Alanyl-glutamine manufacturers

About alanyl-glutamine

Alanyl-glutamine manufacturers include the originator Fresenius Kabi (Dipeptiven) and more than 20 Chinese API producers. Alanyl-glutamine (N(2)-L-alanyl-L-glutamine) is a dipeptide that delivers glutamine in a stable, soluble form for parenteral nutrition. It is used in patients in hypercatabolic or hypermetabolic states, such as after major surgery or trauma. Pharmaceutical companies can source alanyl-glutamine 20% concentrate for infusion through out-licensing, supply or technology transfer. Dossiers are available in EU CTD and Chinese formats.

Alanyl-glutamine key facts

Alanyl-glutamine manufacturers and licensing history

Fresenius Kabi developed alanyl-glutamine as Dipeptiven to solve a formulation problem: free glutamine is unstable and poorly soluble in solution. Dipeptiven is manufactured by Fresenius Kabi Austria in Graz and registered in Europe, the UK, Singapore, South Africa and many other markets.

China is now the largest alanyl-glutamine market. More than 20 Chinese companies hold active CDE registrations for alanyl-glutamine API, and both imported and domestic injections are approved. Dipeptiven is listed in China's catalogue of reference preparations.

Alanyl-glutamine API is also sold for cell culture media. Buyers should confirm pharmaceutical-grade GMP production, a DMF or CDE registration, and endotoxin and impurity data before choosing a dossier partner.

Alanyl-glutamine dosage forms and dossier types

Alanyl-glutamine is approved as a 20% concentrate for solution for infusion, in 50 ml and 100 ml bottles. Generic alanyl-glutamine manufacturers develop the same concentrate, referencing Dipeptiven.

Alanyl-glutamine regulatory and patent status

Dipeptiven is authorised nationally in Europe and in many other markets. Its core compound patent expired in China in 2007, and in Europe and the US around 2008–2009. Alanyl-glutamine is not approved as a medicine in the US.

Current labels limit Dipeptiven to adults, as safety and efficacy in children have not been established. In the UK, use with parenteral or enteral nutrition should not exceed three weeks.

Alanyl-glutamine mechanism of action and therapeutic use

Alanyl-glutamine is broken down in the body into L-alanine and L-glutamine. Glutamine becomes conditionally essential in severe illness, when the body's own supply cannot meet demand. Alanyl-glutamine is given as part of parenteral or enteral nutrition in patients in hypercatabolic or hypermetabolic states. It is mixed with a compatible amino acid solution before infusion.

Alanyl-glutamine licensing and sourcing

Alanyl-glutamine suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, WHO GMP), sterile manufacturing capability, dossier format and territory availability. Current offers and supplier contacts are listed among the alanyl-glutamine manufacturers on Pipelinepharma.

Frequently asked questions about alanyl-glutamine

Who are the main alanyl-glutamine manufacturers? Fresenius Kabi makes the originator, Dipeptiven, in Graz, Austria. In China, more than 20 companies hold API registrations, and many domestic injections are approved.

Is an alanyl-glutamine EU CTD dossier available for licensing? Yes. Alanyl-glutamine 20% concentrate dossiers in EU CTD format can be licensed, referencing Dipeptiven. Sterile manufacturing and endotoxin data are key parts of the dossier.

Is there a generic version of alanyl-glutamine? Yes. The core patent expired in China in 2007, and many Chinese generics are approved. In Europe, Dipeptiven remains the main brand.

What forms and strengths of alanyl-glutamine are available? Alanyl-glutamine is available as a 200 mg/ml concentrate for solution for infusion, in 50 ml and 100 ml bottles.

Is alanyl-glutamine approved in the US? No. Alanyl-glutamine is not approved as a medicine in the US, although it is used in Europe, China and many other markets.