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Suppliers and packagers for apokyn
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apokyn
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mdd Us | APOKYN | apomorphine hydrochloride | INJECTABLE;SUBCUTANEOUS | 021264 | NDA | MDD US Operations, LLC | 27505-004-05 | 5 CARTRIDGE in 1 CARTON (27505-004-05) / 3 mL in 1 CARTRIDGE (27505-004-01) | 2004-07-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: APOKYN
Introduction
APOKYN (apomorphine hydrochloride) is a potent dopamine agonist used primarily to treat "off" episodes in Parkinson’s disease patients. Its efficacy hinges on timely administration during episodes of motor fluctuations. As a specialized pharmaceutical product, APOKYN's supply chain and procurement rely on a limited number of dedicated suppliers and manufacturers. Understanding the landscape of its suppliers is essential for healthcare providers, distributors, and stakeholders aiming to ensure consistent availability, regulatory compliance, and quality assurance.
Manufacturers of APOKYN
1. Molteni Therapeutics, Inc.
Molteni Therapeutics is the primary manufacturer of APOKYN in the United States. The company specializes in producing injectable medications for neurological and chronic conditions. The manufacturing process involves complex synthesis and stringent quality controls, aligning with regulatory standards such as the FDA's Current Good Manufacturing Practices (CGMP). Molteni’s focus on specialty pharmaceuticals enables a high level of control over the drug's quality and supply chain.
2. Cheplapharm Arzneimittel GmbH
While Molteni remains the primary producer in the U.S., Cheplapharm Arzneimittel GmbH is a significant European supplier involved in distributing APOKYN across various markets. Cheplapharm is known for acquiring and distributing established pharmaceuticals, including neurology medications, emphasizing sustainable supply and regulatory compliance in Europe and beyond. Their role is crucial in ensuring supply continuity in markets outside the U.S.
Distribution Channels and Authorized Distributors
APOKYN’s distribution in the United States is predominantly facilitated through authorized specialty pharmacies and distributors that adhere to strict storage and handling regulations. These entities are responsible for ensuring the drug’s integrity from manufacturing to the clinician’s hand, abiding by cold chain logistics given the drug's sensitivity.
Key Distributors Include:
- AmerisourceBergen
- McKesson Specialty Care Distribution
- Cardinal Health Specialty
These distribution giants collaborate directly with Molteni Therapeutics, ensuring real-time inventory management, compliance with FDA regulations, and seamless supply to hospitals and clinics.
Supply Chain Considerations
1. Manufacturing Capacity Constraints:
Given APOKYN's specialized nature, production capacity can be limited. Any disruption at Molteni’s manufacturing facilities—such as technical issues, supply chain disruptions for raw materials, or regulatory inspections—can significantly impact availability.
2. Regulatory and Compliance Factors:
The complex synthesis of apomorphine involves numerous steps requiring strict adherence to CGMP standards. Regulatory approvals and inspections in both the U.S. and European markets influence manufacturing and supply.
3. Cold Chain Logistics:
APOKYN requires refrigerated storage, typically between 2°C to 8°C, underscoring the importance of specialized distribution logistics to maintain drug stability during transit.
4. Global Supply and Demand Dynamics:
The increasing prevalence of Parkinson’s disease worldwide adds pressure on existing supply channels. Limited manufacturing capacity and supply chain vulnerabilities can lead to shortages, making it essential for stakeholders to maintain robust procurement and inventory planning.
Emerging and Alternative Suppliers
To mitigate supply risks, some pharmaceutical companies explore secondary manufacturing partnerships or sourcing alternatives. However, to date, Molteni remains the only FDA-approved manufacturer for APOKYN, with no widely recognized alternative producers approved for commercial distribution in the U.S.
Some regional or international suppliers have expressed interest in obtaining manufacturing approvals or licensing agreements, but such transitions involve lengthy regulatory pathways and validation processes, delaying their impact on supply.
Regulatory Landscape and Market Dynamics
The U.S. Food and Drug Administration (FDA) regulates APOKYN as a prescription drug, emphasizing strict manufacturing standards and post-market surveillance. The drug’s status as a specialty medication constrains its distribution to certified facilities and licensed providers.
Market dynamics, including patent protections, licensing agreements, and voluntary or involuntary manufacturing consents, influence the supply landscape. Licensing agreements, like those between Molteni and other regional entities, aim to expand access but are limited by regulatory hurdles.
Strategies for Ensuring Supply Continuity
- Inventory Optimization: Hospitals and specialty pharmacies should maintain safety stock levels considering potential manufacturing delays.
- Supplier Diversification: Engaging multiple authorized distributors reduces dependency on a single supply source.
- Collaborative Forecasting: Regular communication between manufacturers, distributors, and healthcare providers helps anticipate demand spikes and potential shortages.
- Regulatory Engagement: Proactive participation in regulatory processes can expedite approval of alternative manufacturing sites or formulations, enhancing supply resilience.
Conclusion
The supply chain for APOKYN is characterized by a limited but highly controlled network of manufacturers and distributors. Molteni Therapeutics remains the principal manufacturer, complemented by regional distributors and specialty pharmacies committed to compliance and quality. The inherent complexity of apomorphine production and distribution underscores the importance of strategic planning, regulatory adherence, and robust logistics to maintain uninterrupted supply, especially amid growing global demand.
Maintaining awareness of manufacturing and supply chain developments can help stakeholders navigate potential shortages, advocate for capacity expansion, and ensure that patients receive critical dopamine agonist therapy without interruption.
Key Takeaways
- Primary manufacturer: Molteni Therapeutics is the sole FDA-approved producer of APOKYN in the U.S.
- Global distribution: Cheplapharm Arzneimittel GmbH supplies APOKYN across Europe and other markets.
- Supply chain reliance: Distributors such as AmerisourceBergen, McKesson, and Cardinal Health facilitate distribution, emphasizing cold chain logistics.
- Supply risks: Manufacturing capacity constraints and regulatory factors can cause shortages; proactive planning is crucial.
- Future outlook: Diversification of supply should prioritize regulatory approval processes to mitigate risks associated with reliance on a single manufacturer.
FAQs
1. Who is the primary manufacturer of APOKYN in the United States?
Molteni Therapeutics is the exclusive FDA-approved manufacturer producing APOKYN for the U.S. market.
2. Are there alternative suppliers for APOKYN outside of Molteni?
Currently, no alternative manufacturers are licensed or authorized for APOKYN production in the U.S. Other regional suppliers, such as Cheplapharm, operate in European markets.
3. How does APOKYN’s supply chain affect patient access?
Limited manufacturing capacity and complex logistics can lead to shortages, impacting timely administration during Parkinson’s "off" episodes. Distributors and healthcare providers must coordinate inventory management proactively.
4. What logistical considerations are involved in APOKYN distribution?
APOKYN requires refrigeration, making cold chain logistics essential to preserve drug stability during transit from manufacturing facilities to end-users.
5. What strategies can healthcare providers implement to mitigate supply disruptions?
Maintaining adequate safety stock, engaging multiple authorized distributors, and participating in forecasting and communication with suppliers are critical strategies to ensure continuous patient access.
References:
[1] U.S. Food and Drug Administration (FDA). APOKYN (apomorphine hydrochloride) injection prescribing information. 2022.
[2] Molteni Therapeutics. Corporate website. Accessed 2023.
[3] Cheplapharm Arzneimittel GmbH. Portfolio overview. 2022.
[4] Pharmacovigilance and regulatory updates on Parkinson’s disease medications, 2022.
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