Aniracetam manufacturers

About aniracetam

Aniracetam manufacturers include the holders of Ampamet in Italy and Memodrin and Referan in Greece, and several Chinese generic producers. Aniracetam is a racetam-class cognitive enhancer, first made by Hoffmann-La Roche in the 1970s. It is a prescription medicine in Italy and Greece for memory and attention disorders in older adults. It is not approved in the US. Pharmaceutical companies can source aniracetam tablets, granules and API through out-licensing, supply or technology transfer.

Aniracetam key facts

Aniracetam manufacturers and licensing history

Hoffmann-La Roche first made aniracetam in the 1970s, with patents filed in 1979. It was developed as a more potent, fat-soluble relative of piracetam.

In Italy, Ampamet was first authorised on 20 August 1993, as 750 mg tablets and 1,500 mg granules. In Greece, it is sold as Memodrin and Referan. In Japan, Draganon was used for about eight years for anxiety and depressed mood after stroke, but it was withdrawn after a new placebo-controlled trial failed. Aniracetam is also marketed in China.

In the US, aniracetam is not approved as a medicine and is not a lawful dietary supplement ingredient, although it is sold online. Buyers should confirm GMP status, a DMF and the regulatory status in each target market before choosing a dossier partner.

Aniracetam dosage forms and dossier types

Aniracetam is approved as 750 mg film-coated tablets and 1,500 mg granules for oral suspension in Italy. Generic manufacturers most often develop 750 mg tablets.

Aniracetam regulatory and patent status

Aniracetam is off-patent and authorised nationally in Italy and Greece, and in China. Ampamet was first authorised in Italy on 20 August 1993 and renewed in 2008. It was withdrawn in Japan after a failed trial. In the US, it is an unapproved new drug, and its use in dietary supplements is unlawful. In Australia, it is a prescription-only medicine.

Aniracetam mechanism of action and therapeutic use

Aniracetam positively modulates AMPA glutamate receptors, which strengthens signalling between nerve cells. Its main metabolite, N-anisoyl-GABA, increases acetylcholine release in the brain. In Italy, aniracetam is used for attention and memory disorders in older adults, at 1,500 mg per day. It is rapidly broken down in the liver after oral intake.

Aniracetam licensing and sourcing

Aniracetam suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, WHO GMP), dossier format and readiness, API source and territory availability. Current offers and supplier contacts are listed among the aniracetam manufacturers on Pipelinepharma.

Frequently asked questions about aniracetam

Who are the main aniracetam manufacturers? Aniracetam was developed by Hoffmann-La Roche. Today, it is sold as Ampamet in Italy and Memodrin and Referan in Greece, and several Chinese companies produce generics.

Is aniracetam approved in the US? No. Aniracetam is not approved by the FDA, and its use in dietary supplements is unlawful.

Is an aniracetam dossier available for licensing? Aniracetam tablet and granule dossiers are available in EU national formats, referencing Ampamet.

What forms and strengths of aniracetam are available? Aniracetam is available as 750 mg film-coated tablets and 1,500 mg granules for oral suspension.

Why was aniracetam withdrawn in Japan? Aniracetam (Draganon) was withdrawn in Japan after a new placebo-controlled trial failed to confirm its benefit.