Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE


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ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Pierrel ORABLOC articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022466 NDA AUTHORIZED GENERIC Burkhart Dental Supply Co., Inc 43498-816-01 50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE 2024-11-04
Pierrel ORABLOC articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022466 NDA AUTHORIZED GENERIC Burkhart Dental Supply Co., Inc 43498-993-01 50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGE 2024-11-04
Pierrel ORABLOC articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022466 NDA Pierrel S.p.A. 45146-110-01 100 CARTRIDGE in 1 BOX (45146-110-01) / 1.8 mL in 1 CARTRIDGE 2011-03-01
Pierrel ORABLOC articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022466 NDA Pierrel S.p.A. 45146-110-02 50 CARTRIDGE in 1 BOX (45146-110-02) / 1.8 mL in 1 CARTRIDGE 2011-03-01
Pierrel ORABLOC articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 022466 NDA Pierrel S.p.A. 45146-120-01 100 CARTRIDGE in 1 BOX (45146-120-01) / 1.8 mL in 1 CARTRIDGE 2011-03-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Articaine Hydrochloride and Epinephrine Bitartrate (API)

Last updated: April 23, 2026

What suppliers make Articaine Hydrochloride API?

Articaine Hydrochloride (API) suppliers (manufacturer-disclosed sources): Supplier / Manufacturer Product role Evidence source
Alfa Aesar / Thermo Fisher Scientific API catalog supply Item pages for “Articaine hydrochloride” listed under supplier/distributor offerings (Thermo Fisher product catalog). [1]
Jiangsu Huayi API manufacturer Company product listings for “Articaine hydrochloride” on manufacturer site (catalog entry). [2]
TCI Chemicals API / reference material supply Product listing for “Articaine hydrochloride” in TCI catalog. [3]

What suppliers make Epinephrine Bitartrate API?

Epinephrine Bitartrate (API) suppliers (manufacturer-disclosed sources): Supplier / Manufacturer Product role Evidence source
Alfa Aesar / Thermo Fisher Scientific API catalog supply Item pages for “Epinephrine bitartrate” listed in Thermo Fisher catalog. [4]
MilliporeSigma (Merck KGaA) API / reagent supply Sigma-Aldrich product pages for “Epinephrine bitartrate” (catalog). [5]
Nacalai Tesque API / reagent supply Product listing for “Epinephrine bitartrate” in Nacalai catalog. [6]

What suppliers are present across both APIs?

Overlap across both lists is limited in the sources above to major distributors carrying both APIs:

  • Alfa Aesar / Thermo Fisher Scientific: stocks both Articaine hydrochloride and Epinephrine bitartrate in catalog form. [1], [4]

What are the most actionable ways to qualify these suppliers for pharmaceutical use?

For R&D and commercial procurement, use the following qualification checkpoints against each supplier that supplies the API:

  1. Quality documentation

    • Certificate of Analysis (CoA) for each batch.
    • Test methods that match the intended pharmacopeia (for example, USP/EP monographs where applicable).
    • Impurity statement aligned to specifications.
  2. Regulatory posture

    • Availability of DMF/ASMF status when targeting approval filing (where applicable to the jurisdiction and route).
    • Auditable manufacturing site details.
  3. Supply chain and control

    • Confirm sourcing route (synthetic vs. derivative intermediates), and whether polymorph/salt form is controlled for the exact intended grade (salt form matters for both drugs).

Key Takeaways

  • Articaine hydrochloride has catalog supply from Alfa Aesar/Thermo Fisher, Jiangsu Huayi, and TCI Chemicals. [1]-[3]
  • Epinephrine bitartrate has catalog supply from Alfa Aesar/Thermo Fisher, MilliporeSigma, and Nacalai Tesque. [4]-[6]
  • Only Alfa Aesar/Thermo Fisher shows overlap in the supplied sources for both APIs. [1], [4]

FAQs

1) Are these suppliers likely to provide API-grade material for pharmaceutical production?

The sources cited are catalog listings; pharma-grade suitability depends on the supplier’s documented specifications, batch CoAs, and regulatory package for the specific grade you request.

2) Does salt form matter for these two APIs?

Yes. The cited drug substances are specifically articaine hydrochloride and epinephrine bitartrate, so the supplier must provide the correct salt form and grade.

3) Can one supplier cover both APIs?

Yes. Alfa Aesar/Thermo Fisher stocks both APIs per the cited catalog entries. [1], [4]

4) What documents should be demanded before purchasing?

CoA for the batch, specification sheet, and test methods consistent with the intended pharmacopeia/spec target.

5) How do I compare suppliers efficiently?

Compare by salt form confirmation, impurity profile controls, CoA consistency across batches, and availability of regulatory documentation for the intended market.


References (APA)

[1] Thermo Fisher Scientific. (n.d.). Articaine hydrochloride (catalog product page). https://www.thermofisher.com
[2] Jiangsu Huayi. (n.d.). Articaine hydrochloride (product listing). https://www.jshychem.com
[3] TCI Chemicals. (n.d.). Articaine hydrochloride (product page). https://www.tcichemicals.com
[4] Thermo Fisher Scientific. (n.d.). Epinephrine bitartrate (catalog product page). https://www.thermofisher.com
[5] Merck (MilliporeSigma). (n.d.). Epinephrine bitartrate (product page). https://www.sigmaaldrich.com
[6] Nacalai Tesque. (n.d.). Epinephrine bitartrate (product page). https://www.nacalai.co.jp

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