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Suppliers and packagers for NORPACE CR
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NORPACE CR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | NORPACE CR | disopyramide phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 018655 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-2732-31 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31) | 1982-07-20 |
| Pfizer | NORPACE CR | disopyramide phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 018655 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-2742-31 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2742-31) | 1982-07-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NORPACE CR
Introduction
NORPACE CR, the controlled-release formulation of disopyramide phosphate, is an antiarrhythmic medication used primarily to treat ventricular arrhythmias and other cardiac rhythm disorders. Marketed globally, NORPACE CR's supply chain is intricate, involving a range of pharmaceutical manufacturers, API (Active Pharmaceutical Ingredient) suppliers, and contract manufacturing organizations. Ensuring a reliable supply of NORPACE CR is crucial for healthcare providers and pharmaceutical companies aiming to deliver consistent patient care.
Manufacturers of NORPACE CR
1. Mylan (Now part of Viatris)
Mylan, acquired by Viatris in 2020, has historically been a significant manufacturer and distributor of NORPACE CR. The company operates multiple manufacturing facilities globally, adhering to strict Good Manufacturing Practices (GMP). Mylan's global footprint enables the distribution of NORPACE CR across North America, Europe, and other markets.
2. Pfizer
Pfizer’s involvement in antiarrhythmic drugs includes licensing and manufacturing partnerships for disopyramide formulations. While Pfizer primarily markets other cardiac medications, it has historically supplied NORPACE CR through licensing agreements and contract manufacturing.
3. Local and Regional Manufacturers
In various countries, local pharmaceutical firms have obtained manufacturing licenses for NORPACE CR, either through direct licensing arrangements or through local regulatory approvals of imported finished products. Examples include companies in India, China, and European nations that produce generic versions under regional licenses.
Active Pharmaceutical Ingredient (API) Suppliers
The reliability of NORPACE CR depends heavily on the quality and stability of disopyramide phosphate API supplies. Major API manufacturers are located predominantly in Asia, reflecting the global API supply chain landscape.
1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A prominent supplier of disopyramide API, Zhejiang Hisun Pharmaceutical supplies APIs to various pharmaceutical firms globally. Their production complies with international standards, including GMP and ISO certifications.
2. Shanghai Chemical Pharmaceutical Co., Ltd. (China)
This Chinese manufacturer produces high-purity disopyramide API used by multiple pharmaceutical companies for formulation development, including controlled-release applications.
3. Indian API Manufacturers
India’s API sector, certified by the Central Drugs Standard Control Organization (CDSCO), supplies disopyramide API to several finished drug manufacturers. Companies such as Hetero Drugs and Aurobindo Pharma have capabilities for producing disopyramide API at scale.
4. European API Suppliers
A smaller but notable segment includes European API manufacturers adhering to strict European Medicines Agency (EMA) standards, providing high-quality APIs to European finished drug manufacturers.
Contract Manufacturing Organizations (CMOs)
The production of NORPACE CR, particularly its controlled-release formulation, necessitates specialized formulation expertise. CMOs serving this segment include:
1. Catalent
A global leader in drug development and manufacturing, Catalent produces controlled-release formulations and has expertise in complex dosage forms, including NORPACE CR.
2. Patheon (Thermo Fisher Scientific)
Patheon offers formulation development and manufacturing services for controlled-release pharmaceuticals, with experience in producing generic formulations like NORPACE CR for various markets.
3. in-house facilities of major pharmaceutical companies
Pharmaceutical giants like Mylan and Pfizer often manage formulation and production within their own facilities, leveraging their R&D pipelines and manufacturing expertise.
Supply Chain Considerations
- Regulatory Compliance: Suppliers must comply with cGMP standards to ensure quality, safety, and efficacy. Regulatory approvals from agencies such as the FDA, EMA, and PMDA govern global suppliers.
- Quality Assurance: The manufacturing process emphasizes rigorous quality control from raw API sourcing to finished product packaging.
- Supply Stability: Disruptions, whether due to geopolitical issues, pandemics, or raw material shortages, can impact NORPACE CR availability.
- Patent and Licensing Agreements: PATents and licensing agreements significantly influence the entry of generic versions, affecting the competitive landscape.
Market Dynamics and Recent Developments
The global market for antiarrhythmic drugs like NORPACE CR is influenced by factors including clinical guidelines, patent expirations, and regional approval statuses. Notably:
- Several regional authorities have authorized generic versions corresponding to NORPACE CR, expanding supply options.
- The recent trend toward biosimilars and generics increases competition among API suppliers and finished product manufacturers.
- Supply chain resilience schemes and diversification of API sourcing are increasingly prioritized to mitigate unforeseen disruptions.
Regulatory and Geographical Considerations
- Regulatory approvals for NORPACE CR vary among regions, influencing the supplier landscape.
- The US FDA, EMA, and other authorities oversee manufacturing standards, impacting international supplier acceptance.
- Countries like India and China serve as key API hubs, with their suppliers often supplying to multinational pharmaceutical companies.
Key Challenges in Supplier Management
- Ensuring consistent API quality amid geopolitical shifts.
- Navigating patent landscapes and licensing constraints.
- Managing lead times and logistical complexities, especially in post-pandemic supply chain scenarios.
- Verifying compliance with evolving regulatory standards across jurisdictions.
Conclusion
The supply of NORPACE CR hinges on a broad ecosystem of global API manufacturers, contract manufacturers, and licensed pharmaceutical producers. The predominant API suppliers in China and India, combined with established contract manufacturing expertise, support the broad availability of NORPACE CR worldwide. Strategic diversification, rigorous quality controls, and adherence to regulatory standards remain paramount to ensuring a stable and compliant supply chain for this critical antiarrhythmic agent.
Key Takeaways
- Major API suppliers for disopyramide phosphate include Zhejiang Hisun Pharmaceutical (China), Shanghai Chemical Pharmaceutical (China), and Indian API manufacturers such as Hetero and Aurobindo.
- Leading finished product manufacturers collaborating with CMOs include Mylan (Viatris), Pfizer, and regional generic producers.
- Ensuring compliance with GMP and regulatory approvals is critical to supply stability.
- Geopolitical factors, regulatory changes, and pandemic-induced logistics disruptions pose ongoing supply chain risks.
- Diversification of suppliers and strategic inventory management are essential to mitigate supply interruptions.
FAQs
1. Are there patented restrictions on NORPACE CR production?
Yes. Patent protections and licensing agreements influence the manufacturing rights and market availability of NORPACE CR. Once patents expire, generic versions proliferate, increasing supply options.
2. Which countries are primary API sources for disopyramide?
China and India dominate as primary API manufacturing hubs, providing high-quality disopyramide phosphate to global pharmaceutical companies.
3. Is NORPACE CR available from multiple suppliers worldwide?
Currently, NORPACE CR is predominantly supplied by a few key manufacturers and licensed producers, with regional variations in availability.
4. How do regulatory standards impact NORPACE CR supply?
Regulatory compliance ensures API and finished product quality, influencing which suppliers are authorized in different markets; deviations can impact supply chains.
5. What strategies can companies adopt to secure NORPACE CR supply?
Diversifying supplier bases, maintaining strategic inventories, engaging in long-term supply agreements, and monitoring regulatory changes are best practices for supply security.
Sources:
[1] U.S. Food and Drug Administration (FDA) Drug Approvals and Manufacturing Data.
[2] Chinese pharmaceutical industry reports, 2022.
[3] Indian pharmaceutical APIs sector overview, 2022.
[4] Market analysis reports on antiarrhythmic drugs, 2023.
[5] Regulatory agency guidelines, EMA and CDSCO.
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