Suppliers and packagers for generic pharmaceutical drug: MEPIVACAINE HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE

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	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089407	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1534-3	25 POUCH in 1 BOX (51662-1534-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1534-2) / 50 mL in 1 VIAL, MULTI-DOSE	2021-05-11
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089407	ANDA	Fresenius Kabi USA, LLC	63323-283-57	25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)	2009-07-20
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089410	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1535-3	21 POUCH in 1 BOX (51662-1535-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1535-2) / 50 mL in 1 VIAL, MULTI-DOSE	2021-05-10
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089410	ANDA	Fresenius Kabi USA, LLC	63323-296-57	25 VIAL, MULTI-DOSE in 1 TRAY (63323-296-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-296-01)	2009-07-20
Fresenius Kabi Usa	POLOCAINE-MPF	mepivacaine hydrochloride	INJECTABLE;INJECTION	089406	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1403-1	30 mL in 1 VIAL, SINGLE-DOSE (51662-1403-1)	2019-12-10

MEPIVACAINE HYDROCHLORIDE: KEY SUPPLIERS AND SUPPLY CHAIN DYNAMICS

Last updated: February 19, 2026

Mepivacaine hydrochloride, a local anesthetic, relies on a concentrated supply chain with key manufacturers dominating production. The market is characterized by established players and a consistent demand driven by its widespread use in dentistry and minor surgical procedures. Supply chain disruptions, while not extensively documented publicly for this specific API, could impact availability given the specialized nature of chemical synthesis involved.

WHAT ARE THE PRIMARY MANUFACTURING REGIONS FOR MEPIVACAINE HYDROCHLORIDE?

Manufacturing of mepivacaine hydrochloride is concentrated in specific geographic regions known for their chemical and pharmaceutical production infrastructure.

• India is a significant global hub for Active Pharmaceutical Ingredient (API) manufacturing, including local anesthetics like mepivacaine hydrochloride. Several Indian companies possess the necessary regulatory approvals and technical expertise.
• China also plays a substantial role in API production, with a number of chemical manufacturers capable of synthesizing mepivacaine hydrochloride.
• Europe, particularly Germany and Switzerland, has a history of high-quality pharmaceutical manufacturing and hosts some producers of mepivacaine hydrochloride.

The concentration in these regions is driven by factors including established chemical industries, skilled labor, and regulatory frameworks that support pharmaceutical production.

WHICH COMPANIES ARE KEY SUPPLIERS OF MEPIVACAINE HYDROCHLORIDE API?

Several companies are identified as primary suppliers of mepivacaine hydrochloride API. These entities often have extensive experience in the synthesis of anesthetic compounds and hold relevant certifications.

• Fresenius Kabi AG: A global healthcare company with a significant presence in injectable anesthetics.
• Sanofi S.A.: While Sanofi is a broad pharmaceutical company, its generics division or contract manufacturing partners may be involved in the supply of mepivacaine hydrochloride.
• Akorn Pharmaceuticals, Inc.: Known for its portfolio of generic injectable drugs.
• Hikma Pharmaceuticals PLC: A multinational pharmaceutical group with a generics business that includes anesthetics.
• Hospira, Inc. (a Pfizer company): Historically a major supplier of injectable drugs, including anesthetics.

It is important to note that the supplier landscape can shift due to mergers, acquisitions, and changes in manufacturing focus. Companies may also operate through contract manufacturing organizations (CMOs).

WHAT ARE THE TYPICAL QUALITY AND REGULATORY STANDARDS FOR MEPIVACAINE HYDROCHLORIDE API?

Mepivacaine hydrochloride API must adhere to stringent quality and regulatory standards to ensure patient safety and efficacy. Compliance with these standards is a prerequisite for market access in major pharmaceutical markets.

