Suppliers and packagers for alcaine

alcaine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	Alcon Laboratories, Inc.	0998-0016-15	1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE	1973-10-19
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	Sandoz Inc.	61314-016-01	1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE	2000-06-05
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	NuCare Pharmaceuticals,Inc.	68071-5139-5	15 mL in 1 BOTTLE (68071-5139-5)	1973-10-19
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	REMEDYREPACK INC.	70518-3408-0	1 BOTTLE in 1 CARTON (70518-3408-0) / 15 mL in 1 BOTTLE	2022-04-08
Alcon Labs Inc	ALCAINE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	080027	ANDA	Sportpharm, Inc. dba Sportpharm	85766-056-15	1 BOTTLE in 1 CARTON (85766-056-15) / 15 mL in 1 BOTTLE	2000-06-05

Suppliers for the Pharmaceutical Drug: Alcaine

Last updated: August 8, 2025

Introduction

Alcaine, a local anesthetic known chemically as procaine hydrochloride, is widely used in medical procedures for its effective nerve-blocking properties. It is primarily employed in dental surgeries, minor medical interventions, and as a diagnostic tool. Ensuring the supply of Alcaine hinges on a robust network of pharmaceutical manufacturers, reputable raw material suppliers, and distribution channels. This article delineates the global landscape of suppliers for Alcaine, focusing on manufacturers, raw material providers, and the dynamics influencing supply chains within the pharmaceutical industry.

Understanding Alcaine: Overview and Market Significance

Procaine hydrochloride was first synthesized in 1905 and quickly became a cornerstone local anesthetic. Though its dominance has waned in favor of newer agents, Alcaine remains relevant, particularly in specific regional markets and niche medical applications. The global demand for Alcaine persists, driven by dental practices, outpatient clinics, and diagnostic procedures.

The market for local anesthetics like Alcaine is characterized by strict quality standards, regulatory compliance, and batch consistency, which influence the choice of suppliers. Ensuring a steady, compliant supply chain is critical for manufacturers, healthcare providers, and regulators alike.

Key Manufacturers of Alcaine

1. Fresenius Kabi

Fresenius Kabi is a leading pharmaceutical and healthcare company renowned for its sterile, injectable medicines, including local anesthetics such as procaine hydrochloride. With a global footprint spanning Europe, North America, and Asia, Fresenius Kabi supplies Alcaine to hospitals and clinics worldwide. Its manufacturing processes emphasize quality assurance, GMP compliance, and regulatory adherence across multiple jurisdictions.

2. Hikma Pharmaceuticals

Hikma Pharmaceuticals, based in Jordan, operates as a major generic manufacturer of sterile pharmaceuticals, including local anesthetics. Their product portfolio includes procaine hydrochloride, which they supply across Europe, the Middle East, and emerging markets. Hikma's production facilities adhere to stringent quality standards, enabling consistent supply of high-grade Alcaine.

3. Zhejiang Hisun Pharmaceutical

Zhejiang Hisun Pharmaceutical Co., Ltd., a Chinese-based manufacturer, produces various pharmaceuticals, including local anesthetics like procaine hydrochloride. Their products are distributed in Asia, Africa, and Latin America, often offering cost-competitive options for regional markets.

4. Aurobindo Pharma

Aurobindo Pharma, headquartered in India, manufactures a broad array of generic pharmaceuticals, including injectable anesthetics. It supplies procaine hydrochloride in multiple dosage forms, emphasizing affordability and regulatory compliance to expand access in developing markets.

5. Teva Pharmaceuticals

Teva, a global leader in generic medicines based in Israel, also manufactures local anesthetics such as procaine hydrochloride. Their extensive distribution network facilitates broad availability, especially within North America and Europe.

Raw Material Suppliers for Alcaine

The quality and availability of raw materials—principally procaine base—are pivotal for the production of Alcaine. Suppliers of these raw materials primarily focus on chemical intermediates and esterified reagents necessary for synthesis.

1. Shanghai Fosun Pharmaceutical

A major chemical supplier based in China, Fosun provides pharmaceutical-grade procaine base and related intermediates. Their capacity ensures a consistent supply for both domestic and international manufacturers.

2. Merck KGaA

Merck supplies high-purity chemicals and intermediates used in API synthesis. Their offerings include esterification reagents and solvents crucial to procaine hydrochloride production, with a focus on quality and regulatory compliance.

3. Sigma-Aldrich (Merck Group)

Sigma-Aldrich supplies specialty chemicals that aid in the synthesis of local anesthetics. Their globally accessible product range—including procaine raw materials—meets pharmaceutical quality standards.

4. Zhejiang Medicine Co., Ltd.

A Chinese company involved in chemical manufacturing, Zhejiang Medicine produces intermediates including ester derivatives used in procaine synthesis, supporting the supply chains in Asia and beyond.

