PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont Inc	PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	epinephrine bitartrate; prilocaine hydrochloride	INJECTABLE;INJECTION	078959	ANDA	Dentsply Pharmaceutical Inc.	66312-580-16	50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE	2017-12-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Prilocaine Hydrochloride and Epinephrine Bitartrate are widely used in local anesthesia formulations, particularly in dental procedures and minor surgical interventions. Prilocaine, a member of the amide anesthetic class, offers rapid onset and intermediate duration of action, while Epinephrine acts as a vasoconstrictor to prolong anesthesia and reduce bleeding. The global demand for these compounds has led to a complex supply chain involving multiple manufacturers, raw material suppliers, and distributors.

This analysis explores the key suppliers of Prilocaine Hydrochloride and Epinephrine Bitartrate, considering their manufacturing capabilities, regulatory compliance, and market positioning. Understanding these suppliers supports stakeholders in procurement, compliance, and strategic planning within the pharmaceutical supply chain.

Market Overview and Key Players

The suppliers for Prilocaine Hydrochloride and Epinephrine Bitartrate primarily comprise large pharmaceutical ingredient manufacturers, specialty chemical companies, and generic drug producers. The global production landscape is characterized by a mix of established pharmaceutical giants, regional manufacturers, and recent entrants leveraging cost advantages.

Major suppliers include:

Hikma Pharmaceuticals
Fresenius Kabi
XTAL Biotech
Mossaglim Pharmaceutical Co.
Selleck Chemicals
Sigma-Aldrich (Merck)
Bachem
Shaanxi Hongda Pharmaceutical Co., Ltd.

Each of these entities supplies active pharmaceutical ingredients (APIs) to pharmaceutical companies, contract manufacturers, and compounding pharmacies worldwide.

Suppliers of Prilocaine Hydrochloride

1. Hikma Pharmaceuticals

Hikma is a prominent manufacturer supplying Prilocaine Hydrochloride globally. The company produces both bulk APIs and finished dosage forms, emphasizing strict regulatory compliance and quality standards, including FDA and EMA approvals. Their manufacturing facilities incorporate robust cGMP practices, ensuring high purity levels suitable for injectable and topical formulations.

2. Fresenius Kabi

Fresenius Kabi is a leading global healthcare company with significant API manufacturing capabilities for local anesthetics, including Prilocaine Hydrochloride. Their focus on sterile injectables and global distribution network positions them as a key supplier, particularly in markets with stringent quality requirements.

3. XTAL Biotech

Focusing on innovative synthetic routes, XTAL Biotech supplies Prilocaine Hydrochloride to the Asian and international markets. Their products adhere to industry standards, and they often serve as OEM suppliers for generic pharmaceutical companies.

4. Chinese Manufacturers (e.g., Shaanxi Hongda Pharmaceutical Co., Ltd.)

Chinese API producers such as Shaanxi Hongda Pharmaceutical engage in large-scale production of Prilocaine Hydrochloride, offering competitive pricing and reliable supply chains. These companies have expanded their markets through exports to North America and Europe, often achieving certifications like ISO and cGMP to meet regulatory standards.

Suppliers of Epinephrine Bitartrate

1. Bachem

Bachem AG is renowned for producing high-quality peptide-based APIs, including Epinephrine Bitartrate. Their manufacturing processes ensure consistent bioavailability, and they provide comprehensive documentation for regulatory submissions. Bachem’s strategic global manufacturing sites bolster their supply reliability.

2. Spectrum Chemical & Laboratory Products

Spectrum Chemicals supplies Epinephrine Bitartrate in bulk to research institutions, compounding pharmacies, and pharmaceutical manufacturers. Their product offerings conform to pharmacopoeial standards (USP, EP, BP), and they maintain rigorous quality controls.

3. Merck (Sigma-Aldrich)

A global leader in chemicals and biochemicals, Merck's Sigma-Aldrich division offers Epinephrine Bitartrate with high purity and extensive documentation. Their extensive distribution network ensures quick availability worldwide.

