Unichem Says U.S. FDA Issued Zero Observations For Its Roha Facility In Maharashtra
The U.S. FDA conducted inspection at Unichem Laboratories’ APl manufacturing unit at Roha, Maharashtra, from Feb.17-21, 2020.
United States Food and Drug Administration has completed inspection of Unichem Laboratories Ltd.’s facility in Roha, Maharashtra, with zero observations, the Indian drugmaker said on Monday.
The US FDA conducted inspection at the company's APl manufacturing unit at Roha from Feb.17-21, 2020, Unichem said in a filing to the Bombay Stock Exchange. "The inspection was a routine cGMP surveillance and successfully concluded without any FDA form 483 issued," it added.
The U.S. FDA issues Form 483 to a firm’s facility if it is found in violation of the U.S Food Drug and Cosmetics Act and related legislation, upon completion of an inspection.
On Monday, Unichem shares rose 7.82 percent to Rs 147.60 apiece on the NSE while the benchmark Nifty 50 fell 2.01 percent to end the day at 11,838.60 points.