New product manufacturing

(Arvind) #1

If a company(API) already having the drug license for beta lactam and planning for new product which is not a beta lactam. How to proceed with regularity authority in India. We have to produced it in our same facility and sell it out in India only.

(vijay kumar) #2

According to my knowledge beta lactome manufacturing company or plant…
It will not allowed the any other products.regulatory body will not also accept due to cross contamination

(Arvind) #3

thanks vijay ji