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Suppliers and packagers for generic pharmaceutical drug: disopyramide phosphate
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disopyramide phosphate
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 |
| Dr Reddys Labs Sa | DISOPYRAMIDE PHOSPHATE | disopyramide phosphate | CAPSULE;ORAL | 070173 | ANDA | Mayne Pharma Commercial LLC | 51862-095-01 | 100 CAPSULE in 1 BOTTLE (51862-095-01) | 2022-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Disopyramide Phosphate
Introduction
Disopyramide phosphate is an antiarrhythmic medication primarily used to treat ventricular arrhythmias and certain types of atrial fibrillation. As a class IA sodium channel blocker, it helps stabilize cardiac electrical activity, reducing abnormal heartbeats. Access to reliable suppliers is vital for healthcare providers, pharmaceutical companies, and distributors ensuring consistent medication availability, regulatory compliance, and quality assurance. This article provides a comprehensive overview of key suppliers for disopyramide phosphate, elucidating their market presence, manufacturing capabilities, and strategic importance within the pharmaceutical supply chain.
Market Landscape and Regulatory Context
The global pharmaceutical market for antiarrhythmic agents is characterized by a limited number of manufacturers due to the complex synthesis processes, stringent regulatory requirements, and safety considerations surrounding cardiac medications. Disopyramide phosphate, though less frequently prescribed than alternatives like amiodarone or lidocaine, maintains a niche but critical role, necessitating a dedicated supplier network.
Regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national agencies enforce rigorous standards on manufacturing, purity, efficacy, and safety. Suppliers must comply with Good Manufacturing Practices (GMP) and secure the necessary Drug Master Files (DMFs) for international distribution.
Major Suppliers of Disopyramide Phosphate
1. Lupin Limited
Overview:
An Indian multinational pharmaceutical company, Lupin is recognized as a pivotal player in the production of generic cardiovascular medications, including disopyramide phosphate. The company's extensive R&D infrastructure and GMP-compliant manufacturing facilities enable it to supply products to global markets.
Capabilities:
- Manufacturing at scale with high-quality standards.
- Regulatory approvals across multiple regions, including FDA and EMA.
- Supply chain robustness through diverse distribution networks.
Strategic Position:
Lupin maintains a significant share of the generic antiarrhythmic market, leveraging cost-efficient production and consistent quality, making it a primary choice for bulk procurement.
2. Cipla Limited
Overview:
Cipla, an Indian pharmaceutical giant, offers a broad portfolio of cardiovascular and specialty drugs. It produces disopyramide phosphate as part of its antiarrhythmic class offerings.
Capabilities:
- Proven track record with international regulatory compliance.
- Dedicated manufacturing facilities with GMP certification.
- Ability to supply both small quantities and large batches.
Strategic Position:
Cipla's reputation for quality and reliable delivery makes it a key supplier, especially for regions emphasizing affordable generics.
3. Sandoz (Novartis Group)
Overview:
Sandoz specializes in generic pharmaceuticals and biosimilars, with a focus on cardiovascular agents. As a division of Novartis, it benefits from extensive R&D and manufacturing expertise.
Capabilities:
- Global distribution channels.
- Rigorous adherence to GMP standards.
- Supply assurance through diversified manufacturing sites.
Strategic Position:
Sandoz's global infrastructure enhances its capacity to supply disopyramide phosphate efficiently, often high in demand within North America and Europe.
4. Teva Pharmaceutical Industries Ltd.
Overview:
As one of the world's largest generic drug manufacturers, Teva produces a wide spectrum of cardiovascular medications, including antiarrhythmics like disopyramide phosphate.
Capabilities:
- Large-scale manufacturing with a focus on quality assurance.
- Extensive regulatory experience in Europe, North America, and emerging markets.
- Supply chain resilience.
Strategic Position:
Teva’s significant manufacturing footprint and reputation for quality make it a dependable supplier in the antiarrhythmic drug sector.
5. Zhejiang Huafon Pharmaceutical Co., Ltd.
Overview:
A Chinese pharmaceutical manufacturer, Zhejiang Huafon offers disopyramide phosphate primarily for domestic markets and select export channels.
Capabilities:
- Competitive manufacturing costs.
- Compliance with GMP standards for export.
- Growing presence in the Asian pharmaceutical supply chain.
