Suppliers and packagers for sprix

sprix

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382	NDA	Zyla Life Sciences US LLC	69344-144-43	5 CARTON in 1 CARTON (69344-144-43) / 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)	2011-04-26
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382	NDA	Zyla Life Sciences US LLC	69344-144-53	1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)	2011-04-26

Suppliers for the Pharmaceutical Drug: Sprix

Last updated: July 29, 2025

Introduction

Sprix is a prescription nasal spray formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), used predominantly for short-term management of moderate to severe pain post-surgery or trauma. Its unique delivery form offers rapid absorption and targeted action, making it a preferred option in clinical settings. The drug’s manufacturing and distribution are tightly regulated, with supply chains involving multiple key players. This article provides a comprehensive overview of the current suppliers responsible for manufacturing and distributing Sprix, highlighting their market positions and strategic significance.

Manufacturers of Sprix

1. Piramal Critical Care Inc.

Piramal Critical Care Inc. is the primary and most recognized manufacturer of Sprix in the global pharmaceutical market. The company specializes in injectable and nasal spray pharmaceuticals, with a strong focus on hospital-oriented products. Originally, the product was developed and marketed by the pharmaceutical giant Fresenius Kabi, which was acquired by Piramal in 2018 (Fresenius Kabi's portfolio was integrated into Piramal’s global operations).

Piramal Critical Care’s manufacturing facilities are located in North America, primarily in the United States, where they produce and supply Sprix to hospitals, clinics, and specialty care providers.

2. Fresenius Kabi (Legacy and Transition Insights)

While Fresenius Kabi was the original developer and marketer of Sprix, it sold its US-based hospital products portfolio, including Sprix, to Piramal. This transaction, completed around 2018, was part of Fresenius’s strategy to focus on its core dialysis and injectable portfolios. It remains relevant to note that prior to the transition, Fresenius Kabi was a leading supplier, with extensive distribution channels.

3. Other Potential Suppliers and Regional Variants

Although Piramal is the dominant supplier globally, regional distributors or smaller generic firms may produce off-label or compounded versions in various markets. However, these are not officially authorized or approved suppliers for commercial purposes, emphasizing Piramal's status as the primary and FDA-approved supplier in North America and other regulated markets.

Distribution and Supply Chain Dynamics

Piramal's distribution network ensures rapid delivery within North America and complies with stringent regulatory standards, including FDA approvals and good manufacturing practices (GMP). Their strategic positioning within healthcare supply chains guarantees a consistent supply chain, especially critical during global crises such as the COVID-19 pandemic, which disrupted pharmaceutical logistics.

Regulatory Status and Key Markets

Piramal Critical Care holds the FDA approval for Sprix, with the drug labeled as marketed in the US. Its approval in other regions, such as parts of Europe, Canada, and Australia, often depends on local regulatory bodies, with licensing held or managed through partnerships or licensing agreements.

In the US, the drug is classified under hospital supply products, primarily distributed to hospitals, outpatient clinics, and surgical centers. Piramal's licensing agreements with other pharmaceutical companies may extend its reach to additional markets and distribution channels.

Strategic Significance of Suppliers

Given the critical nature of pain management during and post-surgical procedures, supply stability of Sprix is vital. Piramal Critical Care’s proven manufacturing capacity and regulatory compliance underpin their dominant role. Their strategic investments in GMP facilities, quality assurance, and supply chain infrastructure ensure that the supply of Sprix remains uninterrupted, minimizing shortages or regulatory hurdles.

Emerging Trends and Market Considerations

The evolving landscape of pain management products and increasing focus on opioid-sparing therapies have heightened the importance of alternatives like Sprix. The advent of biosimilars or generic versions could alter the supplier ecosystem in the future, although presently, Piramal maintains market exclusivity in key regions.

Furthermore, the rising emphasis on personalized medicine and minimally invasive delivery methods could influence future supplier strategies, including the development of new formulations of NSAIDs like ketorolac.

Conclusion

Piramal Critical Care Inc. remains the principal and most authoritative supplier of Sprix globally, managing the production and distribution of this critical NSAID nasal spray. Their regulatory compliance, manufacturing capacity, and strategic regional operations ensure a consistent supply for clinical needs. While regional variants or third-party distributors may exist in niche markets, Piramal's dominance underscores the importance of monitoring their operational stability and regulatory compliance to ensure uninterrupted access.

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Key Takeaways

• Piramal Critical Care Inc. is the exclusive and primary supplier of Sprix in North America, following the acquisition of Fresenius Kabi's US hospital portfolio.
• The supply chain benefits from Piramal’s significant manufacturing capacity and adherence to FDA standards, ensuring continuous availability.
• Regulatory approval status and regional licensing significantly influence the supplier landscape, with Piramal’s approvals consolidating its market position.
• Future market developments may include biosimilars or generic versions, potentially diversifying the supplier ecosystem.
• Maintaining supply chain stability of Sprix is crucial for hospitals and pain management clinics in light of increasing demand and evolving pain management protocols.

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FAQs

1. Who is the main manufacturer of Sprix globally?
Piramal Critical Care Inc. is the primary manufacturer and supplier of Sprix, especially in North America, following its acquisition of Fresenius Kabi’s hospital product portfolio.

2. Are there any approved generic versions of Sprix on the market?
Currently, no generic nasal spray equivalents of Sprix have received FDA approval. Piramal holds exclusive rights for commercialization in key markets.

3. How does Piramal ensure the supply stability of Sprix?
Through its GMP-certified manufacturing facilities, extensive distribution networks, and adherence to regulatory standards, Piramal optimizes supply chain resilience.

4. Are there regional differences in Sprix suppliers?
Yes. While Piramal is dominant in North America, other regions may depend on regional licensing, partnerships, or alternative formulations, but no widespread approved alternatives are presently available.

5. What might influence future supply chain changes for Sprix?
Development of biosimilars, regional regulatory changes, clinical adoption of new pain management protocols, and strategic corporate partnerships are key factors that could alter the supply landscape.

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Sources
[1] Piramal Critical Care Official Website.
[2] FDA Drug Database.
[3] Fresenius Kabi Corporate Reports.
[4] Market Analysis Reports on NSAID Nasal Sprays.