Indian authorities, who have been criticized for turning a blind eye to serious problems at Ranbaxy Laboratories plants there, have stopped a Ranbaxy API plant in Toansa from being able to sell products outside of India.
The European Medicines Agency (EMA) said Wednesday in an emailed statement that "On 26 March 2014, Indian authorities withdrew the site's 'Written Confirmation,' effectively making the suspension of the exports official for the time being. The Written Confirmation is a document that accompanies all APIs exported to the EU (and elsewhere) to certify that relevant manufacturing standards have been met."
Read more: Indian authority withdraws Ranbaxy plant export permit - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/indian-authority-withdraws-ranbaxy-plant-export-permit/2014-04-09#ixzz2yUpsOYTo
Subscribe at FiercePharma Manufacturing
The European Medicines Agency (EMA) said Wednesday in an emailed statement that "On 26 March 2014, Indian authorities withdrew the site's 'Written Confirmation,' effectively making the suspension of the exports official for the time being. The Written Confirmation is a document that accompanies all APIs exported to the EU (and elsewhere) to certify that relevant manufacturing standards have been met."
Read more: Indian authority withdraws Ranbaxy plant export permit - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/indian-authority-withdraws-ranbaxy-plant-export-permit/2014-04-09#ixzz2yUpsOYTo
Subscribe at FiercePharma Manufacturing
No comments:
Post a Comment