USFDA Proscribed Two Indian Manufacturing Units on GMP violations
The succession of banning imports on Indian Manufacturing Units is not desisting.
The USFDA has served import alerts to Canadian Drug CompanyApotex Research’s manufacturing facility in Bangalore and manufacturing unit of Indian firm Micro Labs in Goa and this is their second facility banned by USFDA.
Moreover, Sun pharma is relaxed as USFDA has issued Form 483 seeking corrective actions with no import ban.
ApotexPharmachem, the other unit of Apotex in Bangalore was prohibited by USFDA in April 2014, where the USFDA had said the company reported deceitful data for years. Micro Labs manufacturing unit in Bangalore was earlier banned in Aug 2013.
The details on the warning letters given to these two companies for the latest import ban have yet not being released by the USFDA
These import alerts bring the limelight back on the issues of data integrity at Indian manufacturing units and adds to the growing list of facilities being pulled up for these lapses.
Since 2013 USFDA has banned 27 Indian units for violations. This year till now, USFDA has already cracked down on 7 manufacturing units, the big name in the list being Sun Pharma ’s Kharkadi plant in Gujarat..