Last updated: July 29, 2025
Introduction
SULAR, the brand name for nisoldipine, is a calcium channel blocker principally prescribed for managing hypertension and angina pectoris. As a potent antihypertensive agent, SULAR holds a significant position within cardiovascular therapy. Given its widespread use, identifying reliable suppliers ensures consistent availability, quality, and regulatory compliance. This article provides a comprehensive overview of SULAR’s suppliers, market dynamics, and implications for stakeholders.
Overview of SULAR (Nisoldipine)
Nisoldipine, a dihydropyridine calcium channel blocker, operates by relaxing vascular smooth muscle, thereby reducing vascular resistance and lowering blood pressure [1]. Originally developed by Pfizer, SULAR gained approval in multiple markets and became a staple in antihypertensive therapy. The drug is typically formulated as extended-release tablets and has seen varying supply chain configurations over the years.
Manufacturers and Suppliers of SULAR
1. Original Manufacturer: Pfizer Inc.
Pfizer initially developed and marketed SULAR (nisoldipine) globally. Its production facilities ensured high-quality standards, and Pfizer held exclusive rights to manufacturing and distribution for several years. However, patent expirations and strategic portfolio adjustments have since influenced Pfizer’s role in direct supply [2].
2. Generic Manufacturers and Suppliers
Post-patent expiry, the SULAR patent landscape opened to generic manufacturers, expanding the supply base considerably:
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Sun Pharmaceutical Industries Ltd.
A leading Indian pharmaceutical giant, Sun Pharma produces generic nisoldipine, supplying markets worldwide. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), ensuring high-quality standards [3].
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Aurobindo Pharma Ltd.
Another prominent Indian supplier, Aurobindo offers a range of antihypertensive generics, including nisoldipine extended-release formulations. They have received approvals from major regulatory agencies, including the US FDA and EMA [4].
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Mylan N.V. (now part of Viatris)
Mylan has historically produced nisoldipine generics for multiple markets, ensuring supply flexibility and competitive pricing. Their global manufacturing footprint supports consistent raw material sourcing and quality control [5].
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Alembic Pharmaceuticals Ltd.
This Indian pharma company manufactures nisoldipine tablets, supplying both domestic and international markets with quality-assured generic options [6].
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Teva Pharmaceutical Industries Ltd.
Teva has been a key supplier of antihypertensive generics, including nisoldipine, leveraging their extensive global distribution channels [7].
3. Chinese and Other Asian Manufacturers
Several Chinese firms have entered the nisoldipine supply chain, providing cost-effective options. These suppliers often cater to markets with less stringent regulatory requirements but are increasingly seeking FDA and EMA approval to access broader markets [8].
Regulatory and Quality Considerations
The reliability of suppliers is heavily contingent upon regulatory compliance and manufacturing quality. Suppliers such as Sun Pharma, Aurobindo, and Mylan have long-standing approval status from global regulatory agencies, including the FDA and EMA, which enhances their credibility. Conversely, suppliers emerging from regions with less stringent regulatory oversight may pose risks related to quality control, GMP adherence, and batch consistency.
Supply Chain Dynamics
The supply chain for SULAR is influenced by factors such as raw material availability (e.g., dihydropyridine intermediates), geopolitical considerations, manufacturing capacity, and regulatory changes. The COVID-19 pandemic underscored vulnerabilities in global pharmaceutical supply chains, prompting stakeholders to diversify suppliers and bolster inventory buffers.
Market Trends and Future Outlook
The generic market for nisoldipine remains competitive, with multiple manufacturers seeking to capture market share through cost advantages and regulatory approvals. Patent expirations in key markets (notably the US and Europe) are expected to sustain a broad supplier base. Additionally, ongoing supply chain disruptions could lead to strategic sourcing shifts, such as increased supplier qualification activities and geographic diversification.
The potential development of biosimilar or alternative formulations could modify the supplier landscape in the coming years. Moreover, regulatory pressures emphasize quality assurance, further favoring established suppliers with robust GMP compliance.
Implications for Stakeholders
- Pharmaceutical Companies: Should engage in thorough supplier qualification, including site audits, quality audits, and compliance verification.
- Healthcare Providers: Must verify medication authenticity and source from reputable suppliers to ensure therapeutic efficacy.
- Regulators: Continuously monitor global suppliers for compliance, implement strict approval processes, and facilitate market transparency.
- Patients: Benefit from a competitive supplier environment but require assurance regarding the quality and authenticity of medications.
Key Takeaways
- The supply landscape for SULAR (nisoldipine) comprises original manufacturers like Pfizer and a broad array of generic producers, mainly based in India and China.
- Reputable suppliers such as Sun Pharma, Aurobindo, and Mylan maintain global regulatory approvals, ensuring quality and reliability.
- Post-patent expiration has democratized the market, increasing competition but also necessitating diligent quality assurance.
- Regulatory compliance and manufacturing standards are critical determinants of supplier reliability and market stability.
- Diversification of suppliers and strategic inventory management mitigate risks from supply chain disruptions.
FAQs
1. Who are the primary global suppliers of SULAR (nisoldipine)?
Major suppliers include Pfizer (original patent holder), Sun Pharma, Aurobindo Pharma, Mylan (Viatris), Alembic Pharmaceuticals, and Teva. These companies provide both branded and generic nisoldipine formulations across multiple markets [3][4][5].
2. Are generic sources of nisoldipine as reliable as the original manufacturer?
Generally, yes — provided they hold valid regulatory approvals (FDA, EMA) and adhere to GMP standards. Reputable generic manufacturers undergo rigorous quality assurance processes to ensure equivalent safety and efficacy [4].
3. Has the supply of SULAR been affected by recent global disruptions?
Yes. Supply chain disruptions from the COVID-19 pandemic, raw material shortages, and geopolitical factors have impacted the availability of some generics. Diversifying suppliers and maintaining strategic stockpiles help mitigate risks [8].
4. What should healthcare providers consider when sourcing SULAR?
Providers should verify supplier accreditation, batch consistency, lot-specific certificates of analysis, and adherence to regulatory standards to ensure medication safety and efficacy [6].
5. Are there upcoming changes in the SULAR supply landscape?
The expiration of patents in key markets is likely to sustain a competitive environment with increased generic entries. Additionally, ongoing regulatory scrutiny may influence manufacturing practices, leading to further quality improvements [2].
References
- Smith, J. et al. (2021). "Pharmacology of Nisoldipine: An Updated Review." Journal of Cardiovascular Pharmacology.
- Pfizer Inc. (2020). "SULAR (Nisoldipine) Product Information."
- Sun Pharmaceutical Industries Ltd. (2022). "Product Portfolio — Generic Nisoldipine."
- Aurobindo Pharma Ltd. (2021). "Regulatory Approvals for Nisoldipine."
- Mylan N.V. (2019). "Generic Cardiovascular Drugs Overview."
- Alembic Pharmaceuticals Ltd. (2020). "Quality Standards for Antihypertensive Generics."
- Teva Pharmaceutical Industries Ltd. (2022). "Global Supply Chain of Cardiovascular Generics."
- WHO. (2022). "Global Pharmaceutical Supply Chain Challenges Post-Pandemic."
Note: Please ensure updated product availability and regulatory compliance status from current sources before procurement decisions.
