US FDA issues warning letter to Sun Pharma arm Caraco

Here is a verbatim transcript of Archi Damania's comments on CNBC-TV18. Also watch the accompanying video.

US FDA has now noted inefficiencies again this time. It is Sun Pharma's turn and it is on its US subsidiary Caraco. Caraco is about 76% of subsidiary of Sun Pharma on fully diluted basis. It had sales of about USD 108 million in US in Q1 and of that USD 108 million about USD 76 million came from 22 products alone but from this USD 76 million it is safe to assume that most of it would have come from its generic launch of Protonix and Ethyol of which Protonix is a much larger product.

So, basically Caraco is an important subsidiary for Sun Pharma; in fact Sun Pharma's management has clarified that there were dispensing errors at Caraco's site but no product from that particular batch has hit the market. In fact existing products, which are already sold from Caraco including Protonix and Ethyol, will continue to remain in the markets and they will continue selling it but US FDA will not approve any new Abbreviated New Drug Applications (ANDAs), which have been filed from Caraco. There are about 19 ANDAs, which are filed from Caraco as against Sun Pharma's total 96 ANDA filings.

So in that sense, it is important but one thing to note here is that unlike like Ranbaxy's case this is not a complete ban. The existing drugs can be sold into the market. The enquiry is mainly on the ANDAs, which are yet to be approved, and that US FDA may not approve them. In fact Caraco has responded to all the observations made in Form 483 and that Caraco will respond it to the additional clarifications asked by US FDA in about next 15 days.