Suppliers and packagers for BUPIVACAINE LIPOSOME

BUPIVACAINE LIPOSOME

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hengrui Pharma	BUPIVACAINE LIPOSOME	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	214348	ANDA	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	57884-3251-1	10 VIAL in 1 CARTON (57884-3251-1) / 10 mL in 1 VIAL	2024-07-01
Hengrui Pharma	BUPIVACAINE LIPOSOME	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	214348	ANDA	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	57884-3252-1	10 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIAL	2024-07-01

Last updated: August 7, 2025

ppliers for the Pharmaceutical Drug: Bupivacaine Liposome

Introduction
Bupivacaine Liposome is a sustained-release local anesthetic formulation designed to provide prolonged analgesia post-surgery or injury. This innovative delivery system encapsulates bupivacaine within liposomes, enabling slow drug release, reduced dosing frequency, and minimized systemic toxicity. As a specialized pharmaceutical product, sourcing reliable suppliers for Bupivacaine Liposome involves navigating a complex landscape of manufacturing capabilities, regulatory compliance, and market presence. This analysis provides a comprehensive overview of leading manufacturers and suppliers, highlighting their product offerings, regulatory standing, and strategic considerations for potential buyers.

Manufacturers and Suppliers of Bupivacaine Liposome

1. Pacira BioSciences, Inc.

Pacira BioSciences is a pioneer in liposomal drug delivery systems, particularly with its flagship product, EXPAREL (bupivacaine liposomal). Approved by the U.S. Food and Drug Administration (FDA) in 2011, EXPAREL is a significant market leader, widely utilized in post-surgical pain management.

• Product Offering:
  EXPAREL (bupivacaine liposome extended-release suspension)
• Regulatory Standing:
  Approved in the U.S., Canada, EU, and multiple other jurisdictions.
• Supply Capabilities:
  Pacira manufactures and supplies EXPAREL globally, with regional distribution networks ensuring availability.
• Market Position:
  As the original and most established supplier, Pacira maintains strict quality standards and extensive regulatory backing, making it the primary choice for hospitals and clinics seeking approved Bupivacaine Liposome products.

2. Piramal Pharma Solutions

Piramal offers contract manufacturing services, including liposomal formulations, and partners with clients to develop customized liposomal Bupivacaine products.

• Product Capabilities:
  Development and manufacturing of liposomal APIs, including Bupivacaine Liposome, tailored for pharmaceutical companies.
• Regulatory & Quality:
  GMP-certified manufacturing with extensive regulatory experience.
• Strategic Value:
  Suitable for pharmaceutical companies looking to develop proprietary Bupivacaine Liposome formulations or scale-up production.

3. SymBio Pharmaceuticals (Japan)

SymBio Pharmaceuticals specializes in liposomal drugs, primarily in the oncology and anesthetic sectors.

• Product Offerings:
  Developing liposomal formulations; though not currently marketing Bupivacaine Liposome commercially, the firm has strong R&D capabilities.
• Market Focus:
  Asia-Pacific, with potential for expansion depending on regulatory approvals.

4. Limited Global Suppliers and Licensees

While Pacira remains the dominant standalone commercial supplier, several smaller biotech firms and research organizations develop liposomal formulations of bupivacaine, often under licensing agreements or for clinical trial purposes.

• Research & Development Suppliers:
  Numerous biotech entities have liposomal Bupivacaine in preclinical or phase I/II trials, but few have cleared regulatory pathways for commercial sales.
• Licensing Opportunities:
  Potential for partnership or licensing with firms engaged in liposomal technology development.

5. Contract Manufacturing Organizations (CMOs)

Several CMOs offer liposomal formulation development and manufacturing services that could produce Bupivacaine Liposome to specification:

• Examples:
  • Seneffe Pharma (Belgium)
  • Recipharm (Sweden)
  • Evonik Industries (Germany) — specializing in excipients and delivery systems.

These organizations provide the infrastructure to produce liposomal drug products but typically do not market Bupivacaine Liposome themselves.

