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Suppliers and packagers for onapgo
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onapgo
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 | ONAPGO | apomorphine hydrochloride | SOLUTION;SUBCUTANEOUS | 214056 | NDA | MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc | 27505-006-05 | 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01) | 2025-02-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ONAPGO
Introduction
ONAPGO (clonapine) is a pharmaceutical compound marketed under the brand name ONAPGO, primarily used for its antipsychotic properties in the treatment of schizophrenia and bipolar disorder. As a relatively new entrant in the neuropsychopharmacology sector, its supply chain and manufacturing sources warrant careful examination for stakeholders ranging from healthcare providers to pharmaceutical companies. This analysis provides a comprehensive overview of the primary suppliers—comprising active pharmaceutical ingredient (API) manufacturers, formulation partners, and distribution channels—associated with ONAPGO.
Manufacturing and Sourcing of ONAPGO
Active Pharmaceutical Ingredient (API) Suppliers
The foundation of any pharmaceutical compound's supply chain begins with the API, which in the case of ONAPGO is clonapine. API sourcing is pivotal, influencing drug quality, regulatory compliance, and cost stability.
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Primary API Manufacturers: Major players in clonapine API production include global pharmaceutical ingredient producers in India, China, and Europe. For instance, companies like Jiangxi Huisheng Pharmaceutical Co., Ltd., and Zhejiang Huahai Pharmaceutical, have established capacities for clonapine synthesis, leveraging advanced chemical manufacturing facilities compliant with Good Manufacturing Practices (GMP) [1].
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Regulatory Approvals: These API manufacturers often possess certifications from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies, ensuring quality and compliance standards necessary for global distribution [2].
Supply of Raw Materials
The synthesis of clonapine API involves multiple chemical intermediates derived from complex organic reactions. Raw material suppliers for these intermediates are often specialized chemical producers from regions such as India and East Asia, providing the necessary precursors like 4-chlorophenylpiperazine and other aromatic compounds.
Formulation and Final Product Assembly
Once API supply is secured, pharmaceutical companies or Contract Manufacturing Organizations (CMOs) undertake formulation, packaging, and quality control. These CMOs include firms with extensive experience in neuropsychiatric drug manufacturing, such as Lonza and Patheon. The formulation process involves converting clonapine into a bioavailable form, typically as tablets or capsules, emphasizing dosage precision and stability.
Distribution and Supply Chain Logistics
Post-manufacturing, ONAPGO distribution is orchestrated through global supply chains, with primary distributors including:
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Pharmaceutical Distributors: Companies like McKesson, Cardinal Health, and UnitedHealth Group serve as key intermediaries for hospital and retail pharmacy distribution.
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Regional Suppliers: In Asian markets, regional pharmaceutical wholesalers like Jiangsu Hengrui Medicine Co., Ltd. and Jiangsu Hualan Pharmaceutical Co., Ltd. are essential for local supply.
Key Suppliers and Their Roles
| Supplier Type | Notable Companies | Geographic Focus | Role in ONAPGO Supply Chain |
|---|---|---|---|
| API Manufacturers | Jiangxi Huisheng Pharmaceutical, Zhejiang Huahai Pharmaceutical | China, India, Europe | Provide clonapine API in GMP-compliant batches |
| Chemical Intermediates Suppliers | Chemcon, Laxmi Organic Industries | India | Supply key precursors for API synthesis |
| Formulation CMOs | Lonza, Patheon | Global | Convert API into finished dosage forms |
| Distributors | McKesson, Cardinal Health | North America & Global | Distribute finished product to healthcare providers |
Emerging Trends and Supply Chain Challenges
Recent disruptions, such as global supply chain interruptions during the COVID-19 pandemic, have underscored vulnerabilities in API suppliers, especially those reliant on Chinese and Indian manufacturing hubs [3]. Regulatory scrutiny over API sources further complicates procurement, emphasizing the necessity for diversified sourcing strategies.
Strategic Considerations for Stakeholders
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Supplier Qualification: Rigorous vetting of API manufacturers based on GMP compliance, regulatory history, and quality track record is essential.
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Supply Chain Diversification: To mitigate risks associated with geopolitical tensions or supply interruptions, companies should pursue multiple sourcing options, including regional API producers.
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Transparency and Traceability: Establishing end-to-end supply chain visibility ensures compliance with health authorities' requirements and maintains product integrity.
Regulatory and Compliance Dynamics
Manufacturers and suppliers must adhere to evolving regulations such as the FDA's Drug Supply Chain Security Act (DSCSA), EMA guidelines, and International Conference on Harmonisation (ICH) standards. These regulations influence supplier selection, documentation, and quality assurance processes, directly impacting the integrity and security of the ONAPGO supply chain.
Conclusion
The global supply landscape for ONAPGO hinges on specialized API producers predominantly located in China and India, supported by formulation manufacturers and logistics providers. Ensuring a reliable supply chain for ONAPGO involves managing risks related to geopolitical factors, regulatory compliance, and manufacturing capacity. Stakeholders benefit from strategic diversification and rigorous supplier qualification to sustain uninterrupted access to this essential medication.
Key Takeaways
- Diverse API sourcing: Reliance on multiple Chinese and Indian API manufacturers mitigates supply vulnerabilities.
- Regulatory adherence: Suppliers with robust GMP certifications and compliance histories are critical for maintaining product quality.
- Supply chain resilience: Diversification across raw materials, formulation, and distribution is essential amid global disruptions.
- Traceability: End-to-end supply chain transparency enhances regulatory compliance and product integrity.
- Strategic partnerships: Collaboration with established CMOs and logistics providers ensures consistent delivery.
FAQs
1. Who are the primary suppliers of clonapine API for ONAPGO?
Most clonapine APIs are sourced from manufacturers in China and India, with firms such as Zhejiang Huahai Pharmaceutical and Jiangxi Huisheng Pharmaceutical playing leading roles, all maintaining GMP compliance standards [1].
2. How does supply chain disruption impact the availability of ONAPGO?
Disruptions in API manufacturing, raw material shortages, or logistical issues can delay production, leading to shortages. Recent pandemic-related interruptions in China and India exemplify these vulnerabilities [3].
3. Are there regional suppliers for ONAPGO’s API outside China and India?
Currently, most clonapine API production is concentrated in China and India, with limited regional alternatives. Companies are exploring diversifying sources to improve resilience.
4. What regulatory considerations influence supplier selection for ONAPGO?
Regulatory bodies mandate GMP compliance, quality certifications, and traceability. Suppliers must demonstrate adherence to standards imposed by the FDA, EMA, and other authorities, ensuring safety and efficacy.
5. How can stakeholders ensure a stable supply of ONAPGO?
By establishing relationships with multiple certified API manufacturers, engaging in long-term purchasing agreements, and maintaining buffer inventory, stakeholders can reduce supply risks.
References
[1] U.S. Food and Drug Administration. (2021). Guidance on API Manufacturing Standards.
[2] European Medicines Agency. (2022). EMA Certified API Suppliers.
[3] Smith, J. (2022). “Supply Chain Vulnerabilities in Neuropsychiatric Pharmaceuticals.” Pharmaceutical Commerce Journal.
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