Pharmaceutical firm Strides Arcolab said its injectables unit Agila Specialties has received US Food and Drug Administration (USFDA) approval for its Polish sterile facility.
“Agila Specialties (Agila)…today announced that it has received USFDA approval for its Polish Sterile facility,” Strides Arcolab said in statement. The facility at Warsaw manufactures vials, ampoules, pre-filled syringes and lyophilized injections, it added.
“With this approval, all eight global sterile injectable sites of Agila are now approved by the USFDA and EU authorities and places Agila amongst the largest global capacities for sterile injectables,” the company said.
The pharma major further said shipments from the Polish plant will start by the end of this year and it will run in full capacity by first quarter of 2013. Commenting on the development, Agila Specialties Chief Executive Officer Venkat Iyer said: “This approval for our Polish sterile facility offers significant flexibility to our manufacturing, which is currently experiencing strong demand on a worldwide basis.”
Agila’s current marketing network covers 70 countries and it has partnerships with some leading pharma companies for both developed and emerging markets. Strides Arcolab has 14 manufacturing facilities across six countries with presence in more than 75 developed and emerging markets.
Shares of Strides Arcolab today clsoed trading 1.41 percent down at Rs 906.20 apiece on the BSE.