Caplin Point Laboratories Limited CC-Mar24.pdf · 2024-05-16
Yes. So, our last FDA inspection for the injectable plant was last year. And obviously, there is no set period for when the FDA would conduct the inspections. For example, if you look at the EU, it's once in three years, if you look at INVlMA it’s once in three years. But whereas when it comes to the U.S., it is very much up to their own evaluation of when the facility needs to be audited. But we are always following the policy of “being anytime ready”. So, a state of compliance throughout, a state of good manufacturing practices throughout is what is needed. And when it comes to the softgel plant, we have just completed the INVlMA inspection, and we are not looking for U.S. FDA for this site. We are focused on Latin America much more from this place. And the question that you were asking in terms of 25 soft gel, that would be from this plant into Mexico. But that will happen over a period of time, like Chairman said, it will happen over the next two years.
Tushar, when it comes to OPEX, we are probably looking at, after the injectable one is also done, we are probably looking at around Rs. 1 crore to Rs. 2 crores maximum at the initial period per month.