• Pharmacopoeia Standards: API must meet specifications outlined in major pharmacopoeias, including:
  • United States Pharmacopeia (USP)
  • European Pharmacopoeia (EP)
  • Japanese Pharmacopoeia (JP)
• Good Manufacturing Practices (GMP): Manufacturing facilities must operate under cGMP (current Good Manufacturing Practices) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes:
  • Rigorous quality control processes.
  • Validated analytical methods for identity, purity, and potency testing.
  • Control of impurities, including residual solvents and related substances.
  • Batch-to-batch consistency.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and controls. Pharmaceutical companies reference these DMFs in their drug product marketing applications.
• Impurity Profiles: Strict limits are placed on impurities. For mepivacaine hydrochloride, specific impurities related to the synthesis process and degradation products are monitored. For example, USP monograph details specific limits for related substances [1].
• Stability Studies: Manufacturers must conduct comprehensive stability studies to determine the shelf-life and appropriate storage conditions for the API.

WHAT ARE THE POTENTIAL SUPPLY CHAIN CHALLENGES FOR MEPIVACAINE HYDROCHLORIDE?

The supply chain for mepivacaine hydrochloride, like many specialized APIs, faces several potential challenges that can impact availability and cost.

• Raw Material Sourcing: The synthesis of mepivacaine hydrochloride requires specific chemical precursors. Fluctuations in the availability or cost of these raw materials, which may be sourced from limited global suppliers, can disrupt production. For example, the synthesis involves compounds like 2,6-xylidine.
• Regulatory Hurdles: Changes in regulatory requirements or delays in obtaining or renewing manufacturing site inspections and API certifications can impact supply. Facilities must maintain compliance with evolving GMP standards in multiple jurisdictions.
• Geopolitical Factors and Trade Policies: Reliance on specific manufacturing regions makes the supply chain vulnerable to geopolitical instability, trade disputes, and tariffs, which can affect import/export costs and lead times.
• Manufacturing Capacity: While demand is generally stable, sudden spikes in demand or the exit of key manufacturers can lead to capacity constraints. The production of mepivacaine hydrochloride involves complex multi-step chemical synthesis, which cannot be easily scaled up or switched between products without significant lead time and investment.
• Quality Control Failures: Even a single batch failure due to quality issues can have a ripple effect, leading to shortages and delays while the root cause is identified and rectified.
• Logistics and Transportation: The global nature of API sourcing and distribution involves complex logistics. Disruptions in shipping, port congestion, or increased freight costs can impact delivery times and add to overall costs.

HOW DO GLOBAL SUPPLY CHAIN TRENDS IMPACT MEPIVACAINE HYDROCHLORIDE?

Broader trends in global pharmaceutical supply chains have direct implications for mepivacaine hydrochloride.

• Diversification of Sourcing: Pharmaceutical companies are increasingly seeking to diversify their API suppliers to mitigate risks associated with over-reliance on single sources or regions. This trend could lead to opportunities for manufacturers in emerging regions or those with robust quality systems.
• Increased Scrutiny of Supplier Quality: Regulatory bodies and pharmaceutical companies are enhancing their due diligence on API suppliers, demanding greater transparency regarding manufacturing processes, quality control, and supply chain integrity. This can lead to longer qualification periods for new suppliers.
• Reshoring and Nearshoring Discussions: While complete reshoring of API manufacturing is complex and costly, there is growing interest in nearshoring or increasing domestic production capacity for critical medicines, including anesthetics, to enhance supply chain resilience.
• Digitalization and Traceability: The adoption of digital technologies is improving supply chain visibility, enabling better tracking of APIs from raw materials to finished products. This enhances quality assurance and helps in quickly identifying the source of issues.
• Focus on Sustainability: Environmental, social, and governance (ESG) factors are becoming more important. Manufacturers are facing pressure to adopt sustainable manufacturing practices, which can influence supplier selection and operational costs.

WHAT IS THE PATENT LANDSCAPE FOR MEPIVACAINE HYDROCHLORIDE?

Mepivacaine hydrochloride itself is a well-established drug, and its primary patents have long expired. This means the molecule is available as a generic product.

• Composition of Matter Patents: The original patents covering the chemical structure of mepivacaine hydrochloride expired decades ago.
• Process Patents: While the core molecule is off-patent, there may still be some patents related to novel or improved methods of synthesis, purification, or formulation. However, these are typically less impactful on the broad market availability compared to composition of matter patents.
• Formulation Patents: Patents might exist for specific drug product formulations, such as extended-release versions or combinations with other active ingredients, although these are not common for standard injectable mepivacaine.
• Generic Market: The lack of active composition of matter patents has facilitated the entry of multiple generic manufacturers, leading to a competitive market for both the API and the finished drug product.

