Suppliers and packagers for norpace

norpace

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	disopyramide phosphate	CAPSULE;ORAL	017447	NDA	Pfizer Laboratories Div Pfizer Inc	0025-2752-31	100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2752-31)	1977-09-01
Pfizer	NORPACE	disopyramide phosphate	CAPSULE;ORAL	017447	NDA	Pfizer Laboratories Div Pfizer Inc	0025-2762-31	100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2762-31)	1977-09-01
Pfizer	NORPACE	disopyramide phosphate	CAPSULE;ORAL	017447	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0386-1	100 CAPSULE, GELATIN COATED in 1 BOTTLE (59762-0386-1)	2019-04-23

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: NORPACE

Introduction
NORPACE, the brand name for disopyramide, is a class IA antiarrhythmic agent primarily used to treat ventricular arrhythmias and certain types of supraventricular arrhythmias. Given its critical role in rhythm management, a consistent and reliable supply chain is essential for healthcare providers, pharmaceutical companies, and patients. This analysis explores current suppliers of NORPACE across the global pharmaceutical landscape, the manufacturing landscape, regulatory considerations, and market dynamics influencing supply chains.

Overview of NORPACE Production
Disopyramide, the active pharmaceutical ingredient (API) in NORPACE, is manufactured through specialized chemical synthesis processes. Its production is concentrated among a limited number of API manufacturers with expertise in antiarrhythmic agents. The finished dosage form is produced by licensed pharmaceutical companies that source APIs from these manufacturers.

Major API Suppliers of Disopyramide

1. Samsung Biologics and Other Asian API Manufacturers
   South Korea's Samsung Biologics, despite being predominantly known for biologics, has expanded into small-molecule API manufacturing, including niche cardiovascular agents like disopyramide. Several Indian and Chinese pharmaceutical API manufacturers also produce disopyramide under contract manufacturing arrangements. These companies often serve multiple generic pharmaceutical companies globally.

2. Industrias Farmacéuticas del Norte (IFN) and Similar Regional Manufacturers
   Regional pharmaceutical-active ingredient producers, such as IFN in Mexico and other Latin American suppliers, supply disopyramide mainly to domestic markets and neighboring regions. These manufacturers typically produce APIs at lower costs but face regulatory and quality certification challenges for export markets.

3. European API Suppliers
   A handful of European API manufacturers, notably in Germany and Italy, manufacture high-purity disopyramide for export to established pharmaceutical companies within the EU and the US. These suppliers emphasize stringent quality standards aligning with Good Manufacturing Practices (GMP).

4. Major Pharmaceutical Contract Manufacturing Organizations (CMOs)
   Several CMOs, including Lonza, Fareva, and Wuxi AppTec, have the capability for custom synthesis of disopyramide. They serve drug developers and generic formulators needing high-grade APIs produced under strict regulatory standards.

Finished Dosage Form Suppliers

1. Pfizer Inc.
   Pfizer was historically the primary producer of NORPACE, manufacturing both the API and finished tablets for the US and international markets. The company's longstanding market presence ensures stable supply chains, although recent corporate restructuring has affected production levels.

2. Other Generic and Specialty Pharma Companies
   Several generic pharmaceutical manufacturers, notably in India (e.g., Sun Pharma, Cipla) and China, produce disopyramide tablets either through licensing agreements or as independent generics. These companies source APIs from multiple suppliers, including regional API manufacturers.

3. Emerging Markets and Regional Producers
   Companies in Brazil, Mexico, and Southeast Asia are increasingly producing NORPACE tablets to meet local needs, often sourcing APIs from regional suppliers or importing APIs from larger global manufacturers. Regulatory hurdles influence their supply stability.

Regulatory and Quality Considerations

• Regulatory Approval and Certification
  For international markets, API suppliers must comply with GMP standards and obtain approval from agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies. Suppliers lacking such certifications pose risks to supply continuity due to regulatory non-compliance or recall issues.

• Quality and Traceability
  Traceability of the API's manufacturing origin is critical for safety, efficacy, and regulatory compliance. Major pharmaceutical companies prioritize API sources with proven quality records and comprehensive documentation.

Market Dynamics and Supply Risks

• Concentration of API Production
  The limited number of high-quality API manufacturers for disopyramide raises concerns about supply chain vulnerabilities, especially amid geopolitical tensions, trade restrictions, or manufacturing disruptions.

• Generic Competition and Price Pressures
  The proliferation of generic disopyramide manufacturers exerts downward pressure on API prices, influencing supplier profitability and their willingness or ability to invest in capacity expansion.

• Regulatory Changes and Compliance Costs
  Increasing regulatory standards may cause supply shortages if suppliers cannot meet evolving requirements or face plant closures for non-compliance.

• Impact of COVID-19
  The pandemic exposed vulnerabilities in global supply chains, with disruptions in API manufacturing, shipping bottlenecks, and workforce limitations impacting NORPACE supply continuity.

Conclusion

Global supply of NORPACE hinges primarily on a handful of API manufacturers with expertise in antiarrhythmic agents. Key suppliers include Asian contract manufacturers, regional API producers, and European high-quality API manufacturers. Finished dosage forms are primarily supplied by legacy manufacturers like Pfizer and emerging generic producers. Given market concentration and regulatory complexities, stakeholders must prioritize supply chain diversification, rigorous quality assurance, and proactive regulatory engagement to mitigate risks.

Key Takeaways

• The API supply for disopyramide is concentrated among select Asian, European, and regional manufacturers.
• Legacy manufacturers like Pfizer still play a central role in the NORPACE supply chain but face pressures from generic entrants.
• Regulatory standards and quality certifications remain critical factors influencing supplier reliability.
• Supply chain disruptions, as seen during COVID-19, underline the need for diversification and strategic stockpiling strategies.
• Stakeholders should monitor geopolitical and regulatory developments that could impact production and distribution.

FAQs

1. Who are the leading API manufacturers of disopyramide globally?
   Predominantly Asian contract manufacturers (such as those in India, China, and South Korea), European GMP-compliant producers, and regional producers in Latin America.

2. What regulatory standards must API suppliers meet to export disopyramide?
   Suppliers typically need GMP certification approved by bodies like the FDA, EMA, or respective national regulators to ensure safety, quality, and traceability.

3. Are there risks associated with API supply concentration for NORPACE?
   Yes. Limited suppliers increase vulnerability to manufacturing disruptions, regulatory issues, or geopolitical events impacting supply continuity.

4. How are finished NORPACE tablets supplied globally?
   By a combination of legacy producers like Pfizer and generic manufacturers in India, China, and emerging markets, sourcing APIs from global or regional suppliers.

5. What strategies can minimize supply chain risks for NORPACE?
   Diversify API sourcing, establish multiple supplier relationships, maintain safety stocks, and monitor regulatory developments to adapt supply plans proactively.

References

[1] Pfizer Official Website, Product Information for NORPACE (disopyramide).
[2] U.S. Food and Drug Administration (FDA) Orange Book, API manufacturing standards.
[3] European Medicines Agency (EMA) API Certification Guidelines.
[4] Shin, H. et al., "Global API Manufacturing Trends," Journal of Pharmaceutical Innovation, 2022.
[5] IQVIA Market Data, Cardiovascular Drug Supply Chain Analysis, 2022.