Suppliers and packagers for generic pharmaceutical drug: NISOLDIPINE

NISOLDIPINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	091001	ANDA	Mylan Pharmaceuticals Inc.	0378-2096-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2096-01)	2011-01-28
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	091001	ANDA	Mylan Pharmaceuticals Inc.	0378-2097-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01)	2011-01-28
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	091001	ANDA	Mylan Pharmaceuticals Inc.	0378-2098-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2098-01)	2011-01-28

Suppliers for the Pharmaceutical Drug: Nisoldipine

Last updated: July 30, 2025

Introduction

Nisoldipine, a calcium channel blocker used primarily in the treatment of hypertension and angina pectoris, is a well-established pharmaceutical. As a potent antihypertensive agent, its global supply chain comprises a network of manufacturers, generic drug producers, and authorized suppliers. Understanding the key players involved in the production and distribution of nisoldipine is crucial for healthcare providers, pharmaceutical companies, and policymakers aiming to ensure drug availability, quality, and compliance with regulatory standards.

Manufacturers and Original Developers

The origin of nisoldipine dates to the mid-1980s when its chemical synthesis was developed to improve cardiovascular disease management. Originally, pharmaceutical giants such as Ciba-Geigy (now part of Novartis) pioneered the commercial production of nisoldipine. Novartis, as the original innovator, held early patents and marketed the drug under brand names such as Sular or Sular XR in various markets. These original developers laid the foundation for subsequent manufacturing and licensing agreements.

Generic Manufacturers and Global Suppliers

Following patent expirations—primarily in the early 2000s—nisoldipine became available as a generic medication, leading to a diversified manufacturing landscape. Generic companies now dominate the supply chain, offering cost-effective alternatives to branded formulations. Prominent generic suppliers include:

• Teva Pharmaceutical Industries Ltd. (Israel): As one of the world's largest generic drug manufacturers, Teva produces nisoldipine tablets supplied across multiple continents. Their manufacturing facilities adhere to stringent Good Manufacturing Practice (GMP) standards, ensuring product quality and regulatory compliance.

• Mylan N.V. / Viatris (USA): Mylan, now integrated into Viatris, supplies nisoldipine as part of their extensive portfolio of cardiovascular generics. Their global distribution network ensures broad availability in North America, Europe, and emerging markets.

• Sandoz (a Novartis division) (Switzerland): Sandoz offers nisoldipine in various formulations and maintains manufacturing facilities aligned with high safety and quality standards.

• Haupt Pharma (Germany): Known for supplying active pharmaceutical ingredients (API), Haupt Pharma produces the nisoldipine API for various finished drug manufacturers, contributing significantly to global supply.

• Zhejiang Hanzhong Pharmaceutical Co., Ltd. (China): A key API producer in China, their facilities supply raw materials to generic drug makers worldwide, with increasing export footprints attributed to China's expanding pharmaceutical manufacturing capacity.

API Suppliers and Raw Material Producers

The quality of nisoldipine drugs heavily relies on reliable API suppliers. China and India are the primary sources for nisoldipine API, with several firms specializing in advanced chemical synthesis and API manufacturing. These include:

• Shandong Taihe Pharmaceutical Co., Ltd. (China)
• Shenzhen South China Pharmaceutical Co., Ltd. (China)
• Torrent Pharmaceuticals Ltd. (India): While primarily a finished dosage form manufacturer, Torrent also produces API for internal use and external licensing.

Regional Market Dynamics

• North America: Dominated by Mylan, Teva, and Novartis (through Sandoz), with robust regulatory oversight ensuring supply reliability. Excellet relationships with regulatory authorities like the FDA guarantee compliance and product quality.

• Europe: Led by Novartis, Sandoz, and Haupt Pharma, European suppliers benefit from the EU’s centralized regulatory framework, facilitating seamless distribution.

• Asia: China and India serve as manufacturing hubs for API production, with increasing reliance on regional generics. Regulatory variations, however, can impact market access and supply chains.

Regulatory Considerations

Suppliers must adhere to stringent quality standards laid out by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and equivalents in other jurisdictions. API manufacturers are often required to pass rigorous inspections and obtain certifications like the Certificate of Suitability (CEP) from the European Pharmacopoeia or the Drug Master File (DMF) in the U.S. to ensure regulatory compliance of their APIs.

Supply Chain Challenges

Factors influencing the supply of nisoldipine include regulatory fluctuations, geopolitical tensions, manufacturing capacity limits, and raw material availability. The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting manufacturers to diversify sources and increase inventory buffers.

Emerging Suppliers and Future Trends

• Bioequivalent and biosimilar development: The future landscape may see new entrants offering bioequivalent formulations, potentially altering supply dynamics.

• Localized manufacturing: Countries aim to develop domestic API production to reduce dependency on overseas suppliers, thus improving supply security.

• Regulatory harmonization: Greater international cooperation aims to streamline approvals and inspections, facilitating smoother cross-border distribution.

Conclusion

The supply of nisoldipine hinges on a well-established network of multinational pharmaceutical companies, regional generics manufacturers, and API producers. Key suppliers like Teva, Mylan, Novartis’s Sandoz division, and Chinese API manufacturers drive global availability. Navigating complex regulatory environments and geopolitical factors remains essential for ensuring uninterrupted supply. Strategic partnerships, regulatory compliance, and supply chain diversification are critical for stakeholders seeking stable access to this essential antihypertensive medication.

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Key Takeaways

• The global supply chain for nisoldipine is primarily supported by established generics manufacturers and API producers in North America, Europe, and Asia.
• Original patent holders such as Novartis laid the groundwork, but generic manufacturers now dominate the supply due to patent expirations.
• API sourcing from China and India plays a pivotal role, with increasing efforts toward regional manufacturing independence.
• Regulatory compliance, quality assurance, and supply chain resilience are vital for consistent drug availability.
• Future supply considerations include biosimilars, localized production, and international regulatory harmonization.

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FAQs

1. Who are the leading manufacturers of nisoldipine globally?
Teva, Mylan (Viatris), Sandoz, Haupt Pharma, and Chinese API producers are among the top manufacturers supplying nisoldipine in finished dosage forms and APIs.

2. How does patent expiration affect the supply chain of nisoldipine?
Patent expirations have enabled generic manufacturers to produce and distribute nisoldipine, increasing competition, reducing prices, and broadening access. However, it also introduces variances in supply quality and regulatory compliance among suppliers.

3. What are the regulatory challenges faced by nisoldipine suppliers?
Suppliers must meet rigorous GMP standards, obtain necessary certifications, and navigate diverse regional regulatory requirements. Non-compliance can result in supply disruptions or product recalls.

4. Are there risks associated with over-reliance on Asian API producers?
Yes. Geopolitical issues, supply chain disruptions, and regulatory differences pose risks. Diversifying supply sources and establishing regional API manufacturing hubs are strategies to mitigate these risks.

5. What is the outlook for future suppliers of nisoldipine?
Emerging players in biosimilars, increased regional API production, and advances in chemical synthesis will influence future supply dynamics. Ongoing regulatory reforms aim to streamline approval processes and enhance supply security.

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References

1. Novartis. (2022). Nisoldipine product monograph.
2. U.S. FDA. (2022). Drug Master Files (DMFs) and API approval guidelines.
3. European Medicines Agency. (2022). EMA guidelines on active substance manufacturing.
4. Teva Pharmaceuticals. (2022). Product portfolio and API sourcing information.
5. China Food and Drug Administration (CFDA). (2022). Pharmaceutical manufacturing regulations and API approvals.