This import alert is a huge negative for Ranbaxy because this is relatively a new facility, which the company was betting on for growth going forward, says Sarabjit Kour Nangra of Angel Broking.
Given the previous instances of alert bans on Ranbaxy's other units, the latest import alert filed issued for Mohali unit is a huge setback for the pharma major believes Sarabjit Kour Nangra of Angel Broking.
"Mohali is a very important unit for the company given that most of the recent filings and specially after Dewas and Ponta Sahib have been under the trial for so many years,” she told CNBC-TV18 in an interview.
Below is the edited transcript of Nangra's interview to CNBC-TV18.
Q: First-to-file (FTF) launches for Ranbaxy was something expected in calendar year FY14 from Ranbaxy and now it will have to be pushed back?
A: Mohali is a very important unit for the company given that most of the recent filings and specially after Dewas and Ponta Sahib have been under the trial for so many years. New facilities like Ohm and Mohali had become the centre stage for Ranbaxy to file most of its filing in the US markets. So, it had become a kind of severe setback rather than a minor one because already the two facilities were under a kind of question mark and yet another major facility, which is a relatively new facility, is undergoing the scanner again.
It is a huge setback and the management itself had said that going in future in the next five years, they saw Ohm and Mohali contributing roughly around 75 percent of the US business.
This itself indicates that it could be a huge setback for the company. Yes, it is a huge negative specially when the company has already gone through a turmoil and its relatively new facility which promised growth for its company going forward is under scanner again.
Q: We have heard a lot of companies being targeted by the USFDA, a lot of probes coming in by the USFDA more recently. We also heard about Strides Arcolab this morning – what is your view as a whole in your interactions with any US FDA personnel or company as a whole?
A: Most of the Indian companies are grappling, finding it troublesome to figure out when things turn worse with USFDA. So, in a way it is difficult to pin point as to what are the reasons most of these companies are finding it difficult. Even though there is an initiative by most of the Indian companies to make sure it manages or it complies with the USFDA issues they find it a bit heavier on their part to get it done correctly most of the time, so that is what our interaction with most of the companies have indicated that though they are trying they know that they are lagging somewhere.