The U.S. drug regulator has issued a Form-483 observation letter with nine observations after inspecting Sun Pharmaceutical Ltd.'s Halol facility between November 17 and December 1, the company said in a stock exchange filing.
None of these ‘inspectional observations' were repeat ones, the pharmaceutical company added. Shares rose nearly 2 percent following the announcement.
The U.S. Food and Drug Administration (U.S. FDA) issues a Form 483 if its investigators spot any conditions that in their judgment may constitute violations of the U.S. Food Drug and Cosmetic (FD&C) Act and related Acts.
The company is preparing its responses to the observations, which will be submitted to the U.S. FDA within 15 business days of receipt of the Form-483.
The company intends to implement promptly any corrective actions and improvements that may be necessary as a result of the observations and to continue to work cooperatively with U.S. FDA.Sun Pharmaceuticals' stock exchange filing
The company's stock price rallied over 1.7 percent to Rs 675.1 per scrip on the BSE following the announcement.
Read: Sun Pharma Halol Plant Review Resulted in 14-Page FDA Report
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