The U.S. drug regulator started reinspecting Sun Pharmaceutical Industries Ltd.’s facility in Halol, Gujarat, one of its biggest units that’s barred from new drug filings in the American market.
The inspection is likely to continue over the next seven to eight working days, people familiar with the matter told BloombergQuint requesting anonymity. The drugmaker had invited the U.S. Food and Drug Administration for the re-inspection after it received nine observations in July last year.
Sun Pharma gets about half of its revenue from the U.S. market. The Halol unit contributes a majority of its drug filings but is barred from selling new products in the U.S. following a 2015 warning letter. In December 2016, FDA inspectors found its testing programmes were inadequate and that the company didn’t report failed results and potential contamination issues on time. The company’s second-quarter profit more than halved after it lost exclusivity on a key U.S. product because U.S. sanctions hampered new launches from Halol.
Last year, Sun Pharma’s promoter Dilip Sanghvi had said that it is imperative for the company to bring Halol back in compliance as it had a bearing on pending approvals. “Unless there is no successful completion of the re-inspection, we will not get any approvals from this unit.”