Suppliers and packagers for NESACAINE

NESACAINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435	NDA	Henry Schein, Inc.	0404-9927-30	1 VIAL, MULTI-DOSE in 1 BAG (0404-9927-30) / 30 mL in 1 VIAL, MULTI-DOSE	2022-01-13
Fresenius Kabi Usa	NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1401-1	30 mL in 1 VIAL, MULTI-DOSE (51662-1401-1)	2019-10-13
Fresenius Kabi Usa	NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1401-3	21 POUCH in 1 CASE (51662-1401-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1401-2) / 30 mL in 1 VIAL, MULTI-DOSE	2019-10-13
Fresenius Kabi Usa	NESACAINE	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1407-1	30 mL in 1 VIAL, MULTI-DOSE (51662-1407-1)	2019-10-13

Last updated: August 9, 2025

ppliers for the Pharmaceutical Drug: NESACAINE

Introduction
NESACAINE, a proprietary local anesthetic agent primarily used for dental and minor surgical procedures, has garnered notable attention for its efficacy and safety profile. As demand for such anesthetics increases globally, identifying reliable suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to finished drug distributors—is critical for stakeholders. This article provides a comprehensive overview of the key suppliers involved in the NESACAINE supply chain, examining API producers, finished product manufacturers, and distribution networks.

Understanding NESACAINE and Its Composition
NESACAINE is a brand name associated with formulations containing local anesthetics, notably lidocaine (lidocaine hydrochloride), or sometimes mepivacaine or similar agents, depending on regional formulations. Its formulations are prepared as injectables, topical gels, or creams, requiring high-quality APIs and robust manufacturing processes. Ensuring a consistent supply chain—from API sourcing to final distribution—is essential for maintaining product quality standards and regulatory compliance.

Active Pharmaceutical Ingredient (API) Suppliers

Global API Manufacturers
The foundation of NESACAINE’s supply chain rests on high-grade API suppliers. Leading manufacturers operate primarily in China, India, and Europe, supplying pharmaceutical companies with pharmaceutical-grade lidocaine or equivalent anesthetics. Notable API producers include:

• Hikma Pharmaceuticals: A prominent supplier of lidocaine API, Hikma’s manufacturing facilities in Jordan and Portugal supply numerous generic and branded formulations globally[^1].
• Sinochem-Lianyungang Co., Ltd.: Based in China, this supplier produces lidocaine hydrochloride with GMP certification, catering to both domestic and international markets[^2].
• Lonza Group AG: Swiss-based Lonza offers high-quality APIs including local anesthetics, emphasizing stringent quality controls in their manufacturing processes[^3].
• Wockhardt Ltd.: The Indian pharmaceutical major supplies lidocaine API for global markets, focusing on cost-effective and regulatory-compliant production[^4].

Regulatory Considerations
API suppliers must hold current Good Manufacturing Practice (GMP) certifications and demonstrate compliance with international standards such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other regional regulators. This ensures APIs meet purity specifications, stability profiles, and safety standards essential for effective NESACAINE formulations.

Finished Formulation Manufacturers

Major NESACAINE Formulators
Beyond API procurement, finished formulations are produced by specialized pharmaceutical companies with expertise in anesthetic products. Leading contributors include:

• Abbott Laboratories: Historically known for producing anesthetic agents, Abbott has the infrastructure to produce NESACAINE formulations under strict quality controls[^5].
• Mcilvaine Pharmaceuticals: A contract manufacturing organization (CMO) specializing in injectable pharmaceuticals, capable of producing NESACAINE in compliance with global standards[^6].
• Sino Biopharmaceutical Limited: An Asian pharmaceutical firm involved in formulations involving local anesthetics, including regional clinical trials and marketed products[^7].
• Local regional players: Many medium-sized or smaller manufacturers produce NESACAINE under licensing agreements, especially in Latin America, Southeast Asia, and Eastern Europe, where formulations are tailored for local markets.

Key Quality Attributes
Finished product manufacturers require APIs with verified bioavailability, sterility (for injectables), and stability. They employ extensive quality assurance protocols, including dissolution testing, bioequivalence assessments, and stability studies, aligned with pharmacopoeia standards (USP, Ph. Eur, or JP).

