflazacort raw materials to licensed drug manufacturers globally. While specific partnerships for EMFLAZA's API are not publicly confirmed, Biocon’s capacity aligns with the supply needs of multinational pharmaceutical firms. -
Other Potential API Suppliers
Besides these prominent players, several Indian and Chinese API manufacturers possess the technical capacity to produce deflazacort, including Lupin, Zydus Cadila, and Fosun Pharma. These companies often serve as suppliers for generic formulations, although their direct participation in licensed EMFLAZA production remains unconfirmed.
Formulation and Finished Dosage Manufacturers
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Servier Laboratories
Servier, the original developer of deflazacort, manufactures EMFLAZA under licensing agreements, primarily for European markets and other territories. Their manufacturing facilities adhere to rigorous Good Manufacturing Practice (GMP) standards, ensuring pharmaceutical quality and consistency. -
Mallinckrodt Pharmaceuticals
As the sole US licensee, Mallinckrodt handles the formulation, manufacturing, and distribution of EMFLAZA within the United States. Their manufacturing plants are situated across the US and possibly Europe, emphasizing robust supply chain management for an orphan drug. -
Licensed Generic Manufacturers
Post patent expiration and in regions where patent protections lapse or are challenged, multiple generic manufacturers have entered the market. These include firms such as Alfasigma and Hikma Pharmaceuticals, which produce deflazacort formulations for various markets, potentially offering competitive alternatives.
Distribution and Supply Chain Partners
Supply chain resilience for EMFLAZA hinges on partnerships with distributors and logistics providers:
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Distribution Networks
Mallinckrodt, with its established distribution infrastructure, ensures nationwide availability. Similarly, Servier leverages regional distribution partners within Europe and other territories. The supply chain features cold chain logistics for stability and integrity of the corticosteroid formulations. -
Supply Chain Risks and Contingencies
Dependence on a limited few API and formulation suppliers introduces risk factors such as manufacturing delays, geopolitical issues, or raw material shortages. The ongoing global supply chain disruptions in pharmaceuticals highlight the importance of diversified sourcing and inventory buffers.
Regulatory and Licensing Dynamics
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Patent and Exclusivity
EMFLAZA holds patent protection primarily in the US and certain other jurisdictions, granting exclusivity to manufacturers like Mallinckrodt. Patent expiration opens avenues for generics, increasing the number of suppliers. -
Global Regulatory Approvals
Suppliers must comply with jurisdiction-specific regulatory standards, including FDA regulations in the US, EMA standards in Europe, and others. This complexity influences sourcing strategies and influences which suppliers are eligible to produce or distribute EMFLAZA.
Market and Competitive Landscape
The supplier ecosystem for EMFLAZA is evolving:
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Generic Market Entry
Following patent expiry, multiple generic manufacturers incorporated deflazacort into their portfolios, diversifying supply sources and improving market competition. This broadening reduces reliance on a handful of suppliers and stabilizes pricing. -
Emerging Biotech Developments
The potential advent of biosimilar-like formulations or new corticosteroid analogs could alter supplier relationships and expand avenues for supply.
Implications for Stakeholders
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Pharmaceutical Companies
Ensuring stable supply chains involves establishing diversified API and formulation partnerships, especially amidst ongoing global supply constraints. -
Healthcare Providers and Payers
Reliable sourcing from multiple suppliers preserves drug availability and price stability. -
Regulatory Bodies
Qualification and monitoring of suppliers are critical to maintain standards, avoid shortages, and adhere to compliance standards.
Key Takeaways
- The primary suppliers of EMFLAZA’s API are likely to be established corticosteroid API manufacturers such as Biocon and Indian generics firms.
- Manufacturing and distribution are predominantly managed by licensed entities like Mallinckrodt (US) and Servier (Europe).
- The market faces supply transition risks post-patent expiry, leading to increased generic participation.
- Supply chain resilience relies on diversified sourcing, regulatory compliance, and robust logistics infrastructure.
- Continued monitoring of global API sources and new entrants is vital for stakeholders aiming to ensure uninterrupted access to EMFLAZA.
FAQs
1. Who are the main API suppliers for EMFLAZA?
Primary API suppliers include Biocon Limited and various Indian generic manufacturers such as Lupin and Zydus Cadila, which have the technical capacity to produce deflazacort. Specific contractual details are often proprietary.
2. Is Mallinckrodt the sole producer of EMFLAZA in the US?
Yes, Mallinckrodt holds exclusive licensing rights to manufacture and distribute EMFLAZA within the United States, sourcing APIs and formulations accordingly.
3. How does patent expiration affect EMFLAZA’s supplier landscape?
Patent expiration typically introduces multiple generic manufacturers, expanding supply sources, driving competition, and potentially lowering prices while reducing dependency on a single supplier.
4. Are there risks associated with the current supply chain of EMFLAZA?
Yes. Dependence on limited API sources, manufacturing delays, geopolitical issues, or raw material shortages pose risks, emphasizing the need for diversified suppliers and contingency planning.
5. What should stakeholders monitor to ensure steady EMFLAZA supplies?
Stakeholders should track patent statuses, new generic entries, API manufacturing capacities, and geopolitical developments affecting key sourcing regions like India and China.
References
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