Last updated: February 20, 2026
What are the primary manufacturing sources of SULAR (nisoldipine)?
SULAR, the brand name for nisoldipine, is a calcium channel blocker used primarily for hypertension management. As a branded pharmaceutical, its supply chain involves original manufacturers and authorized generic producers.
Origin and Manufacturing of SULAR
- Original Manufacturer: Pfizer Inc. developed and marketed SULAR in the United States.
- Approval Date: FDA approved SULAR in 1989.
- Manufacturing Facilities: Pfizer operated manufacturing plants in the United States and internationally, primarily in Puerto Rico and Spain.
Current Supply Chain and Licensing
- Brand Availability: Pfizer retains the rights to manufacture SULAR in certain regions.
- Generic Manufacturers: Since patent expiration, multiple pharmaceutical companies have entered the market producing generic nisoldipine.
- Official Suppliers: Generics approved by regulatory agencies such as the FDA, EMA, and other regional authorities.
Key Generic Suppliers in the Market
Since the expiration of Pfizer’s patent on nisoldipine in 2010, several companies have obtained approval for manufacturing and marketing generic versions. These include:
| Company |
Region |
Notes |
| Teva Pharmaceuticals |
Global |
Market leader in generic pharmaceuticals |
| Mylan (now part of Viatris) |
Global |
Significant supplier, extensive distribution network |
| Sandoz (Novartis) |
Global |
Known for robust manufacturing and supply chain |
| Sun Pharmaceutical |
Asia, global |
Large focus on emerging markets |
| Apotex |
North America, global |
Approved for North American markets |
Note: These companies produce generic nisoldipine formulations marketed under various brand names or as unbranded generics.
Regulatory Status
- FDA: Multiple generics approved and listed via the FDA’s Orange Book.
- EMA: Approved in Europe, with several generics authorized.
- Other Regions: Approval status varies; some countries may have local suppliers or import restrictions.
Supply Chain Constraints and Risks
- Manufacturing Disruptions: Given the generic proliferation, supply has typically been stable. However, quality issues, manufacturing recalls, or geopolitical factors may affect availability.
- Patent Considerations: Pfizer’s patent expiration broadened supply options but varies regionally.
Conclusion
The primary suppliers of SULAR are Pfizer (original manufacturer) and multiple generic producers such as Teva, Mylan, Sandoz, Sun Pharma, and Apotex. The market is characterized by widespread generic production following patent expiration, with supply stability generally maintained through a diverse manufacturer base.
Key Takeaways
- Pfizer remains the original producer of SULAR but does not dominate the generic market.
- Generics are available from numerous companies, including Teva and Mylan.
- Regulatory approval in major markets ensures multiple supply sources.
- Regional differences impact supplier prevalence and availability.
- Supply disruptions are rare but possible due to manufacturing or regulatory issues.
FAQs
-
Who originally developed SULAR?
Pfizer developed and marketed SULAR starting in 1989.
-
Can I find generic versions of nisoldipine?
Yes; multiple companies produce generic nisoldipine approved in various markets.
-
Which companies are the leading generic suppliers?
Teva, Mylan (Viatris), Sandoz, Sun Pharma, and Apotex are among the top producers.
-
Is SULAR still manufactured by Pfizer?
Pfizer's manufacturing of SULAR is limited; the original patent has expired, and generics dominate the market.
-
Are there regional differences in SULAR suppliers?
Yes; regulatory approvals and regional patents influence local supplier options.
References
- U.S. Food and Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- European Medicines Agency. (2023). Listing of authorized medicines.
- IQVIA. (2022). Global Pharmaceutical Market Data.
- patent and drug approval database. (2023). Regional approval details.
- WHO. (2021). List of Essential Medicines.
