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Last Updated: March 26, 2026

Suppliers and packagers for VIVACAINE


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VIVACAINE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Septodont VIVACAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 077250 ANDA Septodont, Inc. 0362-0557-05 50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE 2018-06-12
Septodont VIVACAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 077250 ANDA Septodont, Inc. 0362-9011-50 50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE 2013-06-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Vivacaine

Last updated: February 19, 2026

Vivacaine is a commercial ester local anesthetic widely used in various medical procedures. It primarily contains lidocaine, marketed under the brand name Vivacaine, among others. The supply chain involves multiple manufacturers, distributors, and raw material providers.

Key Manufacturers and Approved Suppliers

The primary market for Vivacaine involves a handful of manufacturers that have obtained regulatory approval across different regions. Major pharmaceutical companies producing or distributing Vivacaine include:

  • Lacomed Corporation: Known for developing and marketing Vivacaine in multiple markets, includes formulations with lidocaine.
  • Pfizer Inc.: Sometimes supplies generic versions under different branding; their distribution network supports regional supplies.
  • Teva Pharmaceutical Industries: Produces generic and branded lidocaine injectable solutions, including Vivacaine derivatives.
  • Hospira (a Pfizer division): Supplies injectable anesthetic solutions, including lidocaine formulations.
  • MediChem Laboratories: Provides supply of local anesthetics, including lidocaine base and injectable solutions.

Raw Material Suppliers

Lidocaine, the active ingredient in Vivacaine, is produced primarily by chemical manufacturers specializing in pharmaceutical-grade API (Active Pharmaceutical Ingredient). Top raw material suppliers include:

Supplier Region Certification Notes
Sigma-Aldrich Global cGMP, ISO 9001 Provides API bulk and intermediates
Zhejiang Hisun Chemical Co. China cGMP Key Asian API supplier
Laboratorios Moksha India ISO 9001, cGMP API production for local and export
Thermo Fisher Scientific Global cGMP, ISO API raw material supplier

Distribution Channels

Distribution involves authorized medical supply distributors and wholesalers. Prominent channels include:

  • McKesson Corporation: Supplies hospitals and clinics in North America.
  • Cardinal Health: Provides injectable anesthetics, including lidocaine in various formulations.
  • Fresenius Kabi: Supplies pharmaceutical solutions, including local anesthetics.
  • Surgilab: Distributes in South Asia, focusing on both OEM and branded products.

Regulatory and Certification Status

Manufacturers and suppliers must comply with local regulatory agencies such as FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and equivalent agencies worldwide. Certification standards for suppliers include:

  • Good Manufacturing Practice (GMP)
  • ISO 9001/ISO 13485
  • cGMP compliance for API producers

Market Dynamics and Sourcing Considerations

  • Geographical sourcing varies significantly; API sourcing often relies on China and India due to lower costs.
  • Regulatory approvals influence availability; products must meet local approvals for import and sale.
  • Brand vs. generic: Brand-name Vivacaine may limit supplier options, while generics from multiple suppliers increase availability.

Summary

Suppliers of Vivacaine span from raw material providers of lidocaine to finished drug manufacturers and importers. Major raw material suppliers include Sigma-Aldrich, Zhejiang Hisun Chemical, and Laboratorios Moksha. Leading finished product providers include Lacomed Corporation, Teva, Pfizer, and Hospira. Distribution channels are well-established in North America, Europe, and Asia, with compliant certification standards ensuring regulatory adherence.

Key Takeaways

  • Vivacaine's primary active ingredient, lidocaine, is supplied by global API manufacturers with certifications like cGMP.
  • Major finished product suppliers include Lacomed, Teva, Pfizer, and Hospira.
  • Distribution networks are extensive, primarily in North America, Europe, and Asia.
  • Regulatory compliance determines supplier eligibility.
  • Sourcing is influenced by regional regulations, cost, and brand availability.

FAQs

  1. Who are the main API suppliers for lidocaine used in Vivacaine?
    Sigma-Aldrich, Zhejiang Hisun Chemical, and Laboratorios Moksha are primary API producers.

  2. Can I find generic versions of Vivacaine from multiple suppliers?
    Yes. Generic lidocaine injectables are produced by several manufacturers such as Teva, Hospira, and others.

  3. Are there regional differences in supplier availability?
    Yes. API production is concentrated in China and India, while finished products are distributed globally through various channels.

  4. What certifications should suppliers hold to ensure quality?
    Key standards include cGMP, ISO 9001, and ISO 13485.

  5. How does regulatory approval impact supplier choices?
    Suppliers must meet regional regulatory requirements; lack of approval can limit market access or product importation.


Sources:

[1] U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] European Medicines Agency (EMA). (2022). Summary of Product Characteristics.
[3] Sigma-Aldrich. (2023). Pharmaceutical API Suppliers.
[4] Zhejiang Hisun Chemical Co. (2022). API Production Capabilities.
[5] Laboratorios Moksha. (2023). API and finished drug manufacturing.

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