Acetylleucine manufacturers

About acetylleucine

Acetylleucine manufacturers include the originator Pierre Fabre (Tanganil, France), French generic producers Biogaran, Teva and Viatris, and IntraBio, which markets the L-enantiomer levacetylleucine as Aqneursa in the US and EU. Acetylleucine (N-acetyl-DL-leucine) is a modified amino acid used for the symptomatic treatment of acute vertigo. Levacetylleucine is approved for Niemann-Pick disease type C and, in the US, ataxia-telangiectasia. Pharmaceutical companies can source acetylleucine tablets and injection through out-licensing, supply or technology transfer. Dossiers are typically prepared in EU CTD format.

Acetylleucine key facts

Acetylleucine manufacturers and licensing history

Acetylleucine was developed in France and is marketed by Pierre Fabre as Tanganil. TanganilPro 500 mg tablets are the reference product of the French generic group, alongside Tanganil 500 mg tablets and 500 mg/5 ml IV ampoules (ANSM). Pierre Fabre Médicament Production manufactures Tanganil in France.

Biogaran, Teva and Viatris received French generic authorisations for acetylleucine 500 mg tablets from 2011. Biogaran and Viatris stopped marketing their tablets in 2025 (ANSM, Vidal), which leaves fewer generic competitors in France.

IntraBio, a US company built on research from the University of Oxford and LMU Munich, developed the purified L-enantiomer, levacetylleucine. IntraBio sells it as Aqneursa, and IntraBio Ireland Ltd holds the EU marketing authorisation.

Acetylleucine API suppliers include amino acid derivative producers in China and Europe. Many listed offers are reagent or food grade. Buyers should confirm pharmaceutical-grade GMP production, an EU ASMF and the enantiomeric purity specification before choosing a dossier partner.

Acetylleucine dosage forms and dossier types

Acetylleucine is approved as 500 mg tablets and 500 mg/5 ml IV injection, and levacetylleucine as 1 g granules for oral suspension. Generic acetylleucine manufacturers most often develop 500 mg tablets, because tablets are the main reference form in France.

Acetylleucine regulatory and patent status

Acetylleucine has been studied for vertigo in France since 1957. The current Tanganil national marketing authorisation dates from 30 September 1992 (HAS). The tablets are non-prescription and 30% reimbursed in France. In its 2016 reassessment, HAS rated the efficacy-to-adverse-effect ratio of the tablets as low.

The FDA approved Aqneursa (levacetylleucine) under an NDA on 24 September 2024, for Niemann-Pick disease type C in patients weighing at least 15 kg. Ataxia in ataxia-telangiectasia followed on 18 September 2026. Acetyl-DL-leucine has no US approval, and the Aqneursa label advises against combining it with N-acetyl-DL-leucine.

In Europe, the CHMP adopted a positive opinion on Aqneursa on 24 July 2025 (EMA). The European Commission granted the marketing authorisation in January 2026, for NPC patients aged 6 and over and weighing at least 20 kg. The CHMP concluded that levacetylleucine is not a new active substance, which matters for data exclusivity. IntraBio has also filed an EU variation for ataxia-telangiectasia.

IntraBio holds use patents for acetylleucine in neurological indications, including the EP 3445351 family (priority 2016). Check the FDA Orange Book and national patent registers before developing a levacetylleucine generic.

Acetylleucine mechanism of action and therapeutic use

The mechanism of acetylleucine is not fully established, and the French SmPC describes it as an antivertigo agent with unknown mechanism. Proposed effects include stabilising the membrane potential of vestibular neurons. Nonclinical studies cited by EMA show levacetylleucine improves energy metabolism and ATP production in cerebellar cells. The L-enantiomer enters cells through monocarboxylate transporters, and the D-enantiomer competes for this uptake (FDA label). Approved uses are acute vertigo (acetyl-DL-leucine, France), Niemann-Pick disease type C (levacetylleucine, US and EU) and ataxia-telangiectasia (levacetylleucine, US).

Acetylleucine licensing and sourcing

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

Frequently asked questions about acetylleucine

Who are the main acetylleucine manufacturers?
Pierre Fabre is the originator and sells acetylleucine as Tanganil and TanganilPro in France. Biogaran, Teva and Viatris received French generic approvals for 500 mg tablets from 2011, although Biogaran and Viatris stopped marketing in 2025. IntraBio markets the L-enantiomer, levacetylleucine, as Aqneursa in the US and EU.

Which countries produce acetylleucine API and finished dosage forms?
Finished acetylleucine products are made mainly in France, where Pierre Fabre manufactures Tanganil tablets and injection. API producers are found in China and Europe. Buyers should ask API suppliers for GMP certificates, an EU ASMF and data confirming the DL or L enantiomer specification.

Is an acetylleucine EU CTD dossier available for licensing?
Yes. Acetylleucine 500 mg tablet dossiers in EU CTD format are offered for out-licensing, referencing TanganilPro or Tanganil in France. Buyers should confirm that a reference product is authorised in each target country, because acetylleucine is approved nationally rather than across the EU.

Is there a generic version of acetylleucine?
Yes. Generic acetylleucine 500 mg tablets have been authorised in France since 2011, with Teva among the current holders. No generic levacetylleucine exists, because Aqneursa is protected by exclusivity and patents in the US and EU. Acetyl-DL-leucine has never been approved in the US.

What forms and strengths of acetylleucine are available?
Acetylleucine is available as 500 mg tablets and 500 mg/5 ml IV injection ampoules. Levacetylleucine (Aqneursa) is available as granules for oral suspension in 1 g sachets, approved in the US in 2024 and the EU in 2026.

What is the difference between acetylleucine and levacetylleucine?
Acetylleucine is the racemic mixture (N-acetyl-DL-leucine), used for vertigo in France. Levacetylleucine is the purified L-enantiomer, approved for Niemann-Pick disease type C and, in the US, ataxia-telangiectasia. The FDA label advises against combining them, because the D-enantiomer competes with levacetylleucine for cellular uptake.