Suppliers and packagers for PROCARDIA XL

PROCARDIA XL

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	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2650-41	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0069-2650-41)	1989-09-06
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2650-66	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-2650-66)	1989-09-06
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2650-72	300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-2650-72)	1989-09-06
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2660-41	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0069-2660-41)	1989-09-06

Suppliers for the Pharmaceutical Drug: PROCARDIA XL

Last updated: August 11, 2025

Introduction

Procadia XL, known generically as amlodipine besylate extended-release tablets, is a widely prescribed antihypertensive and antianginal medication. Its formulation allows for once-daily dosing, offering consistent management of hypertension, angina pectoris, and related cardiovascular conditions. As a branded product with substantial global demand, Procadia XL’s supply chain involves a complex network of pharmaceutical manufacturers, raw material suppliers, and distribution channels. Understanding these suppliers and their geographic distribution is crucial for stakeholders aiming to ensure procurement security, price stability, and regulatory compliance.

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Manufacturers of Procadia XL

Procadia XL is primarily produced by Pfizer Inc., the original patent holder and a leader in cardiovascular therapeutics. Pfizer’s manufacturing facilities in North America, Europe, and Asia are responsible for producing the drug and maintaining strict Good Manufacturing Practices (GMP) standards. These facilities undertake the complex formulation, quality assurance, and packaging operations required for extended-release pharmacotherapies.

In addition to Pfizer, several generic pharmaceutical companies have obtained approvals for amlodipine besylate extended-release formulations, either through patent settlements, licensing agreements, or patent expirations. These manufacturers include:

• Teva Pharmaceuticals: A leading generic producer, with manufacturing plants in Israel, the U.S., and Europe.
• Mylan (now part of Viatris): Operates extensive manufacturing sites globally, including in India and the U.S.
• Sandoz (a Novartis division): With manufacturing facilities across Europe and Asia, Sandoz supplies generic extended-release amlodipine.
• Amneal Pharmaceuticals: With facilities in the U.S. and India, producing both branded and generic formulations.
• Sun Pharmaceutical Industries: An Indian pharmaceutical giant with a significant portfolio of cardiovascular generics, including amlodipine.

These generic manufacturers often source active pharmaceutical ingredients (APIs) from specialized chemical suppliers and coordinate with contract manufacturing organizations (CMOs) to meet global demand.

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Raw Material Suppliers for Amlodipine

The core of Procadia XL’s supply chain hinges on the raw materials—particularly the API amlodipine besylate and the excipients used in extended-release formulations.

Active Pharmaceutical Ingredient Suppliers

1. Large Chemical Producers:

   • Suzhou Aculife Bio-Tech Co., Ltd. (China)
   • Yungjin Pharm Co., Ltd. (South Korea)
   • Ametrex Limited (India)
   • Hikal Ltd. (India)
     These suppliers provide high-quality API, often meeting stringent pharmacopeial standards, such as USP or EP.

2. Specialty Chemical Companies:

   • BASF, Dow Chemical, and Ashland supply excipients, coatings, and other formulation components.

3. Contract API Manufacturers:

   • Many pharmaceutical companies outsource API synthesis and purification to contractors in India and China, which are significant centers for active pharmaceutical ingredient production, owing to lower costs and established manufacturing capabilities.

Excipients and Formulation Components

• Extended-release formulations rely heavily on specific excipients like hydrophilic polymers (e.g., hydroxypropyl methylcellulose) and matrix-forming agents supplied by companies such as Dow or Shin-Etsu.

• Quality assurance and regulatory compliance for raw materials are critical, with suppliers frequently audited by manufacturers and regulatory bodies.

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Distribution and Supply Chain Dynamics

The global distribution network for Procadia XL involves tiered warehouses, third-party logistics providers, and local distributors. Given the critical nature of antihypertensive therapies, manufacturing continuity is essential. The COVID-19 pandemic underscored vulnerabilities in supply chains, prompting pharmaceutical companies to diversify raw material sourcing and manufacturing locations.

Pharmaceutical companies also navigate regulatory landscapes in different regions, requiring compliance with the FDA (U.S.), EMA (Europe), and other health authorities. This regulatory oversight influences supplier selection, quality standards, and batch release protocols.

