For past many months there has been issues related GMP production whether it’s Roche, Sanofi and Hospira and the issue was cGMP compliance in manufacturing. For Roche the issue was API production in their API manufacturing in North carolina, US and later Sanofi with their TB drug production in Canada. Why is that developed nations facing the CGMP issues as their regulatory bodies are the most stringent ones in the world?What should be the next steps for this company, third party manufacturing of active API's and products ?