Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

In­di­an-based gener­ics man­u­fac­tur­er Au­robindo Phar­ma has been in the crosshairs of the FDA for sev­er­al years now, but the com­pa­ny is al­so at­tract­ing at­ten­tion from reg­u­la­tors with­in the sub­con­ti­nent.

Ac­cord­ing to the In­di­an busi­ness news site Busi­ness Stan­dard, a warn­ing let­ter was sent to the com­pa­ny from the Se­cu­ri­ties Ex­change Board of In­dia, or SE­BI.

The let­ter is re­lat­ed to dis­clo­sures made by the com­pa­ny on an on­go­ing FDA au­dit of the com­pa­ny’s Unit-1 API fa­cil­i­ty in Hy­der­abad, In­dia as well as ob­ser­va­tions made by the US reg­u­la­tor be­tween 2019 and 2022.

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