Making Ranbaxy units cGMP complaint time consuming: Sun Pharma

PTI New Delhi | Updated on January 17, 2018 Published on August 21, 2016

Sun Pharma Managing Director Dilip Shanghvi. File Photo   -  BusinessLine

The company expects to complete the re-mediation steps in at least one of these facilities in this fiscal

Sun Pharma sees re-mediation process at erstwhile Ranbaxy facilities as a “time consuming” process even as it aims to bring at least one of the plants to conform to current good manufacturing practice regulations (cGMP) in the current fiscal.

In the company’s Annual Report for 2015-16, Sun Pharma Managing Director Dilip Shanghvi also remained bullish on generating targeted synergies of USD 300 million by next fiscal on account of its integration with Ranbaxy Laboratories.

“We are gradually progressing on the remediation process at the erstwhile Ranbaxy facilities, which were found to be non-compliant in the past. While significant efforts to make these facilities compliant are on, this will be a time-consuming process,” Shanghvi said.

The company expects to complete the re-mediation steps in at least one of these facilities in this fiscal, he added.

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.

In April 2014, Sun Pharma had announced the acquisition of the troubled rival Ranbaxy in an all-stock transaction worth USD 4 billion. “The implementation of the integration with Ranbaxy is well on its way, and we are on track to generate targeted synergies of USD 300 million by 2017-18,” Shangvi said.

He further said, “The combined organisation will benefit from substantial synergies that lie in our technologies, combined pipeline and R&D expertise, wider product portfolio and rationalisation of manufacturing footprint, driven by our larger talent pool.”

On company’s Halol plant, which is under the USFDA scanner for violations of cGMP, Shanghvi said the company faced anticipated supply constraints and delays in product approvals driven by the cGMP compliance re-mediation efforts. “This impacted our US revenues for the year. We expect to eventually resolve this in future. However, this did not deter us from continuing to invest heavily in building the speciality business in the US,” he said.

The drug major continues to invest significant time and resources in ensuring that it remains committed to 24x7 cGMP compliance, Shanghvi said. “Over the past year, our cGMP capabilities have been strengthened significantly. Talent with long-standing global expertise has enhanced our abilities in this pertinent area.

We are also targeting appropriate technology-based solutions to facilitate cGMP compliance, coupled with an increased focus on requisite manpower training,” he added.

On business outlook for the current fiscal, Shanghvi said, “The transformation to a better, stronger and faster company will involve crossing critical milestones over the next few years. As we transition, we have guided for our overall consolidated revenues to grow by 8-10 per cent for this fiscal.”

Published on August 21, 2016

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