Atracurium besilate manufacturers

About atracurium besilate

Atracurium besilate manufacturers include many generic injectable producers in Europe, India and the US, following the original Tracrium from Wellcome, later GSK. Atracurium is a non-depolarising neuromuscular blocking agent used during anaesthesia to relax muscles for intubation, surgery and mechanical ventilation. It is broken down in the blood independently of the liver and kidneys. Pharmaceutical companies can source atracurium injection and API through out-licensing, supply or technology transfer. Dossiers are available in EU CTD and US ANDA formats.

Atracurium besilate key facts

Atracurium besilate manufacturers and licensing history

Atracurium was developed at the University of Strathclyde and introduced by Wellcome as Tracrium in the early 1980s. Its unique feature is that it breaks down in the blood by Hofmann elimination and ester hydrolysis, without relying on the liver or kidneys.

GSK later took over Tracrium, and atracurium became widely available as generics. Cisatracurium, one of its isomers, was launched later as Nimbex and has largely replaced atracurium in some markets because it releases less histamine.

Atracurium is unstable at room temperature and must be kept cold. Buyers should confirm GMP status, sterile manufacturing capability, a DMF or CEP and cold-chain capability before choosing a dossier partner.

Atracurium besilate dosage forms and dossier types

Atracurium besilate is supplied as a 10 mg/ml solution for intravenous injection or infusion.

Atracurium besilate regulatory and patent status

Atracurium was approved in the UK in the early 1980s and in the US in 1983. It is off-patent and available from many generic suppliers. Labels warn about histamine release, which can cause flushing and low blood pressure, and about laudanosine, a breakdown product that may cause seizures at very high levels.

Atracurium besilate mechanism of action and therapeutic use

Atracurium blocks acetylcholine receptors at the neuromuscular junction, which relaxes skeletal muscles. It is broken down in the blood by Hofmann elimination and ester hydrolysis, so its action is predictable even in patients with liver or kidney failure. Atracurium is used during general anaesthesia for intubation, surgery and mechanical ventilation.

Atracurium besilate licensing and sourcing

Atracurium 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), sterile manufacturing capability, cold-chain capability and territory availability. Current offers and supplier contacts are listed among the atracurium besilate manufacturers on Pipelinepharma.

Frequently asked questions about atracurium besilate

Who are the main atracurium manufacturers? Atracurium was originally developed by Wellcome as Tracrium. Today, many generic injectable producers in Europe, India and the US make it.

What is the difference between atracurium and cisatracurium? Cisatracurium is one of atracurium's isomers. It is more potent and releases less histamine, so it is preferred in some markets.

Is an atracurium EU CTD dossier available for licensing? Yes. Atracurium 10 mg/ml injection dossiers in EU CTD format are widely available.

What forms and strengths of atracurium are available? Atracurium is available as a 10 mg/ml solution for injection, in 2.5, 5 and 25 ml ampoules or vials.

Why must atracurium be refrigerated? Atracurium slowly breaks down at room temperature, so it must be stored at 2–8 °C and protected from light.