AAIPharma Charleston sterile manufacturing receives MHRA approval
International pharmaceutical services provider AAIPharma's sterile manufacturing plant in Charleston, South Carolina, US, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilised products.
International pharmaceutical services provider AAIPharma's sterile manufacturing plant in Charleston, South Carolina, US, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilised products.
The MHRA approval certifies the plant to produce these products for shipment to countries in the EU and comes on the heels of a US$1.5m (Euro 1m) renovation of the plant. Along with prior approvals from the US FDA, this approval positions the plant to deliver aseptic contract manufacturing services to clients wishing to supply both commercial and clinical sterile drug products throughout the US and Europe.
'This investment and subsequent MHRA approval of our Charleston plant is in line with AAIPharma's goal to deliver high quality pharmaceutical services to meet the needs of the pharma and biotech industries,' said Lee Karras, sr vice president of global pharmaceutical services at AAIPharma.