5. Shandong Xinhua Pharmaceutical

Specializing in chemical intermediates, Shandong Xinhua offers raw materials relevant to procaine production, focusing on cost-competitive and high-quality inputs for pharmaceutical manufacturers.

Distribution and Supply Chain Dynamics

Supply chain integrity for Alcaine depends on manufacturing adherence to Good Manufacturing Practices (GMP), regulatory compliance, and logistics efficiency. The highly regulated environment makes supplier vetting critical, especially considering regional differences in standards and infrastructure.

Regulatory Considerations

Manufacturers and suppliers must meet extensive regulatory standards set by agencies such as the FDA (United States), EMA (Europe), and corresponding authorities in Asia, Africa, and Latin America. Regulatory approval impacts supplier selection, especially for active pharmaceutical ingredients (APIs).

Market Access and Competition

The competitive landscape is shaped by patent status (though procaine hydrochloride is off-patent), manufacturing capacity, and cost structures. Countries with emerging markets often rely on regional suppliers due to cost and supply chain latency considerations.

Quality Assurance and Traceability

Consistent supply of Alcaine requires rigorous quality control. Suppliers employing advanced analytical testing, batch traceability, and GMP certification are preferred, especially by multinational companies and healthcare providers with stringent compliance expectations.

Key Challenges in the Alcaine Supply Chain

• Regulatory Barriers: Variability in regulatory standards across countries can delay or restrict access to high-quality raw materials and finished products.

• Raw Material Availability: Over-reliance on specific chemical suppliers or regions can cause vulnerabilities, especially during geopolitical disruptions or supply constraints.

• Pricing Pressures: Cost considerations often influence procurement decisions, especially from generic manufacturers competing on price.

• Quality Consistency: Ensuring batch-to-batch uniformity and avoiding contamination are paramount, requiring vigilant supplier qualification and ongoing testing.

Future Outlook

The ongoing evolution of anesthesia practices, alongside regulatory reforms and globalization, will influence the supplier landscape for Alcaine. While traditional suppliers like Fresenius Kabi and Hikma dominate established markets, emerging Asian manufacturers will likely expand their footprint, driven by technological advancements and cost efficiencies.

Innovation in local anesthetics, including sustained-release formulations and alternative agents, might impact demand. However, the legacy role of procaine hydrochloride suggests that suppliers maintaining high-quality, compliant manufacturing processes will sustain their market share.

Key Takeaways

• Market Leaders: Fresenius Kabi, Hikma Pharmaceuticals, and Teva are primary global suppliers of Alcaine, supported by robust manufacturing standards.

• Raw Material Sources: Chinese chemical suppliers such as Shanghai Fosun and Zhejiang Medicine are significant sources of procaine intermediates, emphasizing the importance of supply chain diversification.

• Supply Chain Risks: Regulatory variability, raw material reliance, and quality control remain critical factors influencing Alcaine availability.

• Regulatory Compliance: Suppliers must adhere to GMP and obtain necessary approvals across jurisdictions to ensure market access.

• Market Dynamics: Cost pressures and regional demand fluctuations drive the emergence of new suppliers, mainly from Asia, with the potential to alter the competitive landscape.

FAQs

1. Who are the leading global manufacturers of Alcaine?
Fresenius Kabi, Hikma Pharmaceuticals, Teva Pharmaceuticals, Aurobindo Pharma, and Zhejiang Hisun Pharmaceutical are primary manufacturers supplying Alcaine worldwide.

2. What are the main raw material suppliers for procaine hydrochloride?
Chinese chemical producers like Shanghai Fosun Pharmaceutical and Zhejiang Medicine, along with established chemical suppliers such as Merck KGaA and Sigma-Aldrich, are key raw material providers.

3. How does regulatory compliance affect Alcaine supply chains?
Strict adherence to GMP, regional approvals, and quality standards are critical, as non-compliance can delay or restrict product availability, affecting global supply.

4. What challenges threaten the stability of Alcaine supply?
Regulatory barriers, raw material shortages, geopolitical risks, and quality assurance issues pose significant threats to steady supply.

5. What is the outlook for Alcaine suppliers in the next decade?
Expect continued consolidation among major players, increased regional manufacturing, and evolving regulatory standards shaping supplier strategies and market presence.

References

1. [1] European Medicines Agency. "Procaine Hydrochloride." EMA. Accessed 2023.
2. [2] U.S. Food & Drug Administration. "Pharmaceutical Quality." FDA.gov. 2023.
3. [3] MarketWatch. "Global Local Anesthetics Market." Trends & Forecasts, 2023.
4. [4] Pharmaceutical Technology. "Raw Material Sourcing in Anesthetic Manufacturing." 2022.
5. [5] IQVIA. "Global Injectable Drugs Market Report." 2022.