Analysts Cut Sun Forecasts After New Halol Site Faults
Analysts are cutting back profit forecasts for Indian generic giant Sun Pharma after the US FDA detailed a host of new testing and quality control issues at the company’s key Halol factory.
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The US FDA has flagged more issues at Indian firm Sun Pharma’s largest manufacturing plant in Halol but analysts are hoping the infractions are minor and that the Indian facility will get the regulatory green light soon, ending a blacklist on the factory supplying new products to the US.
A US FDA ban on Sun Pharma’s Mohali site, a legacy Ranbaxy facility, is set to be lifted, marking a significant uptick in Sun’s compliance efforts and raising hopes of momentum at the Indian firm’s other tainted facilities.
Against a backdrop of heightened regulatory scrutiny of manufacturing sites and processes, the heads of five top Indian firms told a recent forum in Mumbai how they are “rebooting” quality compliance and culture within their organizations. Tangible and intangible results are beginning to show but there is a long road ahead.