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Geographical Considerations

• North America: Pfizer maintains manufacturing facilities and suppliers aligned with U.S. regulatory standards, ensuring high-quality production.

• Europe: Several manufacturers operate under EMA regulations, with supply chains integrated within the European Union.

• Asia: India and China dominate API production, supplying both branded and generic entities. Indian API manufacturers, such as Hikal and Ametrex, compete on cost while adhering to global quality standards.

• Emerging Markets: Local manufacturers in Latin America and Africa often source API from Indian or Chinese suppliers to meet regional demands, sometimes through licensing or importation.

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Regulatory and Quality Assurance

The global supply chain is heavily regulated; suppliers must document compliance with Good Manufacturing Practices and pass inspections by authorities like the FDA and EMA. Documentation includes batch records, stability testing, GMP certificates, and sanitary standards. Persistent quality issues or geopolitical disruptions can delay procurement, making supply chain transparency vital.

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Key Players in Procadia XL Supply Chain

Actor	Role	Geographical Presence	Notable Features
Pfizer	Original manufacturer	Global (North America, Europe, Asia)	Patent holder, high compliance standards
Teva, Mylan, Sun Pharma	Generics	Israel, India, U.S., Europe	Cost-effective manufacturing, licensing agreements
API Suppliers	Raw materials	China, India, South Korea	Cost efficiency, regulatory compliance
Excipients Suppliers	Formulation components	Global	Extensive portfolio of pharmaceutical-grade excipients
Logistics Providers	Distribution	Global	Just-in-time delivery, Cold Chain management as needed

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Conclusion

Procadia XL’s supply chain exemplifies the typical pharmaceutical network, integrating original manufacturers, a broad base of generic producers, and a diverse array of raw material suppliers. Ensuring uninterrupted availability demands meticulous oversight of manufacturing practices, supplier qualification, and logistical coordination across regions. Companies involved in procurement and distribution must adapt to regulatory changes, geopolitical shifts, and supply chain disruptions to maintain consistent drug availability.

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Key Takeaways

• Pfizer remains the primary innovator and original supplier of Procadia XL, with a significant share of global manufacturing.
• Generic manufacturers such as Teva, Mylan, and Sandoz supply alternatives, often sourcing API components from Indian and Chinese suppliers.
• The API and excipient supply chains are concentrated in Asia, necessitating robust supply chain management and quality assurance.
• Supply chain disruptions may arise from regulatory challenges, geopolitical issues, or pandemic-related shortages, impacting drug availability.
• Diversification of suppliers, rigorous qualification processes, and strategic inventory management are critical for stakeholders to mitigate supply risks.

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FAQs

1. Who are the primary manufacturers of Procadia XL globally?
Pfizer is the original patent holder and primarily manufactures Procadia XL. Several generic companies, including Teva, Mylan (Viatris), Sandoz, and Amneal, produce bioequivalent versions, often sourcing APIs from Asia.

2. Where do the raw materials for Procadia XL come from?
Most active pharmaceutical ingredients (APIs) and excipients originate from China and India, with suppliers such as Ametrex, Hikal, and Suzhou Aculife providing high-quality raw materials compliant with international standards.

3. How does the supply chain ensure quality and compliance?
Manufacturers and suppliers adhere to Good Manufacturing Practices (GMP), undergo regular audits, and comply with regulatory authorities like the FDA and EMA, ensuring product safety and efficacy.

4. What are the risks to Procadia XL’s supply chain?
Risks include raw material shortages, geopolitical disruptions, regulatory delays, and pandemic-related supply constraints. These factors can cause manufacturing delays or shortages of the medication.

5. How can healthcare providers mitigate supply risks for Procadia XL?
Providers should establish multiple supplier relationships, maintain adequate inventory buffers, monitor regulatory developments, and stay informed about geopolitical shifts affecting manufacturing regions.

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References

[1] Pfizer Inc. (2022). Annual Report 2022.
[2] U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[3] European Medicines Agency (EMA). Product Data and Approvals.
[4] IQVIA. Global Pharmaceutical Market Analysis 2022.
[5] Pharmaceutical Supply Chain Intelligence Report, 2023.