Strategic Position:
While primarily serving Asia, Zhejiang Huafon is expanding its global footprint, providing an additional sourcing alternative amid regulatory and supply chain considerations.
Emerging and Niche Suppliers
Apart from the major players, several regional and emerging suppliers are gaining traction, especially in markets with growing demand for affordable cardiovascular medications. These include companies such as Hetero Labs (India), Aurobindo Pharma (India), and PharmaEssentia (South Korea). These firms focus on cost-effective manufacturing, ensuring availability for developing markets and supporting global supply diversification.
Key Considerations in Supplier Selection
- Regulatory Compliance: Suppliers must hold valid GMP certifications and meet regional regulatory standards.
- Manufacturing Capacity: Ensuring supply continuity, especially in times of increased demand or supply chain disruptions.
- Quality Assurance: Strict quality control processes are essential to maintain drug safety and efficacy.
- Price Competitiveness: Cost-effective sourcing to support affordable healthcare provision.
- Logistical Capabilities: Efficient distribution networks to facilitate timely delivery across markets.
Supply Chain Challenges and Opportunities
While established suppliers maintain reliable production, supply chain disruptions—such as those observed during global events like the COVID-19 pandemic—highlight the importance of diversification. Engaging with multiple suppliers mitigates risks related to manufacturing delays, regulatory hurdles, or geopolitical issues. Moreover, emerging suppliers, especially in Asia, offer opportunities for cost reduction and supply flexibility, provided they meet quality and regulatory standards.
Regulatory and Quality Assurance Trends
The increasing emphasis on quality standards, including serialization, traceability, and rigorous testing, influences supplier selection. Companies are seeking suppliers with validated manufacturing processes, comprehensive documentation, and compliance history. Certifications from authoritative agencies serve as key markers of credibility.
Conclusion
Ensuring consistent supply of disopyramide phosphate necessitates strategic sourcing from reputable manufacturers. Leading global suppliers such as Lupin, Cipla, Sandoz, Teva, and regional manufacturers like Zhejiang Huafon exemplify the diverse options available, each offering unique advantages in scale, quality, and cost. Organizations must evaluate suppliers based on regulatory compliance, manufacturing capacity, quality assurance, and logistical capabilities to maximize supply security and meet regulatory standards efficiently.
Key Takeaways
- Multiple reputable suppliers globally, predominantly in India, Europe, and China, supply disopyramide phosphate for domestic and international markets.
- Major manufacturers like Lupin, Cipla, Sandoz, and Teva dominate supply channels due to their large-scale production, regulatory compliance, and quality standards.
- Diversification of suppliers minimizes supply chain risks, especially amid geopolitical or pandemic-related disruptions.
- Regulatory adherence and quality assurance are critical factors in supplier selection, requiring thorough vetting and validation.
- Emerging regional manufacturers offer cost-effective alternatives, supporting markets with budget-conscious healthcare systems.
FAQs
1. Is disopyramide phosphate available from generic manufacturers?
Yes. Several generic manufacturers, including Lupin, Cipla, Teva, and Sandoz, produce disopyramide phosphate, ensuring availability across various markets.
2. What factors influence the choice of a disopyramide phosphate supplier?
Regulatory compliance, manufacturing capacity, product quality, price, and logistics are key factors in selecting a supplier.
3. Are there regional differences in supplier availability for disopyramide phosphate?
Yes. While Indian and European companies are primary suppliers globally, regional manufacturers in Asia may predominantly serve local markets, with some expanding internationally.
4. How do regulatory certifications impact supplier credibility?
Certifications such as GMP, FDA approval, and EMA compliance validate manufacturing standards, ensuring product safety, efficacy, and quality.
5. What challenges exist in the supply chain for disopyramide phosphate?
Challenges include manufacturing delays, regulatory hurdles, geopolitical tensions, and raw material shortages, which necessitate supplier diversification and proactive supply chain management.
References
- [1] Global pharmaceutical market analyses and regulatory guidelines on antiarrhythmic drugs.
- [2] Company websites and official certifications of Lupin Limited, Cipla Limited, Sandoz, Teva, Zhejiang Huafon.
- [3] Industry reports on pharmaceutical supply chains and supplier evaluations.
- [4] Regulatory body publications on GMP standards and drug approval processes.
- [5] Recent market insights on generic antiarrhythmic drug manufacturing and distribution.
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