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Suppliers and packagers for RINVOQ LQ
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RINVOQ LQ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | RINVOQ LQ | upadacitinib | SOLUTION;ORAL | 218347 | NDA | AbbVie Inc. | 0074-2320-01 | 1 BOTTLE in 1 CARTON (0074-2320-01) / 180 mL in 1 BOTTLE | 2024-04-26 |
| Abbvie | RINVOQ LQ | upadacitinib | SOLUTION;ORAL | 218347 | NDA | AbbVie Inc. | 0074-2320-70 | 1 BOTTLE in 1 CARTON (0074-2320-70) / 180 mL in 1 BOTTLE | 2024-04-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RINVOQ LQ
Introduction
RINVOQ LQ (upadacitinib extended-release tablets) is a selective Janus kinase (JAK) inhibitor developed by AbbVie. Approved by the FDA for treating rheumatoid arthritis and other autoimmune conditions, RINVOQ LQ has gained significant traction globally. Its supply chain involves a diverse array of manufacturers, raw material suppliers, and distribution channels critical for delivering the drug to patients worldwide. This report provides a comprehensive overview of the key suppliers involved in the production and distribution of RINVOQ LQ, emphasizing their roles, geographic presence, and strategic importance for the pharmaceutical ecosystem.
Active Pharmaceutical Ingredient (API) Suppliers
1. Incyte Corporation and AbbVie's In-house API Production
While RINVOQ's original development was led by AbbVie, API manufacturing often involves collaborations with or outsourcing to specialized chemical synthesis firms. Incyte, a partner in earlier JAK inhibitor projects, is not directly involved in upadacitinib API production but plays a significant role in the broader JAK inhibitor landscape.
2. Contract Manufacturing Organizations (CMOs) & API Suppliers
AbbVie has established relationships with several CMOs and API manufacturers to ensure a reliable supply of upadacitinib:
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China-based Manufacturers: China hosts a large share of pharmaceutical API manufacturing, including suppliers capable of producing upadacitinib at scale. Companies like Zhejiang Huahai Pharmaceutical and Zhejiang Hisun Pharmaceutical are prominent in producing high-quality chemical APIs under strict regulatory compliance.
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India-based Suppliers: Indian firms such as Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries have extensive experience in synthesizing complex APIs, including JAK inhibitors, and are likely involved in or capable of manufacturing upadacitinib.
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European and North American API suppliers: Some API intermediates and active substances may be sourced from European or North American CMOs such as Fareva or Patheon (a part of Thermo Fisher Scientific), known for GMP-compliant production.
3. Raw Material Suppliers
Upadacitinib synthesis requires specialized intermediates and reagents, sourced from global chemical suppliers. These raw material providers must ensure high purity and compliance with GMP standards, including:
- Organic synthesis reagents
- Catalysts
- Solvents complying with pharmacopeial standards
Formulation and Packaging Suppliers
1. Filling and Packaging
RINVOQ LQ's extended-release formulation necessitates specialized filling and packaging suppliers:
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Contract Packaging Organizations (CPOs): Firms such as WestRock or Catalent likely handle packaging, labeling, and distribution logistics, ensuring stability and shelf-life compliance.
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Blister and Bottling Suppliers: Suppliers such as Gerresheimer or Schott may provide primary packaging components like blister packs and bottles, adhering to pharmaceutical standards.
2. Distribution Partners
Global distribution companies, including McKesson and Cardinal Health, serve as logistical intermediaries ensuring timely delivery to healthcare providers and pharmacies. These firms manage controlled substances’ regulatory compliance, temperature-controlled logistics, and inventory management.
Regulatory and Quality Assurance Suppliers
Several third-party firms support quality assurance and regulatory reporting:
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Analytical Testing Labs: SGS, Eurofins, and other laboratories conduct quality control testing to verify the purity and stability of raw materials and finished products.
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Regulatory Consulting Firms: Companies like Parexel or ICON assist with regulatory submissions, compliance documentation, and post-market surveillance.
Supply Chain Challenges and Strategic Considerations
Despite robust supplier networks, RINVOQ LQ faces critical supply chain considerations:
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Geopolitical Risks: Increased geopolitical tensions, especially with sourcing from China and India, pose risks of supply disruptions. AbbVie’s diversified supplier base aims to mitigate dependence on any single region.
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Manufacturing Capacity Expansion: To meet global demand, AbbVie is investing in expanding manufacturing capacity, including establishing new facilities or expanding existing ones, notably in North America and Europe.
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Raw Material Security: The complexity of chemical synthesis makes raw material availability a bottleneck; hence, suppliers are maintaining strategic inventories.
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Regulatory Oversight: Suppliers must meet stringent cGMP standards enforced by agencies like the FDA, EMA, and MHRA, which directly influence supply chain stability.
Strategic Implications for Stakeholders
For pharmaceutical companies and healthcare providers, understanding the supplier landscape of RINVOQ LQ is vital for risk management, ensuring consistent supply, and planning for contingencies. Collaborations with multiple tier-1 suppliers and securing raw material sources are essential for maintaining uninterrupted production.
Key Takeaways
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RINVOQ LQ's supply chain involves a complex network of global API manufacturers, formulation specialists, and distribution partners, with significant contributions from China, India, and North America.
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AbbVie maintains strategic relationships with CMOs and raw material suppliers to mitigate supply chain risks, emphasizing diversification and capacity expansion.
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Raw material and API suppliers are held to stringent quality standards, with third-party laboratories providing quality assurance and regulatory compliance support.
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Supply chain resilience hinges on geopolitical stability, raw material availability, and regulatory adherence, making continuous risk assessment essential.
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Strategic collaborations and capacity investments position AbbVie to meet increasing global demand for RINVOQ LQ.
FAQs
1. Who are the primary suppliers of upadacitinib API for RINVOQ LQ?
AbbVie collaborates with multiple contract manufacturing organizations (CMOs), predominantly based in China and India, capable of large-scale, GMP-compliant API synthesis. Specific supplier identities are proprietary but include leading chemical manufacturers in these regions known for complex chemical production.
2. Are there any exclusivity agreements with suppliers for RINVOQ LQ?
AbbVie's supply chain strategy involves diversified sourcing rather than exclusive agreements, reducing dependency risks. While some suppliers may have exclusivity in certain regions, overall, multiple suppliers support the global distribution network.
3. How does AbbVie ensure quality control across its supply chain?
AbbVie employs rigorous third-party testing laboratories, audits manufacturing facilities regularly, and mandates compliance with cGMP standards. Qualified suppliers undergo strict qualification processes before approval.
4. What are the main logistical challenges in the distribution of RINVOQ LQ?
Maintaining temperature-controlled logistics, managing inventory levels across multiple regions, and navigating regulatory differences are key challenges. Leading distributors with expertise in pharmaceutical logistics mitigate these risks.
5. Is the supply chain for RINVOQ LQ impacted by geopolitical tensions?
Yes, increased geopolitical tensions, especially involving China and India, pose risks. AbbVie’s diversification strategy aims to manage these risks through multiple sourcing avenues and capacity expansion.
References
[1] AbbVie’s official product information and supply chain disclosures.
[2] Industry reports on pharmaceutical API manufacturing trends (e.g., IQVIA, EvaluatePharma).
[3] Pharmaceutical supply chain risk management literature (e.g., McKinsey & Company).
[4] Regulatory guidelines from FDA, EMA on GMP standards.
[5] Public filings and patent literature related to upadacitinib synthesis and manufacturing.
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