Important to re-establish trust between Ranbaxy and USFDA: Sun Pharma

Says it will focus on one plant at a time as it looks to make four manufacturing units of Ranbaxy compliant with laid out norms

Sun Pharma will focus on one plant at a time as it looks to make four manufacturing units of Ranbaxy, which have been banned by the US health regulator from exporting drugs to the US, compliant with laid out norms.

The Mumbai-based drug major, which acquired Ranbaxy in a $4 billion deal, feels it is important for the merged entity to "re-establish" the trust between Ranbaxy and the US Food and Drug Administration (USFDA).

"Clearly, we will focus our energies on one plant with a view to bring it back to compliance rather then focusing on all the plants in which the whole process would get significantly delayed," Sun Pharma managing director Dilip Shanghvi said in an analyst call.

Currently, all the four manufacturing facilities of Ranbaxy — Mohali and Toansa in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh — have been banned by the USFDA from export of drugs to the US market.

While Paonta Sahib and Dewas facilities have been under US import alert since 2008, the US health regulator has since banned the other two plants at Toansa and Mohali as well.

On re-establishing trust between Ranbaxy and the USFDA, Shanghvi said: "It is important for us to convince, emphasise with the (US) FDA that the trust which was broken between Ranbaxy and FDA, we have to find a way to re-establish that level of trust."

Almost a year after announcing a $4 billion deal, Sun Pharma completed the merger of Ranbaxy with itself in March this year.

In April 2014, Sun Pharma had announced the acquisition of troubled rival Ranbaxy in an all-stock transaction worth $4 billion that includes $800 million debt.

Company is also in the process of implementing corrective steps at Halol facility in Gujarat.

"We continue to implement corrective steps and upgrade our facilities to address the observations indicated by the USFDA during their inspection in September 2014," he said referring to the Halol plant.

"We continue to update FDA what progress we are making," he added.

Shanghvi said supplies from the Halol plant have not yet fully normalised due to some of the remedial steps being taken by the company at the site. "Some of the remedial steps have temporarily impacted our supplies in third quarter. Supplies have not fully normalised and will take some more time to reach optimum levels. We remain committed to achieving 100 per cent compliance," he added.