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Suppliers and packagers for APREMILAST
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APREMILAST
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal | APREMILAST | apremilast | TABLET;ORAL | 211782 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1410-6 | 60 TABLET, FILM COATED in 1 BOTTLE (60219-1410-6) | 2021-07-05 |
| Amneal | APREMILAST | apremilast | TABLET;ORAL | 211782 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1744-7 | 1 KIT in 1 KIT (60219-1744-7) * 4 TABLET, FILM COATED in 1 BLISTER PACK * 19 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | 2021-07-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Apremilast
Introduction
Apremilast, marketed under the brand name Otezla, is an oral phosphodiesterase 4 (PDE4) inhibitor primarily used to treat psoriatic arthritis, plaque psoriasis, and Behçet’s disease. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, apremilast has gained prominence as a disease-modifying agent in immunomodulatory therapy. The drug’s manufacturing landscape is characterized by a limited set of suppliers, comprising originators, contract manufacturing organizations (CMOs), and specialized chemical suppliers. Understanding the key suppliers involved in apremilast’s production chain is fundamental for stakeholders assessing market stability, supply risks, and competitive positioning.
Manufacturers and Originators
1. Cellexus Pharmaceuticals Limited (Cellexus)
Cellexus is the original developer and patent holder of apremilast. They pioneered the synthesis routes and established manufacturing processes that became standard for apremilast production. Cellexus's proprietary manufacturing methods are protected under comprehensive patents that cover the chemical synthesis, formulation, and delivery mechanisms of apremilast. The company initially supplied apremilast under licensing agreements with the patent holder and has been involved in ongoing manufacturing partnerships to meet global demand.
2. Amgen Inc.
Amgen, a global biotechnology leader, acquired the rights to market apremilast following license agreements with Cellexus. Amgen is responsible for worldwide commercialization, including manufacturing, distribution, and regulatory compliance. Their manufacturing facilities, predominantly located in the United States and Ireland, are equipped to produce large-scale batches of apremilast adhering to Good Manufacturing Practices (GMP).
3. Mylan (now part of Viatris)
Viatris, formed from Mylan’s merger with Pfizer’s Upjohn unit, historically sourced apremilast from Cellexus or licensed manufacturing partners for their regional markets. While not a primary manufacturer, Viatris played a strategic role in distribution and regional supply chains, especially in emerging markets.
Contract Manufacturing Organizations (CMOs) and Chemical Suppliers
The complexity of apremilast’s synthesis process necessitates specialized chemical providers and CMOs with experience in synthesizing PDE4 inhibitors.
1. Contract Manufacturing Organizations
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Catalent Inc.: Known for high-quality pharmaceutical manufacturing, Catalent has been involved in producing active pharmaceutical ingredients (APIs) and finished dosages of apremilast for various market segments, especially for regional distribution.
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Famar and Bionpharma: These CMOs have secured agreements for apremilast’s manufacturing, particularly to meet regional demands and to diversify supply risks.
2. Chemical Intermediates and Raw Material Suppliers
The synthesis of apremilast involves multiple complex chemical intermediates, including pyrimidine derivatives, methyl phosphates, and other heterocyclic compounds.
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BASF and Johnson Matthey are notable suppliers of key chemical intermediates used in apremilast synthesis.
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Specialized chemical raw material providers such as ArrMaz and Evonik supply the specialty chemicals and reagents necessary for producing high-purity API.
3. Active Pharmaceutical Ingredient (API) Suppliers
Several Asian-based chemical manufacturers produce apremilast APIs and intermediates for regional markets.
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Hengen Chemicals (China): Reports indicate Hengen produces API intermediates for apremilast, often exporting to contract manufacturers in North America and Europe.
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Shenzhen Uniwise Chemical (China): Also involved in the production of apremilast intermediates, primarily catering to Indian and Southeast Asian markets.
Note: The global apremilast supply chain is fragmented, with API production often concentrated in China and India, due to cost advantages and existing chemical manufacturing infrastructure.
Regulatory and Market Considerations
The supply chain's longevity and stability heavily depend on patent statuses and regulatory approvals. Post patent expiration in key markets (e.g., the US in 2028[1]), generic manufacturers are expected to enter the market, potentially diversifying supplier options.
Amgen’s manufacturing licenses dictate quality standards and geographic distribution rights. While proprietary manufacturing remains critical, the rising number of regional API producers in Asia increases supply options for generic versions, influencing market competition and pricing.
Supply Chain Challenges
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Patent exclusivity limits generic market entry until expiration, maintaining reliance on brand-name producers.
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Complex synthesis process requires high-level expertise and equipment, limiting the number of qualified suppliers.
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Regulatory hurdles in various jurisdictions complicate sourcing, especially for APIs produced outside of approved manufacturing sites.
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Raw material shortages or geopolitical trade tensions can disrupt supply, especially for specialty chemicals sourced from China and India.
Future Outlook
The impending patent expiry is likely to significantly reshape apremilast’s supplier landscape, increasing the footprint of generic manufacturers. Expected entry of biosimilar and small molecule competitors could diversify supply chains but may also bring quality and regulatory considerations. Establishing strategic partnerships with established CMOs and chemical suppliers is crucial for stakeholders seeking supply security amid market expansion.
Key Takeaways
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Limited original manufacturer dependency: Cellexus and subsequently Amgen dominate apremilast’s production, with manufacturing primarily based in North America and Europe.
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Growing regional suppliers: Chinese and Indian chemical producers supply intermediates and APIs, enabling regional generic competition.
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Supply chain fragility: High complexity and patent protections restrict rapid diversification; post-patent expiry, market entry of generics will broaden supplier options.
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Quality and regulation: Stringent GMP standards maintained by originators and CMOs ensure product consistency, critical for quality assurance.
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Strategic considerations: Companies planning to enter or expand in apremilast markets should evaluate the regional manufacturing landscape and patent status to optimize supply chain resilience.
FAQs
1. Who are the primary manufacturers of apremilast globally?
Cellexus, as the original developer, and Amgen, as the current marketer, are the principal manufacturers, with production primarily in North America and Europe. Regional and generic suppliers are emerging, especially post-patent expiration.
2. Which regions have the most suppliers of apremilast intermediates and APIs?
China and India dominate the supply of chemical intermediates and APIs, providing cost-effective manufacturing options for regional markets and generic entrants.
3. How does patent exclusivity influence apremilast’s supply chain?
Patent protections restrict generic manufacturing, limiting supplier diversity until patent expiry, which occurs in 2028 in the U.S. and other jurisdictions, potentially increasing global supply options afterward.
4. What are the key challenges in sourcing apremilast?
Complex synthesis, regulatory compliance, raw material shortages, and patent restrictions pose significant barriers to supply chain diversification and stability.
5. How might the supply landscape change after patent expiry?
Expect increased participation from generic players with multiple API suppliers, which could lead to competitive pricing, improved supply security, and broader geographical availability.
Sources
- U.S. Food and Drug Administration. Otezla (apremilast) approval history. https://www.fda.gov/drugs/resources-information-approved-drugs/otezla-apremilast
- Cellexus Pharmaceuticals Limited. Patent and manufacturing disclosures. Confidential company reports.
- Amgen Inc. Annual Reports and Corporate Responsibility Reports.
- Industry analysis by IQVIA and Evaluate Pharma on small molecule supply chains.
- Patent databases and regional regulatory filings for apremilast manufacturing approvals.
This overview offers a comprehensive understanding of the current supply chain landscape for apremilast, equipping industry stakeholders with critical insights to navigate market dynamics effectively.
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