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Suppliers and packagers for generic pharmaceutical drug: CELECOXIB
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CELECOXIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Viatris Specialty LLC | 58151-082-91 | 60 CAPSULE in 1 BOTTLE (58151-082-91) | 2023-10-11 |
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Viatris Specialty LLC | 58151-083-01 | 100 CAPSULE in 1 BOTTLE (58151-083-01) | 2024-09-13 |
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Viatris Specialty LLC | 58151-083-05 | 500 CAPSULE in 1 BOTTLE (58151-083-05) | 2024-09-13 |
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Viatris Specialty LLC | 58151-083-88 | 100 BLISTER PACK in 1 CARTON (58151-083-88) / 1 CAPSULE in 1 BLISTER PACK (58151-083-32) | 2024-09-13 |
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998 | NDA | Viatris Specialty LLC | 58151-084-01 | 100 CAPSULE in 1 BOTTLE (58151-084-01) | 2024-01-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CELECOXIB
Introduction
Celecoxib, marketed under the brand name Celebrex among others, is a nonsteroidal anti-inflammatory drug (NSAID) used primarily for pain relief, inflammation reduction, and arthritis management. As a selective cyclooxygenase-2 (COX-2) inhibitor, celecoxib exhibits a targeted mechanism that minimizes gastrointestinal side effects associated with traditional NSAIDs. Its global demand necessitates a robust supply chain involving multiple raw material, active pharmaceutical ingredient (API), and finished goods suppliers. This article presents an in-depth overview of the primary suppliers, manufacturing landscape, and strategic considerations within the celecoxib supply ecosystem.
Global Manufacturing Landscape and Key Players
1. Active Pharmaceutical Ingredient (API) Manufacturers
The backbone of celecoxib supply chain comprises API manufacturers that synthesize the pharmacologically active compound. Prominent API producers encompass both multinational pharmaceutical companies and Contract Manufacturing Organizations (CMOs). These manufacturers achieve regulatory compliance across jurisdictions such as the US FDA, EMA, and PMDA, which is critical for market access.
Major API Suppliers:
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Synthesis-based Pharmaceutical Giants:
- Pharmaron (China): A leading CMO with extensive expertise in API manufacturing, including celecoxib, offering high-volume production aligned with international standards.
- Hetero Labs (India): Known for its robust API manufacturing pipeline, Hetero supplies celecoxib to global markets with cost-competitive offerings.
- Cambrex (USA): Provides high-quality APIs, emphasizing compliance with cGMP (current Good Manufacturing Practice) standards suitable for branded and generic pharmaceuticals.
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Specialist API Manufacturers:
- Dr. Reddys Laboratories (India): A prominent API and generic drug manufacturer with a significant portfolio in NSAIDs and celecoxib.
- Mingvac (China): Focused on specialty APIs, including celecoxib, catering mainly to Asian and emerging markets.
2. Raw Material and Intermediate Suppliers
The synthesis of celecoxib involves key intermediates such as substituted phenyl compounds, sulfonamides, and heterocyclic precursors. These intermediates are sourced from chemical suppliers specializing in specialty chemicals for pharmaceutical use.
Key intermediates suppliers include:
- Lotte Chemical (South Korea): Supplies intermediates with high purity suitable for active pharmaceutical synthesis.
- BASF (Germany): Offers advanced intermediates and specialty chemicals utilized in celecoxib manufacturing.
3. Contract Manufacturing Organizations (CMOs)
CMOs contribute significantly to celecoxib production, enabling pharmaceutical companies to scale manufacturing, reduce costs, and focus on R&D and marketing.
Prominent CMOs include:
- Lonza (Switzerland): Offers custom synthesis and manufacturing services with compliance to global GMP standards.
- Boehringer Ingelheim (Germany): Provides large-scale manufacturing of APIs, including celecoxib, especially for branded medication production.
Supply Chain Dynamics and Regulatory Impacts
The supply dynamics of celecoxib are influenced by factors including raw material availability, geopolitical stability, manufacturing capacity, and regulatory compliance. Notably:
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Quality and Regulatory Standards: Globally, API suppliers must adhere to cGMP, FDA, EMA, and other regional regulatory standards. Non-compliance risks supply disruptions and market restrictions.