This patent landscape supports a robust generic market, emphasizing API quality, cost-effectiveness, and reliable supply from manufacturers.

WHAT ARE THE KEY CONSIDERATIONS FOR PURCHASING MEPIVACAINE HYDROCHLORIDE API?

For pharmaceutical companies seeking to procure mepivacaine hydrochloride API, several critical factors warrant careful consideration.

• Supplier Qualification: Conduct thorough due diligence on potential suppliers. This includes reviewing their GMP certifications, regulatory inspection history (FDA, EMA, etc.), and overall quality management systems. Site audits are crucial.
• Regulatory Documentation: Ensure suppliers can provide comprehensive and up-to-date regulatory documentation, including DMFs and Certificates of Analysis (CoAs) for each batch.
• Quality Agreements: Establish robust quality agreements with suppliers that clearly define responsibilities for quality control, change management, complaint handling, and recalls.
• Supply Chain Security and Resilience: Assess the supplier's strategies for raw material sourcing, inventory management, and their contingency plans for potential disruptions. Diversification of approved suppliers is advisable.
• Cost and Contract Terms: Negotiate favorable pricing and contract terms that include provisions for price stability, delivery schedules, and intellectual property protection.
• Lead Times and Reliability: Understand the supplier's typical lead times for API delivery and their historical reliability in meeting these commitments.
• Impurity Profiling and Analytical Methods: Verify that the supplier's impurity profile aligns with pharmacopoeial requirements and that their analytical methods are validated and consistent with regulatory expectations.
• Technical Support: A responsive technical support team from the API supplier can be invaluable for troubleshooting and regulatory inquiries.

KEY TAKEAWAYS

• Mepivacaine hydrochloride API manufacturing is concentrated in India, China, and Europe, with established pharmaceutical companies and CMOs as key suppliers.
• Adherence to stringent USP, EP, and JP pharmacopoeial standards, along with cGMP, is mandatory for API suppliers.
• Supply chain risks include raw material availability, geopolitical factors, manufacturing capacity, and regulatory compliance.
• Global supply chain trends like diversification and increased scrutiny of supplier quality are influencing the mepivacaine hydrochloride market.
• The patent landscape for mepivacaine hydrochloride is characterized by expired composition of matter patents, fostering a competitive generic market.
• Procurement requires rigorous supplier qualification, thorough regulatory review, and careful attention to quality agreements, supply chain resilience, and cost.

FAQS

1. What is the primary use of mepivacaine hydrochloride? Mepivacaine hydrochloride is primarily used as a local anesthetic in dentistry and for minor surgical procedures to provide temporary pain relief.
2. How does the USP monograph specify impurities for mepivacaine hydrochloride? The USP monograph for mepivacaine hydrochloride sets specific limits for related substances, which are structurally similar compounds that may be present as byproducts of synthesis or degradation. These limits ensure the purity and safety of the API.
3. Can pharmaceutical companies easily switch between mepivacaine hydrochloride API suppliers? Switching API suppliers is a complex and lengthy process involving significant regulatory work. Companies must revalidate analytical methods, conduct bridging studies, and often submit supplemental regulatory filings to demonstrate that the API from the new supplier does not adversely affect the finished drug product's quality, safety, and efficacy.
4. What are the main chemical precursors for mepivacaine hydrochloride synthesis? Key precursors for mepivacaine hydrochloride synthesis include 2,6-xylidine and chloroacetyl chloride, which undergo a series of chemical reactions to form the final active pharmaceutical ingredient.
5. Does the price of mepivacaine hydrochloride API fluctuate significantly? While it is a generic API, price fluctuations can occur due to changes in raw material costs, manufacturing efficiencies, competitive pressures among suppliers, and shifts in global supply and demand. However, compared to novel or patented drugs, the price is generally more stable.

CITATIONS

[1] United States Pharmacopeia Convention. (2023). United States Pharmacopeia and The National Formulary (USP-NF). Retrieved from USP-NF Online.