The Hindu Business Line

USFDA com­pletes in­spec­tion at Natco’s API fa­cil­ity

- U.S. Food and Drug Administration · United States of America · Hyderabad · The American Petroleum Institute

Natco Pharma Ltd has an­nounced the com­ple­tion of a reg­u­la­tory in­spec­tion from the United States Food and Drug Ad­min­is­tra­tion (USFDA) for its Ac­tive Phar­ma­ceu­ti­cal In­gre­di­ent (API) fa­cil­ity in Mek­aguda Vil­lage near Hy­der­abad.

The in­spec­tion was con­ducted dur­ing Au­gust 5-9, and the fa­cil­ity re­ceived six ob­ser­va­tions mostly pro­ce­dural in nature, the com­pany said. It be­lieves that none of ob­ser­va­tions are re­lated to data integrity and that all the ob­ser­va­tions can be ad­dressed within a short pe­riod of time.

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