Articaine hydrochloride manufacturers

About articaine hydrochloride

Articaine hydrochloride manufacturers include Septodont (Septanest, Septocaine), 3M (Ubistesin), Pierrel (Orabloc) and Sanofi, whose predecessor Hoechst developed it as Ultracain. Articaine is an amide local anaesthetic used mainly in dentistry, usually combined with adrenaline (epinephrine). It is one of the most widely used dental anaesthetics in Europe. Pharmaceutical companies can source articaine dental cartridges and API through out-licensing, supply or technology transfer. Dossiers are available in EU CTD and US NDA or ANDA formats.

Articaine hydrochloride key facts

Articaine hydrochloride manufacturers and licensing history

Articaine was synthesised in 1969 and introduced in Germany by Hoechst in 1976 as Ultracain. It spread across Europe and became one of the most used dental anaesthetics there. Sanofi now holds Ultracain.

Septodont markets articaine as Septanest in Europe and as Septocaine in the US, where it was approved in April 2000. Other major suppliers include 3M (Ubistesin), Pierrel (Orabloc) and Dentsply (Articadent).

Articaine cartridges require sterile filling and stable adrenaline formulation. Buyers should confirm GMP status, cartridge filling capability, a DMF and sulfite-free or sulfite-containing formulation details before choosing a dossier partner.

Articaine hydrochloride dosage forms and dossier types

Articaine is supplied as 4% solution with adrenaline in dental cartridges. Generic articaine manufacturers develop both adrenaline strengths.

Articaine hydrochloride regulatory and patent status

Articaine has been approved in Germany since 1976 and in the US since April 2000. It is off-patent and authorised in most European countries and many other markets. Labels contain warnings about adrenaline in patients with heart disease and, for some products, about sulfite preservatives.

Articaine hydrochloride mechanism of action and therapeutic use

Articaine blocks sodium channels in nerve membranes, which stops pain signals from travelling. Its thiophene ring makes it highly fat-soluble, helping it spread through tissue and bone. Its ester group means it is quickly broken down in the blood, giving a short half-life. Articaine is used for dental infiltration and nerve-block anaesthesia in adults and children from 4 years of age.

Articaine hydrochloride licensing and sourcing

Articaine suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA), cartridge filling capability, dossier format and territory availability. Current offers and supplier contacts are listed among the articaine hydrochloride manufacturers on Pipelinepharma.

Frequently asked questions about articaine hydrochloride

Who are the main articaine manufacturers? Septodont, 3M, Pierrel and Dentsply are major suppliers. Sanofi holds Ultracain, the original product developed by Hoechst.

When was articaine first approved? Articaine was first approved in Germany in 1976, and in the US in April 2000.

What forms and strengths of articaine are available? Articaine is available as 4% solution with adrenaline 1:100,000 or 1:200,000, in dental cartridges.

Can articaine be used in children? Yes. Articaine is approved for children from 4 years of age.

Is an articaine EU CTD dossier available for licensing? Yes. Articaine dental cartridge dossiers in EU CTD format can be licensed, referencing Ultracain or Septanest.