Suppliers and packagers for generic pharmaceutical drug: CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Caplin	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	217725	ANDA	Caplin Steriles Limited	65145-135-01	1 VIAL, SINGLE-USE in 1 CARTON (65145-135-01) / 5 mL in 1 VIAL, SINGLE-USE	2025-01-17
Caplin	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	217725	ANDA	Caplin Steriles Limited	65145-135-10	10 VIAL, SINGLE-USE in 1 CARTON (65145-135-10) / 5 mL in 1 VIAL, SINGLE-USE	2025-01-17
Caplin	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	217725	ANDA	Caplin Steriles Limited	65145-136-01	1 VIAL, MULTI-DOSE in 1 CARTON (65145-136-01) / 10 mL in 1 VIAL, MULTI-DOSE	2025-01-17
Caplin	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	217725	ANDA	Caplin Steriles Limited	65145-136-10	10 VIAL, MULTI-DOSE in 1 CARTON (65145-136-10) / 10 mL in 1 VIAL, MULTI-DOSE	2025-01-17
Caplin	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	217725	ANDA	Caplin Steriles Limited	65145-137-01	1 VIAL, SINGLE-DOSE in 1 CARTON (65145-137-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2025-01-17
Caplin	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	217725	ANDA	Armas Pharmaceuticals	72485-513-10	10 VIAL, SINGLE-DOSE in 1 CARTON (72485-513-10) / 20 mL in 1 VIAL, SINGLE-DOSE (72485-513-01)	2025-01-15
Eugia Pharma	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	209144	ANDA	Eugia US LLC	55150-286-10	10 VIAL, MULTI-DOSE in 1 CARTON (55150-286-10) / 10 mL in 1 VIAL, MULTI-DOSE (55150-286-01)	2020-05-08

Suppliers for Cisatracurium Besylate

Last updated: February 19, 2026

Cisatracurium besylate is a neuromuscular blocking agent used primarily during anesthesia procedures. Its global supply chain involves multiple manufacturers, both branded and generic.

Major Suppliers and Manufacturers

Company	Location	Market Role	Notable Approvals
Pfizer	United States	Patent holder, branded product	Tradename: Nimbex
Hospira (Pfizer subsidiary)	United States	Generic producer	FDA-approved biosimilar versions
Fresenius Kabi	Germany / Global	Generic manufacturer	Approved in Europe, Asia
Sandoz (Novartis)	Switzerland / Global	Generic producer	Approved in U.S., Europe
Hikma Pharmaceuticals	United Kingdom	Generic provider	Approved in Middle East, Europe
Jiangsu Hengrui Medicine Co., Ltd.	China	Generic manufacturer	Approved in China, some other markets

Supply Chain Considerations

• Patent Status: Pfizer held the original patent. As of 2014, patents expired in many regions, leading to increased generic production.
• Regulatory Approvals: Manufacturers must secure approval from agencies like the FDA, EMA, or equivalent authorities in their markets.
• Manufacturing Capacity: US-based firms (Pfizer, Hospira) dominate high-volume markets. Asian producers (Jiangsu Hengrui) serve regional markets and are expanding globally.
• Pricing Trends: Generic suppliers have driven prices down; Pfizer’s branded Nimbex remains a premium product mainly for specific markets or institutional contracts.

Regulatory and Market Dynamics

• US Market: Dominated by Pfizer’s Nimbex, with generics by Hospira and other suppliers. Approval pathways for generics are streamlined under the Abbreviated New Drug Application (ANDA) process.
• European Market: Several manufacturers, including Fresenius Kabi and Sandoz, offer approved alternatives.
• Emerging Markets: Greater reliance on regional generics, often with local manufacturing sites.

Critical Supply Factors

• Quality Control: Suppliers must maintain rigorous standards due to the drug’s parenteral administration.
• Supply Chain Disruptions: Global logistics, regulatory delays, or manufacturing issues can impact availability.
• Market Entry Barriers: Regulatory approval, scale, and pricing influence new entrants.

Summary

The principal suppliers of cisatracurium besylate are Pfizer (branded Nimbex), Hospira (generic), Fresenius Kabi, Sandoz, and Hikma. These firms collectively serve major markets, with regional players emerging in Asia and other territories.

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Key Takeaways

• Patent expiration has increased the number of generic suppliers.
• Pfizer remains the primary branded manufacturer, especially in the U.S.
• Market distribution varies regionally, influenced by regulatory approvals.
• Supply stability depends on quality control, regulatory compliance, and geopolitical factors.

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FAQs

1. Who is the primary supplier of branded cisatracurium besylate?
Pfizer markets the branded form under the name Nimbex.

2. Are generic versions widely available?
Yes, multiple manufacturers such as Hospira, Fresenius Kabi, and Sandoz supply generic cisatracurium besylate.

3. What regions have the most suppliers?
The U.S. and Europe have numerous approved suppliers; Asian manufacturers are expanding presence globally.

4. How do regulatory approvals impact supply?
Approval delays or restrictions can limit market availability, especially for new entrants and generics.

5. What risks exist for supply chain disruptions?
Manufacturing problems, supply chain logistics, and regulatory issues can cause shortages or delays.

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References

[1] U.S. Food and Drug Administration. (2022). Abbreviated New Drug Application (ANDA) approvals.
[2] European Medicines Agency. (2022). Summary of Product Characteristics for cisatracurium.
[3] GlobalData. (2022). Market analysis of neuromuscular-blocking agents.
[4] Pfizer Inc. (2022). Product information for Nimbex.
[5] Sandoz International GmbH. (2022). Product approvals and manufacturing standards.