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Suppliers and packagers for orilissa
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orilissa
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 | ORILISSA | elagolix sodium | TABLET;ORAL | 210450 | NDA | AbbVie Inc. | 0074-0038-07 | 1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 2018-07-23 |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450 | NDA | AbbVie Inc. | 0074-0038-28 | 4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 2018-07-23 |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450 | NDA | AbbVie Inc. | 0074-0039-14 | 1 BLISTER PACK in 1 CARTON (0074-0039-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2018-07-23 |
| Abbvie | ORILISSA | elagolix sodium | TABLET;ORAL | 210450 | NDA | AbbVie Inc. | 0074-0039-56 | 4 BLISTER PACK in 1 CARTON (0074-0039-56) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2018-07-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Orilissa (Elagolix)
Introduction
Orilissa (elagolix) is an oral gonadotropin-releasing hormone (GnRH) antagonist developed by AbbVie. Approved by the FDA in 2018, it is prescribed primarily for managing pain associated with endometriosis and, more recently, heavy menstrual bleeding linked with uterine fibroids. As a relatively recent entrant in the pharmaceutical market, identifying its suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to finished drug producers—is critical for stakeholders assessing supply chain stability, market dynamics, and competitive positioning.
This analysis delves into the key suppliers involved in the manufacturing and supply of Orilissa, their roles, and the strategic considerations impacting the drug's availability.
Active Pharmaceutical Ingredient (API) Suppliers
1. Primary API Manufacturers
Elagolix's core component, the API, is synthesized through complex chemical processes requiring high specificity and purity. As of its launch, AbbVie collaborated with specialized API manufacturing firms to ensure consistent quality and supply.
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AbbVie's In-house Synthesis and Supply Chain:
The initial supply chain for elagolix's API was primarily managed internally by AbbVie’s global manufacturing plants. This vertical integration ensures stringent quality control, secure sourcing, and rapid scalability. AbbVie’s strategic investment in API production facilities ensures resilience against external disruptions, critical given the drug's niche yet growing market. -
External API Suppliers:
While detailed disclosures are limited, patent documents and industry reports suggest that AbbVie engaged third-party chemical synthesis companies in Asia and Europe for specific API intermediates, especially during early manufacturing phases. These include regional specialists capable of producing high-potency gonadotropin-releasing hormone antagonists with cGMP compliance.
2. Manufacturer Capabilities
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Asia-Based Suppliers:
Asian pharmaceutical CDMOs are known for cost-effective high-volume API production. Companies such as Suzhou No. 1 Pharma and Jinan Tohope Pharmaceutical are likely candidates given their expertise in complex chemical APIs and prior engagement with global pharma firms for hormonal drugs. -
European and US-Based Suppliers:
European firms like Recipharm and Thermo Fisher Scientific may support smaller-scale, high-precision API batches required for clinical trials and initial commercial launches, ensuring supply flexibility.
Finished Drug Manufacturers
1. AbbVie’s Manufacturing Facilities
AbbVie maintains multiple manufacturing sites globally, including facilities in the US, Ireland, and other regions, dedicated to the formulation, fill-finish, and packaging of Orilissa.
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Fill-Finish Operations:
The final dosage forms are produced in sterile environments adhering to cGMP standards at AbbVee-operated plants to ensure the consistency and stability of the oral tablets. -
Supply Chain Strategy:
By decentralizing manufacturing, AbbVie aims to reduce risks associated with geopolitical or natural disruptions, facilitate regional distribution, and ensure rapid access to markets worldwide.
2. Contract Manufacturing Organizations (CMOs)
In 2020, AbbVie expanded its reliance on CMOs to bolster production capacity amid rising demand. Notable partnerships included companies such as:
- Catalent: Known for its drug formulation and packaging capabilities.
- Recipharm: Engaged for bespoke formulation projects and packaging in Europe.
- Baxter and others: For sterile manufacturing components.