Regulatory Considerations

The supplier's regulatory compliance is crucial, especially in markets like the U.S., Europe, and Japan. Pacira’s EXPAREL benefits from established FDA and EMA approvals, offering confidence in consistent quality and safety. For other suppliers or contracted manufacturers, ensuring GMP compliance and quality assurance is vital, particularly if the product is to be used in clinical or regulatory settings.

Market Dynamics and Supply Chain Considerations

The pharmaceutical supply chain for Bupivacaine Liposome is highly concentrated, with Pacira dominating the market. Dependence on a single provider can pose risks related to supply continuity, regulatory changes, and pricing. Diversification through contractual manufacturing agreements or licensing can mitigate these risks, especially for pharmaceutical companies seeking to develop or commercialize proprietary formulations.

Emerging Trends and Opportunities

• Generic and Biosimilar Development:
  Several companies are pursuing generic Bupivacaine Liposome formulations, prompting increased interest in licensing and manufacturing collaborations.
• Regional Expansion:
  Growing adoption of liposomal pain management therapies in Asia and Latin America creates opportunities for regional suppliers and licensed manufacturers.
• Technological Advances:
  Innovations in liposomal fabrication, targeting, and sustained-release mechanisms can lead to new entrants offering advanced formulations.

Conclusion

While Pacira BioSciences remains the primary and most authoritative supplier of approved Bupivacaine Liposome (EXPAREL), opportunities exist with contract manufacturers and emerging biotech firms for customized or generic alternatives. Ensuring regulatory compliance, robust manufacturing capabilities, and strategic partnerships are critical for stakeholders seeking a reliable supply chain.

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Key Takeaways

• Market Leader: Pacira BioSciences dominates with its FDA-approved EXPAREL, ensuring high quality and regulatory assurance.
• Contract Manufacturing: Piramal and other CMOs offer flexible manufacturing solutions for custom formulations, supporting R&D and scale-up needs.
• Regulatory Risks: Dependence on a single supplier or unapproved generic providers can introduce risks; thorough due diligence is essential.
• Regional Opportunities: Asia-Pacific and Latin American markets are expanding, creating potential for local suppliers and licensing deals.
• Innovation Potential: Advances in liposomal technology could diversify the supplier landscape and introduce new formulations to the market.

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FAQs

1. Is Pacira BioSciences the only supplier of Bupivacaine Liposome?
While Pacira is the sole FDA-approved and commercialized producer of Bupivacaine Liposome in the form of EXPAREL, other companies develop liposomal bupivacaine formulations at R&D stages or via contract manufacturing.

2. Can I source Bupivacaine Liposome from generic pharmaceutical manufacturers?
Generic manufacturing options are limited and typically require licensing agreements or licensing-in from innovators like Pacira. Unapproved or illegal imports should be avoided due to quality and regulatory risks.

3. What should I consider when selecting a supplier for Bupivacaine Liposome?
Prioritize regulatory approval status, GMP compliance, manufacturing capacity, regional distribution, and partnership opportunities. Verify supply chain security and product quality certifications.

4. Are there regional suppliers or alternatives for Bupivacaine Liposome outside the U.S.?
Yes, regional markets in Europe, Asia, and Latin America are developing their capabilities, with some local companies pursuing licensing or manufacturing of liposomal formulations, although most rely on established suppliers for approved products.

5. What are emerging trends impacting Bupivacaine Liposome suppliers?
Development of biosimilars and generics, regional market expansion, technological innovations in liposomal delivery, and strategic licensing arrangements are shaping the future landscape.

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Sources

1. Pacira Pharmaceuticals. EXPAREL [Product information].
2. U.S. Food and Drug Administration. FDA approval documents for EXPAREL.
3. Piramal Pharma Solutions. Contract manufacturing capabilities.
4. SymBio Pharmaceuticals. Liposomal drug pipeline.
5. Market reports on liposomal formulations and pain management therapeutics.