Biosim­i­lar gi­ant Bio­con gets hit with 483 for is­sues at sites in Malaysia and In­dia

While Bio­con con­tin­ues to be one of the ma­jor play­ers in the gener­ics and biosim­i­lars mar­kets, sev­er­al of the com­pa­ny’s man­u­fac­tur­ing sites have end­ed up on the FDA’s radar.

In a let­ter sub­mit­ted to the stock ex­change of In­dia, Bio­con stat­ed that the FDA in­spect­ed three man­u­fac­tur­ing fa­cil­i­ties in the city of Ben­galu­ru, In­dia, and Jo­hor, Malaysia. Ac­cord­ing to the let­ter, the in­spec­tions start­ed with the Ben­galu­ru site on Aug. 11 and con­clud­ed in Malaysia on Aug. 31.

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