Poractant Alfa Suppliers & Bulk Manufacturers

Available Forms: Intratracheal suspension

Available Strengths: 80 mg/mL (120 mg/1.5 mL, 240 mg/3 mL vials)

Reference Brands: Curosurf(Eu & US)

Category: Respiratory Disorder

Poractant alfa 80 mg/mL intratracheal suspension, a porcine surfactant dosed by birth weight for preterm infants with respiratory distress syndrome, for neonatal units, importers and distributors.

Product Description:

Poractant alfa 80 mg/mL is a sterile intratracheal suspension of natural pig-lung surfactant, white to creamy in colour. Each millilitre carries 80 mg of phospholipids with the surfactant proteins SP-B and SP-C, which help the lipids spread quickly across the alveolar surface. The high concentration keeps the volume instilled into a tiny airway low. It is given down an endotracheal tube, and some units use a thin catheter in babies breathing on CPAP so that intubation can be avoided.

Dosing is by birth weight. European labelling gives 100 to 200 mg/kg first, then 100 mg/kg about 12 hours apart if the baby still needs ventilation and oxygen, up to a total of 300 to 400 mg/kg. The US label gives 2.5 mL/kg first, then up to two doses of 1.25 mL/kg. Heart rate and saturation are watched during instillation, as transient bradycardia, desaturation and reflux into the tube can occur. Lung compliance can improve within minutes, so ventilator pressures and oxygen are reduced promptly.

Sourcing notes. Cold chain is essential: store at 2 to 8 °C in the original carton away from light, and never freeze. Before use the vial is warmed to room temperature and gently inverted, not shaken, to resuspend it. Labels allow an unopened vial that has warmed to return to the refrigerator once, within 24 hours, which limits waste. Each vial is single-use. Ask for validated shipping data, a CoA per batch, the GMP certificate, a CoPP and a CTD dossier. It is a prescription-only hospital medicine; specify vial sizes and expected quantities.