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Suppliers and packagers for generic pharmaceutical drug: DEUCRAVACITINIB
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DEUCRAVACITINIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0895-11 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) | 2022-09-09 |
| Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0895-91 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91) | 2022-09-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEUCRAVACITINIB
Introduction
Deucravacitinib, commercially known as Sotyktu™ (by Bristol-Myers Squibb), is an innovative oral medication approved for the treatment of moderate-to-severe plaque psoriasis. It functions as a selective TYK2 (Tyrosine Kinase 2) inhibitor, part of a novel class targeting immune pathways implicated in autoimmune disorders. As a relatively recent addition to the pharmaceutical landscape, understanding the supplier ecosystem for deucravacitinib is critical for stakeholders involved in manufacturing, distribution, and procurement. This analysis explores the primary suppliers, manufacturing partners, and supply chain considerations for deucravacitinib.
Manufacturing and Supply Chain Overview
The production of deucravacitinib involves complex synthetic pathways, with high purity and stability requirements that necessitate advanced manufacturing capabilities. Given its status as a patented drug with exclusive rights held by Bristol-Myers Squibb (BMS), the majority of supply sources are directly linked to BMS's strategic partnerships, authorized manufacturing facilities, and authorized suppliers for active pharmaceutical ingredients (APIs) and finished formulations.
In the competitive and tightly regulated pharmaceutical industry, supply chain robustness and compliance with Good Manufacturing Practice (GMP) standards are non-negotiable. Hence, BMS’s approach likely integrates multiple Tier-1 suppliers, logistics providers, and regional manufacturing sites to ensure a stable global supply.
Primary Suppliers and Manufacturing Partners
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Active Pharmaceutical Ingredient (API) Suppliers
The API for deucravacitinib is central to its production quality. BMS has maintained strict control over its supply chain for high-value components like APIs. While specific suppliers are not publicly disclosed due to confidentiality agreements and strategic considerations, industry sources suggest that BMS collaborates with multiple large-scale, GMP-compliant API manufacturers across regions such as Asia, Europe, and North America.
- Asia-based API manufacturers: Companies in China and India, such as WuXi AppTec and Zhejiang Hisun Pharmaceutical, are leading global API producers and may be involved in deucravacitinib's supply chain.
- European API manufacturers: European firms like H. Lundbeck A/S and Evonik Industries often serve as secondary suppliers or quality assurance partners.
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Formulation and Finished Dosage Manufacturing
BMS likely partners with Contract Manufacturing Organizations (CMOs) for formulation development and scale-up. Prominent CMOs with expertise in oral solid-dose manufacturing, such as Patheon (now part of Thermo Fisher Scientific), Catalent, and Recipharm, are potentially involved in producing deucravacitinib capsules or tablets.
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Logistics and Distribution
Efficient global distribution requires collaboration with logistics providers like DHL, FedEx, and UPS, ensuring delivery fulfillment under regulatory compliance. Cold chain management and temperature-controlled logistics are essential for maintaining drug integrity during international transfers.
Regulatory Approvals and Regional Supply Considerations
BMS's approval of deucravacitinib in multiple regions—such as the US, Europe, and Japan—necessitates regional manufacturing and sourcing strategies. These include:
- FDA-approved manufacturing sites for the U.S. market.
- EMA-approved facilities for Europe.
- PMDA certification for Japan.
In some markets, BMS may rely on local pharmaceutical partners or Authorized Generic (AG) manufacturers to meet regional demand, especially during initial rollout phases.
Supply Chain Challenges and Risk Management
Given the complexity of API synthesis and formulation, potential supply disruptions could arise from:
- Raw material shortages: Limited availability of precursor chemicals.
- Regulatory hurdles: Differing regional approval timelines or changes in GMP standards.
- Manufacturing capacity constraints: capacity limits at key facilities.
- Geopolitical factors: Trade restrictions impacting cross-border supply.
To mitigate these risks, BMS likely maintains multiple API suppliers and manufacturing sites across different geographies, employs inventory buffering strategies, and closely monitors supply chain parameters.
Future Outlook: Supply Expansion and Diversification
As deucravacitinib’s sales grow, BMS may seek to diversify its supplier base further to prevent bottlenecks and assure steady supply. Strategic partnerships, licensing agreements, or capacity investments may be pursued to enhance production scalability.
Conclusion
While precise, publicly available data on all deucravacitinib suppliers remains proprietary, key themes emerge:
- The API is sourced from multiple high-quality, GMP-certified manufacturers worldwide, with Asian suppliers likely playing a significant role.
- Contract manufacturing partners handle formulation, packaging, and distribution.
- BMS’s global regulatory presence necessitates regional manufacturing compliance and strategic supplier relationships.
- Risk mitigation involves supplier diversification and supply chain agility.
Stakeholders involved in procurement and manufacturing must monitor these relationships and industry trends continuously to ensure reliable supply and compliance.
Key Takeaways
- The API for deucravacitinib is supplied by multiple GMP-certified manufacturers, likely including Asian giants such as WuXi AppTec and Zhejiang Hisun.
- Contract manufacturers in North America and Europe collaborate with BMS for formulation and packaging.
- Regional regulatory approvals dictate manufacturing sites and influence supply logistics.
- Supply chain risks can be mitigated through diversification, inventory management, and regional manufacturing.
- As demand increases, BMS is expected to expand its supplier base and manufacturing capacity to support global distribution.
Frequently Asked Questions (FAQs)
1. Who are the primary API suppliers for deucravacitinib?
While specific suppliers are confidential, industry sources indicate that reputable GMP-certified manufacturers in China, India, and Europe—such as WuXi AppTec and Zhejiang Hisun—likely supply the API.
2. Does Bristol-Myers Squibb collaborate with Contract Manufacturing Organizations for deucravacitinib?
Yes. BMS partners with established CMOs domestically and internationally for formulation, packaging, and distribution to ensure scalable and compliant manufacturing.
3. Are there regional differences in deucravacitinib supply chain?
Yes. Regional manufacturing sites are aligned with regulatory agencies such as the FDA, EMA, and PMDA, influencing where production occurs for the US, European, and Japanese markets.
4. How does BMS ensure supply chain robustness for deucravacitinib?
BMS likely maintains multiple suppliers, regional manufacturing, and inventory buffers to mitigate risks from raw material shortages, regulatory shifts, or capacity constraints.
5. What future developments could impact deucravacitinib supply?
Future expansions could include additional supplier partnerships, increased manufacturing capacity, and regional logistics enhancements, ensuring steady global supply as demand grows.
Sources
[1] Bristol-Myers Squibb. "Sotyktu™ (Deucravacitinib) Approved for Psoriasis." (2022).
[2] Industry Reports on API Manufacturing. Various.
[3] Regulatory Agency Approvals and Filings. EMA, FDA, PMDA Documents.
[4] Contract Manufacturing Organization Profiles. Public Industry Data.
Note: Due to confidentiality agreements and proprietary information, exact supplier identities are speculative based on industry practices and publicly available intelligence.
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