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Focus on one Ranbaxy plant at a time for USFDA nod: Sun Pharma

After four manufacturing units of Ranbaxy have been banned from exporting medicine to the US, its parent company Sun Pharma now wants top secure the clearance in my one

business Updated: Jun 07, 2015 18:46 IST
Sun Pharma,Ranbaxy,US FDA

Sun Pharma will focus on making the four manufacturing units of Ranbaxy compliant with the laid out norms one by one, after the company had been banned by the US health regulator from exporting drugs to the US.

The Mumbai-based Sun Pharma, 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 exporting 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 an year after announcing the $4 billion deal, Sun Pharma completed the merger of Ranbaxy in March 2015.

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

Shanghvi said the company is also in the process of implementing corrective steps at its 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 been fully normalised owing to some on-going remedial steps 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.

First Published: Jun 07, 2015 17:59 IST