Alkem Lab hits new high on USFDA clearance for Taloja facility

The stock was up 2% to Rs 1,625 on BSE, its highest level since listing in December last year.

Alkem Laboratories was up 2% to Rs 1,625 on BSE after the pharmaceutical company announced the successful US drug regulator inspection at its bioequivalence facility at Taloja, Maharashtra. The stock is trading at its highest level since listing in December last year.

“The United States Food and Drug Administration (USFDA) had conducted an inspection at bioequivalence facility at Taloja, Maharashtra from August 1, to August 10, 2016. At the end of the inspection, there were no 483s issued by the USFDA,” Alkem Laboratories said in a regulatory filing.

A Form 483 is issued for violations of current manufacturing practices which if unaddressed can lead to a warning letter or import alert by the regulator.