Piramal Pharma’s divisions Piramal Critical Care (PCC) and BrePco Biopharma (BPCO) have received receipt of market authorisation from U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), for the use of Neoatricon, the first pediatric strength solution for infusion of dopamine hydrochloride used in treatment for hypotension in neonates, infants, and children. PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions.
Developed by BPCO, Neoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of Dopamine Hydrochloride. It is available in a concentration of 1.5mg/mL in a 30 mL vial and a higher strength containing 4.5mg/mL in a 50 mL vial.
Currently, there are no approved Dopamine Hydrochloride formulations specifically indicated for use in neonates, infants, or children, with off-label use remaining a common practice. The approval of Neoatricon addresses this critical gap by ensuring precise dosing, reducing the risk of under- or overdosing, and minimizing preparation time in neonatal and paediatric intensive care units (NICU & PICU), facilitating faster intervention in emergency settings.
Piramal Pharma provides end-to-end pharma services to customers and a portfolio of differentiated pharma products across a domestic and global distribution network.
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