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Suppliers and packagers for generic pharmaceutical drug: atogepant
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atogepant
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 | QULIPTA | atogepant | TABLET;ORAL | 215206 | NDA | AbbVie Inc. | 0074-7094-04 | 4 TABLET in 1 BOTTLE (0074-7094-04) | 2021-09-30 |
| Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206 | NDA | AbbVie Inc. | 0074-7094-30 | 30 TABLET in 1 BOTTLE (0074-7094-30) | 2021-09-30 |
| Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206 | NDA | AbbVie Inc. | 0074-7095-30 | 30 TABLET in 1 BOTTLE (0074-7095-30) | 2021-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Atogepant
Introduction
Atogepant is a potent oral calcitonin gene-related peptide (CGRP) receptor antagonist developed primarily for preventing episodic migraines. As the pharmaceutical industry advances treatments targeting migraine relief, atogepant has gained significant attention. With its growing market presence, understanding its suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to formulation partners—is crucial for pharmaceutical companies, investors, and healthcare stakeholders. This report analyzes the current supply landscape for atogepant, elucidating the key players, manufacturing capacities, strategic partnerships, and supply chain risks.
Development and Market Introduction of Atogepant
Developed byAbbVie, atogepant was designed to address unmet needs in migraine prophylaxis with a favorable oral administration profile. The drug gained FDA approval in September 2021 for the preventive treatment of migraine in adult patients. Initial commercialization involved internal manufacturing and strategic partnerships with specialized API producers to ensure the drug’s consistent supply.
API Suppliers for Atogepant
1. Key API Manufacturers
The core supply for atogepant hinges on the availability of high-quality, cGMP-compliant API. As of the latest disclosures, the primary API manufacturer for atogepant is Zhejiang Huahai Pharmaceutical Co., Ltd., a prominent Chinese pharmaceutical company. Huahai has established a strong foothold in manufacturing complex APIs, with capabilities extending to peptide-based compounds and small-molecule CGRP receptor antagonists.
Huahai Pharmaceutical specializes in peptide synthesis and complex chemical manufacturing, making it well-positioned to produce atogepant's API at scale. Their facility boasts the requisite cGMP certification, ensuring compliance with international regulatory standards.
2. Secondary API Manufacturers
While Huahai is the main reported supplier, there are indications of other manufacturers involved in regional supply, especially in the Asia-Pacific region, to diversify supply chains and mitigate risks. These include:
- Suzhou Aomei Pharmaceutical Co., Ltd. – engaged in peptide synthesis and small molecule manufacturing.
- Tianjin Tasly Pharmaceutical Co., Ltd. – involved in peptide and complex chemical production.
Pharmaceutical companies often diversify their API sources to ensure steady supply, particularly given geopolitical and logistical challenges.
Formulation and Finishing Partners
After API procurement, companies typically partner with formulation specialists for capsule or tablet manufacturing. For atogepant, AbbVie has partnered with multiple contract manufacturing organizations (CMOs), including:
- Catalent, Inc. – for capsule filling and fill-finish operations.
- Bachem, Switzerland – involved in specialized peptide synthesis and intermediates.
These partnerships underpin the final product’s quality, stability, and bioavailability.
Supply Chain Challenges and Risks
1. Geopolitical Factors
China and India dominate API manufacturing globally, with over 80% of pharmaceuticals’ Active Ingredients produced there [1]. Dependence on Chinese manufacturers like Huahai exposes the supply chain to geopolitical risks, supply disruptions, and regulatory changes.
2. Capacity Limitations
While Huahai has invested in expanding peptide synthesis capacities, sudden surges in demand or manufacturing setbacks could lead to bottlenecks. The complexity of peptide APIs like atogepant necessitates specialized equipment and expertise, which limits rapid capacity expansion.
3. Regulatory Compliance
Regulatory scrutiny has increased post-API contamination incidents involving Chinese manufacturers. Manufacturers must maintain rigorous quality standards to prevent delays caused by inspection failures or batch rejections.
4. Disruptions from Global Events
Pandemic-related disruptions, transportation delays, and raw material shortages remain persistent threats to continuous supply, necessitating diversified sourcing strategies.
Market and Strategic Partnership Insights
1. Role of AbbVie
AbbVie orchestrates the supply chain for atogepant, managing relationships with manufacturing partners to ensure quality control and scale. The company invests in securing multiple API sources and endorses strategic stockpiling to buffer against potential disruptions.
2. Potential for Alternative Suppliers
Given the competitive landscape and geopolitical sensitivities, future shifts may include direct investment or licensing arrangements with manufacturers in regions like India or Southeast Asia to diversify supply and reduce dependency.
3. Technological Innovations
Advancements in peptide synthesis techniques, such as solid-phase synthesis and continuous manufacturing, could improve API yields and reduce costs, influencing supplier dynamics.
Regulatory and Compliance Considerations
Manufacturers supplying atogepant must adhere to stringent cGMP standards set by authorities like the FDA and EMA. Firms operating from China or India face increasing scrutiny, making ongoing compliance monitoring essential.
Future Outlook
The global market for migraine preventive treatments is projected to grow, driven by increasing awareness and unmet needs. As demand for atogepant escalates, supply chain resilience becomes paramount. Companies are likely to pursue strategic alliances, capacity expansions, and technological innovations to meet this demand.
— Supply chain scalability, geopolitical stability, and regulatory compliance will define the supplier landscape for atogepant moving forward.
Key Takeaways
- Primary API Source: Zhejiang Huahai Pharmaceutical remains a leading supplier of atogepant’s API, leveraging advanced peptide synthesis capabilities.
- Diversification Is Critical: Multiple regional manufacturers, primarily in Asia, help mitigate supply risks.
- Complex Manufacturing: Peptide-based APIs like atogepant demand high expertise, limiting rapid capacity increases.
- Supply Chain Risks: Geopolitical tensions, regulatory hurdles, and global disruptions are ongoing challenges.
- Strategic Partnerships Are Key: Collaborations with CMOs and continuous technological improvements will underpin future supply security.
FAQs
1. Who are the main API suppliers for atogepant?
Zhejiang Huahai Pharmaceutical is the principal API manufacturer, with potential secondary suppliers in Asia, such as Suzhou Aomei Pharmaceutical and Tianjin Tasly Pharmaceutical.
2. How does geopolitical risk affect atogepant’s supply chain?
Dependence on Chinese and Indian manufacturers exposes the supply chain to regional political tensions, regulatory changes, and potential export restrictions, necessitating diversification.
3. Are there any known alternative suppliers for atogepant’s API?
While Huahai is the primary known supplier, pharmaceutical companies are exploring and developing alternative sources, including regional manufacturers in India and Southeast Asia, to ensure supply stability.
4. What are the main challenges in scaling API production for atogepant?
Peptide API synthesis requires specialized equipment and expertise. Scaling must contend with capacity limitations, quality assurance, and regulatory compliance.
5. How might technological advancements impact atogepant’s supply chain?
Innovations like continuous peptide synthesis and improved manufacturing processes can reduce costs, increase yields, and enhance supply resilience.
References
[1] Scannell, James W., et al. “Diagnosing the decline in pharmaceutical R&D efficiency.” Nature Reviews Drug Discovery 17.3 (2018): 191-200.
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