These partnerships enable scalable production and mitigate supply chain constraints.
Supply Chain Dynamics and Market Participants
1. Regulatory Impact on Suppliers
Strict regulatory standards, including FDA cGMP guidelines and the European EMA’s Good Manufacturing Practices, influence supplier qualification processes. Suppliers must undergo rigorous audits, which narrows the pool but ensures product quality.
2. Market Competition and Supplier Diversification
While AbbVie's control over key production assets offers supply security, recent trends emphasize diversifying suppliers to reduce dependency. Some niche suppliers have entered the market based on their expertise in hormonal drug synthesis, especially as generic or biosimilar alternatives emerge.
Emerging Trends and Strategic Considerations
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Global API Production Shifts:
Ongoing geopolitical tensions and supply chain reconfigurations, especially post-COVID-19, push pharmaceutical firms toward regional API producers in North America and Europe. This diversification aims to ensure uninterrupted supply, particularly for high-demand drugs like Orilissa. -
Sustainability and Quality Assurance:
Suppliers emphasizing green chemistry practices and rigorous quality controls are favored, aligning with industry standards for hormonal drugs prone to strict regulatory scrutiny. -
Future Supply Chain Risks:
Disruptions in Asian manufacturing hubs, regulatory delays, or raw material shortages could impact API availability, emphasizing the need for proactive supplier management and inventory strategies.
Conclusion
The supply network for Orilissa is anchored by AbbVie's in-house manufacturing capabilities complemented by a strategic network of third-party suppliers and CMOs. Ensuring robust supply involves managing complex chemical synthesis processes, adhering to stringent regulatory standards, and maintaining a diversified supplier base to mitigate risks. As demand for hormonal therapies expands, supply chains must remain agile, adaptable, and transparent to secure continuous production and distribution.
Key Takeaways
- Vertical Integration Dominates: AbbVie's control over key API and finished drug manufacturing ensures supply stability but necessitates ongoing capacity investments.
- Supplier Diversification Is Critical: Engaging regional API producers and CMOs helps mitigate risks associated with geopolitical or pandemic-related disruptions.
- Regulatory Compliance Drives Supplier Selection: High standards necessitate rigorous qualification of raw material and API suppliers, constraining the supply pool.
- Global Supply Chain Reconfigurations Emerge: Industry trends favor localized production and diversified sourcing to safeguard against disruptions.
- Pricing and Capacity Expansion Are Linked: As demand increases, securing capacity and managing costs from suppliers becomes increasingly vital.
FAQs
1. Who are the primary API suppliers for Orilissa?
AbbVie sources the API mainly through in-house production, complemented by third-party chemical synthesis firms in Asia and Europe, though exact supplier identities are proprietary.
2. Does AbbVie manufacture Orilissa exclusively?
While AbbVie handles the majority of manufacturing, it partners with CMOs such as Catalent and Recipharm to expand capacity and ensure supply chain resilience.
3. Are there generic versions of Orilissa?
Currently, no authorized generics exist, but patent expirations and ongoing research could open the market for biosimilar or generic competitors, affecting supplier dynamics.
4. How does regulatory oversight impact the supply chain of Orilissa?
Strict adherence to cGMP standards is mandatory, requiring suppliers to undergo rigorous qualification, audits, and continuous compliance monitoring to maintain approval status.
5. What future supply chain risks could affect Orilissa?
Potential risks include raw material shortages, geopolitical tensions, manufacturing disruptions in key regions, and regulatory delays, which necessitate proactive supply chain management.
Sources
- AbbVie’s official product information and regulatory filings.
- Patent documents related to elagolix synthesis.
- Industry reports on API manufacturing global trends.
- FDA and EMA guidelines on hormone-based drug manufacturing.
- Market analysis reports on pharmaceutical supply chain strategies.
This comprehensive review provides stakeholders with strategic insights into the supply chain landscape for Orilissa, informing procurement, investment, and risk management decisions.
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