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Geopolitical Factors: Trade policies, tariffs, and sanctions impact sourcing and distribution, emphasizing diversification among suppliers to minimize risks.
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Patent and Generic Market Entry: While patented celecoxib manufacturing was initially dominated by Pfizer, generic manufacturers now hold significant market share, expanding the supplier base.
Emerging Suppliers and Market Trends
As demand persists, new entrants from emerging markets such as India and China are expanding their capabilities in celecoxib production. These suppliers benefit from lower manufacturing costs and increasing investments in quality systems.
Recent trends include:
- Sustainability and Green Chemistry: Suppliers are adopting sustainable synthesis practices, reducing environmental impact and ensuring long-term supply robustness.
- Digitalization and Supply Chain Transparency: Utilization of blockchain and advanced tracking ensures authentic, quality-assured celecoxib supply.
- Supply Chain Consolidation: Larger pharmaceutical firms are integrating vertically, investing in API manufacturing to enhance control and reduce dependency on external suppliers.
Supply Chain Challenges and Strategic Considerations
- Commodity Price Fluctuations: Variability in raw material costs affects overall API pricing.
- Regulatory Delays: Stringent approvals for manufacturing sites and processes can delay supply chain continuity.
- Capacity Constraints: Existing manufacturing capacity may not meet surging global demand, especially during health crises or market expansion phases.
- Quality Assurance: Maintaining high-quality standards across diverse suppliers is critical to avoid recalls and regulatory penalties.
Pharmaceutical companies and procurement teams should therefore prioritize diverse, compliant, and technologically advanced suppliers. Strategic inventory management and supplier audits are essential to mitigate risks.
Conclusion
The celecoxib supply ecosystem is characterized by a mix of established pharmaceutical giants, specialized API manufacturers, and emerging regional players. Ensuring a resilient supply chain requires vigilant management of quality standards, regulatory compliance, geopolitical factors, and capacity planning. As the global pharmaceutical landscape evolves, diversification among suppliers, adoption of sustainable practices, and technological integration will remain key to maintaining reliable celecoxib availability.
Key Takeaways
- The core celecoxib supply chain consists of API manufacturers from China, India, and Europe, with major players including Pharmaron, Hetero Labs, Dr. Reddys, and Cambrex.
- Suppliers must adhere to rigid regulatory and quality standards, which influence sourcing and procurement decisions.
- Emerging markets are expanding their manufacturing capabilities, providing opportunities for cost savings and supply diversification.
- Supply chain resilience depends on managing geopolitical risks, capacity constraints, and quality assurance.
- Strategic partnerships with CMOs, adoption of sustainable practices, and real-time supply chain monitoring enhance reliability and compliance.
FAQs
1. Who are the leading suppliers of celecoxib API globally?
Leading suppliers include Pharmaron (China), Hetero Labs (India), Dr. Reddys Laboratories (India), Cambrex (USA), and Lonza (Switzerland), each providing high-quality API in compliance with international standards.
2. What factors influence the choice of celecoxib API suppliers?
Key factors include regulatory compliance, manufacturing capacity, quality standards, cost competitiveness, supply chain reliability, and geographic considerations.
3. Are there regional differences in celecoxib manufacturing?
Yes, Asia (particularly India and China) dominates API production due to lower costs and expanding capacity, while Europe and North America focus on high-quality manufacturing for branded medications.
4. How do geopolitical factors impact celecoxib supply chains?
Trade policies, tariffs, sanctions, and geopolitical tensions can restrict or delay supply chains, emphasizing the importance of supplier diversification and regional risk management.
5. What trends are shaping the future of celecoxib supply?
Future trends include increased focus on sustainability, digital supply chain integration, capacity expansion in emerging markets, and enhanced regulatory compliance.
Sources
- [1] Pharmaceutical Industry Reports, 2023.
- [2] U.S. Food and Drug Administration (FDA) Drug Approvals and Manufacturers Database.
- [3] Market Intelligence on API Suppliers, Chemical Week, 2022.
- [4] Industry analysis: The global NSAID market, IQVIA, 2022.
- [5] Company annual reports and supply chain disclosures from Pharmaron, Hetero, Cambrex, Lonza.
This document serves as a comprehensive guide for stakeholders seeking insights into the global celecoxib supply chain, supporting strategic sourcing decisions and risk management practices.
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