CP Pharma under FDA lens, will reply in 3 weeks: Wockhardt Chief

In a blow to Wockhardt, the US FDA has issued a warning letter to company's US subsidiary CP Pharma.The regulator has issued 12 483 to CP Pharma which is a notice issued to communicate concerns discovered during inspection. The company will give its reply in the next 3 weeks, said company's Chairman Habil Khorakiwala.He also said that there was no product sale from CP Pharma to US market abd hence there is no impact on the business. There are other woes that the company is delaing with which include Morton Grove, Shendra, Chikalthana, Waluj plants.Khorakiwala said that US FDA observations on Morton Grove should be remedied in a few weeks. Remedial measures for Shendra, Chikalthana, Waluj plants are being worked on as well. The company has developed another plant to shift some product manufacturing. It is also in talks with third parties to manufacture products from Chikalthana, Waluj.The import alert still outstanding for Waluj and Chikalthana plants.Below is the verbatim transcript of Habil F Khorakiwala's interview to Latha Venkatesh, Sonia Shenoy and Ekta Batra on CNBC-TV18.Latha: Can you tell us exactly what the USFDA spoke about the CP Pharma unit?A: CP Pharma was expected sometime back and we had received 483. Out of that for about two of them they were not satisfied and given us a warning letter and we are yet to reply to them and correct the situation to meet their requirement. The second aspect is we have no product sale from CP Pharma to US. We are making one small product for third party. So from the business point of view, it does not have any impact whatsoever but we believe that this is something we should be able to deal with rather quickly.Sonia: When will you give that reply?A: We have to give within the prescribed time given by them. So we just received the letter and normally 15 working days are there. So in next three weeks, we will give our reply.Ekta: This is the second time that CP Pharma has received a warning letter from the US FDA and we understand it is for similar issues in the past which was highlighted in 2010 as well. Your response to that?A: I don’t think I will be able to respond to that at the moment but the issues that we have seen are something which we should be able to resolve very quickly and I don’t want to comment on the letter and the response because our experts are looking at it and they will be responding to that.Latha: So no impact at all on sales you say because CP Pharma was anyway not selling to the US?A: Yes.Latha: The previous observations at Morton Grove, are they resolved, have you got a clean chit?A: We have already complied with observation on 483 and whatever timeline we had given for completing some of the observation and they are all completed. So, we have been giving a progress report to FDA but the completion report we should be -- once that is finalised -- submitting them in next few weeks.Ekta: What is the status which Shendra, Waluj as well as Chikalthana when it comes to the USFDA?A: We had a meeting with USFDA and we have worked out very clearly, exactly what they expect from us. So, we have a new consultant now and with that we are working out remedial measure.Simultaneously, we have developed another plan to get some of these products manufactured by the third party where our CB-30 or other requirements are there. So, this plan is under afoot and probably by middle of next year we will have some of these products back in the market to be manufactured from the third party.Ekta: So, currently it is fair to assume that the import alert for Waluj and Chikalthana is still outstanding when it comes to the USFDA?A: That is correct.Ekta: Shendra you have replied with the nine observations that you had received in January 2016, you don't see an escalation of that?A: No, unless we inform the FDA that we are compliant with it, they will not come and visit again. So, when we are ready we will inform them.Ekta: So, this kind of meeting that you had with the USFDA is it fair to assume that it is a kind of contract that you have entered with the USFDA or a sort of consent decree to that effect?A: No, it is not a consent decree definitely but we have a mutual understanding with the FDA to do certain thing and we have more or less finalised that and we are in discussion with them.