europe within 10 weeks, page-3

Hey Fly, hope all is well. It was my understanding that Dr Reddy’s had said in the past that approval time for generic drugs in Europe varies from 12-24 months. After approval, each product needs to clear national phase involving pricing, and other country specific requirements. Timeline for the national approval varies from 2-9 months. Regulatory strategy behind product would play a key role for approval times, from my understanding.