Sun says 'time consuming' remediation paying off

Sun Pharma continues to slog away at its remediation efforts at both its key plant in Halol as well at the four plants it got in its $4 billion buyout of Ranbaxy Laboratories that are banned by the FDA from shipping to the U.S. But Sun Managing Director Dilip Shanghvi says progress is being made on both fronts.

The update was made in the recently filed 2015-2016 annual report from Sun, in which the company said that the Halol facility “underwent a very significant remediation effort in FY16” which has undercut the drugmakers' supplies to the U.S., and so its sales there have suffered. But Sun said it had planned to ask the FDA this summer to reinspect the plant. The company believes that the situation will get better when the entire remediation process is complete and the facility recertified by the FDA.

“Our business in India and the world continues to strengthen, despite challenges; and FY16 was a year of consolidation for us," Shanghvi said in the annual report. "The implementation of the integration with Ranbaxy is well on its way, and we are on track to generate targeted synergies of US$ 300 million by FY18. We are committed to our mandate of providing high-quality and affordable medicines, trusted by customers and patients worldwide.”

As for the Ranbaxy plants that have been affected by FDA bans and warning letters for years because of multiple problems, the company said the “time-consuming process” continues and it expects to wrap up the remediation in at least one of them this fiscal year.

The Ranbaxy plant problems have been costly to Sun in a variety of ways. Bans at two plants in 2014 and 2015 blocked Sun from getting some valuable first-to-file generic drugs to market. The other two plants have been excluded from the U.S. market for more than 6 years. All four plants operate under consent decree overseen by the FDA.

Without giving details, the company said it was working to on its GMP compliance by both installing new technology as well as working on training for its workers.

Sun’s sales in the U.S. have improved despite all of the plant problems that have interrupted shipments of some products. Earlier this month, the company reported that for the first quarter of fiscal 2017, U.S. finished dosage sales grew 25% to $609 million. That was primarily because of the 180-day exclusive it has on sales of its generic version of Novartis ($NVS) chemo drug Gleevec, which generated $4.65 billion for the Swiss drugmaker last year.

- here’s the Sun Pharma annual report

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