4. Chinese and Indian Manufacturers

Numerous Chinese and Indian API manufacturers, such as Jiangsu Hengrui Medicine Co., Ltd., and Hubei Wu Xiang Pharmaceutical Co., Ltd., produce Epinephrine Bitartrate at scale. These players are integral to the global API supply chain due to cost advantages, provided they meet regulatory standards like cGMP.

5. Other Notable Suppliers

Additional manufacturers include Fermenta Biotech (India), Novachem (China), and various regional API companies that supply to generic pharmaceutical producers in Europe, North America, and Asia.

Regulatory and Quality Considerations

Suppliers for these APIs are generally required to comply with standard international regulations, including:

United States Pharmacopeia (USP)
European Pharmacopoeia (EP)
British Pharmacopoeia (BP)
Good Manufacturing Practices (GMP) certification from relevant regulatory agencies (FDA, EMA, NMPA)**

Manufacturers often seek certifications that affirm their compliance, facilitating acceptance across regulated markets.

Supply Chain Dynamics

The global supply chain for Prilocaine Hydrochloride and Epinephrine Bitartrate is subject to several factors:

Raw Material Availability: The synthesis of these APIs, especially for Epinephrine, involves complex chemical processes requiring specialized raw materials (e.g., precursor amino acids).
Manufacturing Capacity: Global geopolitical events, such as trade tensions and pandemic-related disruptions, can impact production capacity and lead times.
Regulatory Changes: Evolving requirements, especially around potency, purity, and traceability, necessitate ongoing compliance efforts.
Pricing Pressures: Cost competitiveness remains vital, with Chinese and Indian manufacturers leveraging lower production costs.

Emerging Trends and Strategic Implications

The evolving landscape features increased outsourcing to contract manufacturers, the advent of biosynthetic processes for hormones like Epinephrine, and advancements in purification technologies improving API quality. Companies seeking supply chain resilience may diversify their supplier base, sourcing from multiple regions, and prioritize suppliers with proven regulatory compliance.

Key Takeaways

The supply of Prilocaine Hydrochloride and Epinephrine Bitartrate is diversified across established global players and regional manufacturers, with China and India being significant contributors.
Leading suppliers prioritize regulatory compliance, GMP standards, and product purity to meet stringent international market requirements.
Supply chain disruptions can substantially impact availability; therefore, strategic supplier diversification is prudent.
Advances in API manufacturing, including biosynthesis and process optimization, are reshaping the supply landscape.
Procurement decisions should consider not only cost but also manufacturing quality, certification status, and supply reliability.

FAQs

1. Who are the top global suppliers of Prilocaine Hydrochloride?
Hikma Pharmaceuticals, Fresenius Kabi, XTAL Biotech, and Chinese API manufacturers like Shaanxi Hongda Pharmaceutical are leading global suppliers, offering high-quality APIs complying with international standards.

2. Which companies dominate the Epinephrine Bitartrate API market?
Bachem, Sigma-Aldrich (Merck), and several Chinese and Indian manufacturers hold significant market shares, with Bachem and Sigma-Aldrich known for high-quality, well-documented products.

3. How do regulatory requirements influence API suppliers?
Suppliers must demonstrate compliance with cGMP, obtain certifications like FDA, EMA, or ISO, and align with pharmacopoeial standards (USP, EP, BP). Regulatory adherence ensures market access and product acceptance.

4. Are there regional differences in API quality standards?
Yes, while global standards aim for harmonization, regional regulatory agencies impose specific requirements. Suppliers often seek international certifications to access multiple markets.

5. What factors should companies consider when selecting an API supplier?
Quality assurance, regulatory compliance, manufacturing capacity, supply chain stability, cost, and certifications are critical factors influencing supplier choice.

References

[1] Global Industry Analysts. "Active Pharmaceutical Ingredients (APIs) Market." 2022.
[2] U.S. Pharmacopeia. "Prilocaine Hydrochloride Monograph." 2022.
[3] European Pharmacopoeia. "Epinephrine Bitartrate Monograph." 2022.
[4] Industry publications and manufacturer websites.

Suppliers and packagers for PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE