Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An ac­tive phar­ma­ceu­ti­cal in­gre­di­ent site in In­dia has been hand­ed a warn­ing let­ter from the FDA, fol­low­ing an Au­gust 2021 in­spec­tion.

Au­ro­Life Phar­ma’s Hy­der­abad site, which is part of the Au­robindo group of com­pa­nies, was hand­ed the let­ter in No­vem­ber. It’s the lat­est in a string of man­u­fac­tur­ing woes the com­pa­ny has bat­tled as of late.

Unit 1 of its Hy­der­abad site was in­spect­ed, and re­ceived an of­fi­cial ac­tion ini­ti­at­ed no­tice from the FDA. “The com­pa­ny be­lieves that this will not im­pact the ex­ist­ing busi­ness from this fa­cil­i­ty,” it said in a fil­ing.

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