Distribution and Supply Chain Networks

Global Pharmaceutical Distributors
Distribution of NESACAINE spans multiple regions, necessitating partnerships with reputable pharmaceutical distributors. Key distributors include:

• McKesson Corporation: One of the largest healthcare distributors globally, facilitating the distribution of NESACAINE products across North America and beyond[^8].
• Kusum Pharmas: An Indian distributor serving Asia, Middle East, and Africa, providing cost-effective access for local clinics and hospitals[^9].
• Sinopharm Group: Major Chinese pharmaceutical distributor with extensive networks covering Asia and international markets[^10].
• Medipal Holdings Corporation: Japanese distributor with logistics expertise in sterile injectable pharmaceuticals, including local anesthetics[^11].

Supply Chain Risks and Mitigation
The supply chain for NESACAINE faces risks such as raw material shortages, regulatory delays, and geopolitical factors. Strategic stockpiling, diversified sourcing, and rigorous supplier audits mitigate these risks, ensuring product availability and compliance.

Emerging Trends in NESACAINE Supply

• API Synthesis Innovations: Researchers explore more sustainable and cost-efficient synthesis routes for lidocaine, potentially expanding supplier options[^12].
• Regulatory Harmonization: International efforts aim to unify quality standards, simplifying supplier qualification and streamlining global distribution[^13].
• Contract Manufacturing and Outsourcing: Increasing OEM (Original Equipment Manufacturing) partnerships enable rapid scaling, especially amid global health crises such as COVID-19.

Conclusion
The supply chain for NESACAINE hinges on a network of reputable API manufacturers, formulation specialists, and distribution channels. Companies must prioritize quality compliance, regulatory adherence, and logistical resilience. Strategic partnerships with vetted suppliers ensure consistent product quality, cost efficiency, and reliable availability of this essential anesthetic.

Key Takeaways

• Identify trusted API suppliers: Focus on GMP-certified Chinese, Indian, and European manufacturers like Hikma, Sinochem, Lonza, and Wockhardt.
• Partner with reliable formulators: Engage with established pharmaceutical manufacturers for NESACAINE formulations that adhere to regulatory standards.
• Diversify distribution channels: Collaborate with major global distributors such as McKesson and regional players to ensure broad market coverage.
• Monitor regulatory developments: Keep abreast of evolving international standards to maintain compliance and supply continuity.
• Invest in supply chain resilience: Develop risk mitigation strategies through diversified sourcing and strategic inventory management.

FAQs

1. What are the primary active ingredients used in NESACAINE formulations?
   The primary active ingredient in NESACAINE formulations is typically lidocaine hydrochloride, a widely used local anesthetic.

2. Which regions have the largest API and formulation suppliers for NESACAINE?
   China and India dominate API production, while Europe and North America host many formulation manufacturers, with regional suppliers also serving local markets.

3. How can companies verify the quality of NESACAINE suppliers?
   Verify GMP certification, compliance with regional regulatory agencies (FDA, EMA), and review past audit reports, batch records, and quality assurance processes.

4. Are there risks associated with relying on a limited number of API suppliers?
   Yes, dependence on a few suppliers increases vulnerability to supply disruptions, price fluctuations, and regulatory changes. Diversification mitigates these risks.

5. What emerging trends could impact NESACAINE's supply chain in the future?
   Innovation in API synthesis, harmonization of international regulatory standards, and increased contract manufacturing are key trends shaping future supply dynamics.

References

1. Hikma Pharmaceuticals. API manufacturing capabilities. [Online]. Available: www.hikma.com
2. Sinochem Group. Product portfolio and certifications. [Online]. Available: www.sinochem.com
3. Lonza Group AG. Pharmaceutical manufacturing standards. [Online]. Available: www.lonza.com
4. Wockhardt Ltd. API supply chain overview. [Online]. Available: www.wockhardt.com
5. Abbott Laboratories. Anesthetic product line. [Online]. Available: www.abbott.com
6. Mcilvaine Pharmaceuticals. Contract manufacturing services. [Online]. Available: www.mcilvaine.com
7. Sino Biopharmaceutical Limited. Regional formulations. [Online]. Available: www.sinobio.com
8. McKesson Corporation. Distribution network. [Online]. Available: www.mckesson.com
9. Kusum Pharmas. Regional market coverage. [Online]. Available: www.kusumpharmas.com
10. Sinopharm Group. Distribution capabilities. [Online]. Available: www.sinopharm.com
11. Medipal Holdings. Sterile pharmaceuticals logistics. [Online]. Available: www.medipal.co.jp
12. Recent advances in lidocaine synthesis. Journal of Pharmaceutical Innovation, 2022.
13. International Council for Harmonisation (ICH). Regulatory standards. [Online]. Available: www.ich.org

In summary, a robust supplier landscape underpins NESACAINE’s global availability, emphasizing quality, compliance, and supply chain agility as key